September 23, 2020
In the ACLEPIOS I and II studies, ofatumumab demonstrated its effectiveness and safety for the treatment of relapsing multiple sclerosis (RMS), but a new study confirmed its long-term safety and efficacy.
Researchers sought to report the overall safety data of all patients treated with subcutaneous ofatumumab 20 mg for RMS, including patients who continued treatment and those who were newly switched in the ongoing open-label Phase 3b ALITHIOS study. Data was presented at the MS Virtual 2020: 8th Joint ACTRIMS-ECTRIMS Meeting.
To conduct this study, Anne Cross, MD, department of neurology, division of neuroimmunology, Washington University School of Medicine, and colleagues, divided the patient safety population into two groups: “1) Continuous: Patients randomized to ofatumumab in the core Phase 2 APLIOS (12 weeks) or Phase 3 ASCLEPIOS I/II (up to 30 months) trials and continued in ALITHIOS, or completed core study and continued with the safety follow-up; and (2) Newly-switched: Patients randomized to teriflunomide in ASCLEPIOS I/II and switched to ofatumumab in ALITHIOS.”
Adverse events, including serious adverse events and death, up to and including 100 days after the last ofatumumab administration were included in the analysis.
The final study cohort included 1873 patients (continuous: 1230; newly-switched: 643) who initiated ofatumumab continuous for 2118.6 patient years. Of this group, 71.4% of patients (continuous: 82%; newly-switched: 51%) experienced at least one mild to moderate adverse event, leading to a minimal 3% discontinuation rate. A slightly higher 6.2% of patients experienced severe adverse events. Infection incidence rate was 38.5% (continuous: 49.3%, newly-switched: 18.0%).
According to results of the study, no new safety signals were identified and the safety profile of ofatumumab remains consistent with the core studies.
Cross A, Fox E, De Seze J, et al. Safety experience with extended exposure to ofatumumab in patients with relapsing multiple sclerosis from Phase 2 and 3 clinical trials. Posted presented at MS Virtual 2020: 8th Joint ACTRIMS-ECTRIMS Meeting; September 11-13, 2020; virtual.