Patient presentation after treatment with bimekizumab demonstrating marked improvement, with resolution of erythematous plaques and scaling across previously affected areas

Patient presentation before treatment with bimekizumab, with patient demonstrating extensive psoriasis, including severe erythematous plaques with scaling across multiple body areas

Case author Danna Calder, MMSc, PA-C presents a case of a 34-year-old male with severe, recalcitrant psoriasis achieving remarkable improvement after decades of treatment challenges.

A Remarkable Result after a Lifetime of Disappointment in the Treatment of Severe, Recalcitrant Psoriasis 

Figure 3. The patient as seen in May 2023 at 12-week follow-up after starting tapinarof 1% cream (PGA 0,1; NRS-I 0,1)

Figure 4. The patient as seen in February 2024

Figure 1. The patient as seen in November 2019, with the left olecranon region displaying redness, thickening, and significant itch

Figure 2. The patient as seen in February 2023 with worsening symptoms after limited response to multiple therapies

Case author Brad Glick, DO, MPH, FAAD, presents the case of a 57-year-old female with worsening plaque psoriasis of the elbow who experienced limited responses to multiple therapies.

Tapinarof 1% Cream Effectively Clears Plaques of the Boney Prominences

Patient at 2-week follow-up with a BSA score of 3% and achievement of PASI 90

Patient at 16-week follow-up and achievement of PASI 100

Patient at baseline with a BSA score of 11% and PASI 17.4

Ron Vender, MD, FRCPC, presents the case of a 31-year-old male with an 8-year history of severe psoriasis who was frustrated with the lack of effective treatment options.

Rapid and sustained clearance of severe psoriasis with dual inhibition of IL-17A and IL-17F

DermInsider - VGR Session 2

Recognize the importance of timely access to biologic therapy to optimize psoriasis outcomes, especially among Medicare patients 

Discuss emerging data for biologic therapies for the treatment of psoriasis 

Identify strategies to increase timely access to biologic therapy for patients with psoriasis covered through Medicare

Mastering Psoriasis Management With Medicare

DermInsider - A Virtual Grand Rounds Series - Session 2: Mastering Psoriasis Management With Medicare

Review the immunopathologic mechanism of psoriatic disease and associated comorbidities 

List key therapies to manage psoriatic disease and associated comorbidities

Select optimal therapies for psoriasis patients based on demographics, comorbidities, and medical history

Describe effective strategies for multidisciplinary care of patients with psoriasis and related co-morbidities

FC24: The Comorbidities of Psoriasis: What Clinicians Need to Know to Optimize Care: An Online Activity

List the barriers of early diagnosis of psoriasis in skin of color and how to overcome them

Describe strategies for multidisciplinary collaboration to more promptly diagnose psoriatic disease in patients with skin of color

Review the role of systemic therapies for the management of psoriatic disease in skin of color patients

FC24: Practical Insights and Pitfalls for Psoriatic Disease in Skin of Color: Early Diagnosis for Effective Treatment: An Online Activity

Define the impact of palmoplantar pustulosis on patient quality of life (QoL) 

Describe strategies for effectively diagnosing palmoplantar pustulosis 

Review the latest clinical data pertaining to emerging therapeutics for palmoplantar pustulosis 

FC24: Palmoplantar Pustulosis: Looking Ahead to New Treatment Options: An Online Activity

CMEswiper: Swiping Away Comorbidities Through the Lens of Psoriatic Disease: An Online Activity

Identify non-steroidal topical agents for the treatment of atopic dermatitis and psoriasis

Discuss strategies to individualize care with topical non-steroidal therapies for the management of atopic dermatitis and psoriasis

Non-Steroidal Topical Therapies in Psoriasis and Atopic Dermatitis: The Paradigm Shift: Online CME Activity 

Overview the key data on the IL-17 and IL-23 classes of biologics 

Compare and contrast IL-17 and IL-23 biologic therapies based on clinical trial and real-world data

Categorize which biologic agents may be more appropriate for specific patient populations based on demographics, co-morbidities and medical history 

IL-17 vs. IL-23 Inhibitors for Psoriasis: The Great Debate

Highlight the key different clinical presentations of plaque psoriasis in skin of color (SOC) 

Review the unique treatment goals in patients with SOC that have psoriasis 

Classify the role of novel targeted agents for the management of plaque psoriasis in SOC

The Many Shades of Plaque Psoriasis: Considerations for Treating Skin of Color

Differentiate between the IL-17 inhibitors and IL-23 inhibitors for the management of chronic inflammatory dermatologic disorders such as psoriasis, psoriatic arthritis, and hidradenitis suppurativa

Overview the role of IL-17 inhibitors for the management of psoriasis, psoriatic arthritis, and hidradenitis suppurativa

Describe how to manage patients with IL-17 inhibitors over the continuum of care with particular attention to the ease of dealing with side effects

Tips in the Use of IL-17 Inhibitors in Dermatology

Now, we're going to go into our next session where we're going to learn about tips on the use of IL 17 inhibitors in dermatology. And who better to do this than two of my dear and esteemed colleagues, Dr. Bruce Strover and Dr. Joseph Morola. And with that, I won't take any more of their time. All right, folks, we are so excited to be with you. We packed a little more than we probably should have into this session, so Bruce and I are going to be doing lightning round here. Bear with us if we go quickly, but the tips are going to be coming fast and furious. This is us. I think we had an intro. I'm Joe Morola. I'm a dermatologist and rheumatologist. And as of Monday, in fact, big change for me. I went from Boston to Dallas. I'm thrilled to be the chair at UT southwestern as of Monday, happy to meet with any Dallas folks. Give me some tips later. And Bruce. Bruce Strober. And if you liked Mona, you'll like me, because we practice in the same practice and nothing more. Connecticut. That's it. Yeah, I can't tell them apart with that. I'm going to turn it over to my colleague and we will go from there. Right. Well, I like to say if you utilize IL 17 inhibitors, you're really covering most of the relevant bases when it comes to treating patients with psoriatic disease. Disease. And that's because, as you can see in this slide, the IL 17 isoforms and they combine up with each other in various combinations, mediate inflammation, not only in the skin, but also in the bones and joints and the ligaments. And this also can be either part of the adaptive immunity or the innate immunity. So blocking IL 17 is going to be very fruitful across various disease states and actually subsets within those disease states, too. That's an important point. Aspects of those diseases that need to be controlled differentially. So for psoriasis, we now have four IL 17 inhibitor pathway inhibitors. Secukinumab, ixicismab being IL 17 a blockers, rodalumab being receptor for il 17 blocker. And bimikizumab, just approved on Tuesday of this week, is an IL 17 a and f blocker. And I'm not going to go through the dosing. You can look it up. Bimikismab, actually, uniquely of this class of drugs, actually has tailored dosing based on weight. So patients weighing more than 120 kg get more frequent injections in the maintenance phase. I ask you to look that up now. All of these drugs have the feature of being rapid with regard to achievements of posey 75 and 9100. Ultimately, if you go out to a year, roughly eight out of ten patients have a posey 75. Seven out of ten have a posey 90, and a half of the patients have a posey 100. So deep responses, rapid responses, if you remember anything about these drugs, deep and rapid and long term response, too. A unique aspect of the study program for ixicismab was the evaluation of efficacy in genital psoriasis, the achievement of PGA zero or zero one. Three out of four patients with genital psoriasis get a genital PGA of zero. One half of them, approximately get a full clearance. So a unique study and definitely a specific use in a special area. I like to always call out one of the safety features of IL 17 inhibitors. There's really no malignancy signal at all. And you can see that's kind of a flat line. And more importantly, I use IL 17 inhibitors in patients with a history of malignancy, where you're really backed into a corner and you have a patient with severe psoriasis and in any really stage of their malignancies. I've been using erythrodermic patients with active lung cancer, really changing the lives. So think about these drugs with a history of malignancy. I really advocate it. And so the oncologists actually approve of this as well. Palmoplanner psoriasis. This is just an example of how sacukinumab achieves PGA one. You certainly could get this level of efficacy with all of the IL 17 inhibitors in palma planner. And just extending that, the ability to use an IL 17 inhibitor, brodaliumab, that's the receptor blocker for patients who have failed other classes. And even within the class, you can get rescue, so to speak, with brodaliumab. So don't forget about brodymab, because it may work. When, for example, an IL 23 doesn't work or a TNF doesn't work. And these data show it clearly how they can achieve PoSI 90 and posey 100. Half of the patients, for the most part or better, maybe two thirds get to posey 100, even though they failed a prior drug, palm implant or postular psoriasis. This was done in Japan. But if you really want to tackle one of the toughest aspects of psoriasis, postural psoriasis of the palms and soles, think about an IL 17 inhibitor. This is brodaliumab. Probably does it as well or better than the others in the class. But I don't know how bimikismab will function, but I actually predict it'll be like this as well, given its broader approach to IL 17 inhibition. And this is bimikizumab's data. Just so you know, it really has remarkably effective ability to achieve Posey 90. There's nine out of ten patients get to posey 90, and they get there very rapidly. So this might be the most rapid and deepest response we've ever seen in a biologic. And notice, they keep that response out a year. And the posey 100 response rates in bimikizumab are in about two thirds of the patients. Two thirds of the patients get Posey 101. Issue you should be aware of with bibikizumab is about 10% to 15% have oral candidiasis. So you'll have to be familiar with treatment of that issue. Usually very mild and treatable. But you should be aware that some patients might have that occurred during the course of treatment. And then there's nail psoriasis. I always say this, I'm a broken record, but if you really want to normalize nails, use an IL 17 inhibitor. These are the data of a head to head between bimikizumab and secukinumab. The ability to clear nails, fully napsy zero at 48 weeks, and you can see 80% of the bimikismab patients have clear nails. That's superlatively good data. But notice the comparator secukinumab. It's in the 60% to 70% range. So both drugs are really good. It takes a while, of course, to normalize a nail, but definitely can impart to patients who have psoriasis with nail disease or simply nail disease alone that they could use a 17 inhibitor and get there over the course of a year. So my psoriasis summary is rapidly acting. High efficacy, effective when other drugs fail. Ideal for nails. And I didn't say scalp, but scalp rates go with il 70 inhibits for scalp psoriasis, really high success rate. Genital palm oplanner. It's worth trying. Top line efficacy for psoriatic arthritis, and that's going to be covered by Joe in just a second. And then actually, don't forget about this one. Great choice for patients with a history of malignancy. It's the most common question I get, and I always say, try an il 17 inhibitor in these patients and you'll have a high rate of success and not create a risk of recurrence more than the baseline for that particular patient. All right, so we're going to move forward to Joe. He's going to talk about psoriatic arthritis. All right, thanks, Bruce. Great tips. We're going to move as quickly as possible. Again, we're watching the clock against us up here. We covered psoriasis. I'll do PSA. We have a little bit on HS, and then we'll sort of wrap up for you. So what about IL 17 in psoriatic arthritis? And I'll say two things to sort of bookend this. On the one hand, really, in the current era for putting my rheumatology hat on, TNF inhibition has been king for a very long time among rheumatologists and psoriatic arthritis. And really, IL 17 has proven itself first line therapy in PSA. And I'll show you why. Similar to what Bruce showed, we have secinumab, ixicasumab approved in the US for psoriatic arthritis. Brodiamab, the receptor blocker approved in Japan for psoriatic arthritis. So we do have some data to look at. And bimicasumab, quite exciting, particularly at this meeting, as you mentioned. Now, approved for psoriasis, not yet for psoriatic arthritis in the US, but it is approved for psoriach arthritis outside the US. And so we have data there to look at as well. So when we think about. People ask me all the time, well, how do you decide in this huge landscape of options for csoric arthritis? If you want to know, you're checking all the boxes here. I'm going to focus. This is my cheat sheet for psoriatic disease treatment by mechanisms in the interest of time, just to focus on the mechanism here of IL 17. What you see is we check all the boxes for psoriatic disease, peripheral arthritis, skin and nail disease, some of the most robust skin and nail disease data that we just saw from Bruce a moment ago, axial disease. And this is not a minor point, jackalitis and endocitis. The highlights I have here are two other points for you, really. It distinguishes itself from other mechanisms. In that coverage of axial disease, we have only TNF inhibitors, IL 17 and jack inhibitors in that space. And also this differentiation point of inhibition of radiographic progression, meaning we know that we are getting an insurance policy for protecting joints and eroding joints with those studies. We have that only for TNF, IL 17, Jack so really have become mainstay for me. IL 17 has really moved to the forefront of first line therapy for psoriatic arthritis. And we don't have nearly the amount of head to head data in rheumatology that we have in dermatology in the psoriatic disease space. Again, TNF has been king. I would argue that TNF has been dethroned as king by IL 17. I think increasingly so by my rheumatology colleagues. And let me show you some of that data. So one key element is the spirit head to head data. This was a look at ixicasumab versus adlimumumab. Right. IL 17 a versus TNF inhibition. What's the take home message? Two points. Number one, that ixicasumab did as well as our gold standard tnf inhibitor across all the metrics in psoriatic arthritis, but did better and was superior to tnf in skin clearance. I think we've seen that repeatedly. The second study similar to that was the exceed study looking at sekicinumab versus adolemab. Same two take home points as good as gold standard TNF in joint outcomes, better skin efficacy. So, bimicationab, we have to talk about. Right, super hot topic, particularly at this meeting, and this is the be complete study. So what you see on the left hand side is the ACR 50. You may be used to looking at ACR 20 data, which is the usual regulatory primary endpoint for psoriatic arthritis. Here we see ACR 50, which is arguably a more clinically meaningful endpoint, higher bar. And we see an impressive 40% ACR 50 with IL 17 AF inhibition in this population. That is tnf inadequate response. So really important. And it's important for us to see that. Right, Bruce, given the current state of where a lot of patients will be coming from in their therapy, heading towards potentially a drug like bimbakizumab in the current era. And Bruce array touched on the robust skin efficacy that was seen as well in the psoriatic arthritis programs here with bimakizumab. Be complete. And I want to point these out to you as well if you want the next level version of the data. I'm a big fan of this MDA measure, minimal disease activity. It's just a low disease activity state, and it really speaks deeply to both the breadth and depth of efficacy in psoriatic arthritis because it covers all the domains of disease and psoriatic arthritis, and it's a low disease activity metric. So it's really very robust, very meaningful to patients. What you see here is some of the highest MDA data that we've seen to date, over 40% meeting that bar as early as week 16. So it's a metric I really like to look at. When I'm looking at drugs for psoriatic arthritis, who are the patients that I think about? So these are two real brief cases recently that I utilized Nile 17 inhibition. In the first one, a 45 year old woman with psoriasis cerric arthritis referred by a rheumatologist to our combined skin clinic in Boston for residual skin disease despite well controlled joints on a limumab. This was a clear patient for an IL 17 inhibitor and a 30 year old man with a history of psorias circulis who had back pain symptoms. We worked it up, had normal x rays, but was B 27 positive. Subsequently had an MRI with sacralitis. The point of this is whether or not you did that workup. This is a patient very much facing an IL 17 because of those back symptoms in the context of psoriasis, psoriarthritis. So my tips IL 17 A has shown efficacy as high as our gold standard PNF inhibitor data in psoriatic arthritis with better skin outcomes. So for me, this is a no brainer first line, putting the rheumatology hat on. I do avoid this when the patient has a personal history of IBD in favor of some of our other agents. However, I will say similar to MS and PNF and others, if they have a first degree relative with IBD, I'm not worried. Inhibition of radiographic progression is a major checkbox for me. And axial disease considerations. Major checkbox distinguishing from other agents in psoriatic arthritis. I'll turn it to Bruce, so we'll wrap up with an HS discussion. Basically, if you block IL 17, you can treat HS. It's going to come down to the potency and the isoforms you hit. These are data from the secukinumab clinical trials for HS. And basically, you see that it beats a placebo and two different studies that beats a placebo. So therefore, you're going to have the ability to use secukinumab dosing yet to be determined when the approval comes out. And in general, dosing for all drugs for HS, as you know, is greater and maybe more frequent. But look for secukinimab for the treatment of HS. This is bimikizumab. We just talked about that. For PSA and psoriasis, IL 17 af blocker. What I would see is even better data. These are high score 75, achievement rates, high score 75. And that's a higher bar. And you're seeing 40% of patients getting to that when on bimikizumab, regardless of the study you look at. So this might be next level bimikizumab. And then finally a drug I would doubt any of you have likely heard a lot about. But it's sonalocumab, which is a nano body, a smaller biologic molecule that blocks ANF as well, like bimikizumab. And recently they portrayed their data at the EADV just last week, and maybe even a little better than bimikismab. It's hard to say because they're different studies, but 43 versus 14% placebo at the high score 75 metric. So here we have two different AF blockers, which are going to be really extremely good, not only treating the inflammatory component of HS, but also the draining tunnels. So if you can cover all the bases with HS with one drug, you're going to really make a difference for patients. Huge unmet need. And FYI, just the enormous pipeline of drugs being developed for HS across the moas we have. So look for a lot of activity in the next five years. So tips for HS and IL 17 variable but convincing efficacy. I'm going to say I think the bimikismab sonolocumab data af blockade is a little better than the a blockade. I think you got to touch f to get even better efficacy for HS safety comparable to that seen in psoriasis. There is candidiasis variably again, across the agents. Bimikismab has higher candidiasis rates, ten to 15% depending on the study you look at. And this is the next frontier for HS beyond TnF inhibition, which makes me wonder, are you going to need to fail a TnF blocker before you get to an Il 17? And how will a patient do who fails a TNF who has moved to an IL 17? Those are interesting questions to answer with future studies. Just to review, some of the AES we can commonly see in patients on IL 17 inhibition, nasopharyngitis, URis, headaches, tinia Canada. All right, tinia in Canada would be. I would warn patients about there's no evidence of tb risk with IL 17, though we have to get quantifier on golds before we start these drugs. And I talked about no evidence of malignancy. There's the Canada risks. Depending on drug, you have higher risk. Bimikizumab topping that rare instances of IBD. I don't like IBD being portrayed as a common issue with IL 17. We've seen that. I don't think that's the issue. It's a rare issue. It's about a one in 500 to one in thousand rate in all the studies. And then Bridalumab has a REMS program for suicidal ideation behavior, but I think it's very soft. I think the whole issue of suicidal ideation behavior with IL 17 blockers is questionable. I'm just going to say in my opinion. I'll be happy to second that. Yeah, and then you're going to see warnings variably in various drug labels, not all of them for that issue, as well as a liver precaution in patients getting bimikismab, which I also think is very soft. I'm not going to file a liver function test based on my knowledge of the data. So while there might be language in the label, you have to sort of gauge it in the context of the true data and not necessarily what is stated. Thank you for your attention. I hope you found the tips and tricks in this section helpful. I would like to remind you just to again bookend our comments that this was the best session that you saw today. Thank you all so much for your attention. And we'll take questions in the back. We can hang around. Thank you so much.

Explain the role of the IL-17 pathway in the pathophysiology of chronic inflammatory dermatologic disorders

Review data for IL-17 inhibitors for the management of inflammatory dermatologic disorders

Discuss strategies to educate patients about IL-17 inhibitors and incorporate these agents into clinical care

2023 Virtual Grand Rounds Session 11: September 13, 2023 - The Role of the IL17 Inhibitors in Targeted Management of Inflammatory Dermatologic Disorders

Therapeutic Hotline: Expert Perspectives on IL17 Inhibitors in Targeted Management of Inflammatory Skin Disorders

Hi, I'm Mark Lebwall, and I am pleased to be giving this talk on the therapeutic hotline on IL 17 inhibitors. This session is supported by an educational grant from UCB. I am the dean for clinical therapeutics at Mount Sinai in New York City, have been chairman of the Department of Dermatology for the 25 years before that, and I'm very pleased to be doing this talk with my friend Ron vendor. Ron, please introduce yourself. I am Ron vendor from Canada. I am part of McMaster University here in Hamilton, the home of evidence based medicine. And this program is approved for one quarter point 25 AMA CME credits. So, Ron, let's start out and tell us what's new in IL 17 inhibition. What are the new developments? Well, we've had three very stable anti IL 17s on the market for quite some time, sachicinumab, ixicizumab, and brodalumab. And the newest, antiil 17 is vimicizumab. That was approved about 18 months ago in Canada and Australia around the same time, February of 2022. And this is a different anti il 17. It affects the a and AF as well as the f part. And this allows a different type of efficacy, as well as an extended type of frequency in terms of injection. So instead of the usual frequent every two to four week injection of the other anti Il seventeen s, the mechizumab allows every four to every eight weeks. Yeah. Interesting. We've always known il 17 a is important because secuchinumab works so well and ixicizumab works so well, and 17 a clearly plays a major role. But it turns out 17 f is more prevalent in the skin of psoriatics, and that may explain why blocking the two together gives an added benefit. One of the things that we know about il 17 blockade is that these are the fastest drugs we have, and we've actually published data on this, where the three fastest drugs, until bimikizumab came out, were indeed bridalumab, ixicizumab, and sechiniumab, in that order, very fast, all three of them. And now, of course, we have this data on bimicizumab, which shows that at week four, over 75% achieved passy 75. So a very fast therapeutic outcome. What about the degree of efficacy, Ron? Well, at the Pasi 100, which is our target that we're trying to get to all the time, by week 16, we're seeing the majority of patients, almost 60%, are Pazi 100. Now, when we have the ixicizumab and psychicinumab and verdeliumab. And we look at them all at four weeks. It's hard to clinically tell the difference at that point. But by week 16, when you're having 58% with bimikizumab that are Pazi 100, that's extremely impressive. Ron, now that you have experience with bimikizumab in the real world, what can you tell us about the fungal infections which we know were reported in the clinical trials? Well, the good news is that my real world evidence that I'm seeing in my practice is mimicking what was reported in the clinical trials where the fungal infections that I see with bimikizumab is oral candidiasis. That's very easily manageable, does not recur often whatsoever. Most of the patients have one or two episodes, responds to either oral nystatin or oral diflucan, which is available by prescription here in Canada. And the patients are doing so well with it that they really don't want to stop the mcKizumab because of one or two yeast infections. And we're not seeing extensive yeast infections. No one had to stop it in my practice, because of oral thrush. It occurs less than 25% of the time in the first four months, and then when the dose is extended to every eight weeks, we see it half of that. So maybe 9% of the time, and that's maybe where they're getting their second episode. Yeah, you show a picture also of tinia versicolor, which I'm glad you're showing. It was not reported in the clinical trials, but we also have seen with other IL 17 blockers. Tinia corporus developed when I, years ago, took care of a patient with chronic mucocutaneous candiditis, which is an IL 17 deficiency. That patient had horrific tinia infections. But in the clinical trial, what we saw really was limited to infrequent, mild to moderate monilial infections that were easy to treat. And as you see here, that in the first year, 9% of patients had one episode, another 4.1% had two episodes, and almost nobody had more than that in that year. Over two years, those numbers hardly changed. A small fraction of a percent more had one or two episodes during the two years, and very few patients had more than two episodes. So, infrequent, mild or moderate, and easy to treat. Agreed. So my next question to you is, how, why, and when do you switch from one biologic to another if the patients are doing well? I'm not switching anything, even if they say, oh, I'd like to have something that's less frequent, leave well enough alone. Very rare nowadays to have a primary non response. This lack of initial efficacy, we just don't see that with the power of these biologics anymore. The secondary non response, again, is very uncommon. It may occur 1015 percent of the time. And we know that the more biologics that we use to treat these patients, the tougher it is and the more secondary response. Of course, if there's an adverse event, we're going to switch the biologic, and occasionally the patient is not that satisfied. So we may do a switch, but generally, if they're doing well, we don't do a switch. If they're not doing well, we'll switch. Now, if they had secondary response, I will switch within class. If they had an adverse event in that class, then I usually switch out of class. Okay. And this is called treatment sharing. I believe there's a word for it. But basically you're sharing with the patient the decision of what to do, and if they're not doing well enough, you switch. And unfortunately, we do have another option. Now, do we know anything else about long term safety? We do know a lot from the clinical trials. Do you know anything from real world safety? Do we have to worry about anything else? The good thing is that these biologics are super targeted, very focused molecules. And in the 18 months of using bimikizumab, there's no signals that have come up. There's very little data from real world registries like coravitus, still a bit too early for that. With other anti IL 17s like secucinomab or ixicizumab, we're not seeing any safety signals long term. We're not seeing malignancy or increase in Canada infections or mace. It just doesn't occur. And we're not seeing a reactivation of tuberculosis, especially in those areas and countries where tuberculosis is more prevalent. We're not seeing that. So short term safety equals long term safety and comfort for the patients especially. And allows the dermatologist or prescribing physician to sleep at night. Right. I will say that when we ask our gastroenterologist, because secucinum was tested for Crohn's disease and did not work, and there were a few patients who even had a little exacerbation, they will not allow us to use 17 blockers in patients with psoriasis and Crohn's disease. The last thing I want to touch on is what other indications are IL 17 blockers used for and I will say that we have a little bit of experience using them off label for hydratinitis separativa. And now, of course, secuchiniumab has been approved. And as you can see, there is very good efficacy data comparing that to placebo. Bimakizumab, I know, is in trials for hydratnitis. So hopefully that will be another future indication. And of course, the 17 blockers are great for psoriatic arthritis. And what you see here is that secuchemab and executionumab are approved in the US for psoriatic arthritis. Burdeliumab is approved for psoriasis along with the other two IL 17 blockers in the US. And we're waiting for approval of vimicizumab for psoriatic arthritis. Bridalimab is approved Xus as is vimakizumab. But secuchenab isa kizumab are available for psoriatic arthritis. The only one approved to date for hydronitis suprativa is indeed secukenumab. And hopefully we'll be getting more for hydratinitis as well. So with that, I want to thank everyone for participating. Thank you, Ron, for that excellent discussion. And we are delighted to have this expanding armamentarium of, of treatments for psoriasis. Thank you. Thank you very much. Thank.

Identify the relationship between psoriasis, psoriatic arthritis and biologics 

Describe the role of IL-17 inhibitors for the management of moderate-to-severe plaque psoriasis in challenging body areas such as, nails, scalp, genitals, palms, and soles of the feet 

Recognize patients who would benefit from IL-17 inhibitors for the management of moderate-to-severe plaque psoriasis in challenging body areas 

Discuss how PAs and NPs can work in a multidisciplinary team to manage patients with moderate-to-severe plaque psoriasis in challenging body areas 


Take the Challenge to Manage Moderate-to-Severe Psoriasis From Head-to-Toe: CME Satellite Symposium - Online CME Activity

Identify the role of IL-17A and IL-17F inhibitors across multiple disease pathways and how therapies target this pathway 

Discuss the benefit-risk profiles of IL-17 inhibitors for the management of psoriasis 

Describe strategies on how to work as a multidisciplinary team to individualize patient care with IL-17 inhibitors 

Taking a Deep Dive Into the Role of IL-17 Inhibitors for Psoriasis: What do PAs and NPs Need to Know? Seminar-in-Depth Online CME Activity

Taking it around. And hopefully we'll be able to incite some knowledge about the aisle seventeen s and psoriasis. There we go. Okay, so the clicker is right here. Excuse me. Thank you. And April and I will. I'm actually very honored to be on the same stage with April, who is an expert in this condition. These are objectives here. We want to talk about the aisle seventeen s and about the mechanism action of il 17 a and 17 f inhibitors. Talk about the risk benefit profiles, and talk about how to work in a multidisciplinary way to individualize patient care. So April is going to start off by talking about the role of il 17 in inflammatory diseases, and then we'll go from there. Great. We ask a lot of you, take the quiz, and then also absorb the information at the same time, but really appreciate your energy and attention. So we're going to dive a little bit into the science for the first section, and then Dr. Paris is going to talk about some of the clinical data, and then we're going to bring together with regards to the clinical relevance. So why do we care about il 17? So, IL 17 has been implicated by in a number of different inflammatory conditions, not only in the skin, but also, importantly, in the joints. And the three conditions that are relevant to what we practice is psoriasis, psoriatic arthritis and hydranitis separativa. And I'm going to show you a little bit with regards to where il 17 acts and how that matters. So, when we look at the psoriasis pathogenesis, for example, we have il 23, which is important for the differentiation of the adaptive th 17 cells. So the blue cells on the top. And then we also, however, have contributions from the red cells, which are those innate lymphocytes. So they both produce il 17. They produce il 17 a as well as il 17 f, which then lead to the skin inflammation that we see clinically. So, not only is this seen in the skin of patients with psoriasis, the same process is also seen in the joints, as well, with bone remodeling, as well as cinovitis, typical findings that we can find in psoriatic arthritis. So what we've noted over time is that IL 17 A as well as IL 17 f, they share some overlapping biology. They're cousins of one another. In fact, they share about 50% similar homology. And both adaptive as well as immune system as well as the innate system, can be responsible for their production. So you can get AA homodimers, FF homodimers, or AF heterodimers, and they can signal through a number of different receptors. So here, the AAF and FF, they signal through one set of receptor. Now, the IL 17 family also has other members as well. We have IL 17 e and its role is still being elucidated. And then we have IL 17 c, and then IL 17 c is very important for the amplification of the cascade. Now, this is important. So what we're looking at on the left hand side are psoriasis, lesions, and the expression of IL 17 A and IL 17 f compared to non lesional psoriasis. And what we see is that we know a is very important. We already have segukinumab and execismab against a, and then the a level is actually relatively, compared to f is less abundant. So we actually have more abundant levels of IL 17 f in psoriasis. Skin on the right hand side, what we see is a level of IL 17 f in HS lesions. And this is something I think we've really come to appreciate, something novel, that IL 17 f is present at high levels in HS lesions as well. And here is a summary of the biologics that target IL 17 axis with regards to what has been approved and as well as what is emerging. So, as you can see here, sekukinumab and ixicismab have the same mechanism action focusing on inhibiting IL 17 A. Bimikizumab, which is an emerging agent. It targets both a and F. Brodalamab, which is also approved for psoriasis, it's a receptor inhibitor. It inhibits IL 17 receptor alpha, and by doing so, it inhibits the actions of signaling pathways of AFC. So with that bit of science as a background, I'm going to turn the podium to Dr. Parasar. Okay, so, real good review of the biology of the drugs that are out there now. I want to talk to you about the clinical safety and efficacy data, and I'm going to do it in a little different way than you're used to seeing. These are the four agents that I'm going to speak about. I want to emphasize that vimakismab is not FDA approved at this point. It's under review. Brodalumab, ixicismab and psychicinimab are all approved. You know, we don't like to compare clinical trials, one clinical trial against another clinical trial, when they weren't a head to head comparison within the same trial, but yet we all kind of do that. And I'm going to take the liberty to sort of do that in this presentation, because all of these il 17, inhibitors for psoriasis had very, very similar clinical trials. They all enrolled adults, some also enrolled children, but all adults, the patients had passes a BSA of 10% or more and a passy of twelve or more. And they all had an IGA of moderate or severe. In that respect, they were pretty similar. So let's talk about these in alphabetical order. Bimikizumab first, because it's the first. In alphabetical order, it is. Again, I'll just emphasize for the last time, this is not an FDA approved. The BLA has been submitted, it's undergoing review. We don't really even know what the approved dose is going to be, but we do have some ideas about that. So there were several studies, and I'm going to throw together the results of different studies, but I'm going to try to make a point. The BIMIC hasemabs start off with this comparative study, double blind study, between the active drug and the placebo, and eustachinumab as another active control with a 16 week primary endpoint, and then continuation for week 52. And so this one we can say, yes, there's a valid, statistically significant difference between the efficacy, the passing 90 and the IGA one clear, or almost clear, in the patients who use bimachizumab versus eustachinumab. And this was because it's the same study, randomized control, good statistical significance. If you look at the passy 75, there's also the same spread. First was passy 75 was on the left side. On the right side is passy 100. And look at that, 58% passy 100. We haven't seen that before, really, in anything, in any of the psoriasis drugs. Secondary endpoint of bimikismab 90, Pazi 90, and the IGA one over a year, basically a very slight decrease in the efficacy. But I want to make a point with this one. If you look at week four already, the Bimachismam group is having a 43% improvement reach, passing 90, 49% IJ of zero one works very, very quickly and it stays effective over a 52 week study. In a long term side effects on biblicismab that we want to look at, I could show you this same slide and tell you it was from any of the biologics, because it really would be any of the Il 17s, rather. And these are all nonspecific ones. If we look at the common ones that are important, we're going to see down near the bottom, candida and candida. The presence of candid infections, mostly mild, some moderate, no real severe candidate infections in any of the biologics. But that's the IL 17 adverse event of interest. Now, they also did in head to head studies not only the eustachinumab that I showed you, but also adelimumab and secukinimab, and showed in a blinded study, increased efficacy in terms of looking at the passing 90 at week 16, which, remember, wheat 16 was not the primary endpoint for the other biologically other IL 17s that we're talking about. Okay, Bimacam is again looking at adelinemab, secukinimabs, igA, one at wheat 16, and for long term three years, it seems to not lose very much effectiveness. The people who achieved apacia 100, still 60, some percent all the way out to week 152 adverse events. Again, this is one of the other studies. And there's Candida again, as the one was the one of significance. All right, let's talk about the others. Bridalumab, the other one, that's another one that's currently on the market. There were two primary studies, placebo controlled registration studies, and again, compared to eustachinumab. Everybody wants to beat up on that, on that one. And you can see that the bridalumab people achieved passive 75 at a rate of 85% with the higher dose at week twelve compared to eustachinumab. And the lower dose, bridalumab, which didn't do quite as well. Long term extensions out to week 52 and beyond seemed to maintain most of its efficacy in both the higher and the lower dosage. Just so very briefly, there were in the phase two study some exacerbating based on existing Crohn's disease. And we know that that's one of the issues with il 17s, inflammatory bowel disease. Candida again, but no neutropenia, some neutropenia, no mace. Bedalliumab has a boxed warning for suicidal ideation and behavior. We can argue whether that is justified or not, but it's there. And there is a REMS program for bridalumab that you have to sign up for exechismab, another currently market drug. Complicated study, but I'm really focused on the induction period. That first twelve weeks were the primary endpoint of two doses of ixicismab versus placebo. And both of those doses showed obviously significant improvement over the placebo in results of passing 75 9100. And the SPGA just focusing on the passing hundred for a minute. A third of the patients, a little more than the third got the passing hundred. That's what we want to see. Nowadays, passing hundred is a realistic goal for most patients and slight decrease of efficacy over time, but not much. Again, the people who were clear through week 60 longer term studies, it stayed about the same as it was at the primary endpoint. So it did not lose a whole lot of efficacy over time. Here's the adverse events from one of the exechismab studies. And where is it? Again, it's Candida. There is the one that shows up as something of significant importance. All right, long term exechismab out to week 60 and in a different study. Again, just to make the point that the pasi 75 rate maintained itself all the way through till the end of the study in week 60, as did the passy 90, and as is the PGA, zero or one. So good improvement. The primary endpoint, long lasting improvement with ixacizumab. Finally secidumab, the other last one, very complicated slide. Don't even look at this except I want to make the point that this was studied in double blind fashion against itself and against the tannercept and in two different doses of secukinimab. Looking at the iga of zero one, passing 90 and passy hundred responses, you can see that again at passy hundred, which is what I always focus on now, is passing 145% with secukinimab. Passing 90, 76% Iga clear. Almost clear. 78. Week 52 pretty much maintained efficacy over that amount of time. Passing 90 results in the passing hundred and iga one. Again pretty much response over time and again, long term result. This was a DLQi which I didn't report on the other ones, but that remained as well about the same as it was at the primary endpoint. Adverse events. I could show you the same table again and look at the bottom last one, candida. That is the major adverse event of the aisle 17s in general. And looking at the rest of them, looking at the other serious the mace events and the inflammatory bowel disease, some one case actually of inflammatory bowel disease, mace events were not much. So this is a slide on the approved dosing. Now for the vimicismab. We don't have an FDA approved dose. What I've listed here for you is the dose which is approved in the EU where it has been approved for a while and this data is available on the handout that you get, but not for bimbikism because that's not approved in the US later. Until later, maybe later this year. We hope so. I will turn it over to April to bring it home about the real world use. So I'm going to talk a little bit about real world applications. This is a slide that I kind of put together, really think about some of the common shared characteristics among IL 17 inhibitors. So they are overall great in terms of the skin psoriasis efficacy, as David has shown, they also have very good efficacy in psoriatic arthritis. So this is one of their key strengths, not only peripheral psoriatic arthritis affecting the hands and the feet, but also axial spine psoriatic arthritis. They have pediatric dosing for secucunumab and ixicismab for six years and older for psoriasis. Where you want to avoid IL 17 inhibitors are those with a personal family history, a personal history of inflammatory bowel disease, and also there's low rates of oral candidiasis, as David has pointed out. In general, I will say that oral candidiasis is not prohibitive. Most of them can continue their il 17 with oral candidates treated with a few days of oral fluconazole. And also one thing that's interesting, based on the literature, is that you can actually switch from one IL 17 inhibitor to another IL 17 inhibitor. So this is a study by Dr. Lebwell's group that looked at people who have failed ixicizumab and failed psychicinumab. And if you put them on brodalamab, as you can see, that patients, about 76% of the patients would still achieve posey 75. Could it be because brodalamab is a receptor inhibitor and therefore is inhibiting other pathways? Possibly, but something to consider, and I'm just going to show some of the strength of IL 17 inhibitors is really inhibiting radiographic progression. And just for 1 minute, I'm going to pretend, have you pretend you're radiologists. So if you look at the left hand side is a normal hand, and on the right hand side is a patient with psoriatic arthritis. So you'll see the joint space is narrowed and joint space narrowing is a bad thing. And they can be quite progressive in our PSA patients. The other finding in PSA is hand. So this is the same picture of someone with PSA. And so what you see, radiology calls these mouse ear signs, where you get erosions, or maybe in Orlando we'll call them Mickey Mouse signs. So you get these erosions that can progress over time. And that's what we try to avoid as well. And what IL 17 inhibitors do, and all of them both approved as well as emerging, what they do is that they are best in terms of halting these radiographic progression, in terms of what I showed you, also, we have data showing that this is with secuchinumab. This is the only trial currently that's showing IL 17 inhibitors being very effective in terms of treating axial psoriatic arthritis. And those are the patients who wake up with a stiff back as their primary manifestation of their PSA in the morning, and it takes them a while to move. All right, what's exciting in the horizon is our IL 17 inhibitors for hydranita separativa. I know tomorrow you're going to hear a talk on HS, but what we see is that this is secukinumab with regards to treatment of patients with HS, as you can see, effective in terms of achieving high score of 50, so at least 50% improvement. So something we are looking to see coming down the pipelines. So secicinumab actually has already been approved in Europe for the treatment of HS not yet approved in America. I feel like usually we get approved in the US, always first. And then recently we've seen this kind of reversal of it being approved elsewhere than in the US, but very exciting. Also, I showed you earlier about IL 17 F and its role in terms of HS. And here we're looking at bimakismab, not yet approved in the US for any indication currently. But this is bimikizumab data in HS as well, showing really great efficacy in this area, too. So very exciting. So now we're going to have, in addition to adelemumab, hopefully very soon, both sekikinumab and bimikizumab for our patients with moderate to severe HS. And just to echo what Dr. Paraser have said, taking a multidisciplinary approach to care. Talk to your rheumatologist when you see a patient with psoriasis and psoriatic arthritis, which I'm sure you are doing already, the trouble is figuring out when you have a mutually agreeable time to talk. But I think having a multidisciplinary approach would be very helpful. And here's conclusion of what we talked about. Il 17 family of cytokines, important in inflammatory skin and joint disease, IL 17 F. We are gaining appreciation for its role in psoriasis, psoriatic arthritis, as well as HS. And we talked about the multiplinary approach. We want to thank you so much for your attention. Thank you. April and Dave bed.

Overview how IL-17 inhibitors target the inflammatory disease pathway

Summarize the clinical trial data for IL-17 inhibitors for psoriasis and psoriatic arthritis

Illustrate how to individualize care with IL-17 inhibitors for the management of psoriasis and psoriatic arthritis

Managing Psoriasis and Psoriatic Arthritis with IL-17 Inhibitors: What do we Know Today?: Online CME Activity

Is everybody having fun yet? Having a good time learning anything? Well, you're about to learn more from Dr. April Armstrong and Dr. Mark Lebwall, two of the codirectors. And they're going to be talking about managing psoriasis and psoriatic arthritis with IL 17 inhibitors. What you need to know, I thank you, Jim. All right, so in this session, we're going to take a deep dive into IL 17 inhibitors for psoriasis. And I'm very excited to share the podium with Dr. Lovewell, who is dean of clinical therapeutics and chairman emeritus at ICANN School of Medicine at Mount Sinai. And we're going to go right into it. So today, there are several learning objectives. Number one is we're going to look at the science of IL 17 family and why they're important in psoriasis pathogenesis. We're then going to talk about the mechanism of action of the various IL 17 inhibitors. And importantly, we're going to summarize some of the clinical trial data for you, and that Dr. Lebo is going to take you through this wonderful case, looking at the real world application of IL 17 inhibitors in patients with psoriasis and psoriatic arthritis. This is accredited. And to earn this extra CME credit, you can go to the special sessions agenda icon, which is right next to the regular agenda icon on your app, and your CME certificate will be emailed to you. All right, so let's first talk about the importance of IL 23 and IL 17 accessing psoriasis, right? This is like the evil accessing psoriasis. And when we think about this, and if you look at the left hand side of the graph, first, you have your myeloidic dendritic cells with these tentacles, and they secrete IL 23. So this IL 23 is this master regulator, and it really signals your naive t cells differentiating into different types of cells. So upon the stimulation of IL 23, your naive T cells can differentiate into th 17 cells, which is a blue ball, on the left hand side, and that th 17 cells then secrete downstream cytokines, principally IL 17. And this is really important because, predominantly, it's the IL 17 from the Th 17 cell type that's responsible for psoriasis. Now, there is a contribution through some of the innate immune system as well. So IL 17 is not only secreted through the Th 17 cells, but also by a number of innate immune cells as well. So ultimately, you get skin inflammation on the right hand side in terms of the clinical manifestation. But what we also learn is that in addition to that IL 17 is important in terms of when you have dysregulated, excessive IL 17 cytokines, you also get psoriatic arthritis. So you see abnormal bone remodeling. This is where you see the erosions on x rays in patients with psoriatic arthritis. They have cinovitis as well. And that's the reason why IL 17 inhibitors are also. Many of them are also approved for psoriatic arthritis. Okay, now let's think about the f word. So when we think about a and f, IL 17 family actually has a number of different members. The two key members that we care a lot about is IL 17 a and IL 17 f. In fact, those two members are related. They have about 50% homology between IL 17 A and IL 17 f. Importantly, they also exist in dimers. So if you look at the right side of the slide, you'll see these dimers, sort of these hamburger appearing graphics. So you can get Il 17 AA exists as a homo dimer or Il 17, or you can get the Il 17 AF heterodimer and also, notably, ilcenting Aaff or Af. They bind to the same receptor. Now, we didn't talk about the other members of the family, which is notable and relevant to us. We have IL 17 e, which we're trying to still understand and study as a field. And then on the right hand side, we have IL 17 C, which is actually secreted mostly by keratinocytes to perpetuate this cycle. All right, so where do our current therapies target? So, this slide, looking at the biologic agents that target IL 17, summarizes where they work. So you'll see that seguchinumab and ixicizumab, they're IL 17 A inhibitors, and therefore they inhibit IL 17 Aa homodimer and AF heterodymer. When you look at the Guring bimachizumab, which is an emerging therapy, it inhibits both the AAF as well as FF. Brodalamab is a receptor inhibitor. Therefore it affects the signaling of AFC and E. All right, so one kind of summarizing approach that I oftentimes think about when I think about the IL 17 inhibitors is that they, as a class, have robust efficacy in psoriasis. There are some differences among the agents. They have also robust efficacy, very important in psoriatic arthritis in terms of both peripheral as well as axial psoriatic arthritis. They have pediatric indication with secukinumab and ixacizumab in kids six years and older. You do want to avoid il 17 inhibitors in those with inflammatory bowel disease and other considerations is that there are low rates of mucocutaneous candidiasis that may be associated with IL 17 inhibitors. So we as a field have learned a lot about IL 17 inhibitors and IL 23 inhibitors over the years. And the type of study that I personally like a lot is head to head comparison. Much like the recent Super bowl. Who is a winner depends on which quarter that you're looking at. So the timing and how the study is designed and at what time point that endpoint is evaluated is very important. I'll highlight two very important studies to our field. So number one, this is our first, IL 23 versus IL 17 inhibitor, comparing Gasell cumab and secukinumab. Gasell cumab is the green line, segukinumab is a red line. So if you are looking at the end of the first quarter, you will see by week 16 they're very similar. However, when you're looking at at the end of one year, what you'll notice is that gaselchumab is superior to segukinumab with a Posi 75 as the comparator. If you look at a head to head exechismab versus gaselchumab study now we're looking at another IL 17 versus gaselchumab. Also, depending on where you look at, is important. This is looking at PoSi 100, right, highest bar. And what we see is that at week twelve, execismab is superior to gaselchumab. However, at week 24, they are pretty much equivalent. And this is secukinumab. Over the years, we learned that every two week dosing for people who are obese are more helpful than every four week dosing. So if you have obese patients who are not responding to every four weeks, consider dose escalating. And you'll see, when we were looking at the various metaanalysis out there, the IL 17 inhibitors tend to rank pretty high. So bimikizumab, as I talked about before, inhibits both IL 17 a as well as f. And then what you'll notice is that the IL 17 a and f expression, if you look at the middle column here, we actually have a lot of IL 17 f expression in the lesional skin of psoriasis. We also see that in the lesions of psoriatic, in the lesions of HS. And that's why it's being studied in both indications and whether it's comparing it to eustachinumab or adolemumab or IL 17. Another comparator, psychicinumab you'll see that bimikismab is superior to that. So seven out of ten patients will be completely clear by week 16 with a bimakismab, which is a tremendous efficacy that we haven't seen before. This efficacy is sustained at one year. And also what we see is that it's also sustained over three years period of time. And with that, I'm going to give the podium to Dr. Levwall. Thanks, April. So we are going to do some interesting cases, and I'm going to start out with this patient. A 36 year old patient with severe psoriasis is on an IL 17 blocker. And this is something that we see all the time. Skin does great, but the joints are still severe. The patient had already failed TNF blocker for both the skin and the joints and failed methotrexate for skin and joints. So what are our options? Should we switch to eustachinumab, switch to a 23 blocker? A few other options. Let's go through these. Eustachinumab is approved for psoriatic arthritis. It is only modestly effective. The delta in ACR 20 scores between placebo and the higher arm is not that great. Uselchumab, an IL 23 blocker, actually has some fairly good data on psoriatic arthritis. It is approved for psoriatic arthritis. So is resent kejumab, the other 23 blocker. Again, the data is not quite as different, as good as it is for the 17 blockers or for the TNF blockers, although here you see statistically significant, really good data for ACR 2050 and 70. When you look for Vonderhide scores, which are a measure of radiographic progression of joint disease, what you see is the q four, which is shown all the way over on the right, is statistically significant. But the drug, of course, is approved only at q eight weeks. So there is a benefit, but it's not statistically significant at the approved dose. So that's the story for use to kinium Evan 23 blockers. What about another IL 17 blocker? Why don't you switch from one to another, or a TnF blocker? And here there is a good option coming. Bimicizumab will be here in June, hopefully. And what you see here is they're not looking at ACR 20s, but actually at ACR 50 as the primary endpoint. So very high bar. And you see the kind of difference that we see with the other drugs for ACR 20, we are seeing ACR 50 changes, so very effective for psoriatic arthritis. And here you see as you go out to week 48, that improvement continues. Now, I will say they just published a phase three trial and compared bimikizumab to adolemumumab, which is the equivalent of many of the 17 blockers. Those are probably the most effective treatments we have for psoriatic arthritis, and it looked like the two were similar, bimikizumab and adolemumumab. We were hoping it would be much more effective. In fact, when you break the data out and you look at monotherapy, bimikizumab was much more effective than adolemab. So hopefully, we do have a better drug coming, hopefully in the near future. And here's even very impressive. Again, phase two data, ACR 70 scores. So a really effective drug for psoriatic arthritis. This is the study that was published which showed equivalence to adolemab, but that's including adolemab with methotrexate. Again, when you do monotherapy, the differences are actually substantially better for bimichizumab. Okay, what about adding a premilaster to creviceitinib? Decreasetinib is not yet approved for psoriatic arthritis. We actually have tried it in combination with biologics, and there may be some added efficacy for ducravacitinib. A premolast is approved for psoriatic arthritis, and we actually use that a fair amount, although as monotherapy, it is only modestly effective for psoriatic arthritis. Okay, what about methotrexate? Methotrexate is interesting. It's been around for decades, and I will say we often use it in combination with other biologic agents to get better improvement in psoriatic arthritis. So it would be a good option. I will point out that as monotherapy, it does not prevent radiographic progression of joint disease. So it's not as good as the TNF blockers and the 17 blockers. Okay, let's go to our next case. I've actually seen several of these, at least two, and we've published, I think two. I get a call from a really good dermatologist on Long island saying, I gave my patient secucinumab, and it's supposed to be two shots a week for the first five weeks, and then you go to once a month. The patient calls me up on Friday. She took the first two shots on Monday, second two shots on Tuesday, Wednesday, Thursday, Friday, and calls me up and says, what do I do? I'm all out of injections. After he cleaned the urine up off his floor, he called me up and I said, don't worry, be happy. The patient will get better very quickly. And the drug is very benign. You cannot overdose on 17 blockers. So it turns out there have been over 100 patients who have done just what that patient did. And here's what happens in their blood. The correct way of doing it is the blue line. You get a little increase in secuchinumab levels each week for the first five weeks. If you take them all over one week, you get that red line. So you get a massive increase in psychicinumab levels, which clears psoriasis very quickly. So the patients do well. And in fact, if you go to the package insert, what you'll see is that they've given ten times the dose to patients with no ill effects. So it's a pretty benign treatment. And you wouldn't expect a lot of side effect here because IL 17 blockade is very benign. There's a human model and also a mouse model of IL 17 blockade. People with chronic mucocutaneous candidiasis are IL 17 deficient, and all they get is yeast infections. They don't get more cancers, they don't get more heart attacks. They get yeast infections. So it was actually kind of calming to us to see. When we did the clinical trials, all we expected were yeast infections. That's all we got. April did mention a very uncommon worsening of inflammatory bowel disease, which occurs again. Okay, let's go to the next patient. And this is one we published a few years ago. We published a series of patients, patient who has a new onset of gutted psoriasis. The patient's hypertensive and alcoholic. So what are your options? This patient's got dots everywhere. Topical therapy is not practical. You're not going to give the patient cyclosporin because of the hypertension. You're not going to give a methotrexate because of the alcoholism. Aprimolast is okay, but it's very slow and modestly effective. So you start a biologic. Now, many patients with gutted psoriasis have it go away and it doesn't come back. And I'm sure you've all seen that phototherapy used to be the gold standard for this. That has changed in my practice. The gold standard is now an IL 17 blocker. Why? And I will say you could use a 23 blocker as well, and it will work. But in general, the IL 17 blockers are fast, which April showed you in the head to head trials. They work right away. And these are patients who actually are not used to having anything wrong with them, and they come in very upset because they're covered with psoriasis. And what we reported were patients who were treated between three and six months, and we then stopped the 17 blockers. At this point, I've probably treated more than 20 patients with this. The first one to recur were some patients I treated in the last few weeks, last few months who came in after the first three month course of a 17 block and recurred. But the vast majority of patients, three to six months of therapy clears of psoriasis completely, and in several years, they have not recurred. Okay, and why do we pick a 17 blocker? Because they're fast. And this is a study in which you looked at passage 75 and 90, and the brown, purple and green bars are the 17 blockers. Bridalumab is actually the fastest, followed very closely behind by ixakisumab and a little bit behind by secukinumab. So all very effective and very rapidly effective treatments for psoriasis. This is actually a patient who came to our office covered head to toe with severe psoriasis, and he was so debilitated by his psoriatic arthritis. Look at how swollen those hands are. He couldn't walk and he couldn't use his hands. And we actually hospitalized him on a Friday. Here he is a week later. The resident on call called me on Sunday and said, he's almost completely better. Can we send him home? And we did. And he came back a week later. There he is. Before and after. In one week on sekikinumab. Why did we pick sekikinumab? That's the one we had samples of in the office. Here's his hands a week later. Look at that dramatic reduction. So this is a study we did with ixicizumab. Look at that difference. At just one week with ixicizumab, this is two weeks, four weeks, eight weeks. I mean, you can't see anything. This is so rapidly effective. I'm going to close with a slide on oral thrush, which is the one side effect that we do indeed see with 17 blockers. So for vaginal candidiasis, a single 150 milligram dose of fluconazole clears it. That, by the way, is over the counter in Canada and the UK if you have oral thrush. April wrote a beautiful review of how that can be treated. I used to treat it with three days of fluconazole, and then I saw her guidelines, so I actually went to 100 to 200 milligrams a day for seven days, usually. And I've never had a patient not respond to that. And this is a slide in which bimikizumab, which is coming, is more effective than the other 17 blockers. It also has more oral thrush. But the number of cases which, by the way, are all mild to moderate and easy to treat was the vast majority of patients gets one, some get two. Very few patients get more than two cases of oral thrush. So very effective treatment. So, in conclusion, we have very useful drugs in IL 17 blockers. If you want to receive your credit, find that on the app. And if you have any questions, you won't find them in the journal of irreproducible results. Thank you very much.

Discuss current management advancement in dermatology from rashes through tumors

Compare strategies to manage dermatologic conditions from laser treatment through systemic therapies

Identify appropriate treatment options for dermatologic conditions based on patient and disease characteristics

Recognize the nuances of managing dermatologic conditions in skin of color

Underline strategies to optimize management in patients with dermatologic conditions

2023 Virtual Grand Rounds Session 3: March 8, 2023 - WCM: Your Questions Answered

Illustrate strategies to manage dermatologic conditions effectively in clinical practice

Discuss the treatment of psoriasis and related disorders with evolving therapies

Describe the modalities for diagnosing and managing skin cancer

Describe strategies to prepare and administer fillers and botulinum

2023 Virtual Grand Rounds Session 1: February 1, 2023 - WCH23 Your Questions Answered

Overview of key data for emerging topical therapies to manage plaque psoriasis

Describe how to individualize care with emerging topical therapies to optimize patient outcomes

Compare between the various topical therapies for the management of plaque psoriasis


Plaque Psoriasis: Itching for New Topical Options: Online CME Activity

Overview IL-17 inhibitors for the management of moderate-to-severe psoriasis

Describe how to prevent and manage side effects associated with IL-17 inhibitors

Discuss strategies to individualize care for patients with moderate-to-severe psoriasis 

Matching the Right Patient with the Right Therapy: The Role of IL-17 Inhibitors for Psoriasis: Online CME Activity

Our next speakers are going to talk about matching the right patient with the right therapy, the role of IL 17 inhibitors and psoriasis. Dr. April Armstrong, one of the program directors, and Dr. Bruce Strover, thank you very much. I first of all want to thank you for staying late today. And also I want to say it's just an honor to cop present this with Dr. Schrober, who's the clinical professor of dermatology at Yale. So today we're going to talk about matching the right patient with the right therapy and specifically looking at the role of IL 17 inhibitors. This is accredited, and we're going to have three learning objectives. First, we're going to go over, give an overview of the currently approved IL 17 inhibitors, as well as emerging IL 17 inhibitor. And we're also going to talk about how we are going to manage some of the side effects that you may see with IL 17 inhibitors, and then finally discuss strategies for individualized care. So when I think about care of a patient with a psoriatic disease, I think about three different aspects. The skin and then the joints, and then specifically for the joints, focusing, looking at both the peripheral arthritis, peripheral psoriatic arthritis, as well as axial psoriatic arthritis. And when we think about our approved therapies for psoriasis in the realm of IL 17 inhibitors, we have our psychicinumab, ixechizumab and brodalamab. So, first of all, in my opinion, that I think they are great in terms of both strong, robust skin efficacy in terms of psoriasis, but also very strong and robust peripheral as well as axial efficacy. They also have pediatric dosing available for psychicenumab as well as ixicizumab down to six years of age. I avoid IL 17 inhibitors in those with a personal history of inflammatory bowel disease. And also other considerations we'll talk about are the low rates of mucocutaneous candidiasis. So when we look at the three approved medications, and I'll start with secukinumab, it's an IL 17 A inhibitor, so it binds to the IL 17, a cytokine. And in adults, it's approved as 300 milligrams every four weeks. Now, in those patients who may be a little bit larger, specifically greater than 90 kg, there's a studies that have been done looking at Q two week dosing versus the approved q four week dosing. And what they found is that in those patients who may be more obese, that q two week dosing tends to be more effective in terms of treating those patients. So for those patients, if you're not finding the efficacy that you need for secuchinumab, then consider dose escalating them, giving them more frequent dosing at Q two weeks. In terms of peripheral joint disease. Here we're looking at the ability of psychicenumab to inhibit radiographic progression in terms of joint narrowing or inhibiting joint erosions. And here, the higher the bar, meaning more radiographic progression. And we see that at two years, 84% of the patients on psychicenumab did not have radiographic progression. And then finally, this is one of the studies, few studies that we have axial data in this particular IL 17 inhibitors, showing the amelioration of axial signs and symptoms for secuchinumab. And moving on to ixicizumab, also IL 17 a inhibitor. It's approved as every four weeks for maintenance. And here is a long term ixicismab data. Look at response through five years, and specifically looking at either clear or almost clear, which is the top two set of lines, or clear. As we can see, overall, depending on the method of analysis that we use, between 72% to 80% of the patients over five years will maintain clear, almost clear. So pretty good response when we are thinking about this particular IL 17 inhibitor. And now this is a comparative effectiveness study using network bed analysis. And what it showed is that over one year period of time, when we look at cumulative benefit, we see that our IL 17 inhibitors are among the top medications that have come up in this particular analysis. For example, specifically, execismab and brodalamab have shown quite good efficacy. And then what about the inhibition of radiographic progression? What we see here, as you can see, is that for executionab, which is the orange bar, there's very little radiographic progression in terms of peripheral joint disease. And then finally to brodalamab, which is different in mechanism, action, it's not a cytokine inhibitor, but rather it is a receptor inhibitor. So it affects the actions of Il 17 AF as well as C Enc. And then probably you didn't know, is a fast onset of action. Quite fast. 60% of the people achieve posey 75 by week four. So this is quite fast. And if you compare that with other biologics, what we see is that in the meantime, for 50% of patients to achieve posey 90, as you can see, numerically shorter time compared to the other biologics here. And also, if you're wondering if you failed, if you have patient failing exechismab or secuchinumab, can the patient respond to brodalamab this is a study looking at that they can. So you can get about 60% of the patients still achieve clear or almost clear, even though they have failed ixicizumab or secicinumab. And with that, I'm going to turn the podium to Dr. Strover. Okay, thank you, Dr. Armstrong. So we're going to move forward with a medication that currently is not approved in the US, bimikizumab. It is approved around the world, though, and we'll probably see this drug approved sometime next year, in the middle of the year. So bimikizamab, an il 17 a and f inhibitor, that makes it somewhat novel. Brodalumab, you saw, has the ability to block multiple il 17 isoforms. But this is a solitary monoclonal antibody that actually blocks a and f together, which is relevant, as you'll see, because as I highlight here, you'll see efficacy, which, in my opinion, we haven't seen before. Nine out of ten patients at week 16 are at posey 90. So essentially, you can tell almost every patient you start on this drug, they're going to get at least 90% improvement. And if you go out over a year on the right side of that graph, similar data. In fact, the Q four and q eight week dosing interval in the maintenance appear very similar. So this will be a novel IL 17 inhibitor given at an eight week interval after an initial 16 weeks every four weeks. I'll talk about the Canada infections in a few slides. And this also speaks to long term efficacy. If you get a patient to posey 102, out of three patients on this medication get to posey 100 by week 16. Well, if you follow those patients another three years, four out of five of them, approximately 80%, keep that positive 100 for three years. And this is a pretty conservative analysis. And note, the Q four and Q eight week intervals are roughly the same in terms of efficacy. So a Q eight week dosing for an IL 17 inhibitor that gets two thirds of its patients to posey 100. And most of those patients keep the POSI 100 over time, as shown here. Now, in case you were wondering, secukinumab April just discussed it. It was put to a head to head with bimikizumab. And the red line is the secukinumab arm with the blue line, the bimikismab arm. And through 48 weeks, whether you're looking at PosI less than or equal to two, that would be the solid lines or the dashed lines, PoSI 100, bimikizumab is more effective and if you switch the people on secukinumab to bimikizumab over here, you get similar efficacy over time. So you can clearly see that bimikizumab does better than sacukinumab. Blocking f in addition to a, gets you to higher efficacy in this instance. Now, April appropriately discussed IL 17 inhibition as a PSA psoriatic arthritis control approach. And there will be no difference here with bimikismab, where ACR 50 scores are right where they need to be compared to a placebo. And then you have ACR 20 and 70 scores, and this is compared to adolemab in the study, roughly comparable. So if you like TNF inhibitors for ACR 2050 and 70, you're going to like bimikizumab. Additionally, you see control of tender and swollen joints, and you will see that bimikizumab controls axial disease as well, which we have to keep thinking about. Axial disease in addition to peripheral psoriatic arthritis. From a safety standpoint, really, there's only one thing that we need to discuss. We don't have to talk about serious infections. They're where they should be with regard to a biologic. Similarly, tb is not even on the radar. There were no cases over three years of tb. There is oral candidiasis, and it's oral candidiasis that seems to be biased towards patients getting vimicismab. It's roughly ten to 18% of patients, depending on dose. The higher rate is for the Q four week maintenance patients, and Q eight week is going to get the 10% rate. So ten to 18%, not really an IBD signal. There are some people who believe the signal is basically background. I'm one of those who believe that the signal is not there. But nevertheless, you could imagine that the label will warn you against using this medication in someone with preexisting IBD. No mace, no malignancy signal. So pretty good. You just have to think about oral candidiasis. Just again to frame that issue. Secukinumab, ixicismab, and brodalumab showing their rates somewhere between two and 5% depending on study. And then you have the bimicizumab rates, ten to 18% depending on dose. And April is about to get into the way we approach that issue with therapy. To conclude, as I write here, rapid response, probably bimikismab is going to be the most rapid drug. It's even going to probably edge out brodaliumab in terms of how quickly it gets people to pose 75 and 90 every eight week dosing. That's unique. Great efficacy for psoriatic arthritis inhibits radiographic progression, as April just pointed out, much like IL 17s typically do low signal for malignancy and serious infections. I didn't mention this, but nail psoriasis will be effectively controlled over time with this medication. There's no doubt IL 17 inhibition gives you the best nail psoriasis efficacy. No. Laboratory monitoring candidiasis a little higher than the other IL 17 inhibitors, usually treatable. Most patients stayed in the study when they had oral candidiasis in the bimikizumab trials. And finally, you will probably see a contraindication with IBD, but clinical trials, to my eye, indicate a very low risk. So now we're going to turn it back over to April with regarding to managing candidiasis in patients on IL 17 inhibitors. So, as Dr. Strober spoke about, there can be oral candidiasis that have been seen. How many of you, just by show of hands, have seen oral candidiasis in patients, in your patients onto the current IL 17 inhibitors? Okay, so I see a few hands coming up. So few things. Is that most of the candidiasis that we see in the clinical trials, as well as real world data, tend to be oral candidiasis versus other types of candidiasis. I think that the management of oral candidiasis is definitely in the wheelhouse of us dermatologists. And the important part to note is that most cases of oral candidiasis that occur with IL 17 inhibitors do not necessitate discontinuation of IL 17 inhibitors. So I think we, as dermatologists, are pretty facile at recognizing oral candidiasis. Typically, this can appear as white, cheesy material in the buckle mucosa or on the tongue. Patients who are most at risk for developing oral candidiasis are patients with uncontrolled diabetes or those with dentures. There are a number of different approaches of treating oral candidiasis, and the table here is the recommendation by the Infectious Disease Society of America. So, if you're facing a patient with mild oral candidiasis, you can treat them topically, for example, with clotrimzole trochis or nystatin suspension. Typically, those would require you, however, to have the patient do it four times a day, for example, for about seven to 14 days. And this can be somewhat inconvenient if you imagine your patient has to go to the bathroom and do this a few times a day. For moderate to severe, they recommend the first line, oral fluconazole, 100 to 200 milligrams QD for seven to 14 days. So I personally like to use oral fluconosol because it's a little bit easier for patients. They can just take a pill. So 100 milligrams, you can do it for seven days. And typically they would then resolve and most of the cases did not require discontinuation. And now I'm going to turn the podium back to Dr. Strover. So I'm just going to bring us home a little bit about clinical perspective, how I think about IL 17s. Just first and foremost excellent psoriatic arthritis drugs in addition to be rapidly acting psoriasis drugs. And then one thing we were learning through corona, this used to be called corona. Now it's core evitas drug. Survival has been shown in biologic naive patients to be very good for ixicismab compared to non Ixi IL 17s, which is mostly sacukinumab, and then tnfs at the bottom there. So this is over 24 months in biologic naive patients in the corona. Now core Evitas study. And then this is biologic experience, which is basically a little lower efficacy over time. But still Ixi does well. So I think of ixicism as a very good long term efficacy medication. And that's where I'm biased in terms of choosing that particular IL 17. And also because of these data which show at week twelve weeks, not much going on with the NaPsI score in terms of normalizing nails. And this was head to head with etannercept. But over the course of time, you see up to 50% to 60% of patients are having fully normal nails who had nail disease at baseline on ixicism. This is why I think IL 17 inhibition probably is your best approach for normalizing psoriatic nail disease. Then you have peeds data. April mentioned this excellent posey 90 and posey 75 responses in peeds with ixicismab really as good or better than the adult data. Similarly, secukinumab posey 90s in the 70% range, and over time retention of that at posey 100. So you clear patients almost two thirds of the time when you give them secukinumab in the pediatric population down to the age of six. So think about IL 17 inhibition for pediatric psoriasis and then the low risk for serious infection. You can see all three of them are depicted here. 1.31.4 events per 100 patient years. That's very low in perspective with other biologics and very comparable to real world studies. And malignancy is similarly just background rates in my opinion, these are background rates of malignancy in patients on IL seventeen s to the point where both IL seventeen s and IL twenty three s I feel are really excellent medications for patients with prior history of malignancy who you really feel you need to have to treat. And I'm constantly now using both classes for patients with prior history of malignancy. I think these are inert medications with regard to malignancy. So to summarize, Il seventeen s I told you rapid response depending on which drug, some are more rapid than others, more frequent dosing than IL 23s. We'll see bimikismab somewhat edges now towards the IL 23s with the Q eight week maintenance comparable efficacy to adolemumumab for psoriatic arthritis. Really, we should be turning to IL 17s for people with significant psoriatic arthritis ahead of tnf blockers because you just get better skin response, low signal for malignancy and serious infections. I think background rates best efficacy for nail psoriasis no laboratory monitoring pediatric psoriasis for both secucanium Ab and ixicas. Your mab join Z ten or sepinyusticinumab in that department lower signal for candidiasis for those IL 17 A inhibitors that we've been discussing all along and the only issue you got to think about is querying for IBD. That's only really what you got to think about hard. When you start a patient on an IL 17, the presence of IBD in their history.

Psoriasis

FRIDAY, Feb. 28, 2025 -- For patients with moderate-to-severe plaque psoriasis, ixekizumab is effective and safe, with induction therapy enhancing initial response, according to a study published online Jan. 29 in the Journal of Clinical Medicine.Ricardo Ruiz-Villaverde, M.D., Ph.D., from Hospital Universitario San Cecilio in Granada, Spain, and colleagues conducted a multicenter, observational study involving 183 patients with moderate-to-severe plaque psoriasis to examine the real-world effectiveness, safety, and drug survival of ixekizumab with and without an induction phase. Patients were divided into an induction group (160 mg at baseline, followed by 80 mg every two weeks through 12 weeks, then every four weeks) and a noninduction group (80 mg every four weeks from initiation).Baseline Psoriasis Activity Skin Index (PASI) and Physician Global Assessment scores were higher in the induction group, indicative of greater disease severity. The researchers observed significant clinical improvements with both regimens, with faster initial responses in the induction group. Lower drug survival was seen in the induction group, possibly due to higher baseline disease burden and severity. Comorbidities were prevalent, especially in the induction group, and included metabolic syndrome, cardiovascular risks, and psychiatric conditions."While induction therapy appears to enhance initial PASI responses, meaningful long-term improvements can also be achieved without induction, particularly in patients with lower baseline disease activity," the authors write. "These findings underscore ixekizumab's versatility and durability as a therapeutic option, even in treatment-experienced populations."<a target="_blank" rel="noopener noreferrer" href="https://www.mdpi.com/2077-0383/14/3/833">Abstract/Full Text</a>

Significant clinical improvements seen with and without induction therapy, with faster initial response with induction

Real-World Study Shows Effectiveness of Ixekizumab for Psoriasis

WEDNESDAY, March 5, 2025 -- For patients with psoriasis, Amjevita and Imraldi are as effective as Humira for new users and in a switcher analysis, according to a study published online March 5 in JAMA Dermatology.Duc Binh Phan, from the University of Manchester in the United Kingdom, and colleagues compared the effectiveness of adalimumab biosimilars Amjevita and Imraldi to Humira for psoriasis in an emulation of two targeted pragmatic clinical trials. A total of 11,400 patients were included. The new user analysis included 6,133 patients (5,416 starting Humira; 382 starting Amjevita; 335 starting Imraldi), and 5,267 patients were included in the switcher analysis (3,808 continuing Humira; 847 switching to Amjevita; 612 switching to Imraldi).The researchers found that compared with Humira users, Amjevita and Imraldi new users exhibited no significantly different probability of achieving a Psoriasis Area and Severity Index (PASI) score of 2 or less or a PASI score of 4 or less. No significant differences in achieving a PASI score of 2 or less or a PASI score of 4 or less were seen for patients who switched to Amjevita and Imraldi versus those who continued Humira."In this study, Amjevita and Imraldi were as effective as the originator Humira for the treatment of psoriasis," the authors write.Several authors disclosed ties to the pharmaceutical industry.

Amjetiva and Imradi as effective as Humira for new users and in switcher analysis

Biosimilars Amjevita and Imraldi as Effective as Humira for Psoriasis

WEDNESDAY, Feb. 12, 2025 -- Children with inflammatory skin diseases have an increased risk for sleep and psychological disorders, according to a study published online Feb. 6 in the Journal of the American Academy of Dermatology.Caroline Mann, M.D., from the University Medical Center Mainz in Germany, and colleagues conducted a retrospective data analysis of a U.S. Collaborative Network involving children of 55 health care providers. Data were retrieved from electronic health records of patients with a diagnosis of atopic dermatitis (AD), psoriasis, or urticaria, as well as a propensity score-matched control cohort.The researchers found that children with psoriasis had a 3.2-, 2.1-, 1.8-, and 1.9-fold higher risk for hypersomnia, sleep apnea, fatigue, and depression, respectively. Children with urticaria and AD had a 1.7-, 1.6-, and 1.4-fold higher risk for sleep disorders, anxiety disorders, and insomnia, respectively. Children with AD had a 1.5-fold increased risk for anxiety disorders."Our findings might be of particular interest for physicians to improve patient monitoring and early screening and treatment [to] potentially prevent onset of these comorbidities, thereby positively influencing the development into adulthood of children with inflammatory skin diseases," the authors write.Several authors disclosed ties to the pharmaceutical and skin care industries.

Risks increased for hypersomnia, sleep apnea, fatigue, and depression for children with psoriasis

Sleep, Psychological Disorders More Prevalent With Pediatric Inflammatory Skin Disease

WEDNESDAY, Jan. 15, 2025 (HealthDay News) -- Cutaneous lupus erythematosus (CLE) is associated with an increased risk for atherosclerotic cardiovascular disease (ASCVD), similar to the risk seen in association with systemic lupus erythematosus (SLE), according to a study published online Dec. 4 in JAMA Dermatology.Henry W. Chen, M.D., from the University of Texas Southwestern Medical Center in Dallas, and colleagues examined the incidence and prevalence of ASCVD among individuals with CLE, SLE, and psoriasis versus a disease-free control group in a retrospective longitudinal cohort study. The study included 8,138 persons with CLE, 24,675 with SLE, 192,577 with psoriasis, and 81,380 controls.The researchers found that the odds of ASCVD were higher for patients with CLE and SLE than controls (odds ratios, 1.72 and 2.41, respectively), but not for those with psoriasis, in a multivariable analysis. Incidence rates of ASCVD were highest for individuals with SLE, followed by CLE, psoriasis, and controls at a median follow-up of three years (24.8, 15.2, 14.0, and 10.3 per 1,000 person-years, respectively). The highest risk for incident ASCVD was in those with SLE followed by CLE in multivariable Cox proportional regression modeling with the control groups as a reference group (hazard ratios, 2.23 and 1.32, respectively); the risk in those with psoriasis was not significantly increased."Clinicians caring for persons with CLE can counsel patients regarding the importance of a heart-healthy lifestyle including diet, exercise, and smoking avoidance," the authors write. "Regular monitoring of blood pressure and cholesterol and prompt treatment can also be recommended in this population."Several authors disclosed ties to the pharmaceutical industry.<a target="_blank" rel="noopener noreferrer" href="https://jamanetwork.com/journals/jamadermatology/article-abstract/2826498">Abstract/Full Text (subscription or payment may be required)</a>

Increased odds of atherosclerotic cardiovascular disease seen in association with CLE and SLE, but not psoriasis

Risk for Atherosclerotic CVD Up in Association With Cutaneous Lupus Erythematosus

MONDAY, Dec. 30, 2024 -- For treatment of scalp psoriasis, the efficacy and safety of tildrakizumab seen at week 16 (W16) are maintained through week 52 (W52), according to a study published online Dec. 22 in the Journal of the American Academy of Dermatology.Howard L. Sofen, M.D., from the David Geffen School of Medicine at UCLA in Los Angeles, and colleagues examined maintenance of tildrakizumab efficacy and safety for the treatment of scalp psoriasis, which was demonstrated in the primary analysis of a phase 3b randomized trial at W16. Patients randomly assigned to tildrakizumab continued to receive tildrakizumab 100 mg every 12 weeks, while those randomly assigned to placebo were switched to tildrakizumab 100 mg at W16 (received tildrakizumab 100 mg at W16, W20, W32, and W44).The researchers found that in patients originally randomly assigned to tildrakizumab versus placebo, the efficacy end points of Investigator Global Assessment modified 2011 (scalp) score of 0 or 1 with improvement of two grades or greater rose from 49.4 versus 7.3 percent at W16 to 62.9 versus 56.1 percent at W52. Furthermore, a ≥90 percent improvement in the Psoriasis Scalp Severity Index score from baseline improved from 60.7 versus 4.9 percent at W16 to 65.2 versus 57.3 percent at W52. Response was maintained by more than 80 percent of W16 responders to tildrakizumab. There were no treatment-related serious adverse events reported."The results in the present study demonstrate the efficacy and safety of tildrakizumab for the treatment of scalp psoriasis are maintained for up to 52 weeks of treatment in a clinical trial setting," the authors write.Several authors disclosed ties to pharmaceutical companies, including Sun Pharma, which manufactures tildrakizumab and funded the study.

Efficacy and safety for scalp psoriasis, seen at week 16, are maintained through week 52

Efficacy, Safety of Tildrakizumab Maintained Through 52 Weeks for Scalp Psoriasis

TUESDAY, Dec. 3, 2024 (HealthDay News) -- High ultraprocessed food (UPF) intake is associated with active psoriasis, according to a research letter published online Nov. 27 in JAMA Dermatology.Laetitia Penso, Ph.D., from Paris-Est University, and colleagues performed a cross-sectional study using data from the Nutri-Net-Santé cohort study to examine the association between UPF intake and active psoriasis. Participants were classified by their psoriasis status (never-had; nonactive; active) using a validated self-diagnosis questionnaire. UPF intake in grams/day was extracted and divided into tertiles, from minimum to maximum intake (tertiles 1 and 3, respectively). Data were included for 18,528 participants, of whom 1,825 (10 percent) had psoriasis, with 803 active cases (4 percent). Compared with the never-had and nonactive groups, the active-psoriasis group had a lower proportion of females and a higher proportion of individuals with a body mass index (BMI) greater than 30 kg/m2. High-intensity physical activity occurred less often in the active and nonactive groups than the never-had group. The researchers found that UPF intake differed between the active and never-had groups in an unadjusted analysis (tertile 3 odds ratio, 1.52). High UPF intake was more likely than lower UPF intake in the active group after adjustments (tertile 3 adjusted odds ratio, 1.36)."After adjustments for age, BMI, alcohol intake, and comorbidities, the results remained significant, suggesting that UPF intake has a proinflammatory action separate from high BMI," the authors write.<a target="_blank" rel="noopener noreferrer" href="https://jamanetwork.com/journals/jamadermatology/article-abstract/2827133">Abstract/Full Text (subscription or payment may be required)</a>

Association persists after adjustment for age, BMI, alcohol intake, and comorbidities

High Ultraprocessed Food Intake Linked to Active Psoriasis

WEDNESDAY, Dec. 4, 2024 -- For patients with psoriasis, the safety profile is consistent and clinical response durable with three years of deucravacitinib, according to a study published online Nov. 27 in JAMA Dermatology.April W. Armstrong, M.D., M.P.H., from the University of California Los Angeles David Geffen School of Medicine, and colleagues examined the long-term safety and efficacy of deucravacitinib through three years in the randomized PSO-1/PSO-2 trials and the nonrandomized long-term extension (LTE) trial conducted in patients with moderate-to-severe plaque psoriasis. Overall, 513 of the 1,519 patients who received one or more doses of deucravacitinib received continuous deucravacitinib from day 1 and entered the LTE trial. The researchers found that in the one- versus three-year cumulative periods, exposure-adjusted incidence rates (EAIRs) per 100 person-years were decreased or similar for adverse events (229.2 versus 144.8), serious adverse events (5.7 versus 5.5), discontinuations due to adverse events (4.4 versus 2.4), and deaths (0.2 versus 0.3). The incidence rates of the most common adverse events during the one- and three-year cumulative periods were nasopharyngitis (26.1 versus 11.4 EAIR per 100 person-years ≥5), COVID-19 (0.5 versus 8.0), and upper respiratory tract infection (13.4 versus 6.2). For adverse events of interest, including herpes zoster, major adverse cardiovascular events, and malignant diseases, EAIRs remained low and were reduced or comparable at the one- and three-year cumulative periods. Throughout three years, clinical response rates were maintained."These findings provide additional support for deucravacitinib as an efficacious and well-tolerated, long-term treatment for patients with moderate-to-severe plaque psoriasis," the authors write. Several authors disclosed ties to pharmaceutical companies, including Bristol Myers Squibb, which manufactures deucravacitinib and funded the study.

Safety profile consistent, clinical response durable among patients with moderate-to-severe plaque psoriasis

Durable Response Seen With Three Years of Deucravacitinib in Psoriasis

WEDNESDAY, Nov. 6, 2024 -- Patients with stage III or IV cancer treated with immune checkpoint inhibitors (ICIs) have an increased risk for psoriasis, according to a study published online Nov. 6 in JAMA Dermatology.Sheng-Yin To, from the National Defense Medical Center in Taipei, Taiwan, and colleagues examined the psoriasis risk associated with ICI use among patients with cancer in a nationwide cohort study with a target trial emulation design using data from the Taiwan National Health Insurance database and the Taiwan Cancer Registry. Participants received antineoplastic medications for cancer at stages III and IV; patients treated with ICIs were classified as ICI users (3,188 patients), while those receiving chemotherapy or targeted therapies were non-ICI users (132,042 patients).The researchers found that the incidence of psoriasis was higher for ICI users versus nonusers (5.76 versus 1.44 cases per 1,000 person-years). ICI users were found to have a twofold increase in the risk for developing psoriasis after adjustment for demographics and comorbidities (inverse probability of treatment weighting [IPTW]-adjusted hazard ratio, 3.31; IPTW-adjusted subdistribution hazard ratio, 2.43). Consistent findings were seen in as-started design and on-treatment design. Across all follow-up intervals and all sensitivity analyses, results were consistent and robust."Although this adverse effect is relatively uncommon, it is important for medical professionals, clinicians, and caregivers to be aware of this potential risk to improve skin health and ensure optimal cancer care," the authors write.One author disclosed ties to IQVIA.

ICI users have about a twofold increase in risk for developing psoriasis, with findings consistent across all follow-up intervals

Risk for Psoriasis Increased With Immune Checkpoint Inhibitor Use in Cancer

MONDAY, Sept. 30, 2024 (HealthDay News) -- For plaque or guttate psoriasis, home-based narrowband ultraviolet B phototherapy is as effective as office-based phototherapy, according to a study published online Sept. 25 in JAMA Dermatology to coincide with the annual meeting of the European Academy of Dermatology and Venereology, held from Sept. 25 to 28 in Amsterdam.Joel M. Gelfand, M.D., from the University of Pennsylvania in Philadelphia, and colleagues conducted an open-label, parallel-group, noninferiority randomized clinical trial involving participants aged 12 years or older with plaque or guttate psoriasis who were candidates for home- and office-based phototherapy.Overall, 393 participants received home-based phototherapy and 390 received office-based phototherapy. Ninety-three of the patients (11.9 percent) were receiving systemic treatment. The researchers found that the mean Physician Global Assessment (PGA) was 2.7 and Dermatology Life Quality Index (DLQI) was 12.2 at baseline. At week 12, 32.8 and 25.6 percent, respectively, of those receiving home-based phototherapy and office-based phototherapy achieved clear/almost clear skin, and 52.4 and 33.6 percent, respectively, achieved a DLQI of 5 or lower. In the overall population and across all skin phototypes, home-based phototherapy was noninferior to office-based phototherapy for PGA and DLQI. Compared with office-based phototherapy, home-based phototherapy was associated with better treatment adherence (51.4 versus 15.9 percent of patients), a lower burden of indirect cost to patients and more episodes of persistent erythema (5.9 versus 1.2 percent of treatments)."Efforts should be made to make these safe, effective, and relatively inexpensive treatment options more available to patients in the modern era of psoriasis therapeutics," the authors write.Several authors disclosed ties to the pharmaceutical industry.<a target="_blank" rel="noopener noreferrer" href="https://jamanetwork.com/journals/jamadermatology/fullarticle/2823901">Abstract/Full Text</a><a target="_blank" rel="noopener noreferrer" href="https://eadv.org/congress/">More Information</a>

For plaque or guttate psoriasis, home-based phototherapy noninferior to office-based phototherapy for PGA and DLQI

Home-Based Phototherapy as Effective as Office-Based for Psoriasis

FRIDAY, Aug. 9, 2024 (HealthDay News) -- There are racial differences in the frequency of skin biopsy for psoriasis, indicating diagnostic uncertainty, according to a research letter published online Aug. 7 in JAMA Dermatology.Fahad Ahmed, from the Perelman School of Medicine at the University of Pennsylvania in Philadelphia, and colleagues conducted a cross-sectional study involving adults seen in outpatient dermatology clinics to examine skin biopsy frequency, as an indicator of diagnostic uncertainty, by race and ethnicity among patients with psoriasis. A total of 10,008 patients were included in the study.The researchers found that 4.8 percent of patients received a skin biopsy for psoriasis. Skin biopsies were performed most frequently among Black patients (9.8 percent), followed by Asian or other Pacific Islander, White, unknown race, Hispanic, and other race patients (4.7, 4.1, 4.0, 3.7, and 1.61 percent, respectively). Compared with White patients, Black patients had significantly higher odds of receiving a skin biopsy for psoriasis in analyses adjusted for sociodemographic and health care utilization factors (odds ratio, 2.03). In sensitivity analyses that evaluated both narrower and broader definitions of a skin biopsy for psoriasis, the findings were robust. "These findings add to the limited literature on diagnostic uncertainty by patient race and ethnicity in the clinical setting; they confirm similar findings from a small prior study and provide important granularity on the association between specific racial and ethnic groups and the likelihood of skin biopsy for psoriasis," the authors write.One author disclosed ties to the pharmaceutical industry.<a target="_blank" rel="noopener noreferrer" href="https://jamanetwork.com/journals/jamadermatology/article-abstract/2822205">Abstract/Full Text (subscription or payment may be required)</a>

Skin biopsies, indicating diagnostic uncertainty, performed most frequently for Black patients

Racial Differences Identified in Frequency of Biopsy for Psoriasis

WEDNESDAY, Aug. 7, 2024 -- For patients with moderate-to-severe psoriasis receiving guselkumab, with early skin clearance at two consecutive visits, extending the dosing interval is noninferior to maintaining the dosing interval, according to a study published online July 31 in JAMA Dermatology.Kilian Eyerich, M.D., from the University of Freiburg in Germany, and colleagues examined early intervention with and prolonging the dosing interval for guselkumab in patients with moderate-to-severe psoriasis as part of the GUIDE phase 3b clinical trial. In GUIDE part 1, patients received guselkumab 100 mg at week (W) 0, 4, 12, and 20; those achieving a Psoriasis Area and Severity Index (PASI) of 0 at both W20 and W28 were considered super responders (SRes). SRes were randomly allocated to guselkumab 100 mg every eight or 16 weeks in part 2 (148 and 149 patients, respectively), while non-SRes continued open-label guselkumab every eight weeks (525 patients).The researchers found that the primary end point of noninferiority of guselkumab every 16 versus every eight weeks was met in SRes, with 91.9 and 92.6 percent of SRes receiving dosing every 16 and every eight weeks, respectively, having a PASI lower than 3 at W68. The clinical effects corresponded with immunologic changes; from baseline, there was a rapid decrease seen in skin CD8-positive tissue resident memory T-cell count, which remained low in both dosing groups. Significant decreases were also seen in serum interleukin (IL)-17A, IL-17F, IL-22, and β defensin-2 levels, which remained low in both groups to W68."Data from the GUIDE trial add new insights into the concepts of disease modification and long-term maintenance of efficacy," the authors write.Several authors disclosed ties to pharmaceutical companies, including Janssen, which manufactures guselkumab and funded the study.<a target="_blank" rel="noopener noreferrer" href="https://jamanetwork.com/journals/jamadermatology/fullarticle/2821677">Abstract/Full Text</a><a target="_blank" rel="noopener noreferrer" href="https://jamanetwork.com/journals/jamadermatology/article-abstract/2821681">Editorial (subscription or payment may be required)</a>

Extending the interval to 16 weeks from eight weeks is noninferior for patients with moderate-to-severe psoriasis

Extending Dosing Interval for Guselkumab Noninferior in Psoriasis

MONDAY, July 29, 2024 (HealthDay News) -- Psoriasis and psoriatic arthritis may be associated with an increased risk of polyneuropathy, according to a study published online June 28 in Muscle &amp; Nerve.Pietro E. Doneddu, M.D., from the IRCCS Humanitas Research Hospital in Milan, and colleagues evaluated the risk and features of peripheral neuropathy in patients with psoriasis and psoriatic arthritis. Analysis included 100 consecutive patients with psoriasis or psoriatic arthritis and 100 controls.The researchers found that nine patients were diagnosed with confirmed polyneuropathy, compared to no controls (relative risk, 19.00). In psoriasis patients, the relative risk for polyneuropathy was 22.09, while those with psoriatic arthritis had a relative risk of 18.75. In the nine patients with polyneuropathy, presentation was length-dependent, symmetrical, and predominantly sensory, with minimal or no disability. Compared to controls, comorbidities and exposure to therapies known to increase the risk of polyneuropathy were more frequent in those with psoriasis or psoriatic arthritis (4 versus 42 percent). When excluding possible contributory causes, risk of polyneuropathy was not significant in patients with psoriasis or psoriatic arthritis. "This increased risk seems to be linked to the higher prevalence of contributing factors for polyneuropathy, rather than a direct increase in neuropathy risk specifically related to psoriasis and psoriatic arthritis," the authors write.<a target="_blank" rel="noopener noreferrer" href="https://onlinelibrary.wiley.com/doi/epdf/10.1002/mus.28196">Abstract/Full Text (subscription or payment may be required)</a>

However, increased risk seems to be linked to the higher prevalence of contributing factors for polyneuropathy

Psoriasis, Psoriatic Arthritis Tied to Higher Risk of Polyneuropathy

THURSDAY, July 18, 2024 (HealthDay News) -- Long-term exposure to air pollution is associated with the development of new psoriasis, according to a study published online July 16 in JAMA Network Open.Junhui Wu, Ph.D., from the Peking University School of Nursing in Beijing, and colleagues examined the association between long-term exposure to air pollution and psoriasis and the interaction between air pollution and genetic susceptibility for incident psoriasis. The analysis included 474,055 individuals with a median follow-up of 11.91 years.The researchers observed a positive association between the risk for psoriasis and air pollutant exposure. For fine particulate matter with a diameter &lt;2.5 μm, fine particulate matter with a diameter &lt;10 μm, nitrogen dioxide, and nitrogen oxides, every interquartile range increase yielded higher risk. Multivariate-adjusted risks were also higher when comparing individuals in the highest exposure quartile with those in the lowest exposure quartile. There were significant interactions between air pollution and genetic predisposition for incident psoriasis, with a substantial risk for psoriasis development in individuals exposed to the highest quartile of air pollution levels concomitant with high genetic risk versus those in the lowest quartile of air pollution levels with low genetic risk."There is a need to devise and implement effective interventions aimed at mitigating air pollution and safeguarding individuals from the effects associated with psoriasis," the authors write.<a target="_blank" rel="noopener noreferrer" href="https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2821169">Abstract/Full Text</a><a target="_blank" rel="noopener noreferrer" href="https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2821171">Editorial</a>

Increase in psoriasis risk also seen among those with higher genetic vulnerability and increased exposure to air pollutants

Air Pollution Exposure Tied to New Psoriasis

MONDAY, July 1, 2024 (HealthDay News) -- Psoriasis is associated with fatigue, especially among those with psoriatic arthritis (PsA), according to a study published in the July issue of the Journal of the American Academy of Dermatology.Lea Nymand, from Bispebjerg Hospital and the University of Copenhagen in Denmark, and colleagues explored the characteristics of fatigue and its potential drivers among patients with psoriasis with or without PsA. A total of 2,741 adults with psoriasis (of whom 593 also had PsA) and 3,788 controls without psoriasis completed the Multidimensional Fatigue Inventory-20 questionnaire.The researchers found that compared with the general population, the impact on total fatigue was greatest for PsA, followed by psoriasis (β = 5.22 and 2.10, respectively). Increasing joint pain intensity was associated with overall fatigue among patients with psoriasis with or without PsA (β = 2.23 for each 1-point increase in joint pain numerical rating scale score)."Main drivers of fatigue were joint pain and itch, whereas psoriasis severity had little impact on fatigue," the authors write. "These findings highlight the importance of a symptom-based approach when treating psoriasis, rather than focusing on objective severity measures alone."Several authors disclosed ties to the biopharmaceutical industry.<a target="_blank" rel="noopener noreferrer" href="https://www.jaad.org/article/S0190-9622(24)00400-6/fulltext">Abstract/Full Text</a>

Increasing joint pain intensity associated with overall fatigue in patients with psoriasis with or without psoriatic arthritis

Psoriasis, With or Without Psoriatic Arthritis, Associated With Fatigue

WEDNESDAY, June 19, 2024 -- Factors negatively associated with treatment outcomes in patients with psoriasis include previous exposure to biologics, higher body mass index (BMI), and current smoking, according to a meta-analysis published online June 18 in JAMA Dermatology.Gustav Hjort, from Copenhagen University Hospital -- Herlev and Gentofte in Denmark, and colleagues conducted a systematic review to examine the association between patient clinical characteristics and effectiveness of biologics in treating psoriasis. Studies that reported treatment outcomes as a reduction in the Psoriasis Area and Severity Index (PASI) of 75 percent (PASI 75) or PASI 90 after 12, 26, and/or 52 weeks of treatment were reviewed; data were included from 40 studies, with 21,438 patients.The researchers observed negative associations for older age, previous exposure to biologics, higher BMI, previous smoking, and current smoking with achieving PASI 90 at six months in observational studies (odds ratios [95 percent confidence intervals], 0.99 [0.98 to 1.00], 0.44 [0.29 to 0.67], 0.96 [0.94 to 0.99], 0.81 [0.67 to 0.98], and 0.78 [0.66 to 0.91], respectively). Only BMI of 30 kg/m2 or higher was negatively associated with treatment response in randomized clinical trials (PASI at three months; odds ratio, 0.57; 95 percent confidence interval, 0.48 to 0.66)."There is a lack of evidence regarding whether these effects, as well as others, vary by biologic therapy," the authors write. "Future studies on this topic may guide clinicians to stratify treatment based on patient characteristics."Several authors disclosed ties to the pharmaceutical industry.

Observational studies show negative links for older age, previous exposure to biologics, higher BMI, and smoking

Meta-Analysis Identifies Factors Linked to Treatment Outcome in Psoriasis

WEDNESDAY, April 24, 2024 (HealthDay News) -- Tobacco smoking is negatively associated with resolution of psoriasis symptoms, according to a study published in the April issue of Tobacco Induced Diseases.Yan Qiang, from the School of Medicine at Tongji University in Shanghai, and colleagues explored the influence of smoking on treatment efficacy in patients with psoriasis. The analysis included 560 patients with psoriasis (72.9 percent were men).&nbsp;The researchers found that a higher proportion of patients without tobacco smoking achieved ≥75 percent reduction in the Psoriasis Area and Severity Index (PASI75) score at week 8. For nonsmokers versus smokers, current smokers, and former smokers, the odds of PASI75 were greater (adjusted odds ratios, 11.43, 14.14, and 3.05, respectively). Compared with current smokers, former smokers had higher PASI75 achievement (adjusted odds ratio, 3.37). Individuals with younger smoking initiation age, longer smoking duration, and higher smoking intensity had lower PASI75 achievement."Tobacco smoking was negatively associated with the proportion of PASI75 achievement among patients with psoriasis, both for those with current or former tobacco smoking habits. Moreover, former smokers had a higher proportion of PASI75 achievement than current smokers," the authors write. "We recommend the implementation of tobacco control measures, the provision of patient-centered, culturally sensitive cessation guides, and bedside support to improve the treatment response among patients with psoriasis."&nbsp;<a target="_blank" rel="noopener noreferrer" href="https://www.tobaccoinduceddiseases.org/Tobacco-smoking-negatively-influences-the-achievement-of-ngreater-than-three-quarters,184143,0,2.html">Abstract/Full Text</a>

Achievement of ≥75 percent reduction in Psoriasis Area and Severity Index lower in both current, former smokers

Tobacco Smoking Reduces the Odds of Psoriasis Improvement

WEDNESDAY, April 3, 2024 -- Tildrakizumab is efficacious for patients with moderate-to-severe plaque psoriasis affecting the scalp, according to a study published online March 28 in the Journal of the American Academy of Dermatology.Kurt Gebauer, M.B.B.S., from Fremantle Dermatology in Australia, and colleagues examined the efficacy and safety of tildrakizumab in a phase 3b randomized study involving patients with moderate-to-severe plaque psoriasis affecting the scalp. Overall, 89 patients were treated with tildrakizumab 100 mg and 82 with placebo at weeks 0 and 4.The researchers found that 49.4 and 7.3 percent of those receiving tildrakizumab and placebo, respectively, achieved an Investigator Global Assessment modified 2011 (scalp) response (score of clear or almost clear with ≥2-point reduction from baseline) at week 16 and 46.1 and 4.9 percent, respectively, achieved a response at week 12. Overall, 60.7 versus 4.9 percent and 48.3 versus 2.4 percent achieved Psoriasis Scalp Severity Index 90 response at weeks 16 and 12, respectively. There were no serious treatment-related adverse events reported."Tildrakizumab 100 mg is efficacious and improves patient-reported scalp itch and quality of life compared with placebo, with no new safety signals," the authors write.Several authors disclosed ties to pharmaceutical companies, including Sun Pharma, which manufactures tildrakizumab and funded the study.

Significant improvement seen in IGA response and PSSI 90, with no serious treatment-related adverse events

Tildrakizumab Efficacious, Safe for Plaque Psoriasis of the Scalp

FRIDAY, March 15, 2024 (HealthDay News) -- Patients with psoriasis treated with bimekizumab rapidly achieve high levels of clinical and health-related quality-of-life responses that are durable at four years, according to research presented at the annual meeting of the American Academy of Dermatology, held from March 8 to 12 in San Diego.Bruce Strober, M.D., Ph.D., from the Yale School of Medicine in New Haven, Connecticut, and colleagues evaluated pooled data from three randomized, phase 3 trials and their open-label extension (OLE) trial (52-week BE VIVID, 56-week BE SURE and BE READY, and OLE BE BRIGHT) to determine the efficacy of responses to bimekizumab through four years of treatment among patients with moderate-to-severe plaque psoriasis. Patients had been randomly assigned to bimekizumab 320 mg every four weeks to week 16, received bimekizumab every four or eight weeks thereafter, and entered the OLE.The researchers found that among 771 patients who received bimekizumab continuously from baseline and entered the OLE, 90.9, 65.8, 78.5, and 71.5 percent, respectively, achieved Psoriasis Area and Severity Index (PASI) ≥90 percent improvement from baseline (PASI90), PASI 100 percent improvement (PASI100), body surface area (BSA) ≤1 percent, and Dermatology Life Quality Index 0/1 (DLQI0/1) at week 16. Durability of the responses was maintained at four years: 86.1, 64.7, 79.8, and 78.7 percent of patients achieved PASI90, PASI100, BSA ≤1 percent, and DLQI0/1, respectively."Analysis shows that through four years of bimekizumab treatment, over six out of 10 patients achieved and maintained complete skin clearance, a clinically meaningful end point and outcome for patients," Strober said in a statement. "These long-term data will be highly welcomed by the dermatology community since they provide important considerations for clinical practice."Several authors disclosed ties to biopharmaceutical companies, including UCB Pharma, which manufactures bimekizumab and funded the study.<a target="_blank" rel="noopener noreferrer" href="https://www.ucb.com/stories-media/Press-Releases/article/First-presentation-of-four-year-BIMZELXRbimekizumab-bkzx-data-showed-long-term-maintenance-of-complete-skin-clearance-in-moderate-to-severe-plaque-psoriasis">Press Release</a><a target="_blank" rel="noopener noreferrer" href="https://www.aad.org/member/meetings-education/am24">More Information</a>

After four years of bimekizumab treatment, more than six in 10 patients achieved and maintained complete skin clearance

AAD: Bimekizumab Response Durable at Four Years for Moderate-to-Severe Psoriasis

TUESDAY, March 5, 2024 (HealthDay News) -- For scalp psoriasis, 0.1 percent tacrolimus microemulsion has good efficacy and safety, according to a study published online Feb. 12 in Dermatology and Therapy.Andreas Pinter, M.D., from the University Hospital Frankfurt in Germany, and colleagues conducted a multicenter, double-blind, vehicle-controlled phase 3 trial to examine the efficacy and safety of 0.1 percent tacrolimus microemulsion when applied topically in 128 patients with scalp psoriasis.The researchers found that at eight weeks, scalp Investigator Global Assessment of 0 or 1 occurred in 28.6 percent of individuals in the tacrolimus group compared with 12.7 percent in the placebo group, indicating a significantly better response. Over time, the Dermatology Life Quality Index improved and was more pronounced in the tacrolimus- versus the placebo-treated group; after eight weeks of use, the difference was not statistically significant. No evidence of cutaneous side effects other than those known were revealed in the safety analysis. The study could not exclude toxicologically relevant serum levels of tacrolimus."In general, the results of this study are in line with a 2016 review of at least 23 studies involving more than 800 subjects evaluating topically applied tacrolimus, showing its general efficacy in treating different types of psoriasis in different areas," the authors write.Preparation of this article was supported by a grant from Bay Pharma.<a target="_blank" rel="noopener noreferrer" href="https://link.springer.com/article/10.1007/s13555-024-01102-6">Abstract/Full Text</a>

Investigator Global Assessment of 0 or 1 occurred in significantly more patients receiving tacrolimus microemulsion versus placebo

Tacrolimus Microemulsion Has Good Efficacy, Safety for Scalp Psoriasis

WEDNESDAY, Feb. 21, 2024 -- For patients with moderate-to-severe plaque psoriasis, deucravacitinib maintains efficacy and demonstrates consistent safety through two years, according to a study published online Jan. 16 in the British Journal of Dermatology.Mark Lebwohl, M.D., from the Icahn School of Medicine at Mount Sinai in New York City, and colleagues examined the safety and efficacy of deucravacitinib over two years. The POETYK long-term extension included adults with moderate-to-severe plaque psoriasis who completed the phase 3 POETYK PSO-1 or PSO-2 trials and received deucravacitinib 6 mg once daily.At data cutoff, 1,519 patients had received one or more doses of deucravacitinib; overall, 79.0 and 39.9 percent of patients had ≥52 and ≥104 weeks of total deucravacitinib exposure, respectively. The researchers found that per 100 person-years, the exposure adjusted incidence rates were similar at one and two years for adverse outcomes, including any adverse events (229.2 versus 154.4), serious adverse events (5.7 versus 6.1), discontinuations (4.4 versus 2.8), deaths (0.2 versus 0.4), and serious infections (1.7 versus 2.6). Over two years, there were no clinically meaningful changes from baseline or trends observed in hematologic, chemistry, or lipid parameters. In patients receiving continuous deucravacitinib treatment from baseline, clinical responses were maintained (≥75 percent reduction from baseline in the Psoriasis Area and Severity Index, 72.4 and 79.7 percent at weeks 52 and 112, respectively; static Physician Global Assessment score of 0/1, 57.9 and 61.1 percent at weeks 52 and 112, respectively)."These findings support deucravacitinib as a safe and efficacious durable, long-term treatment for patients with moderate-to-severe plaque psoriasis," the authors write.Several authors disclosed ties to biopharmaceutical companies, including Bristol Myers Squibb, which manufactures deucravacitinib and funded the study.

Exposure-adjusted incidence rates similar at one, two years for adverse events in patients with moderate-to-severe plaque psoriasis

Efficacy, Safety of Deucravacitinib Maintained Through Two Years

WEDNESDAY, Feb. 14, 2024 -- Apremilast improves signs and symptoms of moderate-to-severe genital psoriasis, according to a study published in the March issue of the Journal of the American Academy of Dermatology.Joseph F. Merola, M.D., from Brigham and Women's Hospital in Boston, and colleagues examined the efficacy and safety of apremilast 30 mg twice daily in patients with genital psoriasis in a phase 3 randomized trial (DISCREET). Patients with moderate-to-severe genital psoriasis were randomly allocated to apremilast or placebo (143 and 146 individuals, respectively) for a 16-week period.The researchers found that 39.6 and 19.5 percent of patients in the apremilast and placebo groups, respectively, achieved a modified static Physician Global Assessment of Genitalia response at week 16, and the 20.1 percent treatment difference was significant. There were improvements observed in genital signs and symptoms, skin involvement, and quality of life. Diarrhea, headache, nausea, and nasopharyngitis were the most common treatment-emergent adverse events reported."Results from DISCREET demonstrated statistically significant and clinically important treatment differences favoring apremilast, including meaningful improvements in disease severity and symptoms, despite participants having a long disease duration," the authors write.Several authors disclosed ties to biopharmaceutical companies, including Amgen, which manufactures apremilast and funded the study.

More patients receiving apremilast achieved modified static Physician Global Assessment of Genitalia response at week 16

Can Apremilast Improve Signs, Symptoms of Genital Psoriasis?

THURSDAY, Feb. 8, 2024 (HealthDay News) -- For patients with moderate-to-severe plaque psoriasis, the interleukin-23-receptor antagonist peptide JNJ-77242113 shows greater efficacy than placebo, according to a study published in the Feb. 8 issue of the New England Journal of Medicine.Robert Bissonnette, M.D., from Innovaderm Research in Montreal, and colleagues conducted a phase 2 dose-finding trial involving 255 patients with moderate-to-severe plaque psoriasis who were randomly assigned to receive JNJ-77242113 at a dose of 25 mg once daily, 25 mg twice daily, 50 mg once daily, 100 mg once daily, or 100 mg twice daily or placebo for 16 weeks. A reduction from baseline of at least 75 percent in the Psoriasis Area and Severity Index (PASI) score (PASI 75 response) at week 16 was the primary end point.The researchers found that the percentage of patients with a PASI 75 response was higher among those receiving JNJ-77242113 versus placebo (37, 51, 58, 65, and 79 percent in the 25-mg once-daily, 25-mg twice-daily, 50-mg once-daily, 100-mg once-daily, and 100-mg twice-daily groups, respectively, versus 9 percent), with a significant dose-response relationship observed. COVID-19 and nasopharyngitis were the most common adverse events. The percentages of patients with at least one adverse event was similar in the combined JNJ-77242113 dose group and the placebo group (52 and 51 percent, respectively)."In this phase 2 trial, JNJ-77242113, an oral interleukin-23-receptor antagonist peptide, showed a dose-response relationship and greater efficacy than placebo," the authors write.The study was funded by Janssen Research and Development, which is developing JNJ-77242113.<a target="_blank" rel="noopener noreferrer" href="https://www.nejm.org/doi/full/10.1056/NEJMoa2308713">Abstract/Full Text (subscription or payment may be required)</a><a target="_blank" rel="noopener noreferrer" href="https://www.nejm.org/doi/full/10.1056/NEJMe2314345">Editorial (subscription or payment may be required)</a>

Percentage of patients with PASI-75 response was higher with the interleukin-23-receptor antagonist peptide

JNJ-77242113 Shows Greater Efficacy Than Placebo for Plaque Psoriasis

FRIDAY, Dec. 29, 2023 (HealthDay News) -- Few randomized controlled trials involving biological agents for psoriasis treatment include patient images, according to a review published online Nov. 15 in the Journal of Dermatological Treatment.Sam Polesie, M.D., Ph.D., from the University of Gothenburg in Sweden, and colleagues conducted a systematic review to assess the proportion of shared clinical images in psoriasis trials. The review was limited to randomized controlled trials involving biological agents for the treatment of psoriasis. Data were included for 152 studies, including 62,871 randomly assigned patients.The researchers found that most investigations (77.0 percent) did not include any patient image material. A total of 203 images depicting 60 patients were identified in the manuscripts, for an overall sharing rate of 0.1 percent. Six investigations included video supplements, but only one included images from patients."We hope that this systematic review can serve as an invitation to the pharmaceutical industry and other sponsors, as well as journal editors and authors, to include more images in scientific publications. Including more clinical images with our original manuscripts could better support patient involvement," Polesie said in a statement.Two authors disclosed ties to the pharmaceutical industry.<a target="_blank" rel="noopener noreferrer" href="https://www.tandfonline.com/doi/full/10.1080/09546634.2023.2281261">Abstract/Full Text</a>

A total of 203 images were shared depicting 60 patients, for an overall sharing rate of 0.1 percent

Biological Agent Trials for Psoriasis Rarely Include Patient Images

WEDNESDAY, Dec. 27, 2023 -- For moderate-to-severe scalp psoriasis, deucravacitinib is more efficacious than placebo or apremilast, according to a study published online Dec. 18 in the Journal of the American Academy of Dermatology.Andrew Blauvelt, M.D., from the Oregon Medical Research Center in Portland, and colleagues examined the efficacy and safety of deucravacitinib in scalp psoriasis in two global phase 3 52-week double-blinded trials involving adults with moderate-to-severe psoriasis. A total of 1,084 patients with moderate-to-severe scalp psoriasis at baseline were randomly assigned to oral placebo, deucravacitinib 6 mg once a day, or apremilast 30 mg twice a day in a 1:2:1 ratio.The researchers found that compared with placebo or apremilast, response rates were greater with deucravacitinib at week 16 for a scalp-specific Physician Global Assessment score of 0 or 1 (64.0 versus 17.3 versus 37.7 percent), ≥90 percent improvement in the Psoriasis Scalp Severity Index (PSSI; 50.6 versus 10.5 versus 26.1 percent), and change from baseline in PSSI. With continuous deucravacitinib, responses were maintained through 52 weeks. Consistent safety was seen with the entire study population."Efficacy in scalp psoriasis with deucravacitinib was superior to placebo and apremilast regardless of baseline body weight, body mass index, or prior antipsoriatic treatment, and efficacy was maintained through 52 weeks in patients who received continuous deucravacitinib treatment," the authors write.Several authors disclosed ties to pharmaceutical companies, including Bristol Myers Squibb, which manufactures deucravacitinib and funded the study.

Deucravacitinib more efficacious for improving moderate-to-severe scalp psoriasis, and is well tolerated

Is Deucravacitinib Better Than Placebo, Apremilast for Scalp Psoriasis?

- 88.5% of adult patients achieved a target lesion Physician Global Assessment (tPGA) score of 0 (clear) or 1 (almost clear) and ≥ 2-grade improvement from baseline at Week 12 (tPGA Success), reinforcing strong efficacy in these areas&nbsp;- 80.8% of adult patients achieved tPGA score of 0 (clear) at Week 12, indicating complete clearance of the target plaque psoriasis lesion in the head and neck region&nbsp;- 96.2% of patients achieved ≥75% improvement in Psoriasis Area and Severity Index (PASI75) of the head and neck region at Week 12&nbsp;- 70% of the adult patients achieved the widely followed standard of improvement in itch as measured by the Peak Pruritis-Numeric Rating Scale (PP-NRS) (head and neck region) of ≥ 4 points at Week 12, with some patients achieving this meaningful reduction in itch as early as Week 1&nbsp;- 96.7% of patients strongly agreed or agreed that VTAMA cream quickly absorbs and 93.3% of subjects strongly agreed or agreed that VTAMA cream was not greasy, including hair-bearing areas such as the scalp&nbsp;- No new safety signals were observed over 12 weeks&nbsp;LONG BEACH, Calif. &amp; BASEL, Switzerland--(BUSINESS WIRE)-- Dermavant Sciences, a biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immunodermatology, today announced positive results from its Phase 4, open-label clinical trial of VTAMA® (tapinarof) cream, 1% for the treatment of plaque psoriasis in the head and neck region in adults (N=31).&nbsp;“Up to 80% of patients with plaque psoriasis experience scalp psoriasis, making it one of the most affected areas of the body. In this Phase 4 trial, a majority of the adult patients suffered from scalp psoriasis, making the outcomes from this trial significant, as they further reinforce the efficacy, safety, tolerability, and cosmetic elegance of VTAMA cream even when used in hair-bearing areas such as the head and neck region,” said Philip M. Brown, MD, JD, Chief Medical Officer at Dermavant. “The Phase 3 PSOARING studies and the Phase 4, open-label, intertriginous plaque psoriasis study combined with the Phase 4, open-label, head and neck data announced today, highlight the versatility of VTAMA cream, an efficacious, safe and well-tolerated, nonsteroidal treatment option for plaque psoriasis in all affected areas of the body.”&nbsp;This Phase 4, open-label study expands the body of data for VTAMA cream in adult plaque psoriasis. In the two 12-week Phase 3 pivotal studies (PSOARING 1 and 2; N=1025), VTAMA cream demonstrated a Physician Global Assessment (PGA) success rate* of 36% and 40% for adult patients with plaque psoriasis versus 6% for patients on vehicle at Week 12, respectively. DMVT-505-4002 (NCT05789576) was a Phase 4, open-label multicenter study to investigate the efficacy and safety of VTAMA (tapinarof) cream, 1% for the treatment of adults with plaque psoriasis specifically in the head and neck region. The efficacy of VTAMA cream was assessed using a PGA evaluation of a target plaque psoriasis lesion in the head and neck region, Scalp n=18 (58.1%), Face n=11 (35.5%), and Neck n=2 (6.5%) identified at baseline. The trial enrolled 31 participants with mild, moderate, and severe head and neck plaque psoriasis (tPGA score ≥2) aged 18 years or older at 8 sites across the US. Patients received VTAMA cream once daily for 12 weeks with a follow-up one week after study completion. Safety and tolerability were assessed by visit based on adverse events and local tolerability scores using the investigator-assessed Local Tolerability Scale (LTS) of the head and neck region and a Patient Satisfaction Questionnaire (PSQ) that was designed to assess patients’ satisfaction with VTAMA cream’s efficacy, formulation elegance, application ease, impact on daily life, and preference versus prior therapies.&nbsp;The primary endpoint of the study was the proportion of adult patients who achieved a tPGA score of 0 (clear) or 1 (almost clear) and ≥2-grade improvement from baseline at Week 12 (tPGA Success). The secondary endpoint of the study was the time to achieve tPGA Success. Additional exploratory endpoints of the study included ≥75% improvement in PASI, change from baseline in Peak Pruritus-Numeric Rating Scale (PP-NRS), ≥4-point reduction in PP-NRS, and improvement in DLQI. Efficacy and PP-NRS assessments were specific to the head and neck region.&nbsp;Phase 4 Results&nbsp;Primary and Secondary Endpoints&nbsp;<ul><li>VTAMA cream reinforced strong efficacy for the treatment of head and neck plaque psoriasis (PsO), with 88.5% of adult patients (n=23/26) achieving a tPGA Success score of 0 (clear) or 1 (almost clear) and ≥2-grade improvement from baseline at Week 12, the primary endpoint of the study.</li><li>VTAMA cream showed a rapid onset of efficacy with tPGA Success achieved as early as Week 1 in some patients, with a median time of approximately 4 weeks, the secondary endpoint of the study.&nbsp;</li></ul>Additional Endpoints&nbsp;<ul><li>At Week 12, 80.8% (n=21/26) of adult patients achieved complete clearance of the target lesion (tPGA=0) which was observed as early as Week 1 and with a median time of 8 weeks.&nbsp;</li><li>At Week 12, 96.2% (n=25/26) of patients achieved PASI75 (≥75% reduction in PASI of the head and neck region), with achievement observed as early as Week 1.&nbsp;</li><li>Onset of itch relief was apparent as early as Week 1 and increased over time with 70% (n=14/20) of patients achieving a clinically meaningful ≥4-point improvement in PP-NRS at Week 12.&nbsp;</li><li>Substantial and clinically meaningful improvement in quality of life, as indicated by a 4-point improvement in DLQI, was achieved as early as Week 1 with further improvement out to Week 12.&nbsp;</li><li>As indicated on the Patient Satisfaction Questionnaire, 93.3% (n=28/30) of subjects strongly agreed or agreed that VTAMA cream was not greasy, 86.7% (n=26/30) of subjects strongly agreed or agreed that VTAMA cream was easy to apply, and 96.7% (n=29/30) of subjects strongly agreed or agreed that VTAMA cream absorbs quickly.&nbsp;</li></ul>Safety and Tolerability&nbsp;<ul><li>VTAMA cream was well tolerated with no new safety signals.&nbsp;</li><li>The most common adverse reactions (incidence ≥ 5%) in subjects treated with VTAMA cream were folliculitis, contact dermatitis, headache, sinusitis, and seborrheic keratosis.&nbsp;</li></ul>“Plaque psoriasis is a chronic condition with a significant negative impact on patients’ quality of life. The scalp region, in particular, is one of the most difficult areas to treat. Many currently available treatment options fail to offer sustained long-term relief due to lack of practical applicability to certain body areas and limitations on the duration of use,” said G. Michael Lewitt, MD, FAAD, Board-Certified Dermatologist, Illinois Dermatology Institute. “The impressive levels of efficacy achieved by VTAMA cream in the open-label trial, where 80% of adult patients achieved complete clearance of the target lesion, is highly encouraging for both patients with plaque psoriasis and their healthcare providers. Importantly, 58% of patients enrolled in the trial had a target plaque psoriasis lesion in the scalp region, and as assessed by both the investigators and the patients in the trial, VTAMA cream demonstrated favorable tolerability even when applied in hair bearing affected areas; making it a versatile and cosmetically elegant treatment option for plaque psoriasis that can be used anywhere on the affected body areas, including the most sensitive areas as well the scalp, head, and neck areas.”&nbsp;On May 24, 2022, Dermavant announced that the FDA approved VTAMA® (tapinarof) cream, 1% for the treatment of plaque psoriasis in adults. The approval made VTAMA cream the first non-steroidal topical novel chemical entity launched for plaque psoriasis in the U.S. in more than 25 years. VTAMA cream is approved for mild, moderate, and severe plaque psoriasis - with no label safety warnings or precautions, restrictions on duration of use or body surface area. On July 15, 2022, VTAMA cream became the #1 prescribed branded topical treatment for plaque psoriasis in adultsi and to date has over 250,000 prescriptions written by over 12,000 unique prescribers†.&nbsp;IMPORTANT SAFETY INFORMATION&nbsp;Indication: VTAMA® (tapinarof) cream, 1% is an aryl hydrocarbon receptor agonist indicated for the topical treatment of plaque psoriasis in adults. Adverse Events: The most common adverse reactions (incidence ≥ 1%) in subjects treated with VTAMA cream were folliculitis (red raised bumps around the hair pores), nasopharyngitis (pain or swelling in the nose and throat), contact dermatitis (skin rash or irritation, including itching and redness, peeling, burning, or stinging), headache, pruritus (itching), and influenza (flu).&nbsp;You are encouraged to report negative side effects of prescription drugs to the FDA. Visit <a target="_blank" rel="noopener noreferrer" href="https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program">www.fda.gov/medwatch</a> or call 1-800-FDA-1088.&nbsp;See full <a target="_blank" rel="noopener noreferrer" href="https://www.vtama.com/PI/">Prescribing Information and Patient Information.&nbsp;</a>About Psoriasis&nbsp;Impacting approximately 8 million Americans and 125 million people worldwide, psoriasis is a complex autoimmune disease — meaning that the body’s immune system targets and attacks its own cells. Plaque psoriasis, also called psoriasis vulgaris, is the most common form and affects about 80% to 90% of people with psoriasis. In people with light skin, plaque psoriasis is characterized by raised, red or pink patches of skin with silvery-white scales. People with black or brown skin are more likely to have brown or violet-colored patches with silvery-white or gray scales. The scales can be itchy, painful, and disfiguring.&nbsp;Psoriasis can begin at any age, but typically appears around 15 to 25 years of age and 50 to 60 years of age. The exact cause of psoriasis is not known, but risk factors and triggers may include genetics or a family history of psoriasis, as well as stress, smoking, heavy alcohol consumption and cold or dry weather conditions. People with psoriasis are at an increased risk of developing other health conditions, including psoriatic arthritis, inflammatory bowel disease, hypertension, diabetes, obesity, and depression. In addition to physical symptoms, psoriasis can have a significant impact on a person’s quality of life and psychological health.&nbsp;About Dermavant&nbsp;Dermavant Sciences, a subsidiary of Roivant Sciences, is a biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology. Dermavant’s focus is to develop therapies that have the potential to address high unmet medical needs while driving greater efficiency in research and clinical development. The company’s medical dermatology pipeline includes earlier-development, late-stage and commercialized product candidates that target specific unmet needs in two of the largest growing immuno-dermatology markets, plaque psoriasis and atopic dermatitis, as well as other immunological and inflammatory diseases. Dermavant is marketing VTAMA® (tapinarof) cream, 1%, for the topical treatment of plaque psoriasis in adults. The FDA approved VTAMA cream for the topical treatment of mild, moderate, and severe plaque psoriasis in May 2022. Dermavant is also developing VTAMA cream for the treatment of atopic dermatitis in adults and children as young as 2 years old and released positive topline results from its ADORING 1 and 2 pivotal Phase 3 clinical trials in 1H 2023. Dermavant’s pipeline includes DMVT-506, a next generation aryl hydrocarbon receptor (AhR) agonist under development as a potential treatment option for immunological and inflammatory diseases with multiple potential routes of administration.&nbsp;For more information, please visit <a target="_blank" rel="noopener noreferrer" href="https://www.dermavant.com/">www.dermavant.com</a> and follow us on X (@dermavant) and LinkedIn (Dermavant Sciences).&nbsp;*PGA success: PGA score of 0 or 1 and ≥2-grade improvement from baseline at Week 12.&nbsp;iIQVIA National Prescription Audit (NPA) for the 3-month period ending 11/24/2023, reflecting estimates of real-world activity. All rights reserved.&nbsp;†IQVIA NPA for the period 5/20/22 to 11/24/2023, reflecting estimates of real-world activity. All rights reserved.&nbsp;©2023 Dermavant Sciences, Inc. All Rights Reserved. All trademarks are the property of Dermavant Sciences, GmbH.&nbsp;View source version on businesswire.com: <a target="_blank" rel="noopener noreferrer" href="https://www.businesswire.com/news/home/20231206358157/en">https://www.businesswire.com/news/home/20231206358157/en/</a>&nbsp;Contacts&nbsp;Gilmartin:&nbsp;&nbsp; Laurence Watts&nbsp; Managing Director&nbsp; <a href="mailto:laurence@gilmartinir.com">laurence@gilmartinir.com</a>&nbsp; 619-916-7620&nbsp;dna Communications:&nbsp;&nbsp; Angela Salerno-Robin&nbsp; Senior Vice President, Media Relations, Healthcare Senior&nbsp; <a href="mailto:ASalerno-Robin@dna-comms.com">ASalerno-Robin@dna-comms.com</a>&nbsp; 212-445-8219

New data highlights the versatility of VTAMA cream, an efficacious, safe and well-tolerated, nonsteroidal treatment option for plaque psoriasis in all affected areas of the body

Dermavant Announces Positive Results from Phase 4 Open-Label Trial of VTAMA® (tapinarof) Cream, 1% for the Treatment of Plaque Psoriasis in the Head and Neck Region in Adults 

WEDNESDAY, Oct. 25, 2023 (HealthDay News) -- Vtama (tapinarof) cream is efficacious, safe, and well tolerated for the treatment of plaque psoriasis in sensitive intertriginous areas, according to a study presented at the annual Fall Clinical Dermatology Conference, held from Oct. 19 to 22 in Las Vegas.In a phase 4 clinical trial, Howard Sofen, M.D., of Dermatology Research Associates in Los Angeles, and colleagues evaluated tapinarof cream, 1 percent, for the once-daily treatment of intertriginous plaque psoriasis among 34 adults.The researchers found that 82.8 percent of participants achieved an intertriginous Physician Global Assessment (iPGA) score of 0 (clear) or 1 (almost clear) and ≥2-grade improvement from baseline at week 12, the primary end point of the study. Two-thirds of participants (65.5 percent) achieved complete disease clearance (iPGA score of 0) at week 12, with a median time to complete disease clearance of eight weeks. Rapid onset of efficacy was seen with iPGA as early as week 2 and with a median time to iPGA success of six weeks, the secondary end point of the study. By week 4, half of patients achieved itch relief (a clinically meaningful ≥4-point improvement in Peak Pruritus-Numeric Rating Scale score), which increased to 75 percent at week 12. No new safety signals were detected, and the most common adverse reactions included folliculitis, nasopharyngitis, contact dermatitis, headache, pruritus, and influenza."The results of this phase 4 study are meaningful because patients that entered this study had suffered with extensive disease, many over 10 years duration. While the rates of disease clearance are impressive, the fast onset of Vtama cream and associated itch relief are particularly noteworthy," Sofen said in a statement. "These data, combined with those of previous studies, further indicate that Vtama cream is a safe and effective treatment for adult patients with intertriginous plaque psoriasis."The study was funded by Dermavant, the manufacturer of tapinarof.

12-week benefits include high rates of skin clearance, meaningful itch relief

Tapinarof Cream Safe, Effective for Plaque Psoriasis in Intertriginous Areas

<div class="raw-html-embed"><mux-player playback-id="02nW008a02SYRirJ6Yj2JUdIXYUvEzqIPxnQBPlbh3jp7s" env-key="ENV_KEY" metadata-video-title="LAUNCH ALERT: Bimzelx Approved For Moderate-to-Severe Plaque psoriasis" controls=""></mux-player></div>Listen as Jim Del Rosso, DO, announces the launch of Bimzelx. Dr Del Rosso comments on the innovative mechanism of action, clinical trial results, warnings, and efficacy of this groundbreaking injectable biologic agent for moderate-to-severe plaque psoriasis.&nbsp;UCB has announced that the US Food and Drug Administration has approved Bimzelx (bimekizumab) for the treatment of moderate-to-severe plaque psoriasis in adults 18 years and older.&nbsp;Bimzelx is the first and only approved psoriasis treatment that selectively inhibits interleukin 17A and interleukin 17F, 2 key cytokines that drive the inflammatory process.&nbsp;Bimzelx was evaluated in multiple Phase 3 studies, versus placebo and ustekinumab, versus placebo, and versus adalimumab. Patients treated with bimekizumab achieved superior levels of skin clearance at week 16 compared to patients who received ustekinumab, placebo, and adalimumab, with patients consistently reaching PASI-75 and PASI-90. Bimekizumab was also evaluated in a head-to-head study with secukinumab, with bimekizumab demonstrating superiority for complete skin clearance as measured by PASI-100.&nbsp;The groundbreaking biologic marks an important step forward in the treatment landscape for adults living with moderate-to-severe plaque psoriasis.

The groundbreaking injectable biologic agent demonstrates unprecedented efficacy in the treatment of psoriasis.

LAUNCH ALERT: Bimzelx Approved For Moderate-to-Severe Plaque psoriasis

WEDNESDAY, Oct. 4, 2023 -- For patients with moderate-to-severe plaque psoriasis, risankizumab treatment is associated with high levels of clear and clear/almost clear skin and significant reductions in symptoms at one year after initiation, according to a study published online Sept. 20 in the Journal of the American Academy of Dermatology.Bruce Strober, M.D., Ph.D., from Yale University in New Haven, Connecticut, and colleagues examined the real-world treatment effectiveness of risankizumab in the treatment of moderate-to-severe plaque psoriasis in a retrospective observational study conducted using the CorEvitas Psoriasis Registry. Skin clearance measures and patient-reported outcomes were analyzed overall and in subgroups based on prior biologic treatment.The researchers found that most of the 287 patients with persistent risankizumab use at one year achieved clear or clear/almost clear skin and reported significant reductions in Dermatology Life Quality Index scores, symptoms of psoriasis (fatigue, skin pain, overall itch), and impairment of work and activity."This analysis provides real-world evidence to support the use of risankizumab for patients with moderate-to-severe plaque psoriasis, regardless of prior biologic treatment history," the authors write.Several authors disclosed ties to biopharmaceutical companies, including CorEvitas LLC, which funded the study, and AbbVie, which manufactures risankizumab and funded the analysis.

High levels of clear and clear/almost clear skin, significant reductions in psoriasis symptoms reported at one year after initiation

 Risankizumab Treatment Beneficial in Real-World Psoriasis Cohort

WEDNESDAY, Sept. 20, 2023 (HealthDay News) -- Coronary microvascular dysfunction (CMD) occurs in 31.5 percent of patients with psoriasis, with disease severity and duration associated with increased risk, according to a study published in the October issue of the Journal of Investigative Dermatology.Stefano Piaserico, M.D., Ph.D., from the University of Padova in Italy, and colleagues examined the prevalence and predictors of CMD in a cohort of 448 patients with psoriasis without clinical cardiovascular disease. The participants underwent assessment of coronary microcirculation by transthoracic Doppler echocardiography.The researchers found that 31.5 percent of the patients had CMD. Independent associations with CMD were seen for higher Psoriasis Area and Severity Index (PASI), longer disease duration, presence of psoriatic arthritis, and hypertension. The risk for CMD was increased 5.8 and 4.6 percent in association with an increase of 1 point of PASI and one year of psoriasis duration, respectively."Our findings extend the observations of earlier small studies by showing a high prevalence of coronary microvascular dysfunction in asymptomatic patients with severe psoriasis and by showing that the excess microvascular dysfunction is independently associated with the severity and duration of psoriasis," the authors write.<a target="_blank" rel="noopener noreferrer" href="https://www.jidonline.org/article/S0022-202X(23)01955-3/fulltext">Abstract/Full Text (subscription or payment may be required)</a>

Independent association with CMD seen for higher PASI, longer disease duration, psoriatic arthritis, hypertension

Coronary Microvascular Dysfunction ID'd in 31.5 Percent With Psoriasis

WEDNESDAY, Aug. 9, 2023 &nbsp;-- For patients with moderate-to-severe plaque psoriasis, risankizumab is well tolerated and has high rates of efficacy through almost five years of therapy, according to a study published online Aug. 6 in the Journal of the American Academy of Dermatology.Kim A. Papp, M.D., Ph.D., from the Alliance Clinical Research and Probity Medical Research in Waterloo, Ontario, Canada, and colleagues examined the long-term safety and efficacy of risankizumab in patients with psoriasis in a phase 3, open-label extension study following multiple phase 2/3 base studies. The safety and efficacy of continuous risankizumab 150 mg every 12 weeks was examined in adults with moderate-to-severe plaque psoriasis. Safety was assessed through 304 weeks in this interim analysis.Overall, 706 of the 897 patients randomly assigned to risankizumab in the base studies were still ongoing at data cutoff. The researchers found low rates of treatment-emergent adverse events (TEAEs), TEAEs leading to discontinuation, and TEAEs of safety interest. Overall, 85.1/52.3 percent of patients achieved ≥90 percent/100 percent improvement in the Psoriasis Area and Severity Index; 85.8 percent achieved a static Physician's Global Assessment of clear/almost clear; and 76.4 percent achieved a Dermatology Life Quality Index of no effect on the patient's life at 256 weeks."These comprehensive results demonstrate a consistent long-term safety profile and high and durable clinical response with continuous risankizumab treatment for up to five years," the authors write.Several authors disclosed ties to pharmaceutical companies, including AbbVie, which manufactures risankizumab and funded the study.

Long-term treatment for up to five years was well tolerated and had high efficacy

Is Risankizumab Safe, Efficacious for Plaque Psoriasis in the Long Term?

FRIDAY, July 28, 2023 (HealthDay News) -- Lower vitamin D levels and a higher proportion of vitamin D deficiency are associated with increasing psoriasis severity, according to a study presented during NUTRITION 2023, the annual meeting of the American Society for Nutrition, held from July 22 to 25 in Boston.Rachel K. Lim, from the Warren Alpert Medical School of Brown University in Providence, Rhode Island, and colleagues examined associations between 25-hydroxyvitamin D (25[OH]D) status and psoriasis severity among 40,401 participants (491 psoriasis cases).The researchers observed a linear trend between increasing severity of psoriasis and decreasing serum 25(OH)D levels. Patients with the least body surface area (BSA) affected by psoriasis showed the highest mean 25(OH)D levels (67 nmol/L), while those with the greatest BSA had the lowest mean 25(OH)D levels (56 nmol/L). Similar results were seen when percentage of vitamin D deficiency was evaluated by BSA, with 25 percent of patients in the lowest BSA category and 39 percent of patients in the highest BSA category being vitamin D-deficient."Topical synthetic vitamin D creams are emerging as new therapies for psoriasis, but these usually require a doctor's prescription," Lim said in a statement. "Our results suggest that a vitamin D-rich diet or oral vitamin D supplementation may also provide some benefit to psoriasis patients."

Higher proportion of vitamin D deficiency seen among those with more body surface area affected by psoriasis

 Low Vitamin D Levels Tied to Higher Severity of Psoriasis

WEDNESDAY, June 28, 2023 -- For patients with generalized pustular psoriasis flare, a single infusion of the anti-interleukin-36 receptor antibody, spesolimab, leads to rapid pustular clearance and clear/almost clear skin, according to a study published in the July issue of the Journal of the American Academy of Dermatology.Boni E. Elewski, M.D., from the University of Alabama School of Medicine in Birmingham, and colleagues examined the effects of spesolimab over a 12-week study for patients presenting with a generalized pustular psoriasis flare. A total of 53 patients were randomly assigned to receive a single intravenous dose of 900 mg spesolimab or placebo on day 1 in a 2:1 ratio. On day 8, patients could receive open-label spesolimab for persistent flare symptoms.The researchers found that most patients receiving spesolimab achieved a Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) pustulation subscore of 0 (60.0 percent) and a GPPGA total score of 0 or 1 (60.0 percent) by week 12. The proportion of patients with GPPGA postulation subscore of 0 increased from 5.6 percent at day 8 to 83.3 percent at week 2 in those randomly assigned to placebo who received open-label spesolimab on day 8. No factors were identified in patient demographics or clinical characteristics that predicted spesolimab response."Although clinically meaningful improvements can be achieved in most patients with a single dose, an optional second dose may be needed in some patients," the authors write.Several authors disclosed ties to pharmaceutical companies, including Boehringer Ingelheim, which manufactures spesolimab and funded the study.

Spesolimab effects rapid control, with 60 percent of patients achieving GPPGA pustulation subscore of 0 and GPPGA total score of 0 or 1 by week 12

Does Spesolimab Control Generalized Pustular Psoriasis Flare Symptoms?

WEDNESDAY, June 21, 2023 (HealthDay News) -- Patients with moderate-to-severe psoriasis have lower fertility rates than women without psoriasis, according to a study published online June 7 in JAMA Dermatology.Teng-Chou Chen, Ph.D., from the School of Health Sciences at the University of Manchester in the United Kingdom, and colleagues used data from 63,681 patients with psoriasis and 318,405 matched controls to assess differences in fertility rates and obstetric outcomes.The researchers found lower fertility rates (rate ratio, 0.75) among patients with moderate-to-severe psoriasis. Pregnancies in patients with psoriasis had a higher risk for loss (odds ratio, 1.06) compared with pregnancies in matched controls without psoriasis. The two groups were similar with respect to the risks for antenatal hemorrhage, preeclampsia, and gestational diabetes."In this cohort study, patients with moderate-to-severe psoriasis had a lower fertility rate, and the risk of pregnancy loss was higher than in matched comparators without psoriasis," the authors write. "Future research should identify the mechanism of increased risk of pregnancy loss among patients with psoriasis."Several authors disclosed financial ties to the pharmaceutical industry.

Additionally, risk for pregnancy loss is higher in patients with psoriasis

Moderate-to-Severe Psoriasis Tied to Lower Fertility Rates in Women

WEDNESDAY, June 14, 2023 (HealthDay News) -- Guselkumab is consistently effective across subpopulations for the treatment of moderate-to-severe plaque psoriasis, according to a study published June 1 in the Journal of the European Academy of Dermatology &amp; Venereology.Knut Schäkel, M.D., from Heidelberg University Hospital in Germany, and colleagues evaluated the impact of early disease intervention on clinical responses following 28 weeks of guselkumab treatment in patients with moderate-to-severe plaque psoriasis. The analysis included 880 patients with a short disease duration (SDD; no more than two years; 40.6 percent) or a long disease duration (LDD; more than two years) receiving guselkumab 100 mg at weeks 0, 4, 12, 20, and 28.The researchers found that more patients with SDD achieved absolute Psoriasis Area and Severity Index (PASI) scores of 0 at week 28 (51.8 versus 39.4 percent among LDD patients) and were super responders with complete skin clearance from weeks 20 to 28 (43.7 versus 28.1 percent). The median time to PASI of 0 was shorter among SDD patients than LDD patients (141 versus 200 days). Disease duration and prior biologic use were not independently associated with super response status. Across all patient groups, guselkumab was associated with a rapid decrease in markers of systemic inflammation at week 4."The proportion of [super responders] was higher in SDD than LDD patients, indicating early treatment intervention may improve clinical outcomes," the authors write.Several authors disclosed ties to pharmaceutical companies, including Janssen-Cilag, which manufactures guselkumab and funded the study.

Systemic responses seen across patient groups, but more complete skin clearance seen with short disease duration

Early Intervention for Psoriasis With Guselkumab Tied to Complete Response

WEDNESDAY, June 7, 2023 -- For patients with psoriasis, higher rates of exacerbation after COVID-19 vaccination are seen for those with low vitamin D levels, according to a study published online May 23 in Frontiers in Medicine.Emmanouil Karampinis, from the University of Thessaly in Larissa, Greece, and colleagues conducted a retrospective study measuring alterations in the Psoriasis Activity and Severity Index not exceeding two weeks after the first and second doses of COVID-19 vaccinations and examined whether these changes were associated with vitamin D levels. The case records of all patients with a documented flare-up after COVID-19 vaccination and those without, during one year, were reviewed.Data were included from 40 psoriasis patients who reported vitamin D levels in the form of 25-hydroxyvitamin D within three weeks of vaccination, including 23 and 17 with and without exacerbation, respectively. The researchers found that psoriasis exacerbation after vaccination was negatively associated with summer, while there was a positive association seen for vaccination during spring with disease flare-up. Vitamin D levels were associated with exacerbation, with a mean value of 31.13 ± 6.67 ng/mL for psoriasis patients without exacerbation, which was significantly higher than the mean value of 23.43 ± 6.49 ng/mL for patients with an exacerbation."Higher rates of exacerbation occurred in patients with low vitamin D, while lower rates of psoriasis exacerbation were observed during summer -- a season with extent sun-exposure," the authors write.

Higher rates of exacerbation after COVID-19 vaccination seen for patients with psoriasis and low vitamin D levels

Is Low Vitamin D Tied to Psoriasis Exacerbation After COVID-19 Vaccination?

WEDNESDAY, May 31, 2023 -- For patients with psoriasis, the efficacy and safety of biosimilars and originators are not clinically or statistically significantly different, according to a review published online May 31 in JAMA Dermatology.Duc Binh Phan, from the University of Manchester in the United Kingdom, and colleagues compared the efficacy/effectiveness and safety of biosimilars to originator biologics for treatment of psoriasis. Data were included from 14 trials and three cohort studies.Overall, 12 trials compared biosimilars with originators in originator-naive patients and 11 trials compared switching from originator to biosimilar with continuous originator treatment. The researchers found that between the comparators, there was no clinically or statistically significant difference in the rates of achieving 75 percent improvement in Psoriasis Area and Severity Index scores or in the risks for adverse events at week 16 and week 52. In two cohort studies, effectiveness and safety outcomes did not differ between originators and biosimilars; more adverse events were seen in patients who switched to biosimilars of adalimumab at 12 months in one study. A low risk for bias was seen in three trials, while 11 trials had a moderate risk for bias and all cohort studies had a moderate-to-high risk for bias."Biosimilars are an important and rapidly expanding class of biologic drugs. From a societal point of view, adopting biosimilars could provide advantages, including improved access to treatment for a larger basis of patients and cost savings on drugs," write the authors of an accompanying editorial.One author disclosed ties to the pharmaceutical industry.

Review finds no clinically or statistically significant difference in rates of achieving PASI-75 or adverse events for biosimilars, originator biologics

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