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OCRELIZUMAB IN PRIMARY PROGRESSIVE MS: THE ORATORIO STUDY
  1. G Giovannoni1,
  2. DL Arnold2,3,
  3. A Bar-Or2,
  4. J de Seze4,
  5. B Hemmer5,6,
  6. X Montalban7,
  7. K Rammohan8,
  8. J Wolinsky9,
  9. on behalf of the ORATORIO clinical investigators1
  1. 1 Queen Mary University of London
  2. 2 McGill University, Montreal, Canada
  3. 3 NeuroRx Research, Montreal, Canada
  4. 4 University Hospitals of Strasbourg, France
  5. 5 Technische Universität Muünchen, Germany
  6. 6 Munich Cluster for Systems Neurology (SyNergy), Germany
  7. 7 Vall d'Hebron University Hospital, Barcelona, Spain
  8. 8 University of Miami, FL, USA
  9. 9 University of Texas Health Science Center at Houston, Houston, USA

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.

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