ACTRIMS 2023 | Four-year efficacy and safety of evobrutinib for relapsing MS

Evobrutinib is a central nervous system (CNS)-penetrant BTK inhibitor, currently under Phase III investigation for patients with relapsing multiple sclerosis (MS). Emily Evans, MD, MBE, EMD Serono, Rockland, MD, shares an update on the long-term safety and efficacy of evobrutinib based on findings from the ongoing Phase II open-label extension study (NCT02975349). After the 48-week double-blind period, trial participants were able to enter the extension study, receiving a dose of 75mg once daily for 50 weeks, before switching to 75mg twice daily for the remainder of the study. No new safety signals were seen after 228 weeks of follow-up, and the medication remained well tolerated. Efficacy was also maintained long-term, with an annualized relapse rate (ARR) of 0.13 up to week 228. Additionally, the pooled ARR reduced from 0.18 to 0.10 following the switch of all participants to twice daily dosing. These data support the twice-daily dosing currently being examined in Phase III trials. This interview took place at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2023 in San Diego, CA.

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