Remibrutinib impact on disease control, sleep, and quality of life: Analysis of phase 3 REMIX-1/2
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. To evaluate the impact of remibrutin...
Key Findings
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. To evaluate the impact of remibrutinib, an oral, highly selective Bruton's tyrosine kinase inhibitor, on disease control, sleep, and QoL in CSU. 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). 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. Remibrutinib showed fast improvements in disease control, sleep, and QoL in REMIX-1/-2, supporting remibrutinib as a valuable therapeutic option for CSU. ClinicalTrials.gov IDs: REMIX-1, NCT05030311 and REMIX-2, NCT05032157.
Why This Matters for Body-Mind Practice
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Source
- Remibrutinib impact on disease control, sleep, and quality of life: Analysis of phase 3 REMIX-1/2. — Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology