P072 Improvement across work productivity and quality of life with remibrutinib treatment in patients with chronic spontaneous urticaria in the REMIX-1/2 trials

Abstract

Remibrutinib, an oral, highly selective Bruton tyrosine kinase inhibitor, has shown efficacy and favourable safety in the REMIX-1/2 studies in patients with chronic spontaneous urticaria (CSU). Herein, we report the impact of remibrutinib treatment on Work Productivity and Activity Impairment (WPAI) and Dermatology Life Quality Index (DLQI) outcomes. REMIX-1 and REMIX-2 were identical, phase III, double-blind, placebo-controlled studies in patients aged ≥ 18 years diagnosed with CSU (≥ 6 months) who remained symptomatic despite treatment with second-generation H1-antihistamines. Patients were randomized 2 : 1 to add-on remibrutinib 25 mg twice daily or placebo over a 24-week double-blind period, followed by 28 weeks’ open-label add-on remibrutinib 25 mg twice daily (patients on placebo transitioned to remibrutinib at week 24). Patients completed WPAI and DLQI questionnaires in their eDiary at baseline and weeks 4 (DLQI only), 12, 24 and 52. At baseline, WPAI and DLQI scores (Table) were comparable for remibrutinib vs. placebo in both REMIX-1 and REMIX-2. By week 24, remibrutinib treatment improved both WPAI and DLQI scores. The responses were generally sustained up to week 52 for remibrutinib-treated patients; for patients on placebo who transitioned to remibrutinib at week 24, a comparable improvement in WPAI and DLQI responses was achieved at week 52. Overall, treatment with remibrutinib improved WPAI and DLQI outcomes in REMIX-1/2 and the improvement was sustained to 52 weeks in patients with CSU. This study was funded by Novartis Pharma AG, Basel, Switzerland.TableTreatment response in REMIX-1 and REMIX-2 BaselineWeek 24Week 52RemibrutinibPlaceboRemibrutinibPlaceboRemibrutinibPlacebo → remibrutinibREMIX-1WPAI Absenteeism7.8 (15.8)9.5 (21.3)3.7 (15.8)4.9 (12.1)3.1 (11.8)3.9 (13.7) Presenteeism47.4 (25.8)42.7 (24.9)16.5 (24.6)24.9 (24.6)15.7 (22.7)15.0 (21.5) Work productivity loss50.0 (27.4)45.2 (26.4)17.3 (25.4)27.8 (26.4)16.9 (24.1)17.2 (24.7) Activity impairment48.0 (25.8)44.2 (25.0)16.0 (23.7)24.0 (25.2)16.0 (23.3)16.6 (23.1)DLQI total score14.2 (7.0)13.5 (6.8)4.3 (6.2)6.1 (6.2)4.6 (6.0)4.1 (5.5)REMIX-2WPAI Absenteeism10.0 (19.0)6.1 (13.5)3.5 (13.6)4.8 (18.9)2.8 (10.8)3.4 (14.4) Presenteeism45.1 (26.3)44.2 (26.3)10.3 (15.7)21.6 (23.3)12.6 (19.9)15.1 (22.2) Work productivity loss48.3 (27.9)46.4 (27.0)11.9 (19.2)22.8 (25.2)14.3 (22.8)16.5 (23.7) Activity impairment45.9 (26.8)43.3 (27.3)11.4 (18.0)20.4 (23.2)12.9 (21.0)15.7 (21.7)DLQI total score14.0 (7.5)13.6 (6.7)4.5 (5.8)7.2 (6.6)4.3 (5.5)5.0 (6.4)Data are shown as the mean (SD) as observed (full analysis set) in 912 patients. REMIX-1: n = 309 remibrutinib and n = 153 placebo. REMIX-2: n = 297 remibrutinib and n = 153 placebo. DLQI, Dermatology Life Quality Index; WPAI, Work Productivity and Activity Impairment.