REMIBRUTINIB TREATMENT IMPROVES SLEEP AND ACTIVITY IN CHRONIC SPONTANEOUS URTICARIA PATIENTS: PHASE 2B STUDY RESULTS

• Published in: Annals of allergy, asthma, & immunology Vol. 129; no. 5; p. S32
• Main Authors: Clore, L., Jain, V., Giménez-Arnau, A., Lheritier, K., Walsh, P., Haemmerle, S., Maurer, M.
• Format: Journal Article
• Language: English
• Published: Elsevier Inc 01.11.2022
• ISSN: 1081-1206; 1534-4436
• DOI: 10.1016/j.anai.2022.08.595

Chronic spontaneous urticaria (CSU) is characterized by spontaneous occurrence of wheals (hives) and/or angioedema for ≥6-weeks and has a major impact on patients’ wellbeing. We explored the effect of remibrutinib (LOU064), a novel oral Bruton's Tyrosine Kinase inhibitor, on sleep and activity in patients with CSU. In this Phase-2b study (NCT03926611), 311 patients with CSU were equally randomized to remibrutinib 10mg once-daily (q.d.)/35mg q.d./100mg q.d./10mg twice-daily (b.i.d)/25mg b.i.d./100mg b.i.d. or placebo for 12-weeks. Outcomes included change from baseline in sleep interference score (SIS) and activity interference score (AIS) and proportion of patients with SIS=0 and AIS=0 (no sleep/activity interference) at Weeks 4 and 12. Changes from baseline in SIS and AIS and proportion of patients with SIS=0 and AIS=0 are summarized in Table-1. The percentage decrease in SIS was higher with remibrutinib (any dose) versus placebo at Week-4 (50.53–74.15% vs 24.39%) and Week-12 (59.16–76.97% vs 23.19%). Proportion of patients with SIS=0 was higher with remibrutinib versus placebo at Week-4 (31.9–58.1% vs 15.0%) and Week-12 (48.9–64.1% vs 33.3%). The percentage decrease in AIS at Week-4 (58.23–77.66% vs 21.50%) and Week-12 (65.69–76.66% vs 33.13%) was higher with remibrutinib versus placebo. Proportion of patients with AIS=0 was higher with remibrutinib versus placebo at Week-4 (37.0–55.0% vs 15.0%) and Week-12 (51.1–60.0% vs 24.3%). Remibrutinib demonstrated improvements in sleep and activity versus placebo at Weeks 4 and 12. Also, more patients on remibrutinib versus placebo achieved no interference in sleep and activity.