Recently published data from three Phase 3 trials of Ocrevus (ocrelizumab) show that the investigational drug does what no other therapy has achieved so far — working to prevent disease in both relapsing and primary progressive (PP) forms of multiple sclerosis (MS).
Publications in the New England Journal of Medicine show that all three studies reached their main goals. In the case of relapsing MS, that meant effectively lowering relapse rates, and for PPMS, slowing the progression of disability.
The two identical OPERA I and OPERA II trials (NCT01247324 and NCT01412333) in relapsing MS were covered in the article “Ocrelizumab versus Interferon Beta-1a in Relapsing Multiple Sclerosis,” and the ORATORIO (NCT01194570) study in PPMS was described in the article “Ocrelizumab versus Placebo in Primary Progressive Multiple Sclerosis.”
In relapsing MS, the trials showed that treatment with Ocrevus, a B-cell depleting drug, was superior to treatment with Rebif (interferon beta-1a), with a 46% and 47% relative reduction in the annualized relapse rate in the two trials. In the PPMS trial, the drug was compared to placebo.
All three trials also met key secondary goals. Among the 1,656 relapsing MS patients who participated in the OPERA trials, this included 94% to 95% fewer new brain lesions over 96 weeks of treatment. One of the trials also indicated that a composite score of how well a patient walked and moved, and taking the impact on cognition into account, was better among those treated with Ocrevus.
In the two OPERA trials, 64% and 89% more of the patients receiving Ocrevus reached “No Evidence of Disease Activity (NEDA)” than those treated with Rebif. NEDA is defined as no relapses, no confirmed disability progression, and no new brain lesions detected on brain scans.
“These publications that indicate that B cells play a central role in MS are the result of a longstanding collaboration between the scientific community and industry for the benefit of people with MS,” Stephen Hauser, MD, chair of the Scientific Steering Committee of the OPERA studies, director of the Weill Institute for Neurosciences and chair of the Department of Neurology at the University of California, San Francisco, said in a press release.
“The consistency of these pioneering data, the effect seen in these clinical studies and the favorable safety profile may support treating MS earlier with a high-efficacy disease-modifying medicine,” he added.
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