Remibrutinib Outperforms Placebo in Chronic Spontaneous Urticaria Control: Study
Key Takeaways
Remibrutinib demonstrated symptom relief in CSU as early as week 1.
Improvements in urticaria, itch, and hives were sustained through 52 weeks.
Safety profile was favorable, with AE rates comparable to placebo.
Remibrutinib showed rapid and sustained efficacy in adults with chronic spontaneous urticaria (CSU) in a pooled analysis of the phase 3 REMIX-1 and REMIX-2 studies.
The multicenter, double-blind, placebo-controlled trials looked at remibrutinib 25 mg twice daily in 606 adults with CSU unresponsive to second-generation H₁-antihistamines (H₁-AH). Patients were randomized 2:1 to remibrutinib or placebo for 24 weeks, with a 28-week open-label extension where all patients received remibrutinib.
The results at week 1 indicated rapid improvement, with a mean percentage change from baseline in weekly Urticaria Activity Score (UAS7) was 38.4% for remibrutinib vs 10.3% for placebo. At week 24, the improvement increased to 73.1% vs 50.8%. By week 52, patients initially randomized to remibrutinib showed a 74.8% reduction in UAS7. Itch and hives severity scores (ISS7 and HSS7) followed similar trajectories, with reductions reaching 73% by week 52. Adverse events (AEs) up to week 24 were similar in both groups (64.9% remibrutinib vs 64.7% placebo), with low discontinuation rates and no treatment-related serious adverse events.
“In the pooled REMIX-1/-2 studies, remibrutinib showed improvements in urticaria symptoms as early as week 1, with over 50% improvement by week 2, which improved further and was sustained through week 52,” the authors wrote. “These outcomes indicate that remibrutinib provides fast and sustained symptom relief for patients with CSU who remained symptomatic despite treatment with second-generation H₁-AH."
Source: Gogate S, et al. Early and sustained efficacy of remibrutinib in adult patients with CSU: Pooled analysis of REMIX-1/-2 studies. Poster R083. Presented at the American College of Allergy, Asthma & Immunology (ACAAI) Annual Meeting, Orlando, held November 6 to 10, 2025.