Early and continuous use of Ocrevus (ocrelizumab) significantly slows disability progression and delays the time until wheelchair reliance in people with primary progressive multiple sclerosis (PPMS), new Phase 3 data spanning more than six years show.
Findings from the ORATORIO trial, comparing immediate use with a two-year delay, support Ocrevus’ sustained and long-term benefits, and highlight gains realized through earlier treatment initiation in PPMS patients.
The study, “Long-term follow-up from the ORATORIO trial of ocrelizumab for primary progressive multiple sclerosis: a post-hoc analysis from the ongoing open-label extension of the randomized, placebo-controlled, phase 3 trial,” was published in the journal The Lancet Neurology.
Its therapeutic benefits in PPMS patients were supported by data from the first part of the ORATORIO Phase 3 trial (NCT01194570), which showed Ocrevus was superior to a placebo at lowering the risk of disease progression and the volume of chronic brain lesions, as well as at preserving hand and arm function.
The study recruited 732 PPMS patients, with a mean age of 44 and relatively severe disability, at more than 180 clinical sites across 29 countries. In its first part, participants were randomly assigned to either 600 mg of Ocrevus (488 patients) or a placebo (244 patients), given directly into the bloodstream every six months, for at least 120 weeks (about 2.3 years).
Then, 517 (95%) of the 544 patients who completed ORATORIO’s first part, and 10 participants who had discontinued treatment early, entered the trial’s open-label extension.
In this second part, all are being given the therapy through December 2022, totaling up to 10 years of Ocrevus treatment (or up to eight years for those on a placebo in the study’s first part).
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