RemIND Trial Results: BTK Inhibition Across Three CIndU Subtypes

In "RemIND Trial Results: BTK Inhibition Across Three CIndU Subtypes," the panel explores the design, endpoints, and results of the RemIND program.

Dr. Cotter introduces RemIND, a trial of remibrutinib 25 mg twice daily in symptomatic dermographism, cold urticaria, and cholinergic urticaria. Dr. Trotter describes it as a global, randomized, double-blind, placebo-controlled phase 3 study. Adults had CIndU for at least four months and remained symptomatic despite antihistamines. The primary endpoint was complete response at week 12. Secondary endpoints included change from baseline and complete response as early as week 2 and as late as week 24, capturing both early and late responders.

Dr. Finklea explains the provocation endpoints for a dermatology audience. The FricTest 4.0 uses four pins of increasing length drawn across the forearm and read after five minutes. Patients needed a score of at least 3 of 4, and averaged 3.5. Cold urticaria patients needed a critical temperature threshold of at least 15 °C and an itch score of at least 5. Cholinergic patients completed pulse-controlled ergometry, a stepped 30-minute exercise test, with response graded 30 minutes later.

Both experts stress that the binary endpoint is unusual in dermatology. Dr. Cotter contrasts it with subjective measures such as IGA, EASI, and PASI.

On results, Dr. Finklea reports that almost 30% of symptomatic dermographism patients achieved complete response at week 12, more than double placebo. These patients responded early, with 29% responding by week 2, and responses were durable through week 24. Cold urticaria responses were higher, about 56%, as Dr. Cotter and Dr. Trotter recall. Cholinergic patients, predominantly younger men, achieved about 30% complete response by week 12. Dr. Cotter attributes this consistency to BTK sitting downstream of many activation pathways. Rapid control also helps avoid systemic corticosteroids, which both panelists discourage.

The next episode in this series, "Remibrutinib Safety in CIndU: Bleeding, Surgery, and Immunoglobulins," features the panel addressing the safety questions that accompany a new BTK inhibitor.