Remibrutinib Doubles Dermographism Responses: Dareen Siri, MD

Remibrutinib (Rhapsido), an oral Bruton tyrosine kinase (BTK) inhibitor, roughly doubled complete response rates versus placebo in symptomatic dermographism, a form of chronic inducible urticaria, in the phase 3 RemIND trial, supporting its approval as the first FDA-approved treatment for the condition.^1,2 Dareen Siri, MD, chief executive officer and chief medical officer of Midwest Allergy Sinus Asthma and medical director of SWIA Clinical Research Center, discussed the approval in an interview.

Siri spoke with HCPLive at the American College of Allergy, Asthma & Immunology (ACAAI) 2026 Annual Scientific Meeting in Phoenix, held November 12 to 16, 2026. The FDA approved remibrutinib on October 7, 2026, for adults with symptomatic dermographism inadequately controlled on H1 antihistamines, adding to its chronic spontaneous urticaria indication.² Siri said many patients have overlapping features of both conditions, making a single therapy for both useful in practice.

"Patients do not come into the office looking to be 25% better or 50% better. They really want elimination of the problem, or as near complete elimination as possible. And so, I think what is great is that there are a subset of patients that have demonstrated exactly that in both indications," Siri said.

RemIND randomized 362 adults with chronic inducible urticaria to remibrutinib 25 mg twice daily or placebo added to second-generation H1 antihistamines.¹ In the symptomatic dermographism cohort (n = 115), 29.3% of patients receiving remibrutinib achieved a TotalFric score of 0 at week 12 versus 14.0% with placebo (P = .0229). The cold urticaria (56.3% vs 14.6%; P < .0001) and cholinergic urticaria (29.3% vs 15.8%; P = .0133) cohorts also met their complete response endpoints, although only symptomatic dermographism is approved.

Siri said chronic inducible urticaria is often overlooked because the skin looks normal between triggers, though cold-induced disease can provoke anaphylaxis, and patients who break through antihistamines may cycle through emergency visits for corticosteroids. She said safety in RemIND was consistent with the chronic spontaneous urticaria profile. RemIND results have been presented at a congress but not yet published in full.

Relevant disclosures include Novartis.

References

1. Hornick I. Remibrutinib helps adults with chronic inducible urticaria achieve symptom control. Healio. July 1, 2026. Accessed November 12, 2026. https://www.healio.com/news/allergy-asthma/20260701/remibrutinib-helps-adults-with-chronic-inducible-urticaria-achieve-symptom-control

2. Remibrutinib receives FDA approval for symptomatic dermographism. HCPLive. October 7, 2026. Accessed November 12, 2026. https://www.hcplive.com/view/remibrutinib-receives-fda-approval-symptomatic-dermographism