BACKGROUND: No evidence of disease activity (NEDA; defined as no 12-week confirmed disability progression, no protocol-defined relapses, no new/enlarging T2 lesions and no T1 gadolinium-enhancing lesions) using a fixed-study entry baseline is commonly used as a treatment outcome in multiple sclerosis (MS). OBJECTIVE: The objective of this paper is to assess the effect of ocrelizumab on NEDA using re-baselining analysis, and the predictive value of NEDA status. METHODS: NEDA was assessed in a modified intent-to-treat population (n = 1520) from the pooled OPERA I and OPERA II studies over various epochs in patients with relapsing MS receiving ocrelizumab (600 mg) or interferon beta-1a (IFN β-1a; 44 μg). RESULTS: NEDA was increased with ocrelizumab vs IFN β-1a over 96 weeks by 75% (p < 0.001), from Week 0‒24 by 33% (p < 0.001) and from Week 24‒96 by 72% (p < 0.001). Among patients with disease activity during Weeks 0‒24, 66.4% vs 24.3% achieved NEDA during Weeks 24‒96 in the ocrelizumab and IFN β-1a groups (relative increase: 177%; p < 0.001). CONCLUSION: Superior efficacy with ocrelizumab compared with IFN β-1a was consistently seen in maintaining NEDA status in all epochs evaluated. By contrast with IFN β-1a, the majority of patients with disease activity early in the study subsequently attained NEDA status with ocrelizumab.

Blizard Institute Barts and The London School of Medicine and Dentistry Queen Mary University London UK

Department of Neurology and Center for Clinical Neuroscience Charles University Czech Republic

Department of Neurology and Center for Neuroinflammation and Experimental Therapeutics University of Pennsylvania USA

Department of Neurology and Neurosurgery McGill University Canada

Department of Neurology Icahn School of Medicine at Mount Sinai USA

Department of Neurology University of California San Francisco USA

Division of Neurology Department of Medicine University of British Columbia Canada

F Hoffmann La Roche Ltd Switzerland

Genentech Inc USA

Medical Faculty Heinrich Heine University Düsseldorf Germany

Medical University of Lodz Poland

Neurologic Clinic and Policlinic Departments of Medicine Clinical Research Biomedicine and Biomedical Engineering University Hospital Basel Switzerland

Neurology Department and INSPE Institute of Experimental Neurology Vita Salute San Raffaele University Italy

NeuroRx Research Canada

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