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Link to original content: http://www.ncbi.nlm.nih.gov/pubmed/28002688
Ocrelizumab versus Placebo in Primary Progressive Multiple Sclerosis - PubMed Skip to main page content
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Clinical Trial
. 2017 Jan 19;376(3):209-220.
doi: 10.1056/NEJMoa1606468. Epub 2016 Dec 21.

Ocrelizumab versus Placebo in Primary Progressive Multiple Sclerosis

Xavier Montalban  1 , Stephen L Hauser  1 , Ludwig Kappos  1 , Douglas L Arnold  1 , Amit Bar-Or  1 , Giancarlo Comi  1 , Jérôme de Seze  1 , Gavin Giovannoni  1 , Hans-Peter Hartung  1 , Bernhard Hemmer  1 , Fred Lublin  1 , Kottil W Rammohan  1 , Krzysztof Selmaj  1 , Anthony Traboulsee  1 , Annette Sauter  1 , Donna Masterman  1 , Paulo Fontoura  1 , Shibeshih Belachew  1 , Hideki Garren  1 , Nicole Mairon  1 , Peter Chin  1 , Jerry S Wolinsky  1 ; ORATORIO Clinical Investigators
Collaborators, Affiliations
Free article
Clinical Trial

Ocrelizumab versus Placebo in Primary Progressive Multiple Sclerosis

Xavier Montalban et al. N Engl J Med. .
Free article

Abstract

Background: An evolving understanding of the immunopathogenesis of multiple sclerosis suggests that depleting B cells could be useful for treatment. We studied ocrelizumab, a humanized monoclonal antibody that selectively depletes CD20-expressing B cells, in the primary progressive form of the disease.

Methods: In this phase 3 trial, we randomly assigned 732 patients with primary progressive multiple sclerosis in a 2:1 ratio to receive intravenous ocrelizumab (600 mg) or placebo every 24 weeks for at least 120 weeks and until a prespecified number of confirmed disability progression events had occurred. The primary end point was the percentage of patients with disability progression confirmed at 12 weeks in a time-to-event analysis.

Results: The percentage of patients with 12-week confirmed disability progression was 32.9% with ocrelizumab versus 39.3% with placebo (hazard ratio, 0.76; 95% confidence interval [CI], 0.59 to 0.98; P=0.03). The percentage of patients with 24-week confirmed disability progression was 29.6% with ocrelizumab versus 35.7% with placebo (hazard ratio, 0.75; 95% CI, 0.58 to 0.98; P=0.04). By week 120, performance on the timed 25-foot walk worsened by 38.9% with ocrelizumab versus 55.1% with placebo (P=0.04); the total volume of brain lesions on T2-weighted magnetic resonance imaging (MRI) decreased by 3.4% with ocrelizumab and increased by 7.4% with placebo (P<0.001); and the percentage of brain-volume loss was 0.90% with ocrelizumab versus 1.09% with placebo (P=0.02). There was no significant difference in the change in the Physical Component Summary score of the 36-Item Short-Form Health Survey. Infusion-related reactions, upper respiratory tract infections, and oral herpes infections were more frequent with ocrelizumab than with placebo. Neoplasms occurred in 2.3% of patients who received ocrelizumab and in 0.8% of patients who received placebo; there was no clinically significant difference between groups in the rates of serious adverse events and serious infections.

Conclusions: Among patients with primary progressive multiple sclerosis, ocrelizumab was associated with lower rates of clinical and MRI progression than placebo. Extended observation is required to determine the long-term safety and efficacy of ocrelizumab. (Funded by F. Hoffmann-La Roche; ORATORIO ClinicalTrials.gov number, NCT01194570 .).

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