Long-Term Safety of Ocrelizumab in Multiple Sclerosis

Ocrelizumab was approved for relapsing multiple sclerosis (RMS) and primary progressive (PP) MS in 2017. Investigators have now evaluated safety from 11 clinical trials, including open-label extension periods, during 7 years of follow-up. Included were 5680 participants with MS in the clinical trials.

Among all the participants, 7.3 serious adverse events (AEs) occurred per 100 patient-years. Overall, 3.2% of patients discontinued treatment due to adverse events and 26 patients died (11 of 4376 with RMS, 15 of 1304 with PPMS). Causes included suicides (n=7), infections (n=4), malignancies (n=4), and cardiac events (n=3). Lymphopenia occurred in 5.3% to 6.8% of study participants. Immunoglobulin M levels were 55.8% lower with ocrelizumab than…