Atopic Dermatitis Pipeline and Remibrutinib Approval for Dermographism

Clinicians treating moderate to severe atopic dermatitis now select from several biologics targeting IL-13 signaling, including dupilumab, tralokinumab, and lebrikizumab. With limited head-to-head data, differences in study design, patient populations, outcome measures, and safety reporting complicate both indirect comparisons and shared decision-making with patients.

The pipeline continues to widen beyond injectable monotherapy. Investigational strategies include daily oral small molecules aiming for biologic-level efficacy, bispecific and trispecific antibodies designed to raise the efficacy ceiling, and targets outside conventional atopic dermatitis pathways.

Advances in urticaria have arrived on a parallel track. On October 7, 2026, the US Food and Drug Administration (FDA) approved remibrutinib (Rhapsido; Novartis), an oral Bruton's tyrosine kinase inhibitor, for adults with symptomatic dermographism inadequately controlled by H1 antihistamines.¹ The agency first approved remibrutinib for chronic spontaneous urticaria on September 30, 2025.²

Novartis describes symptomatic dermographism as the most prevalent form of chronic inducible urticaria.¹ In the phase 3 RemIND trial, 29.3% (17/58) of patients receiving remibrutinib 25 mg twice daily achieved a complete Total Fric Score response at week 12 compared with 14.0% (8/57) receiving placebo (P = .0229).³ Responses emerged as early as week 2.¹

The label expansion gives dermatologists an on-label option for a population historically managed with off-label therapy. Raj Chovatiya, MD, PhD, is an associate professor at Rosalind Franklin University Chicago Medical School and founder and director of the Center for Medical Dermatology and Immunology Research in Chicago, Illinois. Chovatiya spoke with the HCPLive team during the 2026 Fall Clinical Dermatology Conference in Las Vegas about biologic selection, emerging therapeutic strategies, the remibrutinib approval, and his research on overlapping dermatologic and gastrointestinal comorbidities:

HCPLive: What are the key takeaways from your session on biologic decision-making for moderate to severe atopic dermatitis?

Raj Chovatiya, MD, PhD: At this year's Fall Clinical meeting, I had the opportunity to talk all about our biologic landscape for atopic dermatitis and, in particular, how we make treatment decisions based on the data available to us. If there are a couple of points I really want people to take away, number one: There really are no wrong answers as long as you're able to get your systemic therapy-ready patient on a systemic therapy. For many patients, that's going to be a biologic. There are a lot of different reasons why you might choose a biologic therapy, but as long as you can help your patient get past that hump of remaining uncontrolled on topicals, you're doing a good thing.

My second point is a very important one: Understand the data as it relates to our current biologic therapies. We have an embarrassment of riches, more so than we've ever had in the world of atopic dermatitis, and on paper, it can sometimes be very difficult to make choices, especially when talking to your patient about treatments like dupilumab, tralokinumab, and lebrikizumab. In the world of medications that can block IL-13, it's important to, one, understand how the data compare to one another, if not directly, then indirectly, particularly in the way of differences in trial designs, patient populations, different types of outcomes of interest, and safety, and two, really try to find a way to easily translate that into the real world to ultimately equip you and your patient to make the best treatment choice possible.

HCPLive: Coming off EADV 2026, which updates in atopic dermatitis or other inflammatory diseases are you watching this year and next?

Raj Chovatiya, MD, PhD: In the world of atopic dermatitis, there's a lot of therapeutic innovation continuing to happen. It really hasn't slowed down in the last 10 years, and at EADV 2026 this year in Vienna, we had a number of late-breaking and cutting-edge talks that were really designed to give us a lot of hope for what's happening in the future of this disease state. I'll focus on a few ideas that I think are really important to where we're at in atopic dermatitis.

One is the idea of: Can we make for a more convenient patient experience when it comes to thinking about treatment? We have a whole host of oral molecules that are trying to target well-validated targets to ultimately allow our patients to achieve biologic-like efficacy in the form of a daily oral medication.

Another big theme has been trying to raise the efficacy ceiling. If we combine targets that we do know with ones that we don't know and put them all together in a single biologic therapy, might we be able to safely and effectively increase treatment response in our patients? This is the theme of multispecific antibodies, i.e., bispecific and trispecific antibodies, which we've paid very close attention to over the last few years.

Finally, theme number 3: What about targets that are well off the beaten path, that don't necessarily have anything to do with atopic dermatitis at the forefront of our minds, but may in fact be a way that we can safely and effectively treat even more patients? This is the other big theme that continues to loom as we start to think outside the box and look at various treatment targets that may not necessarily be household names but potentially offer us a chance to really change the course of disease.

HCPLive: Remibrutinib was just approved for symptomatic dermographism. What might this approval mean for clinicians and their patients?

Raj Chovatiya, MD, PhD: This is some exciting news breaking in 2026 before we make our way deep into the fall. Remibrutinib, a Bruton's tyrosine kinase, or BTK, inhibitor, has really been game-changing for us in the world of chronic spontaneous urticaria. Now, our latest update comes from the world of inducible forms of urticaria, essentially the whole host of other chronic urticarial diseases where, based on outside influences and clear triggers, urticaria can happen.

Symptomatic dermatographism is the newest indication for us. Whenever you've spent time in the doctor's office tracing with a little bit of pressure on somebody's back and noticing that, indeed, urticaria can form, that's what we're talking about. For many folks in the world of dermatology treatment, there's been a lot of off-label use of therapies, and this is a really exciting movement for us to have an on-label indication for what can be an extremely uncomfortable and chronic issue for a lot of our patients dealing with chronic urticaria. I'd say this is probably one of several more indications to come in the life of remibrutinib, and ultimately, a really exciting piece of news that I'm happy I can use to help my patients.

HCPLive: What research are you currently working on that you would like to highlight for colleagues?

Raj Chovatiya, MD, PhD: In the world of research, there are oftentimes a lot of things I'm working on with various members of my group, fellows, and students, and things that really strike our interest in the world of dermatology. I could spend another hour catching you up on everything I'm interested in, but one area of research that has really caught a lot of our attention is trying to better understand comorbid burden as it relates to diseases where we oftentimes expect there to be some degree of overlap, as well as some where there isn't quite so much.

One of the things that's been very interesting to me, as the husband of a very successful and smart gastroenterologist, is understanding the overlap between dermatologic disease and gastroenterologic disease. Jointly, we've been working together to better understand some of the overlapping comorbid burden as it relates to both hepatic disease and gastrointestinal disease compared with some of the disease states we think about all the time, both the more common associations, when we think about psoriasis and hidradenitis suppurativa, as well as the less common associations, like vitiligo. More results to follow, so stay tuned.

Editor's Note: This transcript has been edited for grammar and clarity using artificial intelligence tools. Chovatiya previously reported serving as an adviser, consultant, speaker, and/or investigator for AbbVie, Amgen, Apogee Therapeutics, Arcutis, Argenx, ASLAN Pharmaceuticals, Beiersdorf, Boehringer Ingelheim, Bristol Myers Squibb, Cara Therapeutics, Dermavant, Eli Lilly and Company, FIDE, Formation Bio, Galderma, Genentech, GSK, Incyte, LEO Pharma, L’Oréal, Nektar Therapeutics, Novartis, Opsidio, Pfizer Inc., Regeneron, RAPT, Sanofi, Sitryx, and UCB.

References

1. Novartis. Novartis Rhapsido (remibrutinib) receives FDA approval as first treatment for symptomatic dermographism (SD), expanding its use beyond chronic spontaneous urticaria (CSU). Published October 7, 2026. Accessed October 11, 2026. https://www.novartis.com/us-en/news/media-releases/novartis-rhapsido-remibrutinib-receives-fda-approval-first-treatment-symptomatic-dermographism-sd-expanding-its-use-beyond-chronic-spontaneous-urticaria-csu.

2. Novartis. Novartis receives FDA approval for Rhapsido (remibrutinib), the only oral targeted BTKi treatment for chronic spontaneous urticaria (CSU). Published September 30, 2025. Accessed October 11, 2026. https://www.novartis.com/us-en/news/media-releases/novartis-receives-fda-approval-rhapsido-remibrutinib-only-oral-targeted-btki-treatment-chronic-spontaneous-urticaria-csu.

3. Johnson V. Remibrutinib receives FDA approval for symptomatic dermographism. HCPLive. Published October 7, 2026. Accessed October 11, 2026. https://www.hcplive.com/view/remibrutinib-receives-fda-approval-symptomatic-dermographism.