OCRELIZUMAB IN PRIMARY PROGRESSIVE MS: THE ORATORIO STUDY. Issue 12 (15th November 2016)

• Record Type: Journal Article
• Authors: Giovannoni, G; Arnold, DL; Bar-Or, A; de Seze, J; Hemmer, B; Montalban, X; Rammohan, K; Wolinsky, J
• Is Part Of: Journal of neurology, neurosurgery and psychiatry. Volume 87:Issue 12(2016)
• Page Start: e1
• Page End: e1
• Publication Date: 2016-11-15
• Subjects: Neurology -- Periodicals; Nervous system -- Surgery -- Periodicals; Psychiatry -- Periodicals; 616.8
• DOI: 10.1136/jnnp-2016-315106.143
• Languages: English
• ISSNs: 0022-3050

Abstract

Abstract : Introduction: B cells are implicated in MS pathophysiology, including primary progressive MS (PPMS). Ocrelizumab (OCR) is a humanised monoclonal antibody that selectively targets CD20+ B cells. OCR was evaluated in PPMS in a Phase III, randomised, double-blind, placebo-controlled study (ORATORIO; NCT01194570 ). Methods: Eligible PPMS patients were randomised 2:1 to receive OCR 600 mg or placebo every 24 weeks for ≥120 weeks, until a pre-specified number of 12-week confirmed disability progression (CDP) events occurred. The primary endpoint was time-to-onset of 12-week CDP. Secondary endpoints included: time-to-onset of ≥24-week CDP; changes in timed 25-foot walk (T25-FW), total T2 lesion volume at 120 weeks and total brain volume between 24 and 120 weeks; and safety. Results: Compared with placebo, OCR significantly reduced: risk of 12- (24%; p=0.0321) and 24-week CDP (25%; p=0.0365); T25FW progression rate (29% [OCR: +39%; placebo: +55%; p=0.0404]); T2 lesion volume (OCR: –3.4%; placebo: +7.4%; p<0.0001); and brain volume loss rate (17.5% [OCR: –0.9%; placebo: –1.1%; p=0.0206]). Adverse events (AEs) and serious AEs were balanced between groups. Conclusions: OCR is the first investigational therapy to meet key efficacy outcomes with a favourable safety profile in a Phase III PPMS study. Sponsored by F. Hoffmann-La Roche Ltd.