Figure 1. Images post-treatment (B, D, F, H) of affected skin areas treated with once-daily tapinarof cream 1% for 8 weeks. 

Figure 1. Images at baseline (A, C, E, G) of affected skin areas treated with once-daily tapinarof cream 1% for 8 weeks. 

Case author Naiem T. Issa, MD, PhD, presents a case of a 10-year old white male with a 5-year history of atopic dermatitis, allergic rhinitis and exercise-induced asthma. 

Utility of Tapinarof Cream 1% in a Case of Severe and Recalcitrant Atopic Dermatitis In a Pediatric Patient

Controlling the Wolf in Sheep’s Clothing: Managing Pediatric Atopic Dermatitis with Biologic Therapies

Discuss the burden of moderate-to-severe atopic dermatitis (AD) and its associated comorbidities on pediatric patients’ quality of life

Identify the immune pathways implicated in the pathophysiology of moderate-to-severe AD

Apply recent clinical data for biologic therapies into the management of pediatric moderate-to-severe AD in order to prevent progression

PEDS25: Controlling the Wolf in Sheep’s Clothing: Managing Pediatric Atopic Dermatitis with Biologic Therapies: An Online Activity

Shining a Light on IL-13: Optimizing Moderate-to-Severe Atopic Dermatitis Treatment in Daily Practice

Differentiate biologic therapies targeting IL-13 based on their clinical profile

Review emerging clinical data for IL-13 biologics in the treatment of moderate-to-severe AD

Identify patients with moderate-to-severe AD eligible for biologic therapy according to the 2023 American Academy of Dermatology guidelines

Shining a Light on IL-13: Optimizing Moderate-to-Severe Atopic Dermatitis Treatment in Daily Practice: An Online Activity

Discuss strategies for effective clinical management of patients with atopic dermatitis (AD) inadequately controlled with biologic treatment 

Identify patients with moderate-to-severe AD for systemic therapy with Janus kinase (JAK) inhibitors 

Select the appropriate dose of JAK inhibitors to optimize treatment of AD

WCM25: Path to Relief: Advancing Care in Atopic Dermatitis With JAK Inhibitors: An Online Activity

Identify the burden of atopic dermatitis (AD) and plaque psoriasis on pediatric patients’ quality of life

Review the latest clinical evidence on approved and emerging non-steroidal topicals to manage AD and plaque psoriasis in pediatric patients

Outline practical and communication strategies for managing pediatric patients with AD and plaque psoriasis

PEDS24: Paving the Way for Non-Steroidal Topicals for Pediatric Patients With Atopic Dermatitis and Plaque Psoriasis: An Online Activity

Discuss optimization of treatment selection based on head-to-head data on systemic Janus kinase (JAK) inhibitors in moderate-to-severe atopic dermatitis 

Review long-term benefit-risk profile for systemic JAK inhibitors for the treatment of moderate-to-severe AD

Identify strategies to employ new efficacy targets in the treat-to-target framework for the management of moderate-to-severe atopic dermatitis 

Describe shared decision-making approaches for managing moderate-to-severe atopic dermatitis with systemic JAK inhibitors 

FC24: Is EASI 75 Good Enough or Can We Do Better? Elevating Efficacy and Long-Term Safety With JAK Inhibitors in Moderate-to-Severe Atopic Dermatitis: An Online Activity

Review emerging long-term data for nonsteroidal topical agents for the treatment of atopic dermatitis (AD) 

 Identify patients with AD who are eligible candidates for nonsteroidal topical agents

FC24: Gamechangers in Nonsteroidal Topical Management of Atopic Dermatitis: The Next Generation: An Online Activity

Recognize the burden of itch in chronic, recurrent flares in moderate-to-severe atopic dermatitis (AD) despite topical corticosteroid use

Discuss the role of interleukin (IL)-13 in the pathophysiology of the AD disease course

2024 Virtual Grand Rounds Session 16: November 20, 2024 - Lighting the Path for IL-13’s Role in Atopic Dermatitis

Describe the novel mechanisms of action of targeted atopic dermatitis (AD) therapies

Review the efficacy and safety from key clinical trials in emerging therapies for atopic dermatitis (AD)

2024 Virtual Grand Rounds Session 12: September 25, 2024 - New Targets in Atopic Dermatitis: What’s on Deck?

Describe how biologics target the disease pathway for AD

Review the clinical trial data for biologics to treat moderate-to-severe AD

Discuss the safety profile of biologics and how to manage adverse effects 

'HowTo' Closing the Healthcare Gaps in the Management of Moderate-to-Severe Atopic Dermatitis With Biologics: Microlearning CME Activity

Hello, I'm Dr. Jim Dorasso, and I'm happy to bring to you how to close the healthcare gaps in the management of moderate to severe atopic dermatitis with biologics, supported by an educational grant from Lilly. So this is how to for dermatologists. And who better than to have with me Dr. Peter Leo from Chicago, well known for his knowledge in atopic dermatitis and other areas, and Dr. To April Armstrong, who comes to us as chief of the division of dermatology at UCLA. The good news is this program is accredited for the CME credit. You get zero point 25 AMA category one credits. So be sure that you claim them. The learning objectives are here. And basically, this is going to be a conversation to show dermatologists how to. So at this point, I'd like to open the discussion to Dr. Leo or Dr. Armstrong, whoever wants to go first. How do you decide when to start a systemic or a biologic agent for a patient with atopic dermatitis? I'll jump right in first and I'll say, I think this is an exciting area that is rapidly changing because even just as recently as six years ago, we didn't have biologics. So there's still a relatively new addition to our armamentarium. And for me, what I'm finding is that little by little, my threshold is going down where I might start it. So this is a moving target. But ultimately, we want to try, of course, to do our topical therapies, make sure they're maximizing that we want to make sure that we really have the correct diagnosis, because some of the referrals, I'm sure we all get, it's like, wait a minute, is this really atopic dermatitis? Should we do patch testing? Should we do a biopsy to make sure the reason this is failing is because we've got the wrong disease? And then, of course, we want to ensure that it's having a big impact on quality of life. If those are met, if we know we've tried our best with topicals, we know it is atopic derm and it's having a big impact. I think that is a very reasonable time to say, listen, the next step is going to be systemic. And generally speaking, our first line, systemic therapy, is going to be a biologic. Yeah, question about that, April, I'll ask you, is Peter said about starting with topical therapies, but a lot of times we see patients that come in that have really extensive disease, severe disease, they've been around the block a few times, and we're going to want to start systemic therapy right away along with topicals. Do you agree with that? Absolutely. I think when we first assess patients disease severity, and Peter couldn't have said it better in terms of looking at the history of patients and assessing for disease burden, I think disease severity definitely is one of those things that reigns supreme in this decision making process. I just want to offer also a practical tip of what payers are looking for. And this is really important because sometimes they have these automated systems where they scan your note and then looking for the keywords there. So very important. Moderate to severe atopic dermatitis, if you put any numbers there. So they're looking for BSA 10% or greater. If you put an easy score, they're looking for easy score, 16 or greater. And if you put IGA score, they're looking for IGA score three or greater. And the reason is because these are typically the parameters in which the patients were evaluated in the clinical trials. And knowing what they're looking for, I think can be very important in terms of getting our medications approved for our patients. And I find that it's important to capture anything they previously used and how it interferes with their life, interferes with sleep, missing work, et cetera. Now, I've been in practice for 37 years. So for 30 years, I did not have any of these right. So I've been practicing in, I don't want to say the stone age, but these agents are new. It's a lot to learn for a lot of people, even new people coming out, a lot of new information. So how do you decide whether these are the same when you're looking at different agents or whether there are differences between them, how do you distinguish that? Peter, let's go back to you. I think it is a challenge because even for the nerdy ones of us who are focused on these, the ones that we have right now, and we, of course, have two approved in the United States, with a third really close to being approved. It's already approved in Europe, but hopefully we'll have it here soon. So we have dupliumab, trailokinumab and waiting in the wings, lebrechizumab. Now, it's important, and I'm going to turn it over to April to tell us how they're different, but it's important to know that they're targeting roughly the same pathway. They're really focused on IL 13, and dupliumab, of course, also gives us aisle four. But generally speaking, this is kind of the same mechanism, and this is not something totally different. We have other different mechanisms like the jack inhibitors, and we have things like anti IL 30 ones coming, but these guys are all kind of tightly focused. And then maybe, April, you could tell us, because you do it beautifully, about how molecularly they're slightly different and what that might mean. Let's take a look at the MoA of these biologics. Dupilamab is a receptor binder. So you see dupilamab here, monoclonal antibody binding to Il four receptor alpha, thereby inhibiting the signaling of Il four as well as IL 13. When we look at trailoquinumab, trailoquinumab here binds to IL 13 as a ligand binder, and it binds to IL 13 at a site such that IL 13 cannot interact directly with its native receptor. When we look at lebrechizumab, it's different from trilokinumab in that lebrchizumab, while binding to IL 13 ligand directly, it binds to a site where IL 13 can still interact with its native receptor. However, inhibits IL 13 signaling by preventing the dimerization between the two subunits of the receptor. Here. Another difference between lebricizumab and trailokinumab is that when we look at trailokinumab, trilocinumab bound IL 13 cannot interact with its decoy receptor, whereas leprechizumab bound IL 13 can still interact with its decoy receptor. Now, the significance of that is still unknown, but something that we're continuously hoping to study. Yeah, I think it's important because Peter was talking about how they're very similar in their mechanism, but I think we have to make sure people understand there are a lot of differences between these different agents, and you can't think of them as entirely being interchangeable. They have differences in their dosing. They have differences in their pharmacokinetics. They have differences in where they bind and their binding affinities. You may have an adverse event from one where you don't necessarily have that same adverse event from the other. You may have differences in how patients respond. So it's still nice to have these choices. It's not like they're all, I'll use PETA's favorite food, pizzas that all taste the same. There are differences between them. They're slices of pizza, but they're a little different from one another. So I'll ask the final question. When patients come in and you want to start one of these systemic biologic agents and even some of the other agents that we have, systemic agents and they ask, am I going to be on this forever? It's a long term disease, right? So how do you address that with the patients? Peter, I'll go back to you. The key question my patients ask me, and I'm really happy to say that for at least some, and I never want to over promise and under deliver. So I under promise it when I say it. But I say for at least some patients, if they do well for a period of time, and usually I say on the order of months or even maybe a year or two, where they're stable and comfortable and clear, I truly believe that patients can come off of these medicines and sometimes be in a relative state of remission. And we've seen this both in kind of the natural history of the disease, where I've had patients who've had to stop it for varying reasons. Maybe they're going to try to conceive or they're going to go out of the country, and then I followed up with them and they've actually done okay. And of course, we know that for trailocinumab, it actually even has a decreased dosing regimen for when they're doing well, and increased interval at monthly instead of every two weeks. So we can already see that we can at least taper in some of these situations or potentially even take a break for some patients. And I think that's pretty exciting. April, you have anything to add on that? Yes. I think when we look at our various biologics, and if we look at some of our long term data from some of these biologics, you look at sometimes I have this withdrawal arm where the patients are actually taken off of the medication. And what is seen is that actually there is a good maintenance of response, actually, especially in patients who have been responders in the first place. So that do tell us that, in fact, there are some patients, perhaps you can get these even greater than the approved increase in terms of the interval in which you can get them to be off the drug and still maintain that response. I have to say it's a very individualized decision. I typically want to see my patients to first of all achieve clear, because if they don't achieve clear, they have some type of subclinical inflammation that tells me that maybe we're not able to stretch out, for example, the dosing interval. So if they have been clear on the dosing that they are approved to be on for a while, then I think it's not unreasonable to consider possibly longer dosing intervals for our patients. What I use as my measuring stick is not always to wait for the examiner's dermatitis to appear, but when their itching starts to come back because it's the itch that rashes, remember. Now I understand why they told me that back in the 1980s when I was a resident. But one of the things I think is important, when patients ask, am I going to be on this forever? They don't know how much better they can be. They've been living with the disease or the parents, been living with the kid and dealing with it once they get started and their life is now different and they're so much better than what they were. They're not itching all the time. Their threshold for wanting to stop it changes. They're willing to go longer in many cases because they never felt that good. I tell them, we can stop it anytime you want to. Just give me a chance to help you manage it. Don't disappear for six months and go back to square one because that makes it a lot harder. So I really appreciate the discussion today. It's great talking to you. I always learn from both of you. And I think it's important for our listeners to recognize that we have great therapies here. We have two agents that are approved, another one coming. There's similarities, but there are differences between them. So learn those differences so you can use them optimally and make sure you're talking to the patient about what their problems are and what they need, because ultimately that's what's going to lead to success or failure. So thank all of you for joining us today, and I hope you learned how to utilize these agents. Bye.

Discuss the burden of disease in patients with moderate-to-severe AD

Discuss the safety profile of biologics and how to manage adverse effects

Closing the Healthcare Gaps in the Management of Moderate-to-Severe Atopic Dermatitis (AD) With Biologics

Appreciate the widespread prevalence and current epidemiology of syphilis 

Integrate new FDA approved treatment for scabies, as needed 

To review the current systemic therapies from the American academy of dermatology’s newly published guidelines of care for atopic dermatitis

To review assessments of severity for choosing systemic therapies or phototherapy

2023 Virtual Grand Rounds Session 15: November 29, 2023 - Atopic Dermatitis Guideline Update and What You Need to Know Now about STDs

Describe the risk-benefit profile on the long-term use of topical steroids

Review the key data on topical non-steroidal treatments for the management of psoriasis

Review new developments in treatment options for rosacea

Discuss how antibiotics can be incorporated into rosacea therapy while minimizing the potential for resistance.

2023 Virtual Grand Rounds Session 12: September 20, 2023 - What's New in Topical Therapy of Psoriasis and What's New in Rosacea

Identify challenges associated with the use of topical corticosteroids in patients with AD and psoriasis 

Review nonsteroid topical agents for the treatment of AD and psoriasis 

Discuss clinical considerations for PAs and NPs who prescribe topical therapies to patients with AD and psoriasis 

What is New in Non-Steroidal Topical Options for Atopic Dermatitis and Psoriasis:  Clinical Insights for Dermatology PAs and NPs: Seminar-in-Depth Online CME Activity

All right, so next we have Dr. Linda Steingle and Dr. Jim del Rossell coming onto the stage, and we're going to have a discussion on topical management of inflammatory skin disease and specifically focusing on atopic dermatitis as well as psoriasis. So I'll have them go ahead, take it away. Okay. Thanks so much, April. And we have a lot to talk about. It's a braid new world for the treatment of atopic dermatitis and psoriasis, and we have some really wonderful new topical agents, and it's been a long time. We really need some topical agents. If we think about what we prescribe, the vast majority are actually topical therapy. So we're going to talk about what's new in non steroidal topical options for atopic dermatitis and psoriasis, clinical insights for dermatology, pas, and nps. This is where we come from, and this is a CME accredited symposium. So our objectives for this short presentation are to identify the challenges associated with topical corticosteroids for atopic derm and psoriasis, review our non steroidal options, and discuss clinical considerations for pas and nps who prescribe topical therapies, which we all do. So when we're thinking about topical therapy for either atopic dermatitis or psoriasis, we know that topical steroids really seem to be the mainstay of therapy. But I consider topical, especially potent topical steroids to be a short term solution to a long term problem. They can get the disease under control fairly quickly, but you can't use them long term. They're just not going to be ok. We have a number of local as well as systemic potential side effects. So what do we have, Jim, in terms of new options? So we have a couple of different options, but I think one of the other things about topical corticosteroids is patients are typically told about the concerns. So a lot of times they don't even use them. And so there's inconsistency with their use, even though we know they're very effective. So we have three agents. We have topical ruxalitinib, which is FDA approved for mild to moderate atopic dermatitis patients twelve years of age and older. We have topical topiniroff, that's an arrow hydrocarbon modulating agent agonist, 18 years of age and older, for plaque psoriasis and reflumalast. Twelve years of age and older, which is a pd four inhibitor. Tembrinoroff and reflumalast are also under evaluation for atopic dermatitis. So we'll get into this. So where do we start? Let's start with plaque psoriasis. And here's an example of a patient that had psoriasis for many years, was going into a study with Tapinirov, and was washed out of some of the standard therapies, had moderate severity, which is a physician global assessment of three, and significant itching. Remember that psoriasis does have in many patients a fair amount of itching and was very bothersome to him. He had it in other areas. But here we're showing you on the lower extremities, and now you're seeing at week four, and this was with once daily use, the itching went down from an eight out of ten to one out of ten. So a marked reduction in itching. And the Pazi score went down from a nine to four, which is a very good reduction when you're looking at that particular scenario. But is this considered a successful result to the patient or to the clinician? So in your own mind, would you be thinking this is something that after four weeks with a non steroidal treatment, that's the only thing that they used, that this would be something that you would be happy with and that the patient would be happy with knowing that you have to go further. So in the clinical trial, when you look at this particular patient, they got to mild, so they would be considered an endpoint failure in the study. If you were looking at the study and the same at week twelve, they continued to improve, but they were still rated as mild global assessment of two. So that's considered an endpoint failure in the study. But we can determine for ourselves if we think this is a pretty darn good result. So I'm going to turn it over to linder to go over some of the pivotal information in the trial. But I think what's important to look at is you could keep going with this therapy. You don't have to be concerned about stopping, you don't have to be concerned about where they're using it, you don't have to be concerned about the severity at baseline and can keep pushing it till hopefully they get to completely clear, because you don't have that baggage of side effects with the topical steroids. And as you mentioned, Jim, this kind of simplifies the treatment regimen. We all have patients who come in with a bag of medications. They don't even know what they're using. Half of them are the same, half are expired. They have no idea. Now we can simplify it down one topical, they can use it wherever they want. They can use on the face, the skin folds, wherever they need to. And in clinical trials, up to 40% of patients got to clear, or almost clear with that two grade improvements, using this cream once a day for twelve weeks. Now, when we think about our non steroidal options, they can work, but often they're stinging and burning. And if you think about topical vitamin A, vitamin D, even the atopic drugs, they all sting and burn. But when we look at using to pin her off in the sensitive areas, it was overall very well tolerated. So you can use it on those very sensitive areas and generally not have to talk that patient down from the stinging and burning. When we look at the side effect profile, we saw that folliculitis and contact dermatitis were the most common adverse events, but generally these were mild or moderate, and they tended to really go away without even any treatment. We do have a long term study, and Jim mentioned this earlier today. Patients got to completely clear, and then we took their drug away. But guess how many people got to clear? Almost clear, almost 60%. And that's patients who had up to 20% body surface area who weren't using any steroids concomitantly, and actually almost 41% got completely clear of all of their psoriasis using a non steroidal option. And we did see patients had a durable remission. In fact, when they stopped their medication, they had a durable disease free period that went for about four months. That meant you could go on holiday for a few weeks and maybe leave your medication at home. Half of them went more than four months, half of them went less than four months. But if you look at the charts, almost everyone went at least one month without their disease coming back. But that was pushing them to be completely clear, which hadn't been done before in previous trials. So here's another case I'm looking at. So this is thinking about this being in the same patient, okay. Involvement on the elbows, involvement on the anterior tibial area, the Shin area, and the axilla. Remember, in clinical trials, we almost expect that all the lesions that are involved in different areas are going to march to the same rate of clearance, but that's not going to be the case in the real world. Thick elbows may take longer than an intitrogenous area or a thinner plaque on a location, but if you look at how this patient is progressing along, these are actually not the same patient. But you could think about it in terms of that. This could all be on the same patient, and they're going to progress at a different rate. So those smiley faces tell you where they actually got to endpoint success in the study, that they got at least a two grade improvement. And to clear. Almost clear. But look at how the visible progress happens. And I think that's really what we have to look at. The clinical trials help us. But looking at a chart or a graph or a line graph or a bar graph, it doesn't show you what's actually happening. It just gives you average results to get a drug approved by the FDA. So here are two areas, the knee and the back of the hand, that were actually not endpoint success, but you can see a significant difference. And all these patients were being treated with topical refumalast. Okay, so these were patients that were being treated with the 0.3% once a day in the clinical trial, and you can see a pretty successful result. So Linda is going to go through the data from that particular study group. And, Jim, you really reinforced the fact that when we're looking at endpoints in a clinical trial, it's a very high bar. Doesn't mean that that last patient won't be your best friend and want to give you a Christmas gift, even though they didn't reach the actual endpoint. I prefer Hanukkah, because you get, like, seven gifts or eight. Right, eight. So let's look at the clinical data for reflumolast. And as you mentioned, this is another topical non steroidal option, PdE four, using this also once a day. It's a cream formulation, no steroids, nothing else. And we saw a nice separation from vehicle as early as week two. And by the end of eight weeks now, we see up to 42% of patients getting to clear. Almost clear again with that two grade improvement. What was different about these studies is we actually separately looked at the intertrignous areas and evaluated them separately, and we saw up to about 70% of patients got to clear or almost clear, and most of them got to completely clear of their inverse psoriasis. That is tough to treat. You can't put a potent steroid on a skin fold because you're risking potentially strier. You can use a non steroidal, but it might sting and burn. What we found with reflumolas was this was well tolerated. The local tolerability was very, very good. The main side effects, as you can see, little bit of headache, diarrhea, hypertension, low. But we do see a very small amount of systemic absorption. This drug is a potent drug, but we use oral PD four, s, and we know that they're safe. We did do a long term study, and the long term studies are really done to look to see if there's any extra safety signal. Bottom line was this drug was well tolerated. No new safety signals, even when patients had access to this drug over the course of an entire year. We also have a foam formulation, and I think this is really exciting. It's not psoriasis or atopic derm, but for sebderm. And we did also study it for scalp psoriasis and body psoriasis. This drug works in the foam formulation just as well and has a very similar side effect profile. So I think one of the things that's important, when you look at the safety of rufumalast and you look at the reported cases of diarrhea, they were very uncommon, and none of them led to discontinuation. They were very, very mild. And if you look at that formulation, the ingredient that actually solubilizes it is the same one that was used with axone and similar type of thing. You don't want systemic absorption, so it actually partitions the drug superficially. So you get very, very low systemic levels. So it's not likely that if you use it appropriately, that a patient's going to get diarrhea that's actually related to the drug. So what about atopic dermatitis so far? Here's a case, and my nurse practitioner, who's been working with me since 1997, Lisa's over there on the corner. She's probably going to crawl under the table. But this is a 15 year old patient. Eczema since childhood. Multiple food allergies. Established patient with contact dermis with atopic dermatitis that had a flare on the distal extremities. This patient had some splits between the creases of the fingers. Significant discomfort with that. He had a girlfriend. He didn't feel comfortable holding her hands. He was concerned she's going to get infected. Went to an urgent care and got some cephalaxin and some eupyn. Had been using hydrocortisone. They had previously used topical corticosteroids when he was younger. They didn't particularly like using topical steroids, but they weren't totally adamant against it. And so this is after the patient was put on topical ruxalitinib. So they got the topical ruxalitinib and was applying that twice a day. The big difference here was the itching turned off very, very quickly. He had difficulty sleeping during the day or during the evening, so it made a big difference in terms of the itching. But look at two weeks, how much visible difference there is in the eruption, some continuation of the lichenification, but that is expected to continue to improve. So this was, I think, very impressive. This is what we had gleaned from the clinical studies and was a case that we actually saw in clinical practice. And thank you, Lisa, for sharing that with us. So what did we see in the clinical trials? And as Jim mentioned, it's really nice. And with all three of these drugs, the actual practice really does mirror what we saw in the clinical trials. So this is a topical jack inhibitor. Two studies mirror images of each other. We see separation as early as week two. Over 50% of patients using this drug twice a day. No steroids got to clear or almost clear. And this is after just eight weeks. And as you mentioned, it turns off the itch really dramatically. And we see that very steep line within the first few days of people really noticing a significant decrease in their itch. And that continues to improve over the know. Linda, I almost didn't know from seeing the studies, but I was thinking, is this really going to be true? And we've actually been seeing it in several different patients. How quick it turns off the itching in many patients really made me feel much better about it. Yeah. And in terms of the side effect profile, again, we are not seeing local tolerability problems, even though this is a non steroidal, basically, the drug was well tolerated. Now, this is a topical jack inhibitor, and we spoke several times already about where the box warning comes. I want you to know, ruxalidinib is FDA approved in the oral formulation. And guess what? The oral does not have a box warning. Okay? So that just shows what's going on with the FDA. You have to treat these box warnings seriously. You should not use this drug in more than 20% body surface area, but keep it all in perspective. And so when you actually look at this, and we went over this previously in the program, if you're looking at the application of the drug and how it actually gets very limited systemic exposure orally, you get systemic exposure topically. It's primarily within the skin. And if you look at the maximum use studies, you can see here that it takes getting up to about 38% to 40% body surface area before you might even see getting to a level that can trigger some of the potential problems that you can have with thromboembolism. So there's a real safety net put in there if you're utilizing it on 20% body surface area or less. And when we actually look at invitiligo, it's 10% body surface area or less, because you're going to be using that over a more prolonged period of time. This is a case I showed earlier today. This was a patient that was working at a radiology tech. She had more of a lichenified, not as inflamed, but atopic dermatitis. That was very pardic. She couldn't sleep. She had actually not done well with topical corticosteroids. Some of them she was using intermittently because she was concerned about side effects. And she did extremely well with a rapid reduction in itching. Right. She went from an eight out of ten to a two out of ten very, very quickly and had a very, very good clinical response. And if you look at the data, there's a couple of very nice publications. Andy Blauvelt just did a very nice one, looking at the actual reduction in itching. Two point improvement and four point improvement, both very, very early and clinically relevant. And there is data on utilizing this long term. No new safety signals. When it flares back up, you go back to it. When the patient's completely clear, you stop it. And so what about continuing on with some of the other agents? So we mentioned that the arrowhydrocarbon receptor agonist to Pinarov is being evaluated for atopic dermatitis, and so is reflumolast, which is a PD four inhibitor. So let's look first at reflumalast. It's a zero point 15% cream. Once a day, four weeks of patients using this. And you can see here there's significant difference between the active in the vehicle and easy 75 and in IgA. Right. And here's a patient that was shared with me by a nurse practitioner from Texas. He used it on his child. Right. And it used the higher strength that's available. And you can see here an atopic dermatitis flared. You see all the previous treatments the patient had, and two weeks later was completely cleared with excellent tolerability. So this is encouraging that we have this coming along to pin her off the adoring data. Eight weeks, you can see here, very impressive results versus the vehicle. The same type of adverse effects, very low and very limited, very well tolerated. And here's a patient. This was sent to me by Matt Bruno from Texas, 39 years old, long history of atopic dermatitis, very pritic. She doesn't like medication. She's used corticosteroids and other non steroidals in the past. Uses a lot of homeopathic things, but they're not working. So she was treated with topical topinoroff. Here you see her at baseline, and then two weeks later, she was substantially improved and continued it on to four weeks later. So you can see her at two weeks, and then at four weeks, she was essentially completely clear. And in the axilla, she had the same type of situation with an excellent response. So I think, Linda, that gives them some idea of where we're at, and we'll let you summarize the end. So again, topical corticosteroids have been the cornerstone, but we need long term options. We see that these new topicals are a short term solution as well as a long term solution. And we have some really great molecules in the pipeline. So it's an exciting time. We have the cadence of like, newscasters. Absolutely. We should be on tv. Thank you very much.

Overview the role of biologics for the management of moderate-to-severe atopic dermatitis 

Identify patients who would benefit from biologics for the management of moderate-to-severe atopic dermatitis 

Discuss how PAs and NPs can work in a multidisciplinary team to manage patients with moderate-to-severe AD on biologics

The PA and NPs Role in Managing Atopic Dermatitis With Biologics in Clinical Practice: Online CME Activity

Identify challenges associated with the use of topical corticosteroids in patients with atopic dermatitis (AD) and psoriasis

Review nonsteroid topical agents for the treatment of AD and psoriasis

Discuss clinical considerations for prescribing topical therapies to patients with AD and psoriasis


2023 Virtual Grand Rounds Session 9: June 14, 2023 - Topical Non-Steroidal Management of Atopic Dermatitis and Psoriasis: Clinical Insights for Dermatology Providers

Describe the clinical trial data on JAK inhibitors for the management of atopic dermatitis (AD) 

Identify patients who would benefit from the management of AD with JAK inhibitors 

Construct a treatment plan to manage patients with AD on JAK inhibitors 

Managing Atopic Dermatitis from Head-to-Toe with JAK Inhibitors: Online CME Activity

Apply the latest evidence-based guidelines and data to management of patients with a range of dermatologic conditions

Evaluate findings from recent clinical trials to identify appropriate adjustments to current treatment and management strategies

Recognize the benefits of newly studied treatments

2023 Virtual Grand Rounds Session 5: March 29, 2023 - Highlights from the AAD

Underline the multidimensional burden of moderate-to-severe atopic dermatitis in children and adolescents

Recall the multidimensional benefits of systemic biologics for the management of moderate-to-severe atopic dermatitis in children and adolescents

Discuss seamless integration of biologics into daily clinical practice through enhanced multidisciplinary care

Strategies to Alleviate the Multidimensional Burden of Moderate-to-Severe Atopic Dermatitis in Children and Adolescents: Online CME Activity

Overview the key data on systemic biologics for the management of moderate-to-severe atopic dermatitis in children and adolescents

Identify children and adolescents who would benefit from biologics for the management of moderate-to-severe atopic dermatitis 

Describe strategies to integrate biologics into daily clinical practice to effectively manage moderate-to-severe AD

Moderate-to-Severe Atopic Dermatitis in Children and Adolescents: Stop the Itch that Rashes: Online CME Activity

Recall the key symptoms for atopic dermatitis

Review the clinical trial data on JAK inhibitors for the management of moderate-to-severe AD

Discuss practical trips to manage side effects associated with JAK inhibitors

Illustrate individualized treatment plans based on patient- and disease-related considerations

The Patient and Physician Journey of Atopic Dermatitis From Diagnosis Through Treatment: Online CME Activity

Describe how biologics targeted the disease pathway for atopic dermatitis

Review the clinical trial data for new and emerging agents to treat moderate-to-severe AD

Discuss strategies to involve patients and their families in the shared-decision making process

Atopic Dermatitis: Inspecting the Evidence & Learning from Expert Experience: Online CME Activity

Review data on JAK inhibitors to treat AD 

Describe how to individualize care with JAK inhibitors in patients with atopic dermatitis 

Discuss strategies to prevent and manage adverse events associated with JAK inhibitors 

Atopic Dermatitis Management - Getting the Inside Track on JAKs: Online CME Activity

Atopic Dermatitis

WEDNESDAY, July 2, 2025 (HealthDay News) -- Increased levels of environmental pollutants are associated with an increased burden of <a href="/conditions/atopic-dermatitis" target="_blank" rel="noopener noreferrer">atopic dermatitis</a>, according to a systematic review and meta-analysis published online June 25 in JAMA Dermatology.Megan Park, from the University of Toronto, and colleagues summarized and assessed the certainty of evidence on associations between environmental factors and atopic dermatitis outcomes in adults aged 18 years and older. A total of 42 studies were included in the review.The researchers found that atopic dermatitis outpatient clinic visits increased for every 10-μg/m3 increase in particulate matter 10 μm in diameter or less, particulate matter 2.5 μm in diameter or less, sulfur dioxide, and nitrogen dioxide (risk ratios, 1.008, 1.013, 1.029, and 1.014, respectively). Increased atopic dermatitis-related visits were seen in association with extreme environmental temperatures (hot and cold). There was a possible association for higher precipitation, including rain, with increased atopic dermatitis severity; probable associations were seen for higher levels of humidity with increased atopic dermatitis severity. An uncertain association was seen for increased duration of sunlight exposure on atopic dermatitis severity. Probable associations were seen for secondhand smoking exposure and traffic and industrial plant exposure with an increased prevalence of atopic dermatitis."These findings have direct public health implications, adding to the impetus to decrease pollution and mitigate climate change worldwide," the authors write.<a target="_blank" rel="noopener noreferrer" href="https://jamanetwork.com/journals/jamadermatology/article-abstract/2835460">Abstract/Full Text</a>

Probable associations seen for secondhand smoking exposure and traffic and industrial plant exposure with increased prevalence of atopic dermatitis

Increased Levels of Environmental Pollutants Linked to Atopic Dermatitis

MONDAY, June 9, 2025 (HealthDay News) -- Early-life dog exposure may modify the genetic effect of the single nucleotide variant rs10214237 on <a href="/conditions/atopic-dermatitis" target="_blank" rel="noopener noreferrer">atopic eczema</a> (AE) via <a href="/podcasts/derms-and-conditions/season3-podcast-episode-49" target="_blank" rel="noopener noreferrer">IL7R</a>, according to a study published online June 4 in Allergy.Marie Standl, Ph.D., from the Helmholtz Zentrum München–German Research Center for Environmental Health in Neuherberg, Germany, and colleagues examined gene-environment interactions to examine the pathophysiology of AE. Interaction was tested between the 24 most significant AE-associated loci identified from genome-wide association studies and 18 early-life environmental factors using data from 16 European studies. A further 10 studies and in vitro modeling were used to independently assess findings.The researchers found that the discovery analysis (25,339 individuals) showed suggestive evidence for interaction between seven environmental factors and at least one established single nucleotide variant (SNV) for AE, with a total of 14 interactions. In the replication analysis, with 254,532 individuals, there was a nominally significant interaction for dog exposure with the SNV rs10214237 (on chromosome 5p13.2 near IL7R), with odds ratiointeraction = 0.91; the risk effect of the T allele was only seen for those not exposed to dogs. For siblings in the discovery analysis, a similar interaction with rs10214237 was observed (odds ratiointeraction = 0.84), but a replication analysis was underpowered. Lower IL-7R expression was seen in human keratinocytes in association with the rs10214237 homozygous risk genotype, and a differential response was seen according to the rs10214237 genotype for dog exposure modeled in vitro."More work is needed, but our findings mean we have a chance to intervene in the risk of allergic disease, to protect future generations," coauthor Sara J. Brown, M.D., Ph.D., from the University of Edinburgh, said in a statement.Several authors disclosed ties to the pharmaceutical industry.<a target="_blank" rel="noopener noreferrer" href="https://onlinelibrary.wiley.com/doi/10.1111/all.16605">Abstract/Full Text</a>

Findings support observational epidemiology showing protective effect of dog exposure early in life

Early Dog Exposure May Modify Genetic Effect on Atopic Eczema Risk

MONDAY, May 19, 2025 (HealthDay News) -- In a clinical report published online May 19 in Pediatrics, the American Academy of Pediatrics presents updated guidance for the treatment of children with atopic dermatitis (AD).Noting that many pediatricians may not feel comfortable treating AD or other dermatologic conditions, Jennifer J. Schoch, M.D., from the University of Florida in Gainesville, and colleagues reviewed pediatric AD and provided an up-to-date approach to skin-directed management incorporating recent advances.The authors note that successful AD treatment involves the triad of maintenance skin care, topical anti-inflammatory medications, and avoidance of triggers. General recommendations for treatment include frequent bathing (daily or every other day) with lukewarm water and gentle cleanser. Products with added fragrance, dyes, or essential oils should be avoided, as they are potential irritants and/or contact allergens. Topical anti-inflammatories, including corticosteroids and calcineurin inhibitors, should be applied once to twice daily to active eczema patches; unless specifically instructed, topical medications should not be mixed with topical emollients, as this dilutes the potency of the medication. Dupilumab and Janus kinase inhibitors are emerging treatments for AD. In patients with AD, moisturizers should be applied liberally to the entire body skin surface at least daily, especially after a bath or shower. Flare can be reduced with reduction of triggers and proactive treatment with topical anti-inflammatories. Patients with severe, recalcitrant, and/or complicated AD should be referred to subspecialists."Ongoing collaboration between pediatric primary care providers and AD specialists can optimize care for patients with complex AD," the authors write.One author disclosed ties to Janssen Biotech and Exactech.<a target="_blank" rel="noopener noreferrer" href="https://publications.aap.org/pediatrics/article/doi/10.1542/peds.2025-071812/201952/Atopic-Dermatitis-Update-on-Skin-Directed">Abstract/Full Text</a>

Topical anti-inflammatories should be applied once to twice daily to active eczema patches

AAP Updates Guidelines for Pediatric Atopic Dermatitis Management

FRIDAY, May 23, 2025 (HealthDay News) -- An artificial intelligence (AI) Three-Item Severity (TIS) score can identify eczema-affected areas and severity scores from user-uploaded images, according to a research letter published online May 19 in Allergy.Utako Okata-Karigane, M.D., from the Keio University School of Medicine in Japan, and colleagues developed an AI-based model to assess eczema severity from user-uploaded photos. Three algorithms were trained and integrated: body part detection, skin lesion detection, and severity assessment. The TIS score, a localized severity assessment ranging from 0 to 9, evaluating erythema, edema/papulation, and excoriation, was adopted because the model analyzes representative images rather than full-body images.A total of 9,656 images with itch scores were included to establish and validate AI-TIS. The researchers found that the trained AI model correctly detected 98 and 100 percent of body parts and eczema areas, respectively; across 220 test images, the model correlated well with TIS scores determined by board-certified dermatologists and/or allergists (R = 0.73). Across 8,556 images, AI-TIS showed a lower correlation with itch intensity on a 0-to-5 numeric rating scale (R = 0.11). In 15 patients, correlations of AI-TIS with TIS, SCORing Atopic Dermatitis (SCORAD), and objective-SCORAD were R = 0.16, 0.4, and 0.53, respectively."This study lays the groundwork for future advancements in AI-driven dermatological assessments, enhancing both patient care and clinical research," the authors write.Several authors disclosed ties to the biopharmaceutical industry.<a target="_blank" rel="noopener noreferrer" href="https://onlinelibrary.wiley.com/doi/10.1111/all.16586">Abstract/Full Text</a>

AI-TIS score correlated well with TIS scores determined by board-certified dermatologists and/or allergists

AI Three-Item Severity Score Can ID Eczema From Patient-Uploaded Images

WEDNESDAY, May 7, 2025 (HealthDay News) -- The global burden of atopic dermatitis (AD) in older adults is considerable and is expected to continue increasing to 2050, according to a study published online April 1 in Frontiers in Public Health.Yi Ou, from the First Affiliated Hospital of Chongqing Medical University in China, and colleagues examined the global burden of AD in older adults from 1990 to 2021 and projected change to 2050. Estimates of prevalence, incidence, and disability-adjusted life-years (DALYs) attributable to AD among individuals aged 60 years and older were extracted from the Global Burden of Diseases Study 2021.The researchers found that the global prevalence of AD in older adults increased from 1990 to 2021 to 11,009,630 cases, even as age-standardized rates decreased, with population growth the main driver. Incidence rates were higher among women and those aged 75 to 79 years. There were positive correlations observed for incidence, prevalence, and DALY rates with sociodemographic index (SDI) levels, while a significant decline was seen in SDI-related inequalities. Increasing incidence, prevalence, and DALY numbers for AD in older adults were anticipated up to 2050, while a decrease was expected in age-standardized DALY rates."Globally, AD represented an underestimated public health concern primarily affecting individuals aged 60 and older, with variations observed across genders, age groups, regions, and nations," the authors write. "Consequently, targeted strategies for the effective prevention and management of AD in the older adult are needed to address the impending challenge."<a target="_blank" rel="noopener noreferrer" href="https://www.frontiersin.org/journals/public-health/articles/10.3389/fpubh.2025.1569119/full">Abstract/Full Text</a>

Global prevalence of older adult AD increased from 1990 to 2021 and is expected to continue increasing to 2050

Global Burden of Atopic Dermatitis in Older Adults Is Considerable

WEDNESDAY, April 30, 2025 (HealthDay News) -- For adolescents and adults with moderate-to-severe atopic dermatitis (AD), once-daily ivarmacitinib is efficacious, according to a study published online April 30 in JAMA Dermatology.Yan Zhao, Ph.D., from the Peking University People's Hospital in Beijing, and colleagues examined the efficacy and adverse events associated with ivarmacitinib among adolescents and adults with moderate-to-severe AD in a multicenter, double-blind, placebo-controlled phase 3 randomized clinical trial. Patients aged 12 to 75 years were randomly assigned to receive once-daily 4- or 8-mg ivarmacitinib or placebo for 16 weeks (113, 112, and 111 patients, respectively).The researchers found that at week 16, significantly more patients in the 4-mg and 8-mg ivarmacitinib groups achieved an Investigator Global Assessment score of 0 (clear) or 1 (almost clear) with at least a 2-grade improvement compared with those in the placebo group (36.3 and 42.0 percent, respectively, versus 9.0 percent). The ivarmacitinib groups also had significantly higher rates of Eczema Area and Severity Index score improvement of 75 percent (54.0 and 66.1 percent versus 21.6 percent in the 4-mg and 8-mg ivarmacitinib groups, respectively, versus placebo). Overall, 69.0, 66.1, and 64.9 percent of patients reported treatment-emergent adverse events in the 4-mg and 8-mg ivarmacitinib and placebo groups, respectively. Serious treatment-emergent adverse events occurred in 2.7, 1.8, and 2.7 percent, respectively."Ivarmacitinib represents a promising new treatment option for patients whose AD is not adequately controlled by topical therapies," the authors write.Several authors disclosed ties to biopharmaceutical companies, including Jiangsu Hengrui, which manufactures ivarmacitinib and funded the study.<a target="_blank" rel="noopener noreferrer" href="https://jamanetwork.com/journals/jamadermatology/fullarticle/2833318">Abstract/Full Text</a>

More patients achieved IGA score of 0 or 1 with at least a 2-grade improvement with once-daily 4-mg or 8-mg ivarmacitinib versus placebo

Ivarmacitinib Efficacious for Moderate-to-Severe Atopic Dermatitis

WEDNESDAY, April 23, 2025 (HealthDay News) -- Children with early-onset atopic dermatitis (AD) have an elevated risk for pediatric uveitis, according to a study published online April 3 in JAMA Ophthalmology.Yung-Yu Chu, M.D., from Chi Mei Medical Center in Tainan City, Taiwan, and colleagues assessed whether the risk for pediatric uveitis is increased in children with early-onset AD versus a matched control population. The analysis included 114,889 patients with early-onset AD and 114,889 propensity score-matched controls without AD.The researchers found that the AD cohort had a higher risk for developing pediatric uveitis versus controls (0.08 versus 0.05 percent; hazard ratio, 1.92). Similar results were seen among patients without dupilumab use (0.08 versus 0.05 percent; hazard ratio, 1.77) and those without autoimmune conditions (0.07 versus 0.05 percent; hazard ratio, 1.52). Patients with severe AD had a higher risk for developing pediatric uveitis versus those with nonsevere AD (0.40 versus 0.08 percent; hazard ratio, 3.64)."This cohort study of children with early-onset AD found an elevated risk of pediatric uveitis compared with matched controls, independent of autoimmune conditions or dupilumab use," the authors write. "These findings support the potential need to consider ophthalmologic monitoring in children with early-onset AD to try to detect and subsequently manage uveitis if it develops."<a target="_blank" rel="noopener noreferrer" href="https://jamanetwork.com/journals/jamaophthalmology/article-abstract/2832128">Abstract/Full Text</a>

Findings independent of autoimmune conditions or dupilumab use

Early-Onset Pediatric Atopic Dermatitis Tied to Higher Risk for Uveitis

FRIDAY, March 14, 2025 -- Patients with atopic dermatitis (AD) who achieve completely clear skin with tapinarof (Vtama) cream maintain low disease activity after about 80 days off treatment, according to a study presented at the annual meeting of the American Academy of Dermatology, held from March 7 to 11 in Orlando, Florida.David Rosmarin, M.D., of the Indiana University School of Medicine in Indianapolis, and colleagues conducted a 48-week open-label, long-term extension study (ADORING 3) evaluating tapinarof in 728 eligible adults and children aged 2 years or older with AD. Patients entering ADORING 3 with Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) ≥1 received tapinarof until vIGA-AD = 0 (completely clear skin). Those entering or achieving vIGA-AD = 0 discontinued tapinarof and were assessed for maintenance while off treatment. Those whose AD returned to vIGA-AD ≥2 were retreated until vIGA-AD = 0.The researchers found that at the end of the first treatment-free interval (mean, 79.8 days), 84.0 percent of patients had vIGA-AD = 2, a mean Eczema Area and Severity Index score of 3.4, and a mean weekly Peak Pruritus-Numerical Rating Scale score of 2.9. At the end of subsequent treatment-free intervals, similar low disease activity was seen. After about 80 consecutive days off treatment, a high proportion of patients demonstrated low disease activity, including itch."These data reinforce the efficacy of Vtama cream in atopic dermatitis, including the durability of effect among patients in the study, including children as young as 2 years old," Juan Camilo Arjona Ferreira, M.D., head of research and development and chief medical officer at Organon, said in a statement.The study was funded by Dermavant Sciences, which was acquired by Organon.<a target="_blank" rel="noopener noreferrer" href="https://www.organon.com/news/new-analysis-of-organons-vtama-tapinarof-cream-1-phase-3-data-shows-atopic-dermatitis-disease-activity-remained-low-after-treatment-free-interval-in-adults-and-children-2-years-of-ag/">Press Release</a><a target="_blank" rel="noopener noreferrer" href="https://www.aad.org/member/meetings-education/am25">More Information</a>

Many patients who achieved clear skin with tapinarof treatment maintained low disease activity after treatment-free interval

AAD: Maintenance of Low Eczema Activity Seen After About 80 Days Off Tapinarof

WEDNESDAY, March 12, 2025 -- For adult patients with moderate-to-severe atopic dermatitis (AD), upadacitinib (UPA) 15 mg and 30 mg are both efficacious for achievement and maintenance of an optimal clinical target of improvement of more than 90 percent in the Eczema Area and Severity Index (EASI90), according to a study presented at the annual meeting of the American Academy of Dermatology, held from March 7 to 11 in Orlando, Florida.Melinda Gooderham, M.D., from the SKiN Centre for Dermatology in Peterborough, Ontario, Canada, and colleagues examined the efficacy and safety of two treatment approaches with UPA based on achievement of EASI90 in adults with moderate-to-severe AD. A total of 461 participants were randomly assigned to receive UPA 15 or 30 mg during a 12-week double-blind period (229 and 232 patients, respectively). At week 12, UPA 15-mg nonresponders were dose-escalated to UPA 30 mg (UPA15/30mg), while responders continued on UPA 15 mg (UPA15/15mg); UPA 30-mg nonresponders continued on UPA 30 mg (UPA30/30mg), while responders switched to UPA 15 mg (UPA30/15mg).The researchers found that at week 24, 48.1 and 29.3 percent of UPA15/30mg and UPA30/30mg, respectively, achieved EASI90 at week 24, while 68.5 and 74.6 percent of those on UPA30/15mg and UPA15/15mg, respectively, maintained EASI90. Overall, 20.7 and 35.0 percent of the UPA15/30mg and UPA30/15mg cohorts, respectively, achieved combined EASI90 with Worst Pruritus Numerical Rating Scale (WP-NRS) 0/1 at week 24; 32.5 and 38.0 percent achieved WP-NRS 0/1; and 24.0 and 35.4 percent achieved Dermatology Life Quality Index 0/1. Treatment-emergent adverse events were reported in 43.1, 54.2, 61.5, and 48.9 percent of the UPA15/15mg, UPA15/30mg, UPA30/30mg, and UPA30/15mg cohorts, respectively."Both UPA treatment approaches demonstrate achievement and maintenance of EASI90," the authors write. "Overall safety findings were consistent with the known UPA safety profile, with no new safety signals identified."The study was funded by AbbVie, the manufacturer of upadacitinib.

Both treatment approaches demonstrate achievement, maintenance of improvement of more than 90 percent in Eczema Area and Severity Index

AAD: 15-mg, 30-mg Upadacitinib Efficacious for Moderate-to-Severe Eczema

WEDNESDAY, Feb. 5, 2025 (HealthDay News) -- For children with atopic dermatitis (AD), early childhood stressful life events are associated with an increased risk for disease activity, according to a study published online Jan. 28 in the Journal of Investigative Dermatology.Katrina Abuabara, M.D., from the University of California in San Francisco, and colleagues conducted a longitudinal cohort study of 13,972 children ages 1 to 8.5 years from the Avon Longitudinal Study of Parents and Children to examine the impact of stressful life events throughout early childhood on AD activity and severity.The researchers found that for each standard deviation increase in stressful life events, there was a small increased risk for concurrent AD activity after adjusting for potential confounders (odds ratio, 1.04), which was higher for moderate-to-severe AD and for a cumulative measure of stressful events across childhood (odds ratios, 1.13 and 1.11, respectively). Common stressful life events such as starting a new school or having a new sibling drove the association more than severe adverse childhood events such as being separated from a parent or being abused."These results suggest that parents and providers may anticipate and proactively moisturize or treat to prevent potential AD flares around life events," the authors write. "In addition, multiple stress-reducing modalities have been shown to improve AD symptoms and may be helpful for patients experiencing stressful life events."One author disclosed ties to the pharmaceutical and cosmetic industries.<a target="_blank" rel="noopener noreferrer" href="https://www.jidonline.org/article/S0022-202X(25)00081-8/fulltext">Abstract/Full Text</a>

Association driven by common stressful life events such as starting new school, having new baby sibling

Early Childhood Stressful Life Events Linked to Increased Eczema Activity

WEDNESDAY, Jan. 22, 2025 (HealthDay News) -- Self-reported manifestations of topical steroid withdrawal (TSW) in atopic dermatitis (AD) include erythema, desquamation, dryness, and oozing affecting the face, neck, and upper extremities, according to a study published online Jan. 3 in Acta Dermato-Venereologica.Mikael Alsterholm, M.D., Ph.D., from the Karolinska Institutet in Stockholm, and colleagues conducted an observational cross-sectional study involving adults reporting both AD and TSW. A questionnaire was posted in a Swedish TSW-themed Facebook group and was accessed by 98 participants and completed by 82.Most respondents were female (95 percent), self-diagnosed with TSW (84 percent), and reported current symptoms of AD and TSW. The researchers note that TSW was defined as dependence on topical glucocorticoids (TGCs) and adverse reactions to their use. The most reported signs were erythema, desquamation, dryness, and oozing affecting the face, neck, and upper extremities. The most reported symptoms were pruritus, sleep disturbance, and signs of anxiety and depression. Sixty percent of respondents reported recurring episodes of manifestations attributed to TSW. Ninety-three percent believed that TGCs were the personal trigger factor, while 33 percent also identified oral glucocorticoids. Twenty-one percent currently use TGCs."As of now, TSW remains an exclusion diagnosis after careful ruling out of established causes for adverse reactions to TGCs," the authors write. "This stance requires that the patients' concerns and beliefs are respected by empathic and open-minded health care providers who uphold an evidence-based approach and offer alternatives to TGCs when possible."Several authors disclosed ties to the pharmaceutical industry.<a target="_blank" rel="noopener noreferrer" href="https://medicaljournalssweden.se/actadv/article/view/40187">Abstract/Full Text (subscription or payment may be required)</a> &nbsp;

The most reported signs were erythema, desquamation, dryness, and oozing affecting the face, neck, and upper extremities

Study IDs Signs of Topical Steroid Withdrawal in Atopic Dermatitis

WEDNESDAY, Dec. 18, 2024 (HealthDay News) -- The U.S. Food and Drug Administration has approved Nemluvio (nemolizumab) for the treatment of moderate-to-severe atopic dermatitis in patients aged 12 years and older.The approval is for use in combination with topical corticosteroids (TCS) and/or calcineurin inhibitors (TCI) when the disease is not adequately controlled with topical prescription therapies. Nemluvio is the first approved monoclonal antibody that targets interleukin-31 receptor alpha, which drives itch and is involved in inflammation and epidermal dysregulation in atopic dermatitis.The approval is based on the results of the phase 3 ARCADIA clinical trial program that included 1,728 patients aged 12 years and older with moderate-to-severe atopic dermatitis. After 16 weeks, patients treated with Nemluvio, administered subcutaneously every four weeks, in combination with TCS (with or without TCI) had statistically significant improvements on skin clearance (either clearance or almost-clearance using the Investigator's Global Assessment score). Patients also achieved a 75 percent reduction in the Eczema Area and Severity Index versus placebo in combination with TCS (with or without TCI), after 16 weeks of treatment. All key secondary end points were met, including significant responses on itch as early as week 1 and statistically significant improvements in sleep disturbance. Overall, Nemluvio was well tolerated, with similar safety profiles observed in both the Nemluvio and placebo groups."Despite currently available treatment options, atopic dermatitis continues to have a massive impact worldwide, with patients not only burdened by intense itch and recurrent skin lesions, but also potentially several associated symptoms, including sleep issues, pain, anxiety, and depression," lead investigator of the ARCADIA trial, Jonathan Silverberg, M.D., Ph.D., from George Washington University in Washington, D.C., said in a statement. "I look forward to being able to offer this option to atopic dermatitis patients in my practice who are seeking relief from burdensome itch and lesions."Approval of nemolizumab was granted to Galderma.<a target="_blank" rel="noopener noreferrer" href="https://www.galderma.com/news/galderma-receives-us-fda-approval-nemluvior-nemolizumab-patients-moderate-severe-atopic">More Information</a>

The monoclonal antibody treatment is for patients ages 12 years and older

FDA Approves Nemluvio for Moderate-to-Severe Atopic Dermatitis

THURSDAY, Dec. 19, 2024 (HealthDay News) -- The U.S. Food and Drug Administration has approved Vtama (tapinarof) 1 percent cream for an additional indication -- the topical treatment of atopic dermatitis in adult and pediatric patients aged 2 years and older.The cream, an aryl hydrocarbon receptor agonist, was previously approved as a topical, nonsteroidal treatment for plaque psoriasis.The approval was based on results from the ADORING 1 and ADORING 2 trials, in which a statistically significant difference in the proportion of patients achieving a score of clear (0) or almost clear (1) and a minimum two-grade improvement from baseline at week 8 on the Validated Investigator Global Assessment for AD (vIGA-AD) was seen for Vtama compared with vehicle (ADORING 1: 45.4 versus 13.9 percent; ADORING 2: 46.4 versus 18.0 percent). Statistically significant benefits were seen for secondary end points, including an Eczema Area and Severity Index score improvement of at least 75 percent from baseline at week 8 and achievement of a ≥4-point improvement in the patient-reported Peak Pruritus Numerical Rating Scale from baseline at week 8 in patients aged 12 years and older.Upper respiratory tract infection (12 percent), folliculitis (9 percent), lower respiratory tract infection (5 percent), headache (4 percent), asthma (2 percent), vomiting (2 percent), ear infection (2 percent), pain in extremity (2 percent), and abdominal pain (1 percent) were the most common adverse reactions reported."With the FDA's approval of Vtama cream in atopic dermatitis for adults and children as young as 2 years old, there is now a therapy that offers the potential for powerful skin clearance with no label warnings or precautions, contraindications, and no restrictions on duration of use or percentage of body surface area affected," Kevin Ali, the CEO of Organon, said in a statement.Approval of Vtama was granted to Organon.<a target="_blank" rel="noopener noreferrer" href="https://www.organon.com/news/fda-approves-vtama-tapinarof-cream-1-for-the-treatment-of-atopic-dermatitis-in-adults-and-children-2-years-of-age-and-older/">More Information&nbsp;</a>

<div class="p-alt arr--sub-headline arrow-component subheadline-m_subheadline__3fd7z subheadline-m_dark__28u00" style="-webkit-line-clamp:none;" data-test-id="subheadline">The nonsteroidal topical treatment is approved for patients 2 years and older</div>

FDA Expands Approval of Vtama to Include Atopic Dermatitis

<div class="raw-html-embed"> <mux-player playback-id="8VuszifCdWyu800ia94clcPMQNcy7xC1FR00zTDSCQSGg" env-key="ENV_KEY" metadata-video-title="YCANTH Launch Alert" controls="" autoplay="true"></mux-player></div>Watch for Dr James Del Rosso’s overview of VTAMA (tapinarof), 1% cream for atopic dermatitis, including his insights on clinical trial data, safety and systemic exposure, its potential remittive effect, and more.The US FDA has approved VTAMA (tapinarof) cream, 1% for the treatment of atopic dermatitis (AD) in adults and children aged 2 years and older. This marks the second FDA-approved indication for VTAMA, an aryl hydrocarbon receptor agonist, following its initial approval in May 2022 for the treatment of plaque psoriasis in adults.Clinical trial insightsThe approval of VTAMA for atopic dermatitis is supported by robust data from the ADORING 1 and ADORING 2 pivotal studies as well as the long-term extension (LTE) study, ADORING 3.<ul><li>Primary endpoint: At Week 8, a significantly higher percentage of patients achieved a Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of 0 (clear) or 1 (almost clear) with a minimum 2-grade improvement from baseline:<ul><li>ADORING 1: 45.4% (VTAMA) vs 13.9% (vehicle)</li><li>ADORING 2: 46.4% (VTAMA) vs 18.0% (vehicle)</li><li>Both results were statistically significant (P &lt;0.0001)</li></ul></li><li>Secondary endpoints:<ul><li>Improvement of at least 75% in Eczema Area and Severity Index at Week 8</li><li>≥4-point improvement in the Peak Pruritus Numerical Rating Scale in patients aged 12 years and older</li></ul></li></ul>ADORING 3 (48-week long-term study):<ul><li>Patients achieving complete disease clearance (vIGA-AD=0) experienced a mean treatment-free interval of ~80 days</li><li>Retreatment with VTAMA was effective in regaining disease control when symptoms recurred</li><li>The safety profile over 48 weeks remained consistent with that observed in the 8-week pivotal studies</li></ul>Safety profileVTAMA cream demonstrated a favorable safety profile across all studies, including long-term use, and was well-tolerated on sensitive skin areas. The most common adverse reactions (≥1%) reported were upper respiratory tract infections, folliculitis, lower respiratory tract infections, headache, asthma, vomiting, ear infections, abdominal pain, and extremity pain. &nbsp;Expanding therapeutic optionsThe approval of VTAMA cream, 1%, adds to the growing list of treatment options for atopic dermatitis, offering a nonsteroidal topical alternative for patients. With its demonstrated efficacy and safety profile, VTAMA provides dermatologists with an additional choice for managing this chronic condition.&nbsp;

CLICK HERE to watch Dr James Del Rosso give his expert clinical insights on VTAMA for atopic dermatitis

LAUNCH ALERT: FDA Approves VTAMA (Tapinarof) Cream for Atopic Dermatitis

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</div>Watch as Dr James Del Rosso provides an in-depth overview of Nemluvio (nemolizumab) for atopic dermatitis, including clinical trial results, dosing, safety, and more.&nbsp;Galderma has announced that the US Food and Drug Administration (FDA) has approved Nemluvio (nemolizumab) for the treatment of moderate-to-severe atopic dermatitis in patients 12 years and older. This approval allows the use of Nemluvio in combination with topical corticosteroids (TCS) and/or calcineurin inhibitors (TCI) for cases where topical prescription therapies alone do not provide adequate disease control.&nbsp;Innovative mechanism of action&nbsp;Nemluvio is the first monoclonal antibody approved to specifically target the IL-31 receptor alpha, inhibiting the signaling of IL-31, a neuroimmune cytokine linked to itch, inflammation, and epidermal dysregulation in atopic dermatitis.&nbsp;Clinical trial insights&nbsp;The FDA approval is based on positive findings from the Phase III ARCADIA clinical trial program, which assessed the efficacy and safety of Nemluvio in combination with TCS, with or without TCI, compared to placebo in 1728 patients aged 12 years or older with moderate-to-severe atopic dermatitis.&nbsp;Key findings from the study include:&nbsp;<ul><li>Improved skin clearance: Patients treated with Nemluvio, in combination with TCS, with or without TCI, achieved statistically significant improvements in both coprimary endpoints:&nbsp;<ul><li>Investigator’s Global Assessment (IGA) scores of “clear” (0) or “almost clear” (1) of skin lesions&nbsp;</li><li>At least a 75% reduction in the Eczema Area and Severity Index (EASI-75) compared to placebo, in combination with TCS, with or without TCI, after 16 weeks of treatment&nbsp;</li></ul></li><li>Rapid itch relief: Significant responses in itch reduction were observed as early as Week 1, along with improvements in sleep disturbance, when compared to placebo&nbsp;</li></ul>Safety profile&nbsp;Nemluvio demonstrated a favorable safety profile, with tolerability comparable to placebo. The most common adverse reactions (≥1%) in patients treated with Nemluvio included headache (including migraine), arthalgia, urticaria, and myalgia.&nbsp;Expanding therapeutic options&nbsp;This approval builds on Nemluvio’s earlier FDA approval in August 2024 for the treatment of prurigo nodularis in adults, highlighting its versatility in managing conditions associated with IL-31 dysregulation.

CLICK HERE to watch Dr James Del Rosso provide an in-depth overview of Nemluvio (nemolizumab) for atopic dermatitis

LAUNCH ALERT: FDA Approves Nemluvio for Moderate-to-Severe Atopic Dermatitis 

WEDNESDAY, Dec. 18, 2024 -- A brief self-guided cognitive behavioral therapy (CBT) intervention is noninferior to clinician-guided CBT for atopic dermatitis (AD), according to a study published online Dec. 18 in JAMA Dermatology.Dorian Kern, Ph.D., from the Karolinska Institutet in Stockholm, and colleagues conducted a single-blind randomized noninferiority trial involving adults with AD. Participants were randomly assigned to a self-guided online CBT intervention for 12 weeks without clinician support or to a clinician-guided online CBT intervention for 12 weeks (86 and 82 participants, respectively).The researchers found that postintervention, the clinician-guided group and self-guided group improved 4.20 and 4.60 points on the self-reported Patient-Oriented Eczema Measure, corresponding to an estimated 0.36-point mean difference in change, which was below the noninferiority margin of 3 points. There were no reports of serious adverse events. Clinicians spent a mean of 36.0 minutes of treatment guidance and 14.0 minutes on assessments in the clinician-guided group compared with 15.8 minutes on assessments in the self-guided group. "The findings support a self-guided intervention as a noninferior and cost-effective alternative to a previously evaluated clinician-guided treatment," the authors write. "Because psychological interventions are rare in dermatological care, this study is an important step toward implementation of CBT for people with AD."Several authors disclosed ties to the pharmaceutical and publishing industries.

Self-guided cognitive behavioral therapy intervention noninferior to clinician-guided therapy

Self-Guided Cognitive Therapy Intervention Noninferior in Atopic Dermatitis

JERSEY CITY, NJ, December 16, 2024 – Organon (NYSE: OGN), a global healthcare company with a mission to improve the health of women throughout their lives, today announced that the U.S. Food and Drug Administration (FDA) has approved VTAMA® (tapinarof) cream, 1%, an aryl hydrocarbon receptor agonist, for an additional indication of the topical treatment of atopic dermatitis (AD) in adults and pediatric patients 2 years of age and older.1 Organon received the FDA approval prior to its extended target action date (PDUFA) of March 12, 2025.&nbsp;“With the FDA’s approval of VTAMA cream in atopic dermatitis for adults and children as young as 2 years old, there is now a therapy that offers the potential for powerful skin clearance with no label warnings or precautions, contraindications, and no restrictions on duration of use or percentage of body surface area affected,” said Kevin Ali, Organon’s Chief Executive Officer. “Introducing this new first-in-class therapy for AD patients reaffirms Organon’s commitment to addressing areas of high unmet need.”&nbsp;In the ADORING pivotal studies, VTAMA cream, 1% demonstrated, in moderate to severe patients as young as 2 years old with AD, a statistically significant difference versus vehicle in the proportion of patients achieving a score of clear (0) or almost clear (1) and a minimum 2-grade improvement from baseline at Week 8 on the Validated Investigator Global Assessment for AD (vIGA-AD) 45.4% versus 13.9% of patients in ADORING 1 and 46.4% versus 18.0% in ADORING 2 (both P&lt;0.0001). The difference between patients who received VTAMA cream and those that received vehicle in all secondary endpoints was statistically significant, including the Eczema Area and Severity Index (EASI) score improvement of at least 75% (EASI75) from baseline at Week 8 and achievement of a ≥4-point improvement in the patients reported Peak Pruritus Numerical Rating Scale (PP-NRS) from baseline at Week 8 in patients ≥12 years of age. The most common adverse reactions (incidence ≥1%) were upper respiratory tract infection (12%), red raised bumps around the hair pores (folliculitis) (9%), lower respiratory tract infection (5%), headache (4%), asthma (2%), vomiting (2%), ear infection (2%), pain in extremity (2%), and stomach-area (abdominal) pain (1%).&nbsp;ADORING 3, a 48-week open-label, LTE study, enrolled eligible patients from ADORING 1, ADORING 2, a 4-week maximal usage pharmacokinetics trial, and direct enrollees who were VTAMA cream-naive patients 2-17 years of age with mild, moderate or severe AD (vIGA-AD scores of 2, 3, or 4, respectively), that did not meet pivotal studies inclusion criteria.&nbsp;In ADORING 3, patients (N=728) were followed for up to 48 weeks, with safety and efficacy endpoints that included the achievement of complete disease clearance (vIGA-AD=0), and the achievement of clear or almost clear skin (vIGA-AD=0 or 1). Patients entering with any disease activity (vIGA-AD≥1) were treated with VTAMA cream, 1% until complete disease clearance was achieved (vIGA-AD=0) or study completion. For the 378 patients who entered with or achieved complete disease clearance (vIGA-AD=0) in ADORING 3 and discontinued treatment with VTAMA cream, the mean duration of the first treatment-free (remittive) interval was approximately 80 consecutive days. Patients whose AD returned to mild or above (vIGA-AD≥2) were re-treated with VTAMA cream until complete disease clearance was achieved again or study completion. The safety profile with long term use was generally consistent with the safety profile observed at Week 8.&nbsp;“VTAMA cream approval in AD is important because it can be prescribed for children as young as 2 years old. VTAMA cream has the potential to bring much needed relief to a significant number of children suffering from this disease,” said Adelaide A. Hebert, MD, Professor and Chief of Pediatric Dermatology at McGovern Medical School at UTHealth Houston and Children’s Memorial Hermann Hospital and lead investigator for the ADORING program. “Moreover, because the prevalence of itch makes this condition extremely burdensome to patients and their families, the itch data from the ADORING program demonstrates reduction of one of the condition’s most prevalent symptoms with use of VTAMA cream.”&nbsp;In May 2022, the FDA approved VTAMA® (tapinarof) cream, 1% for the treatment of plaque psoriasis in adults, making it 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 warnings or precautions, contraindications, restrictions on duration of use, or percentage of body surface area affected.&nbsp;For more information about VTAMA (tapinarof) cream, 1%, visit <a target="_blank" rel="noopener noreferrer" href="http://www.vtama.com/">www.VTAMA.com</a>.&nbsp;IMPORTANT SAFETY INFORMATION&nbsp;Indications: VTAMA® (tapinarof) cream, 1% is an aryl hydrocarbon receptor agonist indicated for:<ul><li>the topical treatment of plaque psoriasis in adults.&nbsp;</li><li>the topical treatment of atopic dermatitis in adults and pediatric patients 2 years of age and older.&nbsp;</li></ul>Adverse Events: In plaque psoriasis, the most common adverse reactions (incidence ≥1%) were: red raised bumps around the hair pores (folliculitis); pain or swelling in the nose and throat (nasopharyngitis); skin rash or irritation, including itching and redness, peeling, burning, or stinging (contact dermatitis); headache; itching (pruritus); and flu (influenza).&nbsp;Adverse Events: In atopic dermatitis, the most common adverse reactions (incidence ≥1%) were: upper respiratory tract infection; red raised bumps around the hair pores (folliculitis); lower respiratory tract infection; headache; asthma; vomiting; ear infection; pain in extremity; and stomach-area (abdominal) pain.&nbsp;You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch 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</a>.&nbsp;About Atopic Dermatitis&nbsp;Atopic dermatitis (AD), commonly referred to as eczema, is one of the most prevalent inflammatory skin diseases, affecting over 26 million people in the U.S. alone and up to 10% of adults worldwide. AD occurs most frequently in children, affecting up to 20% worldwide. The disease results in itchy, red, swollen, and cracked skin, often on the folds of the arms, back of the knees, hands, face, and neck. Itching is an especially bothersome symptom for those with AD, and tends to worsen at night, disturbing sleep and causing fatigue, which in children can lead to inattention at school. People with AD may also experience social and emotional distress due to the visibility and discomfort of the disease.&nbsp;About Organon&nbsp;Organon is an independent global healthcare company with a mission to help improve the health of women throughout their lives. Organon’s diverse portfolio offers more than 60 medicines and products in women’s health, biosimilars, and a large franchise of established medicines across a range of therapeutic areas. In addition to Organon’s current products, the company invests in innovative solutions and research to drive future growth opportunities in women’s health and biosimilars. Organon is also pursuing opportunities to collaborate with biopharmaceutical partners and innovators who look to commercialize their products by leveraging Organon’s scale and agile presence in fast growing international markets.&nbsp;Organon has geographic scope with significant reach, world-class commercial capabilities, and approximately 10,000 employees with headquarters located in Jersey City, New Jersey.&nbsp;For more information, visit <a target="_blank" rel="noopener noreferrer" href="http://www.organon.com">http://www.organon.com</a> and connect with us on <a target="_blank" rel="noopener noreferrer" href="https://nam04.safelinks.protection.outlook.com/?url=https%3A%2F%2Fcts.businesswire.com%2Fct%2FCT%3Fid%3Dsmartlink%26url%3Dhttps%253A%252F%252Fwww.linkedin.com%252Fcompany%252Forganon%26esheet%3D54091823%26newsitemid%3D20240709233122%26lan%3Den-US%26anchor%3DLinkedIn%26index%3D5%26md5%3Db9d34e2420dd642a4dd08f083aa18a01&amp;data=05%7C02%7Cfelicia.bisaro%40organon.com%7Cbb31fe48972c45b125e308dca4fbd799%7C484a70d1caaf4a03a4771cbe688304af%7C0%7C0%7C638566648773192618%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&amp;sdata=PlcTp29h5ph5xNpvUSPvsuD15qXO85hlBMOdV9CScJ4%3D&amp;reserved=0">LinkedIn</a>, <a target="_blank" rel="noopener noreferrer" href="https://nam04.safelinks.protection.outlook.com/?url=https%3A%2F%2Fcts.businesswire.com%2Fct%2FCT%3Fid%3Dsmartlink%26url%3Dhttps%253A%252F%252Fwww.instagram.com%252Forganonllc%252F%26esheet%3D54091823%26newsitemid%3D20240709233122%26lan%3Den-US%26anchor%3DInstagram%26index%3D6%26md5%3D5c2fb948e614c523f58ed3fc816d1e3b&amp;data=05%7C02%7Cfelicia.bisaro%40organon.com%7Cbb31fe48972c45b125e308dca4fbd799%7C484a70d1caaf4a03a4771cbe688304af%7C0%7C0%7C638566648773200211%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&amp;sdata=iXpptgdkNQJCzNXrDcRU%2Bw%2B9y5xUBnwIG36wnEteGdU%3D&amp;reserved=0">Instagram</a>, <a target="_blank" rel="noopener noreferrer" href="https://nam04.safelinks.protection.outlook.com/?url=https%3A%2F%2Fcts.businesswire.com%2Fct%2FCT%3Fid%3Dsmartlink%26url%3Dhttps%253A%252F%252Ftwitter.com%252FOrganonLLC%26esheet%3D54091823%26newsitemid%3D20240709233122%26lan%3Den-US%26anchor%3DX%2B%2528formerly%2Bknown%2Bas%2BTwitter%2529%26index%3D7%26md5%3Daffd94fdb672fc603baff39313804eb1&amp;data=05%7C02%7Cfelicia.bisaro%40organon.com%7Cbb31fe48972c45b125e308dca4fbd799%7C484a70d1caaf4a03a4771cbe688304af%7C0%7C0%7C638566648773207112%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&amp;sdata=adrEkR9fwrQXuJmgQM9nQCEnaTfy4yM%2Fwn5b5Qz5psg%3D&amp;reserved=0">X (formerly known as Twitter)</a> and <a target="_blank" rel="noopener noreferrer" href="https://nam04.safelinks.protection.outlook.com/?url=https%3A%2F%2Fcts.businesswire.com%2Fct%2FCT%3Fid%3Dsmartlink%26url%3Dhttps%253A%252F%252Fwww.facebook.com%252FOrganonLLC%26esheet%3D54091823%26newsitemid%3D20240709233122%26lan%3Den-US%26anchor%3DFacebook%26index%3D8%26md5%3D8f0887a6af1bdc640140f2a09de91dc9&amp;data=05%7C02%7Cfelicia.bisaro%40organon.com%7Cbb31fe48972c45b125e308dca4fbd799%7C484a70d1caaf4a03a4771cbe688304af%7C0%7C0%7C638566648773216375%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&amp;sdata=tQPXPtwqwkTDIhXbNt1nv1OUkTwHBSZyQQypYsISGis%3D&amp;reserved=0">Facebook</a>.&nbsp;vIGA-AD is the trademark of Eli Lilly and Co.&nbsp;Cautionary Note Regarding Forward-Looking Statements&nbsp;Except for historical information, this press release includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including, but not limited to, statements about management’s expectations about the potential safety, effectiveness, tolerability, uses, and market for VTAMA cream. Forward-looking statements may be identified by words such as “pursuing,” “opportunities,” “future,” “potential,” “potentially,” “expected,” “expects,” “will” or words of similar meaning. These statements are based upon the current beliefs and expectations of Organon’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or additional risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include, but are not limited to, an inability to execute on our business development strategy or realize the benefits of the FDA approval described above; weakening of economic conditions that could adversely affect the level of demand for VTAMA; pricing pressures globally, including rules and practices of managed care groups, judicial decisions and governmental laws and regulations related to Medicare, Medicaid and health care reform, pharmaceutical reimbursement and pricing in general; an inability to fully execute on Organon’s product development and commercialization plans; an inability to adapt to the industry-wide trend toward highly discounted channels; expanded brand and class competition in the markets in which Organon operates; and governmental initiatives that adversely impact Organon’s marketing activities. Organon undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Organon’s filings with the Securities and Exchange Commission (SEC), including Organon’s most recent Annual Report on Form 10-K and subsequent SEC filings, available at the SEC’s Internet site www.sec.gov. References and links to websites have been provided for convenience, and the information contained on any such website is not a part of, or incorporated by reference into, this press release. Organon is not responsible for the contents of third-party websites.&nbsp;1 VTAMA label.

FDA Approves VTAMA® (tapinarof) cream, 1% for the Treatment of Atopic Dermatitis in Adults and Children 2 Years of Age and Older<ul><li>EFFICACY: In the pivotal studies, ADORING 1 and ADORING 2, up to 46% of patients on VTAMA cream achieved vIGA-ADTM treatment success at Week 8 versus 18% of patients on vehicle.</li><li>POWERFUL SKIN CLEARANCE: The majority of patients entered with or achieved complete disease clearance (vIGA-AD=0) at least once in the 48-week open-label ADORING long-term extension (LTE) study and remained treatment-free (remittive effect) for an average of ~80 consecutive days.&nbsp;</li><li>RAPID ITCH RELIEF: Itch improvement as early as 24 hours after first application of VTAMA cream was reported by patients and caregivers.&nbsp;</li><li>SAFE AND TOLERABLE: VTAMA cream demonstrated a favorable and consistent safety profile in both the 8-week pivotal studies and the 48-week long-term extension (LTE) study; and was well-tolerated, including on affected sensitive skin areas.</li></ul>Organon (NYSE: OGN), a global healthcare company with a mission to improve the health of women throughout their lives, today announced that the U.S. Food and Drug Administration (FDA) has approved VTAMA® (tapinarof) cream, 1%, an aryl hydrocarbon receptor agonist, for an additional indication of the topical treatment of atopic dermatitis (AD) in adults and pediatric patients 2 years of age and older.

FDA Approves VTAMA® (tapinarof) cream, 1% for the Treatment of Atopic Dermatitis in Adults and Children 2 Years of Age and Older

FRIDAY, Dec. 6, 2024 (HealthDay News) -- The prevalence of Meniere disease is higher in people with atopic dermatitis (AD), according to a study published online Nov. 12 in The Laryngoscope.Cha Dong Yeo, M.D., Ph.D., from Jeonbuk National University in Jeonju, South Korea, and colleagues used data from the National Health Insurance Service-National Sample Cohort to explore the potential correlation between AD and Meniere disease. The analysis included 84,579 individuals with and without AD. The researchers found that the overall risk for Meniere disease was higher in the AD group (hazard ratio [HR], 1.44). Risk varied in a subgroup analysis and was lower for men (adjusted HR, 0.42) and higher in the middle-aged (40 to 59 years; HR, 4.99) and in older-age groups (60 years and older; HR, 8.21). Additionally, the risk for developing Meniere disease was higher in patients with comorbidities, including allergic rhinitis (adjusted HR, 1.18), allergic contact dermatitis (adjusted HR, 1.32), and allergic conjunctivitis (adjusted HR, 1.54)."These findings highlight the importance of comprehensive management strategies that address both Meniere's disease and AD in affected patients," the authors write. "As our understanding of the relationship between AD and Meniere's disease continues to develop, further research will be crucial in creating targeted interventions to improve outcomes and optimize care for these patients."<a target="_blank" rel="noopener noreferrer" href="https://onlinelibrary.wiley.com/doi/10.1002/lary.31906">Abstract/Full Text (subscription or payment may be required)</a>

Older age, female sex, and allergic comorbidities increase risk for developing Meniere disease

Risk for Meniere Disease Higher in Patients With Atopic Dermatitis

WEDNESDAY, Dec. 11, 2024 (HealthDay News) -- Dupilumab treatment improves signs and symptoms of atopic dermatitis (AD) in young children, according to a study published in the December issue of Advances in Therapy.Mark Boguniewicz, M.D., from University of Colorado School of Medicine in Aurora, and colleagues evaluated the impact of type 2 comorbidities on the response to and safety of dupilumab in young children with AD. The analysis included children (aged 6 months to 5 years) with moderate-to-severe AD. The researchers found that at week 16, significantly more patients receiving dupilumab versus placebo, with or without asthma and allergic rhinitis (AR), achieved an Investigator’s Global Assessment (IGA) score of 0/1 and a ≥75 percent improvement in the Eczema Area and Severity Index. Significantly more patients receiving dupilumab with food allergies (FAs) and numerically more patients without FAs achieved an IGA score of 0/1 versus placebo. Compared with those taking placebo, numerically more patients receiving dupilumab with asthma and significantly more patients without asthma achieved a ≥4-point reduction in the weekly average of the daily score on the Worst Scratch/Itch Numeric Rating Scale (WSI-NRS). Similarly, a ≥4-point reduction in the weekly average of the daily score on the WSI-NRS was achieved by significantly more patients receiving dupilumab than placebo with or without AR and with or without FAs. Safety was consistent with the known dupilumab safety profile."These results suggest that dupilumab treatment may be effective in children with or without other type 2 conditions," the authors write.The study was funded by Sanofi and Regeneron, which manufacture dupilumab. <a target="_blank" rel="noopener noreferrer" href="https://link.springer.com/article/10.1007/s12325-024-02998-4">Abstract/Full Text</a>

Findings seen for children with and without comorbidities, such as asthma, allergic rhinitis, food allergies

Dupilumab Efficacious for Atopic Dermatitis in Young Children

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</div>Watch as Dr James Q Del Rosso provides a comprehensive overview of lebrikizumab’s clinical trial results, efficacy, safety, dosing, and more.&nbsp;Eli Lilly’s EBGLYSS (lebrikizumab-lbkz) has been approved by the FDA for adults and children aged 12 and older with moderate-to-severe atopic dermatitis that is inadequately controlled with topical therapies.&nbsp;EBGLYSS, a targeted IL-13 inhibitor, works by targeting eczema inflammation throughout the body that can lead to dry, itchy, and irritated skin. EBGLYSS is available in a 250 mg/2 mL injection that can be used with or without topical corticosteroids and is dosed as a single monthly maintenance injection following the initial phase of treatment. &nbsp;Clinical trial insights&nbsp;The approval follows positive results from the ADvocate 1, ADvocate 2, and ADhere clinical trials, which included over 1000 adults and children aged 12 and older. In an average of the ADvocate 1 and ADvocate 2 studies, 38% of patients achieved clear or almost-clear skin at 16 weeks versus 12% with placebo, with 10% demonstrating improvements as early as 4 weeks. Of those who achieved clear or almost-clear skin at Week 16, 77% maintained skin clearance through one year of monthly maintenance treatment.&nbsp;Beyond skin clearance, both studies also evaluated itch relief among participants, with 43% reporting meaningful relief at 16 weeks compared to 12% with placebo, and 5% experiencing relief within 3 weeks. Of those who reported itch relief at Week 16, 85% still experienced relief through one year of monthly maintenance treatment.&nbsp;Safety profile&nbsp;EBGLYSS was generally well-tolerated, with the most common side effects including eye and eyelid inflammation, injection site reactions, and, in some cases, shingles (herpes zoster). Safety outcomes in the maintenance period were generally consistent with the 16-week safety profile.&nbsp;Patients should avoid EBGLYSS if they are allergic to lebrikizumab or any of its components.&nbsp;Future outlook&nbsp;EBGLYSS is expected to be available in the United States in the coming weeks. Lilly will offer a patient support program, including copay assistance, for eligible patients.

The IL-13 inhibitor offers a new first-line biologic treatment option for moderate-to-severe atopic dermatitis not well-controlled with topicals

FDA Approves EBGLYSS for Moderate-to-Severe Atopic Dermatitis in Adults and Adolescents 

WEDNESDAY, Oct. 16, 2024 -- For pediatric patients with atopic dermatitis, one-, two-, and three-year drug survival is superior for dupilumab versus methotrexate (MTX) and cyclosporin A (CsA), according to a study published online Oct. 16 in JAMA Dermatology.Lisa P. van der Rijst, M.D., from the University Medical Center Utrecht in the Netherlands, and colleagues examined drug survival of dupilumab, MTX, and CsA and assessed associated predictors among patients with AD aged 2 to 17 years. Data were extracted from the prospective BioDay and TREAT Netherlands registries.The analyses included 502 treatment episodes in 362 unique patients, including 192 dupilumab episodes, 94 MTX episodes, and 216 CsA episodes. The researchers found that overall drug survival rates were 84.1, 72.3, and 62.0 percent at one, two, and three years for dupilumab; 60.7, 39.3, and 25.3 percent for MTX; and 43.9, 21.5, and 10.4 percent for CsA, respectively. The most frequent reason for drug discontinuation was ineffectiveness, accounting for 35.5 percent of episodes, mainly in patients treated with CsA, followed by adverse effects (18.7 percent). Independent associations were seen for treatment with MTX and CsA versus dupilumab with a higher risk for drug discontinuation due to ineffectiveness (hazard ratios, 4.45 and 10.88, respectively) and adverse effects (hazard ratios, 4.39 and 3.83, respectively). Independent associations were seen for patients aged 12 to 17 years starting systemic treatment with a higher risk for drug discontinuation due to ineffectiveness and adverse effects (hazard ratios, 1.55 and 2.39)."These results have provided new insight into drug survival resulting from the effectiveness, safety, and tolerability of these systemic treatments, contributing to the optimization of patient outcomes in pediatric patients with AD," the authors write.Several authors disclosed ties to the biopharmaceutical industry; the BioDay registry was sponsored by Sanofi, Regeneron Pharmaceuticals, Pfizer, and LEO Pharma. The TREAT Netherlands registry was sponsored by LEO Pharma, Sanofi, Novartis, Pfizer, Galderma, and AbbVie.

Risk for drug discontinuation higher due to ineffectiveness, adverse events for MTX, CsA versus dupilumab

Superior Drug Survival Seen for Dupilumab in Pediatric Patients With AD

WEDNESDAY, Sept. 18, 2024 (HealthDay News) -- The U.S. Food and Drug Administration has approved Ebglyss (lebrikizumab-lbkz) for adults and children aged 12 years and older with moderate-to-severe atopic dermatitis.The targeted interleukin-13 inhibitor is administered via a 250-mg/2 mL injection with or without topical corticosteroids in patients with atopic dermatitis not well controlled despite treatment with topical prescription therapies. The approval is dosed as a single monthly maintenance injection (250 mg) following the initial phase of treatment of 500 mg (two 250-mg injections) at week 0 and week 2, followed by 250 mg every two weeks until week 16 or later when adequate clinical response is achieved.The approval was based on results from the ADvocate 1, ADvocate 2, and ADhere studies, with &gt;1,000 participants. In an average of two studies (ADvocate 1 and 2), 38 percent of those who took Ebglyss achieved clear or almost-clear skin at 16 weeks versus 12 percent with placebo. Ten percent of individuals saw these results as early as four weeks. Among participants achieving clear or almost-clear skin at week 16, 77 percent maintained those results at one year with once-monthly dosing. Furthermore, 48 percent of responders who were switched from Ebglyss to placebo at week 16 maintained results at one year. Participants in both studies showed significant itch relief with Ebglyss (43 percent at 16 weeks versus 12 percent who took placebo)."Patients still struggle to control their moderate-to-severe atopic dermatitis with currently available therapies," Jonathan Silverberg, M.D., Ph.D., from George Washington University in Washington, D.C., and first author of a paper published in the <a target="_blank" rel="noopener noreferrer" href="https://www.healthday.com/healthpro-news/general-health/physician-s-briefing-eczema-2659599666.html">New England Journal of Medicine</a> summarizing Ebglyss clinical trials, said in a statement. "Many experience poor long-term disease control, and severe itch can significantly impact their daily lives."Approval of Ebglyss was granted to Eli Lilly.<a target="_blank" rel="noopener noreferrer" href="https://investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-ebglysstm-lebrikizumab-lbkz-adults-and">More Information</a>

Approval is for new, first-line biologic treatment of eczema that is not well controlled with topicals in people 12 years and older

FDA Approves Ebglyss for Moderate-to-Severe Atopic Dermatitis

WEDNESDAY, Sept. 18, 2024 -- Once-daily roflumilast cream improves atopic dermatitis (AD) relative to vehicle cream, according to a study published online Sept. 18 in JAMA Dermatology.Eric L. Simpson, M.D., from the Oregon Health &amp; Science University in Portland, and colleagues examined the efficacy and safety of once-daily roflumilast cream, 0.15 percent, versus vehicle cream in two phase 3 randomized trials (INTEGUMENT-1 and INTEGUMENT-2), which included patients aged 6 years and older with mild-to-moderate AD. A total of 1,337 patients were included: 654 in INTEGUMENT-1 and 683 in INTEGUMENT-2.The researchers found that the primary end point (Validated Investigator Global Assessment for Atopic Dermatitis success at week 4) was achieved by significantly more patients treated with roflumilast than vehicle (32.0 versus 15.2 percent in INTEGUMENT-1 and 28.9 versus 12.0 percent in INTEGUMENT-2). For the achievement of at least 75 percent reduction in the Eczema Area and Severity Index, there were significant differences favoring roflumilast at week 4 (43.2 versus 22.0 percent in INTEGUMENT-1 and 42.0 versus 19.7 percent in INTEGUMENT-2). Low rates of treatment-emergent adverse events were seen with roflumilast, which was well tolerated. No signs of irritation were noted in patients treated with roflumilast at each time point."This once-daily nonsteroidal cream addresses several unmet needs in the treatment of AD and thus has the potential to substantially improve treatment," the authors write.Several authors disclosed ties to pharmaceutical companies, including Arcutis Biotherapeutics, which sponsored the study and provided the roflumilast and vehicle creams.

Primary end point achieved by significantly more patients treated with roflumilast versus vehicle cream

Once-Daily Roflumilast Cream Improves Atopic Dermatitis

FRIDAY, Aug. 30, 2024 (HealthDay News) -- Dietary intake of vitamin E may potentially lower the risk for atopic dermatitis, according to a study published online Aug. 9 in Skin Research &amp; Technology.Siqing Wang, from the Beijing University of Chinese Medicine, and colleagues conducted a Mendelian randomization analysis to explore the causal relationship between dietary antioxidant vitamin intake (vitamin C, vitamin E, carotene, and retinol) and atopic dermatitis.The researchers observed a causal relationship between vitamin E intake and atopic dermatitis (odds ratio, 0.859; 95 percent confidence interval, 0.745 to 0.992; P = 0.038). No causal relationship was seen between the other three vitamins and atopic dermatitis (odds ratios [95 percent confidence intervals], 0.953 [0.826 to 1.099; P = 0.507], 1.011 [0.864 to 1.184; P = 0.890], and 1.063 [0.893 to 1.264; P = 0.492] for vitamin C, carotene, and retinol, respectively). In a sensitivity analysis, none of the single-nucleotide polymorphisms were detected as heterogeneous and no significant pleiotropy was observed."The analysis suggests that dietary intake of vitamin E could potentially reduce the risk of atopic dermatitis. Conversely, intake of vitamin C, retinol, and carotene does not appear to be causally related to atopic dermatitis," the authors write. "Although vitamin E intake could be protective against atopic dermatitis, intake of dietary antioxidant vitamins to prevent or treat atopic dermatitis is not necessary."<a target="_blank" rel="noopener noreferrer" href="https://onlinelibrary.wiley.com/doi/10.1111/srt.13883">Abstract/Full Text</a>

Vitamin C, retinol, and carotene are not causally tied to atopic dermatitis

Dietary Vitamin E May Be Protective Against Atopic Dermatitis

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</div>Watch as Dr James Del Rosso provides a detailed overview of the LEVEL UP trial, including study design, data review, and results&nbsp;AbbVie recently announced positive topline results from the LEVEL UP study, a head-to-head Phase 3b/4 clinical trial evaluating the efficacy and safety of upadacitinib (Rinvoq) versus dupilumab (Dupixent) in treating moderate-to-severe atopic dermatitis in adults and adolescents. In the study, upadacitinib demonstrated superior efficacy in achieving the primary endpoint, which was the simultaneous attainment of near-complete skin clearance (EASI 90) and minimal to no itch (WP-NRS 0/1) at Week 16. Specifically, 19.9% of patients treated with upadacitinib met this endpoint, vs 8.9% of those treated with dupilumab (p&lt;0.0001).&nbsp;Study overview: LEVEL UP Phase 3b/4 trial&nbsp;The LEVEL UP study was an open-label, efficacy assessor-blinded study that enrolled patients aged 12 years and older with moderate-to-severe atopic dermatitis who had an inadequate response to systemic therapy or for whom systemic therapy was inadvisable. The trial is the first head-to-head trial in atopic dermatitis to compare upadacitinib at a starting dose of 15 mg daily to dupilumab administered at its labeled dose.&nbsp;Secondary endpoints&nbsp;Upadacitinib also demonstrated superiority vs dupilumab across all ranked secondary endpoints. Notably, 40.8% of patients treated with upadacitinib achieved EASI 90 at Week 16, compared to 22.5% of those treated with dupilumab (p&lt;0.0001). Furthermore, 30.2% of upadacitinib-treated patients reached a WP-NRS of 0/1 at Week 16, compared to 15.5% of dupilumab-treated patients (p&lt;0.0001).&nbsp;Consistent safety profile&nbsp;The safety profile of upadacitinib observed in the LEVEL UP study was consistent with previous studies in upadacitinib for atopic dermatitis, with no new safety signals identified during the 16-week trial period. The most common adverse event reported for both upadacitinib and dupilumab groups was nasopharyngitis. The rate of serious adverse events (0.9%) was the same for both treatment groups, and no malignancies, major adverse cardiac events, venous thromboembolic events, or treatment-emergent deaths were reported in either group.

Upadacitinib outperforms dupilumab in achieving superior efficacy for atopic dermatitis

LAUNCH ALERT: Positive Results Released from LEVEL UP Trial Comparing Upadacitinib and Dupilumab for Atopic Dermatitis 

MONDAY, Aug. 12, 2024 (HealthDay News) -- For patients with atopic dermatitis (AD), dupilumab maintains its clinical effectiveness up to five years and is discontinued by 23.8 percent of patients, according to a study published online Aug. 7 in JAMA Dermatology.Celeste M. Boesjes, M.D., from the University Medical Center Utrecht in the Netherlands, and colleagues examined clinical effectiveness and reasons for discontinuation of dupilumab treatment in 130 children, 1,025 adults, and 131 older adults with AD with up to five years of treatment.The researchers found that most adults maintained controlled AD, with an Eczema Area and Severity Index (EASI) score of 7 or lower varying from 78.6 to 92.3 percent and a numeric rating scale (NRS) for pruritus of 4 or lower varying from 72.2 to 88.2 percent for up to five years of treatment; up to 70.5 percent of all patients extended the dosing interval to mostly 300 mg every three or four weeks. After five years of treatment, the mean EASI and NRS for pruritus were 2.7 and 3.5, respectively. After six months of treatment, median thymus- and activation-related chemokine levels decreased considerably, from 1,751 to 390 pg/mL, and remained low. The median eosinophil levels increased temporarily to week 16, then decreased significantly over time. After a median of 54.0 weeks, 23.8 percent of patients discontinued dupilumab, with adverse events and ineffectiveness being the most frequently reported reasons (7.6 and 6.6 percent, respectively)."This study highlights the importance of multicenter registries to evaluate long-term treatment effects in large daily practice cohorts," the authors write.Several authors disclosed ties to pharmaceutical companies, including Sanofi and Regeneron, which manufacture dupilumab.<a target="_blank" rel="noopener noreferrer" href="https://jamanetwork.com/journals/jamadermatology/article-abstract/2822203">Abstract/Full Text (subscription or payment may be required)</a>

23.8 percent of patients discontinued dupilumab, with adverse events and ineffectiveness the most common reasons

Dupilumab Maintains Its Effectiveness Up to Five Years in Patients With Eczema

TUESDAY, July 30, 2024 (HealthDay News) -- Generation Z (Gen Z) patients present with a higher subjective perception of atopic dermatitis severity than millennial generation patients, according to a study published online July 25 in the International Journal of Dermatology.Clara Ureña-Paniego, from the University of Granada in Spain, and colleagues compared the clinical severity and subjective impact of atopic dermatitis between Gen Z patients (born between 1993 and 2001) and millennials (born between 1978 and 1992). The analysis included 73 patients with moderate-to-severe atopic dermatitis.The researchers found that patients belonging to Gen Z exhibited a lower severity of atopic dermatitis versus millennials (Eczema Area and Severity Index: 9.75 versus 16.63). However, the two generations were similar with respect to their perception of disease severity (SCORing Atopic Dermatitis: 43.54 versus 32.98; Patient-Oriented Eczema Measure: 13.21 versus 15.48)."Gen Z presents a higher subjective perception of severity than millennials. Understanding these generational disparities contributes to creating more effective treatment strategies and provides a more targeted approach to care that addresses each generational group's unique needs and expectations," the authors write. "This approach could include enhanced patient education on treatment risks and expectations, regular follow-up visits for timely treatment adjustment, integration of nonpharmacological therapies like stress management and use of emollients, and inclusion of mental health professionals in the care team."<a target="_blank" rel="noopener noreferrer" href="https://onlinelibrary.wiley.com/doi/10.1111/ijd.17376">Abstract/Full Text</a>

Perceived severity higher among Gen Z compared with millennial patients

Gen Z Perceives Atopic Dermatitis to Be More Severe

MONDAY, July 29, 2024 (HealthDay News) -- Most women with atopic dermatitis have impairment in sexual function, and about half consider that atopic dermatitis may influence their reproductive desire, according to a study published online June 11 in Acta Dermato-Venereologica.Juan-Angel Rodriguez-Pozo, from the Virgen de las Nieves University Hospital in Granada, Spain, and colleagues examined the impact of atopic dermatitis on sexual function and reproductive wishes among women in a cross-sectional study conducted from February to March 2022. A total of 102 women with atopic dermatitis were recruited through online questionnaires.The researchers found that 68.6 percent of the women noted impairment in sexual function, especially those with more severe disease and those with genital and gluteal involvement. About half (51 percent) of the women considered that atopic dermatitis may influence their gestational desire, especially those with gluteal involvement. "Atopic dermatitis affects quality of life, sexuality, and gestational desire. Controllable factors such as the severity and extension of the symptoms enhance this impact. Despite all of this, patients scarcely consult on the issue with a dermatologist," the authors write. "Given this situation, an effort needs to be made by dermatologists to be concerned and to approach patients with atopic dermatitis in a more holistic way, emphasizing psychological and social aspects such as sexuality and reproductive desires."<a target="_blank" rel="noopener noreferrer" href="https://medicaljournalssweden.se/actadv/article/view/35107">Abstract/Full Text (subscription or payment may be required)</a>

About half of women considered that atopic dermatitis may influence their gestational desire

Atopic Dermatitis Has Large Impact on Sexual Function Among Women

THURSDAY, July 11, 2024 (HealthDay News) -- The U.S. Food and Drug Administration has approved Zoryve (roflumilast) cream, 0.15 percent, for the treatment of mild-to-moderate atopic dermatitis in adult and pediatric patients (ages 6 years and older).Zoryve is a once-daily, steroid-free cream that the company says will be available at the end of July.The approval was based on results from the INTEGUMENT-1 and 2 phase 3 trials, in which 1,337 participants with mild-to-moderate atopic dermatitis were assigned to Zoryve cream, 0.15 percent, or vehicle applied once daily for four weeks. Across studies, approximately 40 percent of participants treated with Zoryve cream achieved a validated Investigator Global Assessment-Atopic Dermatitis score of clear (0) or almost clear (1) at week 4 (INTEGUMENT-1: 41.5 versus 25.2 percent; INTEGUMENT-2: 39.0 versus 16.9 percent), with significant improvement seen as early as week 1. More than 40 percent of participants treated with Zoryve cream achieved a 75 percent reduction in the Eczema Area and Severity Index at week 4 versus vehicle (INTEGUMENT-1: 43.2 versus 22.0 percent; INTEGUMENT-2: 42.0 versus 19.7 percent)."People suffering from atopic dermatitis experience intense itch, rash, and sensitive skin, which warrant effective, safe, and well-tolerated treatments," Jonathan Silverberg, M.D., Ph.D., from the George Washington University School of Medicine in Washington, D.C., said in a statement. "Zoryve was developed with the atopic dermatitis patient in mind, to deliver the drug in a moisturizing vehicle that is formulated without common sensitizers or irritants and does not further disrupt the abnormal skin barrier."Approval of Zoryve was granted to Arcutis Biotherapeutics.<a target="_blank" rel="noopener noreferrer" href="https://www.arcutis.com/fda-approves-arcutis-zoryve-roflumilast-cream-0-15-for-the-treatment-of-atopic-dermatitis-in-adults-and-children-down-to-6-years-of-age/">More Information</a>

The once-daily, nonsteroidal cream is approved for adults and children 6 years and older

FDA Approves Zoryve for Atopic Dermatitis

WEDNESDAY, July 17, 2024 -- For patients with moderate-to-severe atopic dermatitis, cendakimab is effective, with a significant reduction seen in the primary end point with 720 mg once weekly, according to a study published online July 17 in JAMA Dermatology.Andrew Blauvelt, M.D., from Oregon Medical Research Center in Portland, and colleagues examined the efficacy and safety of cendakimab versus placebo in patients with moderate-to-severe atopic dermatitis in a phase 2 randomized trial. Adults with moderate-to-severe atopic dermatitis and inadequate response to topical medications were enrolled at 69 sites in five countries, and 220 were randomly assigned to receive subcutaneous cendakimab 360 mg every two weeks (55 patients); 720 mg every two weeks (55 patients); 720 mg once weekly (54 patients); or placebo (56 patients).The researchers found that the primary end point of the mean percentage change in Eczema Area and Severity Index (EASI) scores from baseline to week 16 was met for cendakimab 720 mg once weekly versus placebo (−84.4 versus −62.7), but was not statistically significant for 720 mg every two weeks (−76.0 versus −62.7). The treatment effect was comparable for 360 mg every two weeks and 720 mg once weekly (−16.3 versus −21.8); since the hierarchical testing sequence was interrupted, significance was not claimed. "Cendakimab demonstrated progressive atopic dermatitis improvement at all doses during 16 weeks of treatment," the authors write.Several authors disclosed ties to pharmaceutical companies, including Bristol Myers Squibb, which manufactures cendakimab and funded the study.

Significant reduction seen in primary end point of mean percentage change in EASI score from baseline to week 16 with 720 mg once weekly

Cendakimab Effective for Moderate-to-Severe Atopic Dermatitis

WEDNESDAY, July 10, 2024 -- For patients with moderate-to-severe atopic dermatitis (AD), sustained safety and efficacy are seen for long-term dupilumab treatment, according to a study published online July 10 in JAMA Dermatology.Lisa A. Beck, M.D., from the University of Rochester Medical Center in New York, and colleagues examined the safety and efficacy of dupilumab treatment for up to five years in adults with moderate-to-severe AD in an open-label extension study conducted at 550 sites in 28 countries. A total of 2,677 patients were enrolled and treated in the extension study; 334 patients (12.5 percent) completed treatment up to week 260.The researchers found that the most common reasons for withdrawal were regulatory approval of dupilumab in compliance with the study protocol, patient withdrawal, and adverse events (58.7, 18.0, and 8.4 percent, respectively). Throughout the study, exposure-adjusted rates of treatment-emergent adverse events (TEAEs) were generally stable or declined. Nasopharyngitis, worsening AD, upper respiratory tract infection, conjunctivitis, conjunctivitis allergic, headache, oral herpes, and injection-site reaction were common TEAEs (incidence of ≥5 percent). Overall, 67.5 and 88.9 percent of patients achieved an Investigator's Global Assessment score of 0 or 1 and 75 percent or greater improvement in the Eczema Area and Severity Index, respectively, at week 260. "Dupilumab showed acceptable safety and sustained efficacy with improvements in AD signs, symptoms, and quality of life in adults with moderate-to-severe AD," the authors write.Several authors disclosed financial ties to pharmaceutical companies, including Sanofi and Regeneron, which manufacture dupilumab and funded the study.<a target="_blank" rel="noopener noreferrer" href="https://jamanetwork.com/journals/jamadermatology/fullarticle/2820911">Abstract/Full Text</a>

Sustained benefit seen for adults with moderate-to-severe AD during five-year open-label extension study

Sustained Safety, Efficacy Seen for Dupilumab in Atopic Dermatitis

TUESDAY, June 18, 2024 (HealthDay News) -- Lebrikizumab is associated with sustained effects for moderate-to-severe atopic dermatitis for up to week 52 following withdrawal of treatment, according to a study presented at the annual Revolutionizing Atopic Dermatitis Conference, held from June 8 to 10 in Chicago.Jonathan I. Silverberg, M.D., Ph.D., M.P.H., from the George Washington University School of Medicine and Health Sciences in Washington, D.C., and colleagues examined the relationship between lebrikizumab serum concentration levels and sustained clinical response after treatment cessation among lebrikizumab responders who discontinued treatment.The researchers found that 17 of 60 lebrikizumab responders who were withdrawn from treatment (28 percent) maintained an Eczema Area and Severity Index &gt;90 percent (EASI 90) for 80 percent of the visits during the 38-week withdrawal period. A similar percent achieved EASI 90 at week 52 and did not use rescue medication. At week 16, the mean serum lebrikizumab concentration was 92.4 μg/mL, and the mean serum concentrations decreased to 7.3 μg/mL at week 32 and 0.15 μg/mL at week 52 (92 and &gt;99 percent reduction, respectively). Twelve of 16 patients had serum concentrations below the lower level of quantification (0.09 μg/mL) for the clinical assay at week 52. The mean elimination half-life for lebrikizumab was approximately 24.5 days. "Further studies are needed to identify and characterize this subpopulation of atopic dermatitis patients and lebrikizumab’s potential disease-modifying properties," the authors write.Several authors disclosed financial ties to pharmaceutical companies, including Eli Lilly, which manufactures lebrikizumab and funded the study.<a target="_blank" rel="noopener noreferrer" href="https://djbpnesxepydt.cloudfront.net/RAVE-2024/RAD-Abstracts/732_EASI-90-Response_Lebrikizumab_Silverberg-et-al_Abstract_1717545073090.pdf">Abstract</a><a target="_blank" rel="noopener noreferrer" href="https://revolutionizingad.com">More Information</a>

Findings seen despite negligible remaining lebrikizumab serum concentrations following treatment withdrawal

Lebrikizumab Tied to Sustained Atopic Dermatitis Treatment Effect

FRIDAY, June 14, 2024 (HealthDay News) -- There is no evidence to suggest that administration of live vaccines to patients receiving dupilumab is unsafe, and vaccine efficacy is not affected by dupilumab, according to a position paper published online June 5 in the Annals of Allergy, Asthma &amp; Immunology.Noting that dupilumab targets the interleukin (IL)-4 receptor alpha subunit, blocking the effects of IL-4 and IL-13, and that clinical trials did not allow for patients to receive live vaccines due to an abundance of caution because of its immune modulatory effects, Jay A. Lieberman, M.D., from The University of Tennessee Health Science Center in Memphis, and colleagues conducted a systematic review of the literature on the safety and efficacy of vaccinations in patients receiving dupilumab and provided expert guidance for vaccine receipt.The researchers found that live vaccines are safe based on the available literature on patients who received vaccinations while on dupilumab. In general, vaccine efficacy was not affected by dupilumab. The use of vaccines was agreed to be likely safe and effective. "While the systematic review and expert consensus do not support any demonstrated or theoretical safety concern, robust studies in large patient numbers that could support a narrow confidence interval indicating safety do not exist," the authors write. "Furthermore, such studies are unlikely to be conducted or funded, which complicates the ability to alter regulatory agencies' recommendations on administering live vaccines to patients on dupilumab."Several authors disclosed ties to Sanofi and Regeneron, the manufacturers of dupilumab.<a target="_blank" rel="noopener noreferrer" href="https://www.annallergy.org/article/S1081-1206(24)00337-5/fulltext">Abstract/Full Text</a>

Systematic review shows vaccine efficacy not affected by dupilumab in general

No Evidence That Live Vaccines Are Unsafe for Patients on Dupilumab

WEDNESDAY, June 5, 2024 -- Dietary sodium intake seems to be associated with the risk for atopic dermatitis (AD), according to a study published online June 5 in JAMA Dermatology.Brenda M. Chiang, from the University of California in San Francisco, and colleagues conducted a cross-sectional study of adults from the U.K. Biobank to determine the extent to which higher levels of dietary sodium intake are associated with AD. The analytic sample included 215,832 participants; 5.0 percent had a diagnosis of AD.The researchers found that a 1-g increase in estimated 24-hour urine sodium excretion was associated with increased odds of AD, increased odds of active AD, and increasing severity of AD (adjusted odds ratios, 1.11, 1.16, and 1.11, respectively). A 1-g higher daily dietary sodium intake estimated using dietary recall questionnaires was associated with an increased risk for current AD (adjusted odds ratio, 1.22) in a validation cohort of 13,014 participants from the National Health and Nutrition Examination Survey."Our study opens the potential for future studies on restriction of dietary sodium intake as an intervention for AD that would be cost-effective, low risk, and widely available," the authors write.One author disclosed ties to the pharmaceutical and dermatology industries.

Increased odds of AD, active AD, increasing severity of AD seen with 1-g increase in estimated 24-hour urine sodium excretion

Dietary Sodium Intake May Affect Risk of Atopic Dermatitis

WEDNESDAY, May 15, 2024 -- Dupilumab monotherapy is efficacious and safe for patients with atopic hand and/or foot dermatitis, according to a study published in the June issue of the Journal of the American Academy of Dermatology.Eric L. Simpson, M.D., from the Oregon Health &amp; Science University in Portland, and colleagues examined the efficacy and safety of dupilumab in atopic hand and/or foot dermatitis in a phase 3 study involving adults and adolescents with moderate-to-severe atopic dermatitis (106 adults and 27 adolescents). Participants were randomly assigned to dupilumab monotherapy or matched placebo (67 and 66 patients, respectively). The proportion of patients achieving a Hand and Foot Investigator's Global Assessment score of 0 or 1 at week 16 was examined as the primary end point.The researchers found that significantly more patients receiving dupilumab versus placebo achieved a Hand and Foot Investigator's Global Assessment score of 0 or 1 (27 versus 11 [40.3 versus 16.7 percent]). All other prespecified end points were met and safety was consistent with the known atopic dermatitis dupilumab profile."This study supports dupilumab as a novel efficacious systemic therapy for moderate-to-severe atopic hand and/or foot dermatitis," the authors write.Several authors disclosed ties to biopharmaceutical companies, including Sanofi and Regeneron, which manufacture dupilumab and funded the study.

Significantly more patients achieved Hand and Foot Investigator's Global Assessment score of 0 or 1

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