Ocrelizumab Significantly Reduced PIRA in Patients With Relapsing MS
Researchers at the Joint European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) – Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Meeting presented new data from a post-hoc analysis comparing Ocrevus (ocrelizumab; Genentech) and Rebif (interferon beta-1a; EMD Serono) in patients with relapsing multiple sclerosis (RMS).
In the Phase 3, randomized, double-blind, double-dummy OPERA I and OPERA II studies (n=1,656), Ocrevus significantly decreased the proportion of patients with RMS who experienced Progression Independent of Relapse Activity (PIRA) compared to Rebif. This clinical effect was more pronounced in patients who were at potentially higher risk of progressive disease course based on their baseline Expanded Disability Status Scale (EDSS). PIRA was lowered by 25% in the Ocrevus arm at 12 weeks (P=0.008) and by 23% at 24 weeks (P=0.039). In addition, OPERA I, OPERA II and ORATORIO Phase 3 open-label extension data showed a favorable benefit-risk profile for Ocrevus.
PIRA is measured by cCDP, an indicator of worsening physical disability. It is based on 3 components of physical disability: confirmed disability progression, walking speed, and upper extremity function.
In a separate platform presentation, study authors presented further data regarding underlying MS disease activity. A new algorithm using conventional MRI may serve as a potential biomarker to automatically detect Slowly Evolving Lesions (SELs) to measure chronic disease activity outside of acute lesions in the brain. Stephen Hauser, MD, chair of the Scientific Steering Committee of the OPERA studies, stated, “While we've seen SELs can occur across MS subtypes, this finding may be particularly promising for people with primary progressive MS whose worsening of disability may be related to the presence of SELs."
New findings from the FLOODLIGHT clinical trial program intended to asses sensor-based outcomes from a series of active neurological tests were also presented at ECTRIMS - ACTRIMS.
Ocrevus, a CD20-directed cytolytic monoclonal antibody, is currently approved to treat adults with relapsing or primary progressive forms of multiple sclerosis.
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