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

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

Dupilumab Beneficial for Patients With Hand, Foot Atopic Dermatitis

WEDNESDAY, May 8, 2024 (HealthDay News) -- Systemic antibiotic exposure in the first year of life is associated with higher atopic dermatitis (AD) risk in a dose-response fashion, according to a study published online April 24 in the Journal of Allergy and Clinical Immunology.Courtney Hoskinson, from the University of British Columbia in Vancouver, Canada, and colleagues examined the timing and specific factors mediating the relationship among systemic (oral or intravenous) antibiotic usage, the gut microbiome, and AD.The researchers found that systemic antibiotics during the first year of life, as compared with later, were associated with AD risk (adjusted odds ratio, 1.81), with an increased number of antibiotic courses corresponding to a dose-response increased risk for AD (adjusted odds ratios, 1.67 and 2.16 for one and two or more courses, respectively). Microbiome alterations associated with both AD and systemic antibiotic usage fully mediate the effect of antibiotic usage on the development of AD. Among participants who would later develop AD, alterations in the one-year infant gut microbiome included increased Tyzzerella nexilis, increased monosaccharide utilization, and parallel decreased Bifidobacterium, Eubacterium spp., and fermentative pathways."Our findings indicate that early-life antibiotic usage, especially in the first year of life, modulates key gut microbiome components that may be used as markers to predict and possibly prevent the development of AD," the authors write.<a target="_blank" rel="noopener noreferrer" href="https://www.jacionline.org/article/S0091-6749(24)00409-3/fulltext">Abstract/Full Text</a>

Dose-response relationship seen for number of antibiotic courses and atopic dermatitis risk

Systemic Antibiotics in First Year of Life Tied to Higher Atopic Dermatitis Risk

TUESDAY, April 23, 2024 (HealthDay News) -- Atopic dermatitis (AD) negatively impacts patients’ mental health (MH), especially when a patient has severe AD, according to a study published online March 14 in Dermatitis.Jessica K. Johnson, M.P.H., from the National Eczema Association in San Rafael, California, and colleagues evaluated patient-reported MH symptoms and their correlation with AD disease severity. The analysis included results from 954 survey respondents.&nbsp;The researchers found that 26.0 percent of respondents reported MH symptoms &gt;10 days per month, and most adults (65.5 percent) scored in the borderline/abnormal range on the Hospital Anxiety and Depression Scale. Seven in 10 respondents (70.6 percent) felt their MH was negatively affected by AD in the past 12 months. Perception of this association was impacted by AD severity, with respondents more likely to believe MH was impacted by AD when they or their child had severe AD."Patients and caregivers were aware of the connection between their/their child’s AD symptoms and MH, suggesting the need for ongoing MH support and routine re-evaluation over the course of the disease," the authors write. "Future research may look at barriers to accessing MH services among the AD population and the extent to which providers who treat AD monitor and follow-up with their patients' MH."One author disclosed advisory board honoraria from Pfizer and Incyte.&nbsp;<a target="_blank" rel="noopener noreferrer" href="https://www.liebertpub.com/doi/10.1089/derm.2023.0365">Abstract/Full Text</a>

Greater negative impact seen among patients with severe atopic dermatitis

Atopic Dermatitis Negatively Impacts Mental Health

WEDNESDAY, April 24, 2024 -- For patients with atopic dermatitis (AD), dupilumab is safe and has sustained effectiveness across various patient-reported outcome measures, according to a study published online April 21 in the Journal of the American Academy of Dermatology.Junfen Zhang, M.D., from University Medical Center Groningen in the Netherlands, and colleagues examined patient-reported outcome measures and the safety of dupilumab in patients with moderate-to-severe AD for up to five years. Data were included for 1,223 patients: 1,108 adults and 115 pediatric patients.The researchers found that after one year of treatment or longer, the mean Patient-Oriented Eczema Measure, Dermatology Life Quality Index, and Numeric rating scale-pruritis varied from 7.8 to 8.7, 3.5 to 4.2, and 2.9 to 3.1, respectively, in adults and from 8.9 to 10.9, 4.4 to 6.4, and 3.0 to 3.7, respectively, in pediatric patients. In adults, overall work impairment decreased from 40.1 percent to a range of 13.3 to 16.3 percent at follow-up. Less favorable treatment response was generally seen for class I obesity and itch-dominant patients. Overall, 66.8 percent of patients reported one or more adverse event, with the most common being conjunctivitis (33.7 percent)."In addition to a favorable safety profile, dupilumab has shown rapid and sustained effectiveness in improving various aspects of patient-reported outcomes in both adult and pediatric populations in a long follow-up duration," the authors write. "This highlights the treatment benefits of dupilumab from patients' perspectives."Several authors disclosed ties to pharmaceutical companies, including Sanofi and Regeneron, which manufacture dupilumab.

Improvements seen in patient-reported outcome measures, including Patient-Oriented Eczema Measure, Dermatology Life Quality Index

Dupilumab Safe, Effective Over Long Term for Atopic Dermatitis

MONDAY, March 18, 2024 (HealthDay News) -- Lebrikizumab demonstrates improvement in skin clearance and itch relief in patients with skin of color and moderate-to-severe atopic dermatitis, according to a study presented at the annual meeting of the American Academy of Dermatology, held from March 8 to 12 in San Diego.Andrew Alexis, M.D., M.P.H., from Weill Cornell Medicine in New York City, and colleagues conducted ADmirable, a phase 3b, open-label, 24-week study to evaluate lebrikizumab in adults and adolescents with atopic dermatitis and skin of color. Interim data were presented for 50 patients aged 12 years and older with Fitzpatrick Phototype IV to VI. Self-reported race of the patients was 80 percent Black/African-American, 14 percent Asian, and 6 percent American Indian/Alaska Native. Patients were administered a 500-mg loading dose of lebrikizumab at baseline and week 2 followed by a 250-mg dose every two weeks up until week 16.The researchers found that at week 16, 68.3 percent of patients achieved a ≥75 percent reduction in the Eczema Area and Severity Index (EASI 75) and 39.0 percent achieved an Investigator's Global Assessment of 0 or 1 with ≥2-point improvement. The mean change and percentage change in the EASI were –22.2 and –79.1 percent, respectively; the corresponding changes in the Pruritis Numeric Rating Scale were –4.0 and –53.9 percent. Improvement in mean percentage change for hypopigmented and hyperpigmented lesions was also identified on the PDCA-Derm, a new scale used to describe postinflammatory lesions compared to unaffected skin. No serious adverse events were reported."People with skin of color are disproportionately affected by atopic dermatitis, often experiencing more severe symptoms, a delay in diagnosis, and a lengthier timeframe to find appropriate treatment," Alexis said in a statement. "They also have been historically underrepresented in clinical trials, which means we have lacked data pertaining to the treatment of patients with skin of color. With these initial results, [we are] taking a step toward investigating the needs of people with skin of color affected by atopic dermatitis."Several authors disclosed ties to Eli Lilly, which manufactures lebrikizumab and funded the study.<a target="_blank" rel="noopener noreferrer" href="https://investor.lilly.com/news-releases/news-release-details/more-two-thirds-people-atopic-dermatitis-and-skin-color">Press Release</a><a target="_blank" rel="noopener noreferrer" href="https://www.aad.org/member/meetings-education/am24">More Information</a>

Among patients with atopic dermatitis and self-reported race other than White, 68.3 percent achieved EASI 75 at week 16

AAD: Lebrikizumab Shows Efficacy in Skin-of-Color Patients With Atopic Dermatitis

Dermavant Sciences, a biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology, today announced that it has submitted a Supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for VTAMA® (tapinarof) cream, 1% for the topical treatment of atopic dermatitis (AD) in adults and children 2 years of age and older.VTAMA cream is a novel, aryl hydrocarbon receptor agonist in development as a once-daily, cosmetically elegant, and steroid-free, topical cream for both acute treatment and long-term management of AD. VTAMA cream, 1% is currently approved for the topical treatment of plaque psoriasis in adults in the U.S. and is the same strength and formulation studied in the ADORING Phase 3 development program and included in the sNDA submission for atopic dermatitis.Atopic dermatitis, commonly referred to as eczema, is one of the most common inflammatory skin diseases, impacting approximately 16.5 million adults and more than 9.6 million children in the U.S. Over 85% of people with AD experience itching every day, making it the most common and burdensome symptom. More than 67% of patients with AD report that itch interfered with their sleep in the past week and more than 50% of children with AD report that sleep disturbance is one of the most bothersome symptoms of AD.“The prevalence of atopic dermatitis, an extremely burdensome skin condition, continues to grow, and there is an increasing need for new, long-term, treatment options, especially for children,” said Todd Zavodnick, Chief Executive Officer of Dermavant. “Today’s submission of our sNDA marks a significant milestone as we work towards the approval of VTAMA cream for patients suffering from atopic dermatitis as well as the families and caregivers of these patients. We are confident, that VTAMA cream, if approved by the FDA, will be well positioned as a safe, well-tolerated, steroid-free topical treatment option for patients 2 years of age and older with AD and could provide for long-term disease management, representing meaningful advancement for patients, caregivers, and healthcare providers.”Today’s sNDA submission is supported by positive Phase 3 data from ADORING 1 and ADORING 2, two identical, double-blind, randomized, vehicle-controlled, pivotal trials, as well as data from an interim analysis of ADORING 3, a Phase 3, 48-week, open-label, long-term extension study. In the pivotal trials, VTAMA cream demonstrated highly statistically significant improvement compared to vehicle (both P&lt;0.0001) in the Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) scores of 0 (clear) or 1 (almost clear) with at least a 2-grade improvement from baseline at Week 8, the primary endpoint. VTAMA cream also demonstrated highly statistically significant improvement in the proportion of patients with ≥75% improvement in the Eczema Area and Severity Index (EASI75) from baseline to Week 8 compared to patients on vehicle (both P&lt;0.0001), a key secondary endpoint in the pivotal trials. Patients 12 years of age and older, the population in whom the PP-NRS is validated, who received VTAMA cream also experienced a statistically significant improvement in itch as assessed by a ≥4-point improvement in the patient reported Peak Pruritus Numeric Rating Scale (PP-NRS) score compared to patients on vehicle (P=0.0366 for ADORING 1 and P=0.0015 for ADORING 2), another key secondary endpoint. VTAMA cream, 1% data indicated no new safety or tolerability signals of concern in this population including children 2 years of age and older. Adverse events were mostly mild to moderate with a low study discontinuation rate due to adverse events.On May 24, 2022, Dermavant announced the FDA approved VTAMA® (tapinarof) cream, 1% for the treatment of plaque psoriasis in adults. The approval made VTAMA cream the first non-steroidal topical novel chemical entity launched for psoriasis in the U.S. in more than 25 years. VTAMA cream is a once- daily, cosmetically elegant, steroid-free, topical cream approved for mild, moderate, and severe plaque psoriasis in adults – with no label safety warnings or precautions, or restrictions on duration of use or body surface area.<h5>IMPORTANT SAFETY INFORMATION</h5>Indication: VTAMA® (tapinarof) cream, 1% is an aryl hydrocarbon receptor agonist indicated for the topical treatment of plaque psoriasis in adults. Adverse Events: The most common adverse reactions (incidence ≥ 1%) in subjects treated with VTAMA cream were folliculitis (red raised bumps around the hair pores), nasopharyngitis (pain or swelling in the nose and throat), contact dermatitis (skin rash or irritation, including itching and redness, peeling, burning, or stinging), headache, pruritus (itching), and influenza (flu).You are encouraged to report negative side effects of prescription drugs to the FDA.Visit <a target="_blank" rel="noopener noreferrer" href="http://www.fda.gov/medwatch">http://www.fda.gov/medwatch</a> or call 1-800-FDA-1088.See full <a target="_blank" rel="noopener noreferrer" href="https://www.vtama.com/PI/">Prescribing Information and Patient Information</a>.<h5>About Dermavant’s Phase 3 Program for VTAMA cream in Atopic Dermatitis</h5>ADORING is Dermavant’s Phase 3 atopic dermatitis (AD) clinical development program for VTAMA® (tapinarof) cream, 1%, which consists of ADORING 1 (NCT05014568) and ADORING 2 (NCT05032859), as well as ADORING 3 (NCT05142774), a 48-week open-label, long-term extension study.<h5>About Atopic Dermatitis</h5>Atopic dermatitis (AD), commonly referred to as eczema, is one of the most common inflammatory skin diseases, affects 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 affecting the folds of the arms, back of the knees, hands, face, and neck. Itching is an especially bothersome symptom in 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.<h5>About Dermavant</h5>Dermavant Sciences, a subsidiary of Roivant Sciences, is a biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology. Dermavant’s focus is to develop therapies that have the potential to address high unmet medical needs while driving greater efficiency in research and clinical development. The company’s medical dermatology pipeline includes earlier-development, late-stage and commercialized product candidates that target specific unmet needs in two of the largest growing immuno-dermatology markets, plaque psoriasis and atopic dermatitis, as well as other immunological and inflammatory diseases. Dermavant is marketing VTAMA® (tapinarof) cream, 1%, for the topical treatment of plaque psoriasis in adults. The FDA approved VTAMA cream for the topical treatment of mild, moderate, and severe plaque psoriasis in May 2022. Dermavant has been developing VTAMA cream for the treatment of atopic dermatitis in adults and children 2 years of age and older and released positive topline

<ul><li>sNDA is supported by positive data from the Phase 3 ADORING 1 and ADORING 2 pivotal trials and interim results from the Phase 3 ADORING 3 open-label, long-term extension trial</li><li>In both ADORING 1 and ADORING 2, VTAMA cream demonstrated highly statistically significant improvement in the primary endpoint of vIGA-ADTM treatment success over vehicle at Week 8 and all key secondary endpoints were statistically significant</li></ul>

Dermavant Submits Supplemental New Drug Application (sNDA) to FDA for VTAMA® (tapinarof) Cream, 1% for the Treatment of Atopic Dermatitis in Adults and Children 2 Years of Age and Older

WEDNESDAY, Jan. 24, 2024 (HealthDay News) -- Climatic hazards are likely to aggravate atopic dermatitis (AD), with the impact including direct and indirect effects, according to a review published online Jan. 24 in Allergy.Sheng-Pei Wang, M.D., M.P.H., from the University of California San Francisco, and colleagues identified 18 studies with evidence for an impact of AD by leveraging an existing framework for 10 climatic hazards related to greenhouse gas emissions.&nbsp;The researchers found that evidence for aggravation of AD was seen for most climatic hazards, with the impact ranging from direct effects, such as particulate matter-induced AD exacerbations from wildfires, to indirect effects, such as drought-induced food insecurity and migration. Maps were created to compare the past, present, and future projected burden of climatic hazards to the global prevalence of AD. There was a lack of data, especially in regions most likely to experience climatic hazards."Our study adds to the research on climate change by providing clarity about the extent of research on climatic hazards and AD, including the research gaps and lack of evidence in the locations most impacted now and projected to be most impacted in the future," the authors write.Several authors disclosed ties to the biopharmaceutical, dermatological, and other industries.&nbsp;<a target="_blank" rel="noopener noreferrer" href="https://onlinelibrary.wiley.com/doi/10.1111/all.16007">Abstract/Full Text</a>

Evidence of aggravation of AD seen for most climatic hazards, with impact ranging from direct to indirect effects

Climatic Hazards Linked to Aggravation of Atopic Dermatitis

THURSDAY, Dec. 28, 2023 (HealthDay News) -- In updated guidelines issued by the American Academy of Allergy, Asthma and Immunology/American College of Allergy, Asthma and Immunology, and published online Dec. 17 in the Annals of Allergy, Asthma &amp; Immunology, recommendations are presented for gaining and maintaining control of atopic dermatitis (AD).Derek K. Chu, M.D., Ph.D., from McMaster University in Hamilton, Ontario, Canada, and colleagues agreed upon 25 recommendations to gain and maintain control of mild, moderate, and severe AD. The recommendations addressed optimal use of topical treatments, dilute bleach baths, dietary avoidance/elimination, allergen immunotherapy, and systemic treatments.Changes in this update included guidance on shared decision-making and factors to consider for each of the recommendations. For patients with uncontrolled AD despite moisturizer use, use of topical corticosteroids or topical calcineurin inhibitors (TCIs) is recommended. The safety of TCIs is highlighted with typical use once or twice daily. Once-daily dosing of topical medications can be considered. Crisaborole 2 percent ointment is suggested for mild-to-moderate AD; for patients with mild-to-moderate AD refractory to moisturization alone, there is a suggestion against adding topical Janus kinase inhibitors. For AD alone with no infection, there is a suggestion against use of topical antimicrobials. Bleach baths are suggested as an additive therapy for patients with AD with moderate-to-severe disease, but not for those with mild AD. Elimination diets are not suggested for AD. For moderate-to-severe AD, allergen immunotherapy is suggested."The guidelines emphasize, in addition to standards of trustworthiness, the third principle of evidence-based medicine: that evidence alone is never enough; that patient values and preferences are crucial to arriving at optimal recommendations," Chu said in a statement.<a target="_blank" rel="noopener noreferrer" href="https://www.annallergy.org/article/S1081-1206(23)01455-2/fulltext">Atopic Dermatitis (Eczema) Guidelines</a>

Changes in this update include guidance on shared decision-making, factors to consider for each recommendation

Updated Guidelines Released for Management of Atopic Dermatitis

<div class="raw-html-embed"><mux-player playback-id="6wTEHMvhgpvSNEYoj6Ho01wKyxIHgHvauOvvW1NAxVhA
" env-key="ENV_KEY" metadata-video-title="Adbry launch alert" controls=""></mux-player></div>Dr James Q Del Rosso announces the expanded approval for Adbry, now approved for pediatric patients aged 12-17, discussing dosing and safety for this critical patient group<o:p></o:p>LEO Pharma Inc. has achieved a significant milestone in the treatment of pediatric patients with moderate-to-severe atopic dermatitis (AD) in the United States with the expanded approval of Adbry (tralokinumab-ldrm) by the US Food and Drug Administration (FDA). Adbry is the only FDA-approved biologic designed to target the IL-13 cytokine, a crucial factor in driving the signs and symptoms of AD.&nbsp;The Pediatric AD landscape&nbsp;Approximately 2.4 million pediatric patients aged 12-17 years in the US are living with AD, with around 1.2 million classified as having moderate-to-severe disease. The expanded approval offers a new treatment option for this critical patient group, especially for those whose disease is not adequately controlled with topical prescription therapies or when such therapies are not advisable.&nbsp;Clinical trial insights&nbsp;Adbry's approval for pediatric patients aged 12-17 years is supported by data from the Phase 3 ECZTRA 6 trial, where the efficacy and safety of Adbry were evaluated in 289 pediatric patients with moderate-to-severe AD.&nbsp;The trial results showed that over five times as many pediatric patients had clear or almost clear skin compared with placebo, with 21% of patients who received Adbry achieving an Investigator's Global Assessment (IGA) score of 0 or 1 compared to 4% who received placebo.&nbsp;Approximately five times as many pediatric patients saw a substantial improvement with Adbry compared to placebo, with 29% of patients who received Adbry achieving at least a 75% improvement in their Eczema Area and Severity Index score (EASI-75) compared to 6% who received placebo.&nbsp;More than seven times as many pediatric patients experienced significantly reduced itch with Adbry compared to placebo, with 23% of patients who received Adbry achieving at least a four-point reduction in Adolescent Worst Pruritis Numerical Rating Scale (NRS) compared to 3% with placebo.&nbsp;In ECZTRA-6, a higher proportion of pediatric patients who received Adbry achieved at least a 90% improvement in their Eczema Area and Severity Index score (EASI-90) compared to placebo.&nbsp;Safety profile&nbsp;The safety profile of Adbry during the trial was comparable to that observed in trials involving adults with AD. The most common adverse events were upper respiratory tract infections, conjunctivitis, injection site reactions, and eosinophilia.&nbsp;Future outlook&nbsp;Adbry is already approved for the treatment of adults with moderate-to-severe AD. The expansion of its approval for pediatric patients further solidifies its position as a valuable treatment option in the atopic dermatitis landscape.

Expanded approval for pediatric patients alters the landscape for moderate-to-severe atopic dermatitis care

LAUNCH ALERT: Adbry Receives FDA Approval for Treatment of Moderate-to-severe Atopic Dermatitis in Pediatric Patients Aged 12-17 Years

WEDNESDAY, Nov. 29, 2023 -- For patients with moderate-to-severe atopic dermatitis who did not achieve the Investigator's Global Assessment of clear/almost clear skin (IGA 0/1) at week 16 and/or used rescue medication in the ECZTRA 1 and 2 trials, tralokinumab provides clinically meaningful responses, according to a study published online Oct. 7 in the American Journal of Clinical Dermatology.Eric L. Simpson, M.D., from Oregon Health and Science University in Portland, and colleagues conducted a post-hoc analysis involving 1,328 patients from ECZTRA 1 and 2 who did not achieve the coprimary end point of IGA 0/1 at week 16 without rescue medication. The authors sought to examine the impact of tralokinumab versus placebo on other clinically meaningful parameters.The researchers found that at week 16, a significantly greater proportion of patients receiving tralokinumab versus placebo achieved a 50 percent improvement in the Eczema Area and Severity Index, a ≥3-point improvement in the itch Numerical Rating Scale (22.6 versus 9.4 percent), or a ≥4-point improvement in the Dermatology Life Quality Index (41.2 versus 24.5 percent). Furthermore, a numerically greater proportion of tralokinumab- versus placebo-treated patients achieved all three measures of clinically meaningful response (30 versus 18 percent) or a clinically meaningful change in at least one outcome (48.8 versus 28.5 percent). Additional clinician-reported and patient-reported outcomes were achieved by significantly greater proportions of patients receiving tralokinumab versus placebo."Using multiple validated outcome measures of both efficacy and quality of life, including patient-reported outcomes, alongside IGA scores, can better characterize treatment responses in patients with moderate-to-severe atopic dermatitis," the authors write.Several authors disclosed ties to biopharmaceutical companies, including Leo Pharma A/S, which manufactures tralokinumab and funded the ECZTRA 1 and 2 clinical trials.

Clinically meaningful responses seen for patients who did not achieve coprimary end point in the ECZTRA 1 and 2 trials

How Beneficial Is Tralokinumab for Patients With Atopic Dermatitis?

THURSDAY, Nov. 16, 2023 (HealthDay News) -- In updated guidelines issued by the American Academy of Dermatology and published online Nov. 7 in the Journal of the American Academy of Dermatology, recommendations are presented for use of phototherapy and systemic therapies for atopic dermatitis (AD) and include strong endorsements of monoclonal antibodies and Janus kinase inhibitors.Dawn M. R. Davis, M.D., from the Mayo Clinic in Rochester, Minnesota, and colleagues conducted a systematic review and applied the Grading of Recommendations, Assessment, Development, and Evaluation approach for assessing the certainty of evidence and formulating and grading recommendations to provide evidence-based recommendations for use of phototherapy and systemic therapies for adults with AD.The workgroup developed 11 recommendations on management of AD in adults. These include strong recommendations for dupilumab, tralokinumab, upadacitinib, abrocitinib, and baricitinib for adults with moderate-to-severe AD. Phototherapy is conditionally recommended for adults with AD. Methotrexate is also conditionally recommended, with proper monitoring, as is mycophenolate mofetil, azathioprine, and limited-term use of cyclosporine, all with proper monitoring. There is a conditional recommendation against use of systemic corticosteroids."When AD is more severe or refractory to topical treatment, advanced treatment with phototherapy or systemic medications can be considered," the authors write. "In this clinical practice guideline, we make strong recommendations for the use of dupilumab, tralokinumab, abrocitinib, baricitinib, and upadacitinib."Several authors disclosed ties to the pharmaceutical industry.

Guidelines include strong recommendations for monoclonal antibodies and JAK inhibitors

Recommendations Developed for Atopic Dermatitis Therapies

FRIDAY, Oct. 27, 2023 (HealthDay News) -- Adolescents with versus those without atopic dermatitis (AD) have increased prevalence and frequency of experiencing bullying, according to a study published online Oct. 25 in JAMA Dermatology.Andrew Cheng, from Augusta University/University of Georgia Medical Partnership in Athens, and colleagues analyzed cross-sectional data from caregivers of U.S. adolescents aged 12 to 17 years from the 2021 National Health Interview Survey to examine the association between AD and prevalence and frequency of bullying.Overall, 11.9 percent of the 3,207 adolescents had current AD. The researchers found that adolescents with versus without AD had higher prevalence of experiencing bullying (33.2 versus 19.0 percent) and cyberbullying (9.1 versus 5.8 percent). After adjustment for demographics and atopic comorbidities, adolescents with AD had higher odds of experiencing bullying than those without AD. After adjustment for demographics, adolescents with versus without AD had increased odds of experiencing cyberbullying, but after further adjustment for atopic comorbidities, the association was no longer significant. There was no association seen for AD with perpetration of bullying after adjustment for demographics and atopic comorbidities. After adjustment for demographics and atopic comorbidities, adolescents with AD had greater odds of being bullied at a higher frequency."Adolescents with AD had higher prevalence and frequency of experiencing bullying compared with adolescents without AD," the authors write.One author disclosed ties to the pharmaceutical industry.

Adolescents with atopic dermatitis have higher odds of being bullied at higher frequency after adjustment for demographics, atopic comorbidities

Teens With Atopic Dermatitis More Likely to Experience Bullying

MONDAY, Oct. 2, 2023 (HealthDay News) -- Children with atopic dermatitis (AD) are more likely to have positive patch test (PPT) reactions, according to a study published online Sept. 25 in the Journal of the American Academy of Dermatology.Hadley Johnson, from the University of Minnesota Medical School in Minneapolis, and colleagues provided updated prevalence data of common contact allergens in children with and without AD in a retrospective case-control study. Data were included for 912 children: 615 with and 297 without AD.The researchers found that children with AD were significantly more likely than those without AD to have a longer history of dermatitis (4.1 versus 1.6 years), have seen more providers (2.3 versus 2.1), have more than one PPT result, have a greater number of PPT results (2.3 versus 1.9), and have a more generalized distribution of dermatitis. Compared with those without AD, children with AD had significantly increased PPT to bacitracin, carba mix, and cocamidopropyl betaine."Patients can have atopic dermatitis and allergic contact dermatitis at the same time, and it all looks like the same thing," coauthor JiaDe Yu, M.D., from Massachusetts General Hospital in Boston, said in a statement. "The overall eczema may look very severe but once you remove the allergic component, the eczema seems much more manageable. A board-certified dermatologist can provide you with an accurate diagnosis by performing a patch test to determine whether you have allergic contact dermatitis and determine how to appropriately treat it."

Children with atopic dermatitis more likely to have more than one positive patch test result

Children With Eczema More Likely to Have Allergic Contact Dermatitis

THURSDAY, Aug. 31, 2023 -- Both children and adults with atopic dermatitis have an increased risk for inflammatory bowel disease (IBD), according to a study published online Aug. 30 in JAMA Dermatology.Zelma C. Chiesa Fuxench, M.D., from University of Pennsylvania in Philadelphia, and colleagues examined the association of atopic dermatitis with the risk for ulcerative colitis and Crohn disease. The analysis included more than 1.8 million pediatric controls matched to 409,431 children with atopic dermatitis (93.2 percent mild, 5.5 percent moderate, and 1.3 percent severe) and close to 2.7 million adult controls matched to 625,083 adults with atopic dermatitis (65.7 percent mild, 31.4 percent moderate, and 2.9 percent severe).The researchers found that in fully adjusted models, children with atopic dermatitis had an increased risk for IBD (hazard ratio [HR], 1.44; 95 percent confidence interval [CI], 1.31 to 1.58) and Crohn disease (HR, 1.74; 95 percent CI, 1.54 to 1.97), which increased with worsening atopic dermatitis. However, children with atopic dermatitis did not have an overall increased risk for ulcerative colitis (HR, 1.09; 95 percent CI, 0.94 to 1.27), although those with severe atopic dermatitis did (HR, 1.65; 95 percent CI, 1.02 to 2.67). For adults with atopic dermatitis, there was an increased risk for IBD (HR, 1.34; 95 percent CI, 1.27 to 1.40), Crohn disease (HR, 1.36; 95 percent CI, 1.26 to 1.47), and ulcerative colitis (HR, 1.32; 95 percent CI, 1.24 to 1.41), with the risk increasing with worsening atopic dermatitis."Clinicians should be aware of these risks, particularly when selecting systemic treatments for atopic dermatitis in patients who may have coincident gastrointestinal symptoms," write the authors.Several authors disclosed ties to the pharmaceutical and biopharmaceutical industries.

Risk varies by age, atopic dermatitis severity, and inflammatory bowel disease subtype

Atopic Dermatitis Increases Risk for Inflammatory Bowel Disease

TUESDAY, Aug. 22, 2023 -- For patients with moderate-to-severe atopic dermatitis (AD), clinical responses are maintained with continuous upadacitinib through 40 weeks, and outcomes are improved for patients who switch from dupilumab to upadacitinib, according to a study published in the September issue of the Journal of the American Academy of Dermatology.Andrew Blauvelt, M.D., from Oregon Medical Research Center in Portland, and colleagues examined the long-term safety and efficacy of continuous upadacitinib 30 mg and switching to upadacitinib after dupilumab treatment for 24 weeks. The study included adults who completed the phase 3b clinical trial of oral upadacitinib 30 mg versus injectable dupilumab 300 mg (Heads Up), who entered a 52-week open-label extension (OLE). During the OLE, all patients received 30 mg upadacitinib. The researchers reported the results of a prespecified interim 16-week extension period.The researchers found that high levels of skin and itch response were reported for 239 patients continuing upadacitinib. Additional incremental improvements in clinical responses were seen within four weeks of starting upadacitinib for the 245 patients switching from dupilumab. Of those who did not achieve clinical responses with dupilumab, most did so with upadacitinib. In up to 40 weeks (16 weeks of OLE), the safety profile of upadacitinib was consistent with previous phase 3 studies, and there were no new safety events."Upadacitinib provides greater efficacy compared with dupilumab, has a favorable benefit-risk profile, and patients regardless of prior dupilumab response status experienced improved outcomes when switched to upadacitinib," the authors write.Several authors disclosed ties to the pharmaceutical industry, including AbbVie, which funded the clinical trials included in this analysis.

Patients switching from dupilumab to upadacitinib had additional incremental improvement in clinical response

Long-Term Benefit Seen for Upadacitinib in Moderate-to-Severe AD

TUESDAY, Aug. 22, 2023 (HealthDay News) -- For adults with moderate-to-severe atopic dermatitis (AD), dupilumab treatment yields significant improvement in sleep quality and other AD-related signs and symptoms, according to a study published online Aug. 10 in the British Journal of Dermatology.Joseph F. Merola, M.D., from Brigham and Women's Hospital in Boston, and colleagues conducted a phase 4 randomized, double-blind study to examine the impact of dupilumab treatment on sleep and other patient- and physician-reported outcomes. Adults with moderate-to-severe AD were randomly assigned to dupilumab 300 mg once every two weeks (q2w; 127 participants) or placebo (61 participants) for 12 weeks. Subsequently, patients entered an open-label phase and received dupilumab 300 mg q2w for 12 weeks. Using a novel numeric rating scale (NRS), the primary end point was the percentage change from baseline to week 12 in sleep quality.The researchers found a significant improvement in the sleep quality NRS in dupilumab-treated patients versus those receiving placebo by week 12 (least-squares mean difference, −15.5 percent). With dupilumab versus placebo, there were also significant differences in the peak pruritus NRS, SCORing Atopic Dermatitis (SCORAD), SCORAD sleep visual analog scale, and Patient Reported Outcomes Measurement Information System sleep-related impairment T-score. Compared with the placebo group, the dupilumab group had a lower overall percentage of patients reporting treatment-emergent adverse events."Future analyses will assess the persistence of dupilumab's effect on sleep disturbance through 24 weeks," the authors write.Several authors disclosed ties to the pharmaceutical industry, including Sanofi and Regeneron Pharmaceuticals Inc., which funded the study.

12 weeks of treatment also yields benefits in peak pruritus, change in SCORing Atopic Dermatitis

Dupilumab Treatment Beneficial for Sleep in Atopic Dermatitis

TUESDAY, Aug. 8, 2023 (HealthDay News) -- Having atopic dermatitis is associated with a higher risk for schizophrenia and schizoaffective disorder, according to a study published online July 26 in the Archives of Dermatological Research.Ryan Fan, from the Yale School of Medicine in New Haven, Connecticut, and colleagues used electronic health record data from participants in the All of Us research program (13,433 atopic dermatitis cases and 53,732 matched controls) to assess the relationship between atopic dermatitis and schizophrenia and schizoaffective disorder in a nested, matched, case-control study.The researchers found that participants with atopic dermatitis were more likely to have schizophrenia (2.0 versus 1.1 percent) or schizoaffective disorder (1.8 versus 0.5 percent). Even when controlling for demographics and comorbidities, the association persisted (odds ratios, 1.64 and 2.44 for schizophrenia and schizoaffective disorder, respectively)."This study provides further strong evidence for a potential relationship between atopic dermatitis with schizophrenia and schizoaffective disorder," the authors write. "Dermatologists treating patients with atopic dermatitis should be aware of these associations to facilitate collaborative management with other providers when appropriate."

Authors say awareness of this association can aid collaborative patient care

Higher Risk for Schizophrenia Seen Among Patients With Eczema

<p style="-webkit-text-stroke-width:0px;background-color:rgb(255, 255, 255);color:rgb(90, 88, 88);font-family:&quot;Source Sans Pro&quot;, sans-serif;font-size:18px;font-style:normal;font-variant-caps:normal;font-variant-ligatures:normal;font-weight:100;letter-spacing:normal;margin-left:auto;margin-right:auto;margin-top:0px;max-width:980px;orphans:2;text-align:start;text-decoration-color:initial;text-decoration-style:initial;text-decoration-thickness:initial;text-indent:0px;text-transform:none;white-space:normal;widows:2;word-spacing:0px;">WEDNESDAY, July 12, 2023 (HealthDay News) -- The prevalence of atopic diseases, including atopic dermatitis, is increased in sexually diverse people, including those who identify as lesbian, gay, or bisexual, according to a research letter published online July 12 in JAMA Dermatology.<p style="-webkit-text-stroke-width:0px;background-color:rgb(255, 255, 255);color:rgb(90, 88, 88);font-family:&quot;Source Sans Pro&quot;, sans-serif;font-size:18px;font-style:normal;font-variant-caps:normal;font-variant-ligatures:normal;font-weight:100;letter-spacing:normal;margin-left:auto;margin-right:auto;margin-top:0px;max-width:980px;orphans:2;text-align:start;text-decoration-color:initial;text-decoration-style:initial;text-decoration-thickness:initial;text-indent:0px;text-transform:none;white-space:normal;widows:2;word-spacing:0px;">Katelyn J. Rypka, from the University of Minnesota Medical School in Minneapolis, and colleagues calculated crude and multivariable-adjusted odd ratios for prevalence of atopic dermatitis, asthma, and allergic rhinitis comparing heterosexual and sexually diverse individuals. Data were included for 27,012 respondents to the 2021 National Health Interview Survey, of whom 25,701 were heterosexual and 1,311 were sexually diverse.<p style="-webkit-text-stroke-width:0px;background-color:rgb(255, 255, 255);color:rgb(90, 88, 88);font-family:&quot;Source Sans Pro&quot;, sans-serif;font-size:18px;font-style:normal;font-variant-caps:normal;font-variant-ligatures:normal;font-weight:100;letter-spacing:normal;margin-left:auto;margin-right:auto;margin-top:0px;max-width:980px;orphans:2;text-align:start;text-decoration-color:initial;text-decoration-style:initial;text-decoration-thickness:initial;text-indent:0px;text-transform:none;white-space:normal;widows:2;word-spacing:0px;">The researchers found that sexually diverse individuals were more likely to report atopic dermatitis (11.1 versus 7.2 percent), asthma (12.0 versus 7.8 percent), and allergic rhinitis (33.7 versus 25.6 percent) compared with heterosexual individuals (adjusted odds ratios, 1.49, 1.39, and 1.30, respectively). In sex-stratified analyses, results were similar.<p style="-webkit-text-stroke-width:0px;background-color:rgb(255, 255, 255);color:rgb(90, 88, 88);font-family:&quot;Source Sans Pro&quot;, sans-serif;font-size:18px;font-style:normal;font-variant-caps:normal;font-variant-ligatures:normal;font-weight:100;letter-spacing:normal;margin-left:auto;margin-right:auto;margin-top:0px;max-width:980px;orphans:2;text-align:start;text-decoration-color:initial;text-decoration-style:initial;text-decoration-thickness:initial;text-indent:0px;text-transform:none;white-space:normal;widows:2;word-spacing:0px;">"This study found higher rates of atopic disease among sexually diverse individuals," the authors write. "Further research is needed to identify factors contributing to these differences, including environmental, socioeconomic, and sociocultural factors and minority stress."

Prevalence of atopic dermatitis, asthma, and allergic rhinitis increased compared with heterosexual individuals

Prevalence of Atopic Diseases Increased in Sexually Diverse Individuals

WEDNESDAY, May 31, 2023 (HealthDay News) -- Atopic dermatitis (AD) in adulthood is associated with an increased risk for venous thromboembolism (VTE), according to a study published online May 31 in JAMA Dermatology.Tai-Li Chen, M.D., from Taipei Veterans General Hospital in Taiwan, and colleagues examined the risk for incident VTE among patients with AD. The analysis included 284,858 matched participants (142,429 participants with AD newly diagnosed between 2003 and 2017).The researchers found that 0.7 percent of participants in the AD group and 0.6 percent in the non-AD cohort developed VTE, with incidence rates of 1.05 and 0.82 per 1,000 person-years, respectively. Compared with adults without AD, adults with AD had a significantly increased risk for incident VTE (hazard ratio, 1.28). Specifically, AD was associated with higher risks for deep vein thrombosis (hazard ratio, 1.26) and pulmonary embolism (hazard ratio, 1.30)."The results of this cohort study suggest that AD in adulthood is associated with an increased risk of VTE; however, the absolute risk difference of VTE between adults with and without AD appears small," the authors write. "Nevertheless, cardiovascular examination and imperative management may be considered for adults with AD who present with symptoms suggestive of VTE. Future research is warranted to elucidate the pathophysiology underlying the association between AD and VTE."

While absolute risk difference is small, higher risk seen for both deep vein thrombosis and pulmonary embolism

Atopic Dermatitis Tied to Higher Venous Thromboembolism Risk

WEDNESDAY, May 31, 2023 -- For patients with atopic dermatitis (AD), neither ultraviolet B (UVB) phototherapy nor number of sessions is associated with an increased risk for skin cancer, according to a study published online May 24 in the Journal of the American Academy of Dermatology.Mei-Ju Ko, M.D., Ph.D., from Taipei City Hospital in Taiwan, and colleagues examined the long-term safety of UVB phototherapy in terms of cutaneous carcinogenic risk among 6,205 AD patients in a nationwide population-based cohort study from 2001 to 2018.The researchers found that the risks for skin cancer, nonmelanoma skin cancer, and cutaneous melanoma were not increased among AD patients treated with UVB phototherapy compared with those who did not receive UVB phototherapy (adjusted hazard ratios [95 percent confidence intervals], 0.91 [0.35 to 2.35], 0.80 [0.29 to 2.26], and 0.80 [0.08 to 7.64], respectively). Furthermore, no association was seen between the number of UVB phototherapy sessions and an increased risk for skin cancer, nonmelanoma skin cancer, or cutaneous melanoma."Our results that UVB phototherapy does not increase the risk of skin cancer among AD patients are consistent with previously reported results from patients with psoriasis, vitiligo, and chronic kidney disease," the authors write. "Our findings confirm the safety of UVB phototherapy for AD patients and provide valuable information for clinicians and patients when choosing a treatment for AD."

No increase seen in skin cancer, nonmelanoma skin cancer, cutaneous melanoma for those treated with UVB phototherapy

Does UVB Phototherapy Increase Risk for Skin Cancer in Patients With Eczema?

WEDNESDAY, May 17, 2023 (HealthDay News) -- Domestic violence and abuse (DVA) is significantly associated with a higher risk for developing atopic disease, according to a study published online May 5 in the Journal of Allergy and Clinical Immunology: In Practice.Katrina Nash, M.B.Ch.B., from University of Oxford in the United Kingdom, and colleagues examined the association between exposure to DVA and the subsequent development of atopy. The analysis included women with no history of atopic disease (Jan. 1, 1995, to Sept. 30, 2019) with exposure to DVA (13,852) and unexposed patients (49,036) who were matched by age and deprivation quintile.The researchers found that the incidence rate for new atopic disease was 20.10 per 1,000 person-years in exposed women versus 13.24 per 1,000 person-years in unexposed women. When adjusting for confounders, the adjusted hazard ratio was 1.52 overall and 1.69 for asthma, 1.40 for atopic eczema, and 1.63 for allergic rhinoconjunctivitis."Our study found that women who are exposed to DVA are at increased risk for developing atopic disease, in alignment with previous observational data," the authors write. "Therefore, implementation of systematic public health measures, adopting the consideration of DVA in clinical interactions with patients who present with ill health, and encouragement of measures to prevent DVA in wider society by public health professionals and its devastating downstream consequences are urgently needed."<a target="_blank" rel="noopener noreferrer" href="https://www.jaci-inpractice.org/article/S2213-2198(23)00300-8/fulltext">Abstract/Full Text</a>

Higher risk seen for asthma, atopic eczema, and allergic rhinoconjunctivitis

 Domestic Abuse Tied to Higher Risk for New Atopic Disease

For patients with erythrodermic atopic dermatitis (AD), treatment with dupilumab results in rapid, sustained improvements in signs and symptoms of AD, according to a study published online Feb. 1 in
 
 JAMA Dermatology
 
 .




 Amy S. Paller, M.D., from the Northwestern University Feinberg School of Medicine in Chicago, and colleagues conducted a post-hoc analysis of patients enrolled in six randomized trials. Patients met erythrodermic AD criteria of 90 percent or greater body surface area (BSA) affected by AD and a Global Individual Sign Score of 1 or greater for erythema.




 Overall, 209 of 3,075 randomly assigned patients met the criteria for erythrodermic AD at baseline. The researchers found that compared with placebo, dupilumab once weekly and every two weeks significantly improved the percentage BSA affected by AD (least squares mean percent change, –42.0 and –39.9 versus –17.2 percent with monotherapy; –63.2 and –56.1 versus –14.5 percent with concomitant topical corticosteroids [TCS]), the Eczema Area and Severity Index score (–58.5 and –58.3 versus –22.3 percent with monotherapy; –78.9 and –70.6 versus –19.3 percent with concomitant TCS), and the Peak Pruritus Numerical Rating Scale score (–45.9 and –33.9 versus –0.6 percent with monotherapy; –53.0 and –55.7 versus –26.0 percent with concomitant TCS). As early as week 1, nominally statistically significant improvement was seen. Significant reduction in biomarker levels was seen compared with placebo.




 Several authors disclosed financial ties to biopharmaceutical companies, including Sanofi and Regeneron, which manufacture dupilumab and funded the study.




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Significant improvements reported in percentage BSA affected by AD, Eczema Area and Severity Index score, Peak Pruritus Numerical Rating Scale score

Is Dupilumab Beneficial for Treatment of Erythrodermic Atopic Dermatitis?

In guidelines issued by the American Academy of Dermatology and published online Jan. 11 in the
 
 Journal of the American Academy of Dermatology
 
 , updated recommendations are presented for the topical treatment of atopic dermatitis (AD) in adults.




 Robert Sidbury, M.D., M.P.H., from the University of Washington School of Medicine and Seattle Children's Hospital, and colleagues conducted a systematic review to provide evidence-based recommendations related to management of AD in adults using topical treatments.




 A total of 11 recommendations were developed on management of AD in adults with topical therapies. Strong recommendations were made for use of moisturizers, use of the topical calcineurin inhibitors tacrolimus 0.03 or 0.1 percent and pimecrolimus 1 percent cream for AD and for mild-to-moderate AD, respectively, and topical corticosteroids for adults with AD. In addition, to reduce disease flares and relapse, intermittent use of medium-potency topical corticosteroids is strongly recommended as maintenance therapy (two times/week). The topical phosphodiesterase-4 inhibitor crisaborole and Janus kinase inhibitor ruxolitinib are also strongly recommended for mild-to-moderate AD.




 "While atopic dermatitis cannot be cured, it can be controlled with proper treatment," Sidbury said in a statement. "A plan created by a board-certified dermatologist can help ease symptoms, reduce flare-ups, and prevent it from worsening. Topical treatments remain one of the most popular options due to their effective track record and overall safety."




 Several authors disclosed financial ties to the pharmaceutical industry.




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Strong recommendations include use of moisturizers, topical corticosteroids, topical calcineurin inhibitors

Guidelines Updated for Topical Treatment of Atopic Dermatitis in Adults

For adolescents and adults with moderate-to-severe atopic dermatitis (AD), a monoclonal antibody targeting interleukin-13, lebrikizumab (LEB), combined with topical corticosteroids (TCS), is associated with improved outcomes, according to a study published online Jan. 11 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 LEB combined with low- to mid-potency TCS in a 16-week trial conducted at 54 outpatient sites involving adolescents and adults with moderate-to-severe AD. A total of 211 patients were randomly assigned to LEB or placebo (PBO) in combination with TCS for 16 weeks in a 2:1 ratio.




 The researchers found that the proportion of patients achieving an Investigator's Global Assessment score of 0 or 1 was 41.2 and 22.1 in the LEB TCS and PBO TCS groups, respectively; the corresponding proportions achieving a 75 percent improvement in the Eczema Area and Severity Index were 69.5 and 42.2 percent. Statistically significant improvement in all key secondary end points was seen for the LEB TCS group. Treatment-emergent adverse events (TEAEs) were mostly nonserious, were mild or moderate in severity, and did not lead to discontinuation in the study. Conjunctivitis, headache, hypertension, injection site reactions, and herpes infection were the TEAEs frequently reported in the LEB TCS group, and these TEAEs occurred less frequently in the PBO TCS group.




 "Taken together, the efficacy and safety data reported herein suggest that LEB TCS may be an effective treatment option for adult and adolescent patients with moderate-to-severe AD," the authors write.




 Several authors disclosed financial ties to pharmaceutical companies, including Dermira, a wholly owned subsidiary of Eli Lilly, which manufactures lebrikizumab and funded the study.




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Improvement seen in IGA(0,1) and in EASI-75 with lebrikizumab plus topical corticosteroids versus placebo plus topical corticosteroids

Do Outcomes Improve With Lebrikizumab in Atopic Dermatitis?

Atopic dermatitis (AD) in children is associated with an increased risk for subsequent fracture, according to a research letter published online Nov. 9 in
 
 Allergy
 
 .




 Seung Won Lee, M.D., Ph.D., from Sungkyunkwan University in Suwon, South Korea, and colleagues used data from the National Health Insurance Service in South Korea to examine the relationship between AD diagnosis and fracture. The analysis included 1.78 million infants born between 2009 and 2015, with follow-up through 2019.




 The researchers found that when propensity-matching children and adjusting for confounders, children with AD had a 14 percent greater likelihood of developing fractures than controls (33.37 versus 28.88 per 1,000 person-years). There was a dose response observed, with the risk for fracture increasing with AD severity (28.88, 33.08, and 35.54 per 1,000 person-years for control, mild AD, and moderate-to-severe AD groups, respectively). In an adjusted analysis, the risk for fracture increased in children with mild AD (adjusted hazard ratio [aHR], 1.12) and moderate-to-severe AD (aHR, 1.23). Furthermore , early-onset AD increased fracture risk (aHRs, 1.19, 1.08, and 1.03 for first diagnosis at age younger than 2 years, 2 to 4 years, and 5 years or older, respectively).




 "Several factors may underlie the association of AD with fracture risk in children, including the interaction between immune and bone cells, dietary habits, calcium and vitamin D intake, physical activity, psychological and behavioral disorders, sleep quality, and the effect of systemic corticosteroids on bone mineral metabolism," the authors write.

Findings show dose-response relationship, with higher risk tied to more severe atopic dermatitis

Atopic Dermatitis Raises Subsequent Fracture Risk in Children

For patients with moderate-to-severe atopic dermatitis, tralokinumab is well tolerated, according to research published in the December issue of the
 
 British
 
 
 Journal of Dermatology
 
 .




 Eric L. Simpson, M.D., from the Oregon Health &amp; Science University in Portland, and colleagues characterized the safety profile of tralokinumab for the treatment of moderate-to-severe atopic dermatitis in pooled analyses of phase II and phase III placebo-controlled clinical trials.




 A total of 2,285 patients were randomly assigned in the initial treatment periods up to 16 weeks (1,605 and 680 to tralokinumab and placebo, respectively). The researchers found that for tralokinumab and placebo, the frequencies of any adverse event were 65.7 and 67.2 percent, respectively. Per 100 patient-years of exposure (ep100PYE), the corresponding rates were 640 and 678 events. Serious adverse events occurred in 2.1 and 2.8 percent of those receiving tralokinumab and placebo, respectively (7.4 and 11.9 ep100PYE). Viral upper respiratory tract infection, upper respiratory tract infection, conjunctivitis, and injection-site reactions were the most common adverse events occurring at a higher frequency and rate with tralokinumab versus placebo. No increase in adverse events was seen with continued maintenance and open-label treatment, including rates of common or serious adverse events or those leading to drug discontinuation.




 "This analysis from a large pool of patients exposed to tralokinumab for an extended period of time reaffirms the safety profile of tralokinumab, as it was well tolerated both in combination with topical corticosteroids and as monotherapy with long-term use up to 52 weeks for moderate-to-severe atopic dermatitis," the authors write.




 Several authors disclosed financial ties to pharmaceutical companies, including Leo Pharma, which manufactures tralokinumab.




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No increase in adverse events seen with continued maintenance and open-label treatment

Is Tralokinumab Well Tolerated for Moderate-to-Severe Eczema?

Adults with atopic dermatitis (AD) have a significantly increased risk for new-onset migraine, according to a letter to the editor published online Oct. 21 in the
 
 Journal of the European Academy of Dermatology &amp; Venereology
 
 .




 Ji Hae Lee, from the Catholic University of Korea in Seoul, and colleagues used the Korean National Health Insurance Service claims database to identify 3.5 million adults in Korea who underwent a nationwide health check-up in 2009. The impact of AD on the risk for new-onset migraine was assessed.




 The researchers found that 48,983 adults (1.5 percent) had a diagnosis of AD, while 449,484 new-onset migraines were identified during 7.6 years of median follow-up. In people with AD, the cumulative incidence of new-onset migraine was 21.8 per 1,000 person-years, which was significantly higher than in those without AD (16.5 per 1,000 person-years; hazard ratio, 1.26). The risk for new migraine was slightly higher among those with moderate-to-severe AD (hazard ratio, 1.26) versus those with mild AD. Among patients with AD, smoking and male sex were significantly associated with a higher risk for new-onset migraine. There was also a synergistic increase in the risk for migraine in AD patients with sleep disorders or stroke.




 "Further study is needed to examine whether appropriate management of AD can guard against the risk of new-onset migraine," the authors write.




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Among those with atopic dermatitis, smoking and male sex were significantly associated with higher risk for new-onset migraine

Atopic Dermatitis May Be Risk Factor for New-Onset Migraine

Early application of emollients to infants at high-risk for atopic dermatitis seems to be effective for preventing the development of the skin condition, according to research published online Nov. 23 in the
 
 Journal of the European Academy of Dermatology &amp; Venereology
 
 .




 Junqin Liang, from the People's Hospital of Xinjiang Uygur Autonomous Region in Urumchi, China, and colleagues conducted a network meta-analysis to compare different emollients for preventing infant atopic dermatitis. Data were included for 11 studies. Three types of emollients were compared: cream, emulsion, and mixed types.




 The researchers found that early application of emollients effectively prevented atopic dermatitis development in high-risk infants based on direct meta-analysis (risk ratio, 0.64). In a network meta-analysis, emollient emulsion was suggested as the better option for preventing infant atopic dermatitis development, with a surface under the cumulative ranking curve of 82.6, 78.0, and 79.2 percent for all populations, high-risk populations, and populations with food sensitization, respectively. Adverse events were experienced more frequently by individuals receiving emollients.




 "The results of this systematic review and network meta-analysis show that early application of skin emollients can effectively prevent atopic dermatitis development in infants," the authors write. "Moreover, among the available three types of emollients, the emollient emulsion is probably the optimal option in infancy to prevent atopic dermatitis development more effectively."

Of the types of emollient, emulsion was suggested as the better option for preventing infant atopic dermatitis development

Early Application of Emollients Prevents Development of Eczema

A significant burden of atopic dermatitis and bacterial skin infections exists in urban-living Indigenous children and young people in high-income countries, according to a review published online Nov. 9 in
 
 Pediatric Dermatology
 
 .




 Bernadette M. Ricciardo, M.B.B.S., from the University of Western Australia in Crawley, and colleagues conducted a systematic literature review to assess the burden of atopic dermatitis and bacterial skin infections in urban-living Indigenous children and young people in high-income countries.




 The researchers included 16 studies, including seven papers documenting eight studies on atopic dermatitis and nine papers on bacterial skin infections. Compared with non-Indigenous peers, current and severe symptoms of atopic dermatitis were more common in urban-living Indigenous children and young people in high-income countries, with children having a higher prevalence than adolescents. There was a higher incidence of all measures of bacterial skin infection among urban-living Indigenous children and young people in high-income countries versus non-Indigenous peers. For all measures, Indigenous populations were over-represented compared with their proportion of the background population.




 "We echo the call to action for more studies to better understand the impact of atopic dermatitis and bacterial skin infection in urban-living Indigenous children and young people noting specifically the poor representation of North American Indigenous children and young people in the published literature," the authors write.




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Incidence rates of atopic dermatitis and bacterial skin infections higher among urban-living Indigenous children and young people in high-income countries

Urban Dwelling Indigenous Young People Face Higher Burden of Skin Conditions

For patients with atopic dermatitis (AD) receiving dupilumab, serum dupilumab levels at 16 weeks of treatment are not associated with treatment response, according to a study published online Nov. 2 in
 
 J
 
 
 AMA Dermatology
 
 .




 Lotte S. Spekhorst, M.D., from the University Medical Center Utrecht in the Netherlands, and colleagues examined serum dupilumab levels at 16 weeks of treatment and evaluated the association of these levels with treatment response at 52 weeks in patients with AD in a clinical, prospective, observational study. Data were included for 295 patients with AD.




 The researchers found that the median drug level was 86.6 µg/mL (interquartile range, 64.6 to 110.0 µg/mL) at 16 weeks of treatment. Serum dupilumab levels did not differ significantly based on responder status at week 16. Nonsignificant odds ratios were seen for serum dupilumab levels at 16 weeks in terms of prediction of long-term response or adverse events in multivariate logistic regression.




 "No association with treatment response or adverse effects to dupilumab were identified in patients with AD during the first year of dupilumab treatment," the authors write.




 Several authors disclosed financial ties to pharmaceutical companies, including Sanofi and Regeneron, the manufacturers of dupilumab.




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Odds ratios for serum dupilumab levels at 16 weeks predicting long-term response and adverse events not significant

Serum Dupilumab Levels Not Linked to Treatment Response in Eczema

Online symptom checkers are often inaccurate in identifying skin rashes, according to a study published online Oct. 12 in the
 
 Journal of the American Academy of Dermatology
 
 .




 Nicholas A. Berry, from the Mayo Clinic in Scottsdale, Arizona, and colleagues entered clinical data from 15 rash vignettes into eight online symptom checkers that were capable of diagnosis (not just triage), allow user input of skin rash data, and handle pediatric and adult ages.




 The researchers found that online symptom checkers correctly diagnosed skin rashes in only 37 of 120 entries (30.8 percent). Symptom checkers generated a mean total of 13.6 differential diagnoses in those 37 scenarios. For correct diagnosis via symptom checker, the mean number of data entry terms needed to maintain that correct diagnosis was 6.1 following one-by-one random elimination. Variation existed in each symptom checker's accuracies, ranging from 13.3 to 73.3 percent. Symptom checkers were most often correct for diagnosis of atopic dermatitis (pediatric; 75 percent) and shingles (62.5 percent). No symptom checker was correct for diagnosis of dermatitis herpetiformis. Only one symptom checker correctly diagnosed erythema nodosum, hidradenitis suppurativa, lichen sclerosus, or perioral dermatitis.




 "For diagnosing skin rashes, symptom checkers have poor accuracy due to limitations on asking about pertinent medical history and insufficient diagnoses in their algorithms," the authors write.




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Even when correct in diagnosis, broad differentials and low specificity of results contribute to diagnostic uncertainty

Online Symptom Checkers Often Not Accurate for ID'ing Skin Rashes

In a consensus statement issued by the Harmonizing Outcome Measures for Eczema (HOME) Clinical Practice initiative and published online Oct. 12 in
 
 JAMA Dermatology
 
 , instruments are identified for measuring eczema control and itch intensity in patients with atopic eczema.




 Yael A. Leshem, M.D., from Rabin Medical Center in Petah-Tikva, Israel, and colleagues identified instruments to measure eczema control and itch intensity through systematic reviews informing a consensus process. To optimize instrument selection for clinical practice, feasibility aspects were highlighted. If fewer than 30 percent of the voters disagreed, consensus on an instrument was reached.




 The researchers found that of the seven instruments identified, the Recap of Atopic Eczema and Atopic Dermatitis Control Tool were recommended for measuring eczema control (5 and 10 percent of voters disagreed, respectively). Support was garnered for a single-question patient global assessment, but consensus was not reached. Three of the six available itch-intensity instruments were recommended by consensus: a peak 24-hour numeric rating scale (NRS)-itch and one-week NRS-itch instruments from the Patient-Reported Outcomes Measurement Information System Itch Questionnaire, measuring average and peak itch (17, 22, and 27 percent of voters disagreed, respectively).




 "The HOME Eczema Clinical Practice set is a 'pick and choose' list of well-validated, feasible-to-use instruments that clinicians can use in their daily practice," the authors write. "These instruments can supplement, not replace, the thorough interpersonal medical encounter."




 Several authors disclosed financial ties to the biopharmaceutical industry.




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Consensus reached for Recap of Atopic Eczema and Atopic Dermatitis Control Tool for measuring eczema control

Instruments ID'd for Measuring Eczema Control, Itch Intensity

For patients with atopic dermatitis (AD) enrolled in the ECZTEND trial and receiving tralokinumab, COVID-19 infections were mainly mild or moderate and almost all occurred in unvaccinated patients, according to a research letter published online Oct. 12 in
 
 JAMA Dermatology
 
 .




 Andrew Blauvelt, M.D., from Oregon Medical Research Center in Portland, and colleagues conducted a case series in a subset of adults enrolled in the ongoing ECZTEND trial who received 300 mg subcutaneous tralokinumab every two weeks plus optional topical corticosteroids after a 600-mg loading dose and reported COVID-19 during routine clinic visits. Of 1,442 patients enrolled in the ECZTEND trial, 77 had confirmed COVID-19 (76 were unvaccinated and one was partially vaccinated).




 The researchers found that COVID-19 severity was mainly mild or moderate (68 and 30 percent, respectively); two patients (3 percent) had severe symptoms, both of whom had multiple risk factors for severe COVID-19 and both of whom recovered after hospitalization. Neither case was reported as linked to treatment with tralokinumab. Two cases of COVID-19 were reported as possibly associated with tralokinumab; both occurred in patients younger than 30 years. No deaths were reported from COVID-19. After COVID-19, all patients continued tralokinumab therapy; treatment was not interrupted in 60 patients (78 percent). As of April 30, 2021, 16 percent of participants in the trial had received one or more COVID-19 vaccine doses; no patients reported adverse events resulting in permanent discontinuation of tralokinumab after vaccination.




 "No new safety signals or evidence for reduced effectiveness of severe acute respiratory syndrome coronavirus 2 vaccines administered during tralokinumab treatment were reported," the authors write.




 Several authors disclosed financial ties to biopharmaceutical companies, including Leo Pharma, the manufacturer of tralokinumab.




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76 of 77 patients with COVID-19 were unvaccinated; no new safety signals reported after COVID-19 vaccination

COVID-19 Mainly Mild, Moderate in Eczema Patients Receiving Tralokinumab

For patients with atopic dermatitis, a greater percentage achieve an itch-free state with use of ruxolitinib cream versus vehicle, according to a study published online Sept. 13 in the
 
 Journal of the American Academy of Dermatology
 
 .




 Andrew Blauvelt, M.D., from the Oregon Medical Research Center in Portland, and colleagues examined achievement of an itch-free state among 1,208 patients with atopic dermatitis and baseline itch who received ruxolitinib cream; 41 patients were excluded for quality issues.




 The researchers found that the percentage of patients who applied ruxolitinib cream and achieved an itch-free state was higher than the percentage seen among those who applied vehicle. The difference in itch numerical rating scale (NRS) 0/1 for ruxolitinib compared with vehicle was significant on day 2 (about 36 hours after the first application); significance persisted through week 8. The median time to achieve itch NRS 0/1 was 14.0 and 9.0 days for ruxolitinib 0.75 and 1.5 percent, respectively, compared with not estimable for vehicle. Of the factors examined, the only factor significantly associated with faster itch response was age (younger than 18 years versus 18 years and older; hazard ratio, 0.754).




 "These results demonstrate that ruxolitinib cream addresses an unmet need by rapidly improving itch, a chronic and burdensome symptom, in adults and adolescents with atopic dermatitis," the authors write.




 Several authors disclosed financial ties to pharmaceutical companies, including Incyte, which manufactures ruxolitinib and funded the study.




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Difference in itch numerical rating scale 0/1 was significant on day 2 and persisted through week 8

More Eczema Patients Achieve Itch-Free State With Ruxolitinib

Atopic dermatitis (AD) severity and time spent managing symptoms have the strongest associations with self-reported disease burden, according to a study recently published in
 
 JAMA Dermatology
 
 .




 Rawaan Elsawi, from University of Toronto and Women's College Research Institute, and colleagues examined the burden of AD among 1,065 adult survey respondents (83 percent women).




 The researchers found that 46 percent of participants reported low-moderate AD impact scores (2 to 3), while 51 percent reported high-significant impact scores (4 to 5) and just 3 percent reported no disease burden (impact score, 1). Overall impact scores were strongly associated with current AD severity (odds ratios, 4.13 and 13.63 for moderate and severe, respectively, versus mild) and time spent managing AD (odds ratios, 2.67 and 5.34 for 11 to 20 hours and ≥21 hours, respectively, versus less than five hours).




 "In this survey study, skin disease severity and time spent managing symptoms were strongly associated with AD disease burden. No single aspect of the disease seemed to drive disease burden; rather, the burden is multidimensional and heterogeneous," the authors write. "Further work to address the complex burden of AD, including strategies to reduce time spent managing AD, and understanding the fullness of the patient experience is needed."




 Several authors disclosed financial ties to the pharmaceutical industry.




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Strongest associations seen for disease severity and time spent managing symptoms

Several Factors Significantly Tied to Atopic Dermatitis Disease Burden

For children younger than 6 years, dupilumab significantly improves signs and symptoms of atopic dermatitis, according to a study published in the Sept. 17 issue of
 
 The Lancet
 
 .




 Amy S. Paller, M.D., from the Feinberg School of Medicine at Northwestern University in Chicago, and colleagues conducted a randomized trial at 31 hospitals, clinics, and academic institutions involving patients aged 6 months to younger than 6 years with moderate-to-severe atopic dermatitis (Investigator's Global Assessment [IGA] score of 3 to 4] and an inadequate response to topical corticosteroids. Patients were randomly assigned to subcutaneous placebo or dupilumab (83 and 79 patients, respectively) every four weeks plus low-potency topical corticosteroids for 16 weeks.




 The researchers found that significantly more patients in the dupilumab versus placebo group had an IGA score of 0 to 1 at week 16 (28 versus 4 percent) and had at least a 75 percent improvement from baseline in the Eczema Area and Severity Index (53 versus 11 percent). The overall prevalence of adverse events was similar (64 and 74 percent in the dupilumab and placebo groups, respectively). The incidence of conjunctivitis was higher in the dupilumab versus placebo group (5 versus 0 percent). There were no serious dupilumab-related adverse events reported.




 "By treating more aggressively to calm the immune system activation in these young children with early, severe eczema, we may also reduce the risk of their developing a range of allergic problems, changing their life beyond improving eczema," Paller said in a statement.




 Several authors disclosed financial ties to biopharmaceutical companies, including Regeneron and Sanofi, who jointly developed dupilumab and sponsored the trial.




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Signs and symptoms of atopic dermatitis improved with dupilumab versus placebo in addition to topical corticosteroids

Dupilumab Eases Atopic Dermatitis in Children Younger Than 6 Years

Patients with atopic dermatitis (AD) do not seem to have an increased risk for venous thromboembolism (VTE), nor is treatment with Janus kinase (JAK) inhibitors associated with an increased risk for VTE in AD, according to a review and meta-analysis published online Aug. 24 in
 
 JAMA Dermatology
 
 .




 Tai-Li Chen, M.D., from Taipei Veterans General Hospital in Taiwan, and colleagues examined the association of AD with incident VTE and assessed the risk for incident VTE among AD patients receiving treatment with JAK inhibitors in a systematic review. Data were included from two cohort studies and 15 randomized controlled trials with 466,993 participants.




 The researchers found that in a meta-analysis, there was no significant association between AD and incident VTE (hazard ratio, 0.95; 95 percent confidence interval, 0.62 to 1.45). Overall, 0.05 percent of the 5,722 patients with AD who were receiving treatment with JAK inhibitors experienced VTE compared with 0.03 percent of the 3,065 patients with AD receiving placebo or dupilumab (Mantel-Haenszel risk difference, 0). The incidence rate of VTE among participants with AD receiving JAK inhibitors and placebo was 0.15 and 0.12 events per 100 patient-years, respectively. Similar findings were seen for four unique JAK inhibitors (abrocitinib, baricitinib, upadacitinib, and SHR0302).




 "These findings may provide a reference for clinicians in prescribing JAK inhibitors for patients with AD," the authors write. "Further evidence from real-world data on longer-term safety [is] warranted."




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Systematic review, meta-analysis show no increased incidence of venous thromboembolism in patients with atopic dermatitis, treatment with JAK inhibitors

Is VTE Risk Increased With Atopic Dermatitis, JAK Inhibitor Use?

Dupilumab shows good drug survival at one, two, and three years of treatment for atopic dermatitis (AD), according to a study published online Aug. 10 in
 
 JAMA Dermatology
 
 .




 Lotte S. Spekhorst, M.D., from the University Medical Center Utrecht in the Netherlands, and colleagues describe drug survival of dupilumab and associated predictors in patients with AD using data from the multicenter prospective BioDay registry. Data were included for 715 adult patients.




 The researchers found that the one-, two-, and three-year overall dupilumab drug survival was 90.3, 85.9, and 78.6 percent, respectively, among the patients. Use of immunosuppressant drugs at baseline and being a nonresponder at four weeks were characteristics associated with shorter drug survival owing to ineffectiveness (hazard ratios, 2.64 and 8.68, respectively). Use of immunosuppressant drugs at baseline, age 65 years or older, and an Investigator Global Assessment score of very severe AD were characteristics associated with shorter drug survival owing to adverse effects (hazard ratios, 2.69, 2.94, and 3.51, respectively).




 "In the coming years, daily practice registry data will provide longer follow-up data of new advanced systemic treatments, which will give information on dupilumab drug survival compared with these new systemic treatments," the authors write.




 Several authors disclosed financial ties to pharmaceutical companies, including Sanofi and Regeneron, the manufacturers of dupilumab; patients in this study participated in the BioDay registry, which was sponsored by Sanofi Genzyme.




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Dupilumab demonstrates sufficient drug survival up to three years for treatment of atopic dermatitis

What Is the Long-Term Drug Survival of Dupilumab in Patients With Eczema?

Atopic eczema is associated with a small but increased risk for incident dementia, according to a study published in the August issue of the
 
 Journal of the American Academy of Dermatology
 
 .




 Alexa Magyari, from the University of California Berkeley, and colleagues assessed whether active atopic eczema is associated with incident dementia among 1,767,667 older adults (aged 60 to 99 years) registered with the U.K. Health Improvement Network.




 The researchers found that the incidence of dementia was 57 per 10,000 person-years among those with atopic eczema versus 44 per 10,000 person-years in the control group, yielding a 27 percent increased risk for dementia. Findings were similar for vascular dementia and Alzheimer disease. Even after additionally adjusting for the use of systemic corticosteroids, the association remained. The risk was found to be even higher with more severe eczema.




 "Patients with atopic eczema in a large, population-based primary care cohort had a small increased risk of incident dementia," the authors write. "Atopic eczema is common among older adults; therefore, future work should investigate the impact of screening patients with atopic eczema for cognitive impairment in older adulthood."




 One author disclosed financial ties to TARGET Derm, Pfizer, and Cosmetique Internacional.




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Dose-response relationship seen, with greater risk with more severe eczema

Atopic Eczema Tied to Higher Risk for Dementia in Older Adults

For patients with moderate-to-severe atopic dermatitis, two years of tralokinumab treatment is safe and efficacious, according to a study published online July 18 in the
 
 Journal of the American Academy of Dermatology
 
 .




 Andrew Blauvelt, M.D., from Oregon Medical Research Center in Portland, and colleagues examined the safety and efficacy of up to two years of tralokinumab treatment in a post hoc interim analysis. The safety analysis included 1,174 adult patients from completed parent trials enrolled in an ongoing five-year extension trial (ECZTEND), regardless of tralokinumab exposure duration. Efficacy analyses included adults in ECZTEND treated with tralokinumab for one or more years; subgroup analyses included 345 patients on tralokinumab for two years (one year from parent trial and one year in ECZTEND).




 The researchers found that the exposure-adjusted rate of adverse events was 237.8/100 patient-years exposure for participants on tralokinumab in the safety analysis. For common adverse events, exposure-adjusted incidence rates were comparable to those in parent trials, although the rates were lower. Improvements in the extent and severity of atopic dermatitis were sustained with two years of tralokinumab, with a 75 percent improvement in the Eczema Area and Severity Index reported in 82.5 percent of participants.




 "These data support specific inhibition of interleukin-13 with tralokinumab as a safe and efficacious option for the long-term treatment of moderate-to-severe atopic dermatitis," the authors write.




 Several authors disclosed financial ties to biopharmaceutical companies, including LEO Pharma, which manufactures tralokinumab and sponsored the ECZTEND clinical trial.




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75 percent improvement in Eczema Area and Severity Index was 82.5 percent with two years of tralokinumab

Two Years of Tralokinumab Safe, Efficacious for Atopic Dermatitis

Adults with concomitant atopic dermatitis (AD) and asthma have an increased risk for urgent health care use, according to a study published online July 7 in the
 
 Journal of the European Academy of Dermatology &amp; Venereology
 
 .




 Zarqa Ali, from Copenhagen University Hospital Bispebjerg in Denmark, and colleagues examined differences in health care utilization in adults with concomitant AD and asthma versus those with asthma or AD only. Health care utilization data were obtained from two years before to five years after the index date (date of first hospital diagnosis).




 Data were included for 12,409 patients with AD (11,590 with AD only; 819 with concomitant AD and asthma) and for 65,539 patients with asthma only. The researchers found that the risk for hospitalization for AD and asthma was increased for adults with concomitant AD and asthma compared with those with only AD or asthma (odds ratios, 1.38 and 1.16, respectively). Fewer visits in outpatient clinics were seen for AD and asthma (odds ratios, 0.10 and 0.34, respectively) for patients with concomitant AD and asthma compared with those with only AD or asthma. Patients with concomitant AD and asthma had more frequent clinic visits for rhinitis than patients with only AD or asthma.




 "Individuals with concomitant AD and asthma have higher risk of urgent health care use, that is emergency room visits and hospital admissions indicating that they may be more complicated or more severe," the authors write. "A better understanding of the disease severity and interplay between atopic diseases along with in-depth understanding of the high need for emergency care is warranted."




 Several authors disclosed financial ties to the pharmaceutical industry.




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Those with concomitant atopic dermatitis, asthma had increased risk for hospitalizations and fewer visits in outpatient clinics

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