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- Title
Efficacy and Safety of the Bruton's Tyrosine Kinase Inhibitor (BTKI) Evobrutinib in Relapsing Multiple Sclerosis over 108 Weeks: Open-Label Extension to a Phase 2 Study.
- Authors
Montalban, Xavier; Arnold, Douglas L.; Weber, Martin S.; Staikov, Ivan; Piasecka-Stryczynska, Karolina; Martin, Emily C.; Mandel, Matthew; Ona, Victor; Dangond, Fernando; Wolinsky, Jerry S.
- Abstract
Background: In a phase 2 randomized controlled trial (RCT; trial registration: NCT02975349) in patients with relapsing multiple sclerosis (MS), evobrutinib 75 mg twice daily reduced total T1 gadolinium-enhancing lesions (primary end point) and annualized relapse rate (ARR) over 24 weeks vs placebo, with efficacy maintained through week 48. Objectives: To assess long-term efficacy and safety in the open-label extension (OLE) of the study. Methods: In the 48-week double-blind period, patients received evobrutinib 25 mg or 75 mg once daily, evobrutinib 75 mg twice daily, open-label dimethyl fumarate (240 mg twice daily), or placebo for the first 24 weeks; all arms continued with the original treatment assignment until 48 weeks, except placebo patients who were switched to evobrutinib 25 mg once daily. At week 48, all patients could enter the OLE, where treatment was initially evobrutinib 75 mg once daily (for approximately 48 weeks, median) before switching to 75 mg twice daily. The OLE assessed long-term efficacy (0-108 weeks) and safety (60-week OLE) of evobrutinib. Results: Of 267 randomized patients, 213 (79.8%) completed 108 weeks of treatment (48-week main study, 60-week OLE). For patients who received evobrutinib 75 mg twice daily in the double-blind period, the ARR (95% CI) was 0.11 (0.04-0.25) at week 48 and 0.12 (0.06-0.22) for the 108-week period. Evobrutinib was generally well tolerated, with the safety profile maintained during the 60-week OLE. Transient elevated liver aminotransferases, reported in the 48-week double-blind period, were not observed in the OLE. Conclusions: Efficacy and safety were maintained long-term. Two phase 3 RCTs evaluating the efficacy and safety of evobrutinib in patients with relapsing MS commence in 2020.
- Subjects
CONFERENCES &; conventions; MULTIPLE sclerosis; PROTEIN-tyrosine kinase inhibitors; RANDOMIZED controlled trials; TREATMENT effectiveness; PHARMACODYNAMICS
- Publication
International Journal of MS Care, 2020, Vol 22, Issue S2, p87
- ISSN
1537-2073
- Publication type
Article