Remibrutinib impact on disease control, sleep, and quality of life: Analysis of phase 3 REMIX-1/2

Fuente: PubMed "hive"
Ann Allergy Asthma Immunol. 2026 Jun 15:S1081-1206(26)00271-1. doi: 10.1016/j.anai.2026.06.011. Online ahead of print.ABSTRACTBACKGROUND: Chronic spontaneous urticaria (CSU) substantially reduces patient quality of life (QoL); therefore, it is crucial to include QoL-related patient-reported outcome measures (PROMs) when assessing treatment efficacy.OBJECTIVE: To evaluate the impact of remibrutinib, an oral, highly selective Bruton's tyrosine kinase inhibitor, on disease control, sleep, and QoL in CSU.METHODS: REMIX-1 (NCT05030311) and REMIX-2 (NCT05032157) were phase 3, double-blind, placebo-controlled studies in adults with CSU who remained symptomatic despite second-generation H1-antihistamines. Patients were randomized 2:1 to oral remibrutinib 25 mg twice daily or placebo (24 weeks), followed by an open-label treatment period (28 weeks), and a treatment-free follow-up period (4 weeks); those on placebo transitioned to remibrutinib at week 24. Patients completed PROMs including weekly Urticaria Control Test (UCT7), weekly Urticaria Activity Score (UAS7), weekly Sleep/Activity Interference Score (SIS7/AIS7), Dermatology Life Quality Index (DLQI), EQ-5D-5L, and Work, Productivity, and Activity Impairment (WPAI).RESULTS: The pooled analysis included 606 and 306 patients receiving remibrutinib and placebo, respectively. Within 1 week of starting remibrutinib, greater improvements in mean (SD) change from baseline (CFB), compared with placebo, were noted in urticaria activity (CFB-UAS7, -11.8 [9.9] and -3.6 [7.6]) and sleep (CFB-SIS7, -4.9 [4.9] and -1.9 [4.1]). Improvements with remibrutinib were also observed in UCT7, AIS7, DLQI, EQ-5D-5L, and WPAI, at the earliest time points collected. Across assessments, responses were sustained through week 52 with remibrutinib and comparable improvements in those who transitioned to remibrutinib.CONCLUSION: Remibrutinib showed fast improvements in disease control, sleep, and QoL in REMIX-1/-2, supporting remibrutinib as a valuable therapeutic option for CSU.CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov IDs: REMIX-1, NCT05030311 and REMIX-2, NCT05032157.PMID:42297099 | DOI:10.1016/j.anai.2026.06.011