Remibrutinib in Chronic Spontaneous Urticaria

This pair of phase 3 randomized, double-blind, placebo-controlled trials (REMIX-1 and REMIX-2) assessed the safety and efficacy of remibrutinib, a selective oral Bruton's tyrosine kinase inhibitor, in 925 patients with symptomatic chronic spontaneous urticaria unresponsive to second-generation H₁-antihistamines. Patients receiving remibrutinib (25 mg twice daily) had significantly greater reductions in the urticaria activity score over 7 days (UAS7) at 12 weeks compared with placebo (−20.0 vs. −13.8 and −19.4 vs. −11.7 in REMIX-1 and REMIX-2, respectively; P<0.001). More patients on remibrutinib achieved well-controlled symptoms (UAS7 ≤6) and complete remission (UAS7 = 0). Adverse events were generally mild; however, petechiae occurred more frequently in the remibrutinib group. These findings support remibrutinib’s efficacy and favorable short-term safety as a new therapeutic option for antihistamine-refractory chronic urticaria.

This pair of phase 3 randomized, double-blind, placebo-controlled trials (REMIX-1 and REMIX-2) assessed the safety and efficacy of remibrutinib, a selective oral Bruton's tyrosine kinase inhibitor, in 925 patients with symptomatic chronic spontaneous urticaria unresponsive to second-generation H₁-antihistamines. Patients receiving remibrutinib (25 mg twice daily) had significantly greater reductions in the urticaria activity score over 7 days (UAS7) at 12 weeks compared with placebo (−20.0 vs. −13.8 and −19.4 vs. −11.7 in REMIX-1 and REMIX-2, respectively; P<0.001). More patients on remibrutinib achieved well-controlled symptoms (UAS7 ≤6) and complete remission (UAS7 = 0). Adverse events were generally mild; however, petechiae occurred more frequently in the remibrutinib group. These findings support remibrutinib’s efficacy and favorable short-term safety as a new therapeutic option for antihistamine-refractory chronic urticaria.