Special Report: Remibrutinib, an Oral BTKi, for Chronic Inducible Urticaria

Chronic inducible urticaria (CIndU) has long lacked approved therapies, leaving clinicians to rely on up-dosed antihistamines and off-label agents for a frequently persistent disease.

In this HCPLive Special Report, Andrea Nguyen, DMSc, MPAS, PA-C, of First OC Dermatology, spoke with Adam Friedman, MD, of George Washington University School of Medicine and Health Sciences, about how the approval of remibrutinib (Rhapsido), an oral Bruton tyrosine kinase (BTK) inhibitor, for adults with symptomatic dermographism inadequately controlled by H1 antihistamines.

In the phase 3 RemIND trial, 115 adults with a mean disease duration of 5.8 years received remibrutinib 25 mg or placebo twice daily. At week 12, 29.3% (17/58) vs 14.0% (8/57) achieved a complete response on the Total Fric Score (P = .0229). Responses emerged by week 2, persisted through week 24, and held regardless of baseline total IgE.

A complete response means no wheal after standardized friction provocation, a stringent bar in easily provoked skin. This consistency across IgE levels supports broad applicability, unlike CSU, where IgE can predict response to omalizumab (Xolair).

Remibrutinib blocks BTK downstream of high-affinity IgE receptor cross-linking, halting mast cell degranulation whether activation is IgE- or IgG-mediated. Its efficacy in dermographism also suggests a BTK role in inducible mast cell activation.

Safety mirrored the REMIX trials in CSU, where petechiae occurred more often with remibrutinib than placebo (3.8% vs 0.3%).1 Mild mucocutaneous bleeding reflects BTK's role in platelet function, and no routine laboratory monitoring is required.

Collectively, the approval gives clinicians evidence-based footing in a long-neglected condition. Data from cold and cholinergic urticaria cohorts may extend the reach of BTK inhibition further.

References

1. Metz M, Giménez-Arnau A, Hide M, et al. Remibrutinib in chronic spontaneous urticaria. N Engl J Med. 2025;392(10):984-994. doi:10.1056/NEJMoa2408792

2. 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 7, 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