Ocrelizumab Controls Disease Progression in Phase 3b Open-Label Study

In an open-label phase 3b study (NCT03085810), 85% of people who used ocrelizumab (Ocrevus; Genentech, South San Francisco, CA) as their first treatment for relapsing multiple sclerosis (RMS) had no evidence of disease activity (NEDA) at 48 weeks of treatment. Participants in the trial had ocrelizumab infusions every 6 months and NEDA was defined as 1) no relapses, 2) no worsening of disability, and 3) no new or enlarging brain lesions with prespecified MRI after re-baselining at 8 weeks. 

The average annual relapse rate (ARR) was 0.005, and mean change in Expanded Disability Status Scale score (EDSS) from baseline significantly improved from 1.7 to 1.55 (P=.002). 

“All patients regardless of their form of MS experience disease progression from the start,” said Levi Garraway, MD, PhD, chief medical officer and head of global product development, Genentech. “Therefore, we are encouraged by these new analyses showing that early treatment with Ocrevus may significantly control disease progression in both relapsing-remitting MS and in primary progressive MS. Controlling progression can enable people with MS to maintain mobility and limit their disability. In addition, our data show that more people with MS are staying on Ocrevus, the only twice-yearly treatment for MS, compared with other therapies, which may translate to improved outcomes.” 

Additionally, in analysis of 2-year insurance claims databases, approximately 80% of people who began treatment with ocrelizumab continued with regular 6-month dosing for 2 years. Continuation of regular treatment was dependent on route of administration with 35% for injectables, 55% for oral and 54% for infusions. 

Ocrelizumab is a humanized monoclonal antibody that targets CD20-positive B cells, thought to be a key contributor to myelin and axonal damage. 

These data were presented at the American Academy of Neurology (AAN) Virtual Annual Meeting April 17-22, 2021.