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  1. E Silber1,
  2. DL Arnold2,3,
  3. A Bar-Or2,
  4. G Comi4,
  5. HP Hartung5,
  6. SL Hauser6,
  7. F Lublin7,
  8. K Selmaj8,
  9. A Traboulsee9,
  10. L Kappos10,
  11. on behalf of the OPERA I and II clinical investigators1
  1. 1 King's College London
  2. 2 McGill University, Montreal, Canada
  3. 3 NeuroRx Research, Montreal, Canada
  4. 4 Vita-Salute San Raffaele University, Milan, Italy
  5. 5 Heinrich Heine University Düsseldorf, Germany
  6. 6 University of California, San Francisco, USA
  7. 7 Icahn School of Medicine at Mount Sinai, New York, USA
  8. 8 Medical University of Lodz, Poland
  9. 9 The University of British Columbia, Vancouver, Canada
  10. 10 University Hospital Basel, Switzerland


Introduction B cells are implicated in MS pathophysiology. Ocrelizumab (OCR) is a humanised monoclonal antibody that selectively targets CD20+ B cells. OCR was evaluated in relapsing MS (RMS) in two identical, Phase III, randomised, double-blind, double-dummy, interferon beta-1a (IFNβ-1a)-controlled studies (OPERA I/NCT01247324 and OPERA II/NCT01412333).

Methods Eligible RMS patients were randomised 1:1 to receive OCR 600 mg every 24 weeks or IFNβ-1a 44 µg three-times weekly for 96 weeks. The primary endpoint was annualised relapse rate (ARR) by 96 weeks. Key secondary endpoints included: time to 12- and 24-week confirmed disability progression (CDP); total number of T1 gadolinium-enhancing and new/enlarging T2 lesions at weeks 24, 48 and 96; and safety.

Results Compared with IFNβ-1a, OCR reduced: ARR (OPERA I: 46%; OPERA II: 47%; both p<0.0001); 12- and 24-week CDP by 40% each (p=0.0006; p=0.0025, respectively) in pre-specified pooled analyses; T1 gadolinium-enhancing lesions (OPERA I: 94%; OPERA II: 95%; both p<0.0001); and new/enlarging T2 lesions (OPERA I: 77%; OPERA II: 83%; both p<0.0001). Except for infusion- and injection-related events, adverse events (AEs) and serious AEs were similar between groups.

Conclusions OCR demonstrated significantly superior efficacy vs IFNβ-1a and a favourable safety profile in RMS patients.

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