Remibrutinib and the First On-Label Option for Symptomatic Dermographism, With David Cotter, MD, PhD

The US Food and Drug Administration (FDA) approval of remibrutinib (Rhapsido), an oral Bruton tyrosine kinase inhibitor, for adults with symptomatic dermographism (SD) inadequately controlled by H1 antihistamines gives dermatologists the first on-label therapy for a chronic inducible urticaria (CIndU), according to David Cotter, MD, PhD, a board-certified dermatologist at Las Vegas Dermatology and assistant clinical professor at the Kirk Kerkorian School of Medicine at the University of Nevada, Las Vegas.

In an interview with HCPLive, Cotter discussed how the decision reshapes treatment for patients with CIndU, with or without coexisting chronic spontaneous urticaria (CSU).

Novartis announced the approval on October 7, 2026, based on the SD cohort of the phase 3 RemIND trial (NCT05976243).¹ The decision came just over a year after the CSU approval, making remibrutinib the only therapy indicated for both conditions after antihistamine failure. Cotter noted 30% to 50% of patients with CSU also have a CIndU, and vice versa, so a careful history remains the first diagnostic step.

“SD does not typically respond very well to second-generation H1 antihistamines. It actually responds more poorly than even CSU, which leaves these patients without a highly effective therapy. Now that we have an FDA-approved therapy, there is no reason not to use remibrutinib for patients with SD,” Cotter said.

At week 12, 29.3% of patients receiving remibrutinib achieved a complete response on the Total Fric Score, compared with 14.0% receiving placebo (P = .0229), with responses seen as early as week 2.¹ Cotter pointed to the placebo rate, observed in patients on background antihistamines, as evidence of how poorly antihistamines alone control SD.

In clinic, Cotter provokes SD by stroking the forearm with the back of a cotton swab while interviewing the patient, and screens for cold urticaria with an ice cube in a plastic bag when formal threshold testing is unavailable. For patients with atopic dermatitis receiving dupilumab (Dupixent) whose SD persists, he said he would add remibrutinib, while noting the combination has not been studied. Dupilumab did not meet its end points in some CIndU studies, he added.

In CSU, Cotter said omalizumab-experienced patients in his practice typically move to remibrutinib, citing trial data in this population. He urged clinicians not to bucket patients into CSU or CIndU alone, since a brief history often reveals both and guides the next step in therapy.

References

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