Post hoc analysis of data from phase 3 Opera 1 (NCT01247324) and Opera 2 (NCT01298492) studies, including the open-label extensions, suggests ocrelizumab (Ocrevus; Genentech, South San Francisco, CA) treatment reduced disability progression and disease risk of relapsing multiple sclerosis (RMS) and primary progressive MS (PPMS). These new analyses add evidence for the risk-benefit profile of ocrelizumab, including the effect of ocrelizumab treatment on people’s daily lives. The data were selected for the 72nd American Academy of Neurology (AAN) Annual Meeting and will be made available online via virtual presentation in the coming weeks.
“For people with MS, maintaining mobility for as long as possible is very important. We are encouraged by these new longer-term analyses showing that earlier initiation of Ocrevus treatment may reduce the risk of needing a walking aid by nearly 50% over 6 years,” said Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development. “Slowing MS progression earlier in the disease course, not just treating relapses, may bring additional clinically meaningful outcomes to people living with this disease.”
In the Opera trials, individuals who had ocrelizumab treatment for 2 years longer than other participants (who initially had been randomly assigned to receive interferon treatment) were less likely to need an assistive walking device (4.3% vs 7.2%; P=.004). The risk was measured by the length of time until a person reached and sustained a score of 6 or more on the Expanded Disability Status Scale for at least 48 weeks.
Ocrelizumab also progressively slowed thalamic atrophy (as measured by change in thalamic volume) in individuals with RMS or PPMS. Results from the double-blind periods of the phase 3 OPERA 1, OPERA 2 and ORATORIO (NCT01194570) studies showed significantly less thalamic atrophy compared with interferon beta-1a and placebo, respectively (both P<.001).
With rapidly growing real-world experience and more than 150,000 individuals treated globally, ocrelizumab has twice-yearly, 6-monthly, dosing and is the first and only therapy approved for RMS (including relapsing-remitting MS [RRMS] and active, or relapsing, secondary progressive MS [SPMS], in addition to clinically isolated syndrome in the US) and PPMS.