Ocrelizumab: A Review in Multiple Sclerosis

Abstract

Ocrelizumab (Ocrevus^®) is an intravenously administered, humanized anti-CD20 monoclonal antibody approved for the treatment of adults with relapsing forms of multiple sclerosis (RMS) or primary progressive multiple sclerosis (PPMS). The efficacy of ocrelizumab in reducing relapse rates and disease activity in patients with RMS was demonstrated in pivotal trials (versus interferon β-1a) and supporting single-arm studies in specific subpopulations. In patients with PPMS, ocrelizumab reduced measures of clinical and MRI progression relative to placebo. Clinical benefits were maintained over ≥ 7.5 study years of treatment. Ocrelizumab was generally well tolerated and no new safety signals have emerged with long-term use. Extensive (albeit short-term) real-world data pertaining to ocrelizumab is consistent with that from clinical trials. Ocrelizumab provides the convenience of short, half-yearly infusions. Ocrelizumab continues to represent a generally well-tolerated, high-efficacy disease-modifying therapy (DMT) for RMS and is a valuable treatment for delaying disease progression in patients with PPMS (for whom there are currently no other approved DMTs).

Fig. 1.

Adverse events (≥ 10% incidence in any treatment arm) occurring with ocrelizumab in patients with a relapsing multiple sclerosis (pooled OPERA-I and II safety populations [10]) and b primary progressive multiple sclerosis (ORATORIO [16]), and c IRRs occurring with ocrelizumab in patients with relapsing-remitting multiple sclerosis (ENSEMBLE-PLUS [33]; first randomized infusion). IRR infusion-related reaction, PE primary endpoint, URTI upper respiratory tract infection, UTI urinary tract infection, ϴ zero incidence