Starting treatment with Ocrevus early can lower almost by half the need for a walking aid in people with relapsing forms of multiple sclerosis (MS) over six years, new analyses of Phase 3 trial data that compared immediate initiation with a two-year delay show.
Ocrevus (ocrelizumab) is a twice-yearly infusion therapy developed by Genentech, a member of the Roche Group. It is approved by the U.S. Food and Drug Administration and across the European Union to treat adults with relapsing forms of MS (clinically isolated syndrome, relapsing-remitting MS and active secondary progressive MS), as well as those with primary progressive MS — the first therapy ever approved for PPMS.
The treatment works by targeting B-cells, immune cells that drive the inflammation that damages the nervous system in MS.
Ocrevus’ efficacy and safety in relapsing MS were demonstrated in Phase 3 clinical trials, including the OPERA I and II trials (NCT01247324 and NCT01412333). In these trials, 1,656 people with relapsing MS were randomly assigned to Ocrevus, a placebo, or Rebif (interferon beta-1a; an approved relapsing MS therapy) for 96 weeks (about two years).
Following the two-year double-blind part of these studies, people in OPERA I and II were allowed to enroll in open-label extension studies, where all were treated with Ocrevus every six months (600 mg infusion) after an initial loading dose (300 mg given two weeks apart).
Now, a new analyses of these extension studies — comprising a total of six years’ worth of data — show that, compared to patients who started on Rebif in the main trials, those who started on Ocrevus had a significantly lower risk of needing an assistive walking device (4.3% vs. 7.2%). This corresponds to a 49% lower risk of walking with an aid over six years of Ocrevus treatment.
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