P014 Remibrutinib improves dermatology-related quality of life in patients with chronic spontaneous urticaria regardless of baseline disease severity in the phase III REMIX-1 and REMIX-2 studies

Michael R Ardern-Jones, John Reed, Sinisa Savicet al.  British Journal of Dermatology, Volume 195, Issue Supplement_1, June 2026, ljag086.041, https://doi.org/10.1093/bjd/ljag086.041

Abstract

Mean change from baseline in DLQI (observed data, full analysis set).

Many patients with chronic spontaneous urticaria (CSU) experience inadequate disease control and impaired quality of life despite treatment. Remibrutinib, a highly selective Bruton’s tyrosine kinase inhibitor, reduced CSU disease activity and improved quality of life, sleep, and daily activity vs. placebo in the REMIX-1 and REMIX-2 studies. Here, we evaluate the impact of remibrutinib on Dermatology Life Quality Index (DLQI) in the REMIX-1 and REMIX-2 data (pooled), stratified by baseline disease severity per weekly Urticaria Activity Score (UAS7; moderate: 16 ≤ UAS7 < 28, severe: 28 ≤ UAS7 ≤ 42). REMIX-1 and REMIX-2 were randomized, double-blind, placebo-controlled studies of oral remibrutinib 25 mg twice daily in adults with CSU who remained symptomatic with second-generation H₁-antihistamines.

The studies included a 24-week double-blind period, followed by a 28-week open-label treatment during which all patients received remibrutinib. DLQI questionnaires were completed at baseline and weeks 4, 12, 24 and 52. Remibrutinib reduced DLQI vs. placebo as early as week 4, regardless of baseline disease severity, with responses sustained through week 52. Improvements in DLQI were also reported in patients who transitioned from placebo to remibrutinib during the open-label period (Table). More patients achieved a DLQI score of 0–1 (no impact of CSU on dermatology-related quality of life) with remibrutinib than with placebo at week 12 (moderate, 40.0% vs. 20.4%; severe, 39.0% vs. 22.2%) and week 24 (moderate, 46.7% vs. 27.4%; severe, 47.9% vs. 25.5%). In conclusion, overall, remibrutinib improved DLQI in patients with CSU, irrespectively of baseline disease severity.

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