David Rosmarin, MD

First in Class Rezpegaldesleukin: Favorable Safety, Durable Responses in Alopecia Areata, With David Rosmarin, MD

Rezpegaldesleukin, a novel regulatory T-cell agonist, has demonstrated statistically significant hair regrowth in severe-to-very-severe alopecia areata, establishing proof of concept for what may become the first targeted biologic to receive an indication in a disease where JAK inhibitors have been the only approved advanced option.

The data, from the phase 2b REZOLVE-AA study (NCT06340360), were presented as a late-breaking oral presentation at the 

2026 American Academy of Dermatology (AAD) Annual Meeting

 held in Denver, Colorado, from March 27-31, by David Rosmarin, MD, Chair of the Department of Dermatology and Associate Professor of Dermatology at Indiana University School of Medicine in Indianapolis. 

spoke with Rosmarin during the meeting to learn more about the study, which enrolled 92 adults with severe-to-very-severe alopecia areata (SALT ≥50) who had not previously received a JAK inhibitor or biologic. Participants were randomized 3:3:2 to rezpegaldesleukin 18 µg/kg every two weeks (n = 37), 24 µg/kg every two weeks (n = 35), or placebo (n = 20) for 36 weeks, with stratification by baseline SALT ≥50 to <95 versus ≥95 to 100. Mean baseline SALT scores were 80.7, 76.3, and 76.6 across the 3 arms, respectively.

On the primary endpoint of mean percent SALT reduction at week 36, both active arms demonstrated approximately 30% mean reduction versus 6% for placebo — achieving statistical significance (

 <.05) in a modified ITT analysis excluding 4 patients with major eligibility violations, with the 24 µg/kg dose showing statistically significant separation from placebo at every timepoint from week 12 through week 36.

In the secondary analyses, SALT ≤30 was achieved by 29.0% and 21.9% of patients in the 24 µg/kg and 18 µg/kg arms versus 8.4% for placebo; SALT ≤20 by 15.6% and 14.8% versus 6.7%; and SALT ≤10 by 11.5% and 8.3% versus 0.7%. Eyebrow and eyelash regrowth were also observed, with placebo-adjusted ClinRO response rates of 15% and 18% for eyebrows and eyelashes, respectively, in the 24 µg/kg arm.

Rosmarin emphasized that efficacy showed no plateau at week 36, a meaningful observation given the large number of partial responders still on treatment — and 16-week extension data expected in April 2026 may capture additional responders. The safety profile was consistent with over 1,000 patients exposed across 11 studies; the most common adverse events were mild-to-moderate injection site reactions (91.7% combined rezpegaldesleukin arms vs. 30.0% placebo) and eosinophilia (6.9% vs. 0%), with no increased rates of serious infections, MACE, thrombosis, or malignancy.

In our conversation, Rosmarin described the mechanistic rationale as genuinely differentiated — rezpegaldesleukin's selective pegylation allows preferential expansion of Tregs over effector T cells at therapeutic doses, a distinction that avoids the pro-inflammatory activity seen with native IL-2 at higher concentrations, and 1 recognized by the 2025 Nobel Prize in Physiology or Medicine. He noted that Nektar Therapeutics is planning a phase 3 program at the 24 µg/kg dose.

“I have high confidence that [the phase 3 study] will be positive and lead to ultimate FDA approval,” Rosmarin said.

Rosmarin’s disclosures include AbbVie, Abcuro, Ability Biologics, Almirall, AltruBio, Amgen, Arena, Astria, Boehringer-Ingelheim, Bristol Myers Squibb, Celgene, Concert, CSL Behring, Dermavant, Dermira, Dualitas, Edesa Biotech, EMD Serono, Forte Biosciences, Galderma, Incyte, Inmagene, Janssen, Kymera, Kyowa Kirin, Lilly, Merck, Nektar, Novartis, Pfizer, Phothera, RAPT, Recludix, Regeneron, Revolo Biotherapeutics, Sanofi, Sun Pharmaceuticals, Takeda, UCB, VielaBio, and Zura Bio.

Rosmarin D, Ungar B, Mesinkovska N, et al. Novel regulatory T-cell enhancing biologic rezpegaldesleukin: phase 2b efficacy and safety results following 36-weeks of therapy in severe-to-very-severe alopecia areata (REZOLVE-AA). Oral late-breaking presentation presented at: American Academy of Dermatology Annual Meeting; March 27–31, 2026; Denver, CO. Abstract 79863.

Nektar Therapeutics. Data from phase 2b REZOLVE-AD and REZOLVE-AA studies of rezpegaldesleukin presented at 2026 American Academy of Dermatology Annual Meeting. Press release. March 28, 2026. 

https://www.prnewswire.com/news-releases/data-from-phase-2b-rezolve-ad-and-rezolve-aa-studies-of-rezpegaldesleukin-presented-at-2026-american-academy-of-dermatology-annual-meeting-302727838.html

Videos

Rosmarin discussed new late-breaking data from ADVANCE-AA at AAD 2026.

First in Class Rezpegaldesleukin: Favorable Safety, Durable Responses in Alopecia Areata, With David Rosmarin, MD 

David Rosmarin, MD
Credit: Indiana University

New data from the ADORING program demonstrate patients with 

 can discontinue use of tapinarof cream 1% (Vtama) for nearly 80 days without recurrence after achieving completely clear skin.

2025 American Academy of Dermatology (AAD) Annual Meeting

, results of the study offer insight into the long-term effects and can help guide use in real-world settings, according to study investigators.

“For patients with atopic dermatitis, the benefits of many topical treatments are often short-lived, and for some patients, their disease rapidly reappears after taking a break from topical treatments,” said Jonathan Silverberg, MD, PhD, MPH, George Washington University School of Medicine and Health Sciences.

 “As a physician, I’m encouraged that at the end of a break from treatment with [tapinarof cream 1%] cream, patients’ [atopic dermatitis] remained mild. I’m excited to see these data support the use of [tapinarof cream 1%] cream to potentially provide lasting results for itch, which is the universal and most burdensome symptom of [atopic dermatitis].”

Initially approved for treatment of moderate to severe plaque psoriasis in adults in 2022, tapinarof cream 1% received approval for moderate to severe atopic dermatitis in patients aged 2 years or older in December 2024 based on data from the ADORING program. A long-term extension study, ADORING 3 aggregated patients from the ADORING 1 and ADORING 2 trials, patients from a 4-week maximal usage pharmacokinetics study, and VTAMA cream-naive patients 2 to 17 years of age with either mild, moderate, or severe atopic dermatitis that did not meet inclusion criteria in ADORING 1 and ADORING 2.

Per study protocol, 378 patients achieving completely clear skin, which was defined as a score of 0 on the validated Investigator Global Assessment for AD (vIGA-AD), discontinued use of tapinarof cream 1% and were assessed for maintenance of vIGA-AD of 0 or 1 off-treatment.

Results of the AAD 2025 analysis suggested 84% of patients had a vIGA-AD score of 2 at the end of the first treatment-free interval, which lasted an average of 79.8 consecutive days. Further analysis demonstrated this patient population achieved a mean weekly Peak Pruritus Numerical Rating Scale score of 2.9 and a mean Eczema Area and Severity Index score of 3.4.

With an interest in learning more about how these new data might influence the treatment landscapes and unmet need within management of atopic dermatitis, particularly in pediatric patients, the editorial team of HCPLive Dermatology caught up with study presenter David Rosmarin, MD, chair of dermatology at Indiana University School of Medicine, and that conversation is the subject of the following Q&A.

Rosmarin on Tapinarof Cream 1% in Atopic Dermatitis

HCPLive: How does this new data add to the comfortability that clinicians and patients can have when it comes to using tapinarof cream 1%, particularly in such a young patient population?

 This late breaker is giving some of the results from the ADORING 3 long-term extension evaluating tapinarof cream for atopic dermatitis in patients 2 years of age and up. Just for a background, tapinarof is a nonsteroidal arrow hydrocarbon receptor agonist approved, first for adults in psoriasis, but now also FDA approved for atopic dermatitis in patients 2 years of age and older. The long-term extension basically accumulates patients from the pivotal phase 3 studies for of ADORING 1 and ADORING 2, the maximal use PK study, as well as a few people who were directly enrolled into the long-term extension as well.

So, it's a somewhat heterogeneous population. When they first started in the pivotal phase 3 program most of the patients had either moderate or severe atopic dermatitis and a majority of these patients were also pediatric patients. We know that tapinarof is effective at treating these patients, but the question we're trying to answer with the long-term extension is: What happens when you discontinue the treatment after achieving clearance?

So, what is the disease-free interval for these patients? In practical terms, it's helpful for patients to want to take a drug holiday and not be worried that their symptoms or their itch and their disease is going to immediately recur or rebound. That's what makes tapinarof a little bit unique in that nature.

The top line result is that it's about 80 days on average for the first disease-free interval for patients. So, quite a while, making this drug particularly unique. Additionally, when patients do get their disease back it's usually very mild in nature, meaning they're not super itchy—they're not getting a rip-roaring flare. It's usually coming back in a milder nature. The fact that this medicine as a monotherapy and being used once a day can achieve not only great efficacy results, but also this ability to have a long-term holiday.

HCPLive: How unique is this benefit among current management options and what type of impact could this have on quality of life?

 I think it's an added bonus there, and it is important information to have. I think in many ways more critical is the fact that it's once a day, which is fantastic for patients. It's nonsteroidal, which worry patients. There are no restrictions on an antibody surface area or locations or combining with other treatments. I think all of those really combine to make this treatment very advantageous to many of our atopic dermatitis patients and again, with a very favorable safety profile and no Boxed Warnings.

So, I think it's just an added bonus for some patients and it's nice to not have that burden of doing disease. Now there are some topicals, for example, corticosteroids, that can rebound and can do so rather quickly. So, to me, this is rather unique.

One of our strategies, with our current practices, is giving maintenance. So, we may give maintenance of a calcineurin inhibitor, such as tacrolimus, twice a week to maintain. Well, these are patients who were off treatment altogether. To me, it's a quite a nice feature, and it's unique amongst our topicals.

HCPLive: Are we able to further identify what baseline characteristics might predispose someone to see a greater benefit with tapinarof cream 1%?

So, subgroup analysis has not been done. We don't know if there are certain prognostic factors that will lead to a longer disease-free interval. However, the fact that the population entering the study was heterogeneous—there were patients between the age of 2 all the way up to 81 years and so many pediatric patients in different disease severities, different body surface areas, different locations of disease—I think has me optimistic that it seems like many patients can experience this disease free interval, even though we don't yet know if there are particular differences amongst the population dependent on baseline characteristics.

HCPLive: What unmet needs still exist related to management of atopic dermatitis in pediatric patients?

Well, right now we have data for two years of age and older, but it would be great if we had more options for below that that age because we have many patients who start to get atopic dermatitis at just a few months of age. So, given what we're seeing in the safety for the 2 years of age and up range, I'd love to have more data to give me confidence that I can use it in under 2 years of age.

So, I think that's still a need. Also, while this is a great option, there's still some patients who don't respond, and it would be helpful to know if we can predict that in advance? And we're always looking for new options. There are so many patients of ours that have eczema, we'd love to have more options in our armamentarium.

Relevant disclosures for Rosmarin include AbbVie, Abcuro, AltruBio, Boehringer-Ingelheim, Bristol Meyers Squibb, Celgene, Concert, CSL Behring, Dermavant, Dermira, Incyte, Janssen, Kyowa Kirin, Lilly, Novartis, Pfizer, Regeneron, Sanofi, Sun Pharmaceuticals, UCB, and VielaBio.

 Tapinarof Cream 1% Once Daily: Maintenance of Low Disease Activity Including Pruritus Through End of the Treatment-free Interval in a Long-term Extension Trial in Patients Down to 2 Years of Age

Presented at the 2025 American Academy of Dermatology (ADA) Annual Meeting. Orlando, FL. March 07-11, 2025.

Organon. New Analysis of Organon’s VTAMA® (tapinarof) CREAM, 1% phase 3 data shows atopic dermatitis disease activity remained low after treatment-free interval in adults and children 2 years of age and older. Organon. March 8, 2025. Accessed March 8, 2025. 

https://www.organon.com/news/new-analysis-of-organons-vtama-tapinarof-cream-1-phase-3-data-shows-atopic-dermatitis-disease-activity-remained-low-after-treatment-free-interval-in-adults-and-children-2-years-of-ag/

Organon. FDA approves VTAMA® (tapinarof) cream, 1% for the treatment of atopic dermatitis in adults and children 2 years of age and older. Organon. December 16, 2024. Accessed March 8, 2025. 

https://www.organon.com/news/fda-approves-vtama-tapinarof-cream-1-for-the-treatment-of-atopic-dermatitis-in-adults-and-children-2-years-of-age-and-older/

Articles

New data from the ADORING program reveal that patients with atopic dermatitis can discontinue tapinarof cream 1% for nearly 80 days without recurrence after achieving clear skin. This finding, presented at the 2025 AAD Annual Meeting, highlights the cream's potential for long-term efficacy and itch relief. Initially approved for psoriasis, tapinarof cream is now FDA-approved for atopic dermatitis in patients aged 2 and older. The study underscores its unique ability to maintain low disease activity during treatment-free intervals, offering a promising option for pediatric patients.

David Rosmarin, MD, discusses results from ADORING 3 presented at AAD 2025.

Tapinarof Cream 1% Maintains Clear Skin for 80 Days in Atopic Dermatitis, with David Rosmarin, MD

: Heather, taking account of everything that we've been talking about? What advice do you have for dermatologists, and other physicians who are going to encounter vitiligo patients? What advice do you have for them in recognizing and treating vitiligo and counseling patients about this disease?

: I would say my biggest advice is to listen to your patients. That's my biggest advice. Don't make assumptions. Don't assume that it doesn't bother them or that it really bothers them. I also think another big take home is I do always offer my patients hope there are treatments. We have effective treatments, especially on sun-exposed areas. The most I think frustrating thing for vitiligo patients is when someone says, there's nothing we can do. And follow up as needed there's nothing we can do. I don't think that's accurate. The technologies and pharmaceuticals that are coming out right now and will be coming out in the upcoming years are exciting. They offer our vitiligo patients a lot of hope. That's another take home because I do think some people feel vitiligo is something that you just have to live with and you don't need to treat it. Another thing is offer your patients support groups, because it's a disease that people feel very isolated, and reaching out to a support group and participating in group processing meetings, or just even communicating online with people who have your condition, is very helpful for vitiligo patients. And we haven't touched so much on this, but don't forget that we can use camouflage makeup, tell your patients about that, including your male patients because for a lot of patients, it's a very effective way to live with vitiligo.

It's so important. You touch on so many important points, the concept that there's nothing that we can do. Well, first of all, there might be actually something that we can do to achieve repigmentation. But another thing that's been brought up repeatedly is what about halting further disease? Almost certainly we can do something for patients there. And it's not true that there's nothing that we can do. We can do something for the vitiligo that's there. We should be thinking about trying to halt further disease. And then beyond these things, there are masking techniques. And then there's just the community. And knowing that you're not the only person that's suffering from this disease, but there are other people, and it's always useful to know that we're not alone in the world suffering with whatever we're suffering from. And you just raise so many important points about the doctor-patient relationship and the different aspects of the visit and the different aspects of the disease to take time to cover with patients. Thank you so much for that.

: One thing I'd like to mention before Heather goes, if a physician is having difficulty getting coverage for in-office phototherapy or home phototherapy, the global vitiligo foundation website, globalvitiligofoundation.org has sample letters that you can use to get phototherapy coverage in your office, as well as a strong letter for home phototherapy, including references, showing that it works. And then finally an actual four-page handout that you give to the patient that walks them through how to give the treatment to themselves easily at home. I just wanted to mention that.

That's an important point. I want to thank you for watching this 

 Peer Exchange. If you enjoyed the content, please subscribe to our e-newsletters, to receive upcoming peer exchanges and other great content right in your inbox.

And lastly, I want to thank, David, Amit, and Heather, amazing and engaging experts, in vitiligo for their time and for sharing their experiences and expertise.

Dr. Woolery-Lloyd shares her advice for vitiligo providers and tips for helpful communication with patients.

Advice for Providers Treating Vitiligo

Let's move on to segment 4, future directions. This is really an area of a lot of excitement, just because there's so much in development in the vitiligo. And Amit let's start with you. Can you tell us about the drugs that are in development?

: It's a very exciting time for me. I've been practicing for 30 years, and this is the first time we've had medications that are about to be approved and are being studied for vitiligo up until now we didn't have anything that was approved for vitiligo. Ruxolitinib is the one that's closest to being approved. We've had the completion of the phase 2 in the phase 3 studies, and hopefully, we'll be having FDA approval soon. Ruxolitinib is already approved for atopic dermatitis. It is a JAK 1/2 inhibitor and is very effective in removing the T cells from the skin. In these studies, no phototherapy was given, these patients were simply asked to do their normal daily activities, including driving and walking, and the amount of sun exposure they were getting normally. And amazingly, after 52 weeks of treatment, they got 50 to 75% of the color back on their face. And that's called the FVASI, the facial vitiligo area scoring index. It was very exciting to see that result. It is a study ongoing in which we're going to be combining the topical ruxolitinib with phototherapy, and we expect to see even better results with that one. Ruxolitinib is an oral JAK 3 inhibitor and as a JAK 3 inhibitor, it would have less toxicity than oral JAK 2 inhibitors, which is exciting that has completed its phase 2 studies. And it did show response compared to placebo the response wasn't quite as good as what we saw with the topical ruxolitinib. But that might have had something to do with the type of patients that were enrolled patients with active disease and not patients with stable disease. We're going to have to see what further studies show with ruxolitinib, but that was the first oral JAK inhibitor study that completed the phase 2 study. Upadacitinib is ongoing. It's a JAK1 inhibitor. Again, we think that's going to be safer than other type of JAK inhibitors. And that is right now undergoing its phase 2 studies. We should have the results of that hopefully later this year or next year. And that's exciting to have an oral JAK inhibitor, something that can be ingested rather than something to apply topically. There are other oral JAK inhibitor studies going on, as well as a new pathway, which is the IL-15 pathway. And there's a study with AMD 714, which is a subcutaneous injection, which is given for a certain period in patients with vitiligo. And what it does is it blocks, IL-15 production in the skin, which we think is important for resident memory T cells. When vitiligo occurs and goes away when it comes back, it comes back in the same spot frequently. And that's because resident memory T cells are still there. This strategy by blocking IL-15, it gets rid of the resident memory T cells, we think which will give you a durable remission in that area. An exciting study that's being done, and then future studies are going to be done on IL-15 receptor antibodies. And finally, there's a study going on with a kit. And this kit allows you to isolate melanocytes from a skin sample from the patient's hip, and then apply those melanocytes in drop-like fashion onto an area that you've prepared with dermabrasion or laser, where you can expand the donor-recipient ratio a multiple fold. And that study is ongoing. It has finished enrollment and we should see the results of that later this year or next year. There are a lot of great studies going on with both topical and systemic therapy, and we're going to have a lot more in our armamentarium very soon.

It's exciting to think about the idea of we're going to have to become more sophisticated, practitioners, and think much more carefully in a world of multiple choices. David, how do you think about topical versus systemic therapy? What's your algorithm going to look like for that?

: Currently we don't have a single FDA-approved medication to repigment patients with vitiligo. We have a clear need for both topicals as well as systemics. For those patients who have more limited involvement, a body surface area of maybe of 10% or less will probably be thinking of using our topical options, such as ruxolitinib cream. And for patients who have very widespread disease who may have 30% of their body covered with vitiligo, the oral option may make more sense. Additionally, if a patient has progressive disease, if they're getting new lesions, it's hard to use a topical to chase after new lesions, whereas an oral or a systemic option makes a lot more sense. And a lot of the systemics that we decide and will depend on what is the data that comes out of those studies, the safety, the comorbidities of the patient. And it's certainly a bright future.

Amit as you pointed out this is like, just an unbelievably exciting time. Literally, we've gone from having topical corticosteroids, topical calcineurin inhibitors, and phototherapy to a conversation in which we're talking about new topicals that are targeted, new oral agents that are targeted, a subcutaneous treatment that might create a durable remission. It's an unbelievably exciting time. And putting this all together, David, what does the future look like for treating vitiligo?

: With the first medicines that'll be FDA approved, I'm first hoping that we'll get improved access and recognition from the insurance companies and the payers that this is truly a medical disease not just a cosmetic disease and that patients who want treatment are able to receive it. Furthermore, not all patients have access to phototherapy, or providers who are adept at providing that phototherapy. And being able to give patients topical options pills, whether or not in combination, I think is very promising and to tailor the options to the particular needs of the patient, I think provides us with a lot of hope.

I'm glad you brought up the points that you did. We really must and that's part of why we're all here doing this round table is it's really critical that we as providers recognize this disease and recognize that it is a medical disease and treat patients with the respect that they deserve and to try as much as they want to get better, try to make them better. We need to fight as providers for access. We can't just accept the denial. We have to appeal. We have to fight for our patients. And ultimately, in doing this, we can change this disease forever. But ultimately these new treatments coming along are going to create possibility that we've never had before and make the process so much more enjoyable for us as providers and for our patients who are going to get better with these new therapies.

Drs. Pandya, Rosmarin and King share their enthusiasm about emerging therapies and data that is available for ruxolitinib.