Highlights of new four-year efficacy and safety data for BTK inhibitor, evobrutinib, in relapsing multiple sclerosis

These data also continue to demonstrate its treatment benefit in reducing annualized relapse rates (ARR) over four years in people with relapsing multiple sclerosis (RMS).

Data will be presented at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2023, taking place February 23-25.

Data from the ongoing Phase II open-label extension (OLE) trial of evobrutinib showed that treatment benefits were maintained over four years, with no new safety signals. Pooled ARR at week 228 of the OLE for all patients across the original DBP dosing groups was 0.13, with a further reduction seen in the period after switching from evobrutinib 75mg once-daily to 75mg twice-daily, from 0.19 to 0.10. For those receiving 75mg twice-daily dosing in the DBP, ARR was 0.11 at the end of DBP and 0.12 at week 228 of OLE. These data further support the twice-daily dosing currently being examined in Phase III clinical trials.

Overall, treatment emergent adverse events (TEAEs) were mild/moderate in the OLE, with 3.3% (n=7) of patients with RMS experiencing a serious TEAE. No new safety signals were seen in the OLE and evobrutinib continued to show consistent tolerability after up to four years of treatment. There was no dose dependent increase in TEAEs observed in patients who switched to twice-daily evobrutinib 75mg in the OLE.