PT  - JOURNAL ARTICLE
AU  - E Silber
AU  - DL Arnold
AU  - A Bar-Or
AU  - G Comi
AU  - HP Hartung
AU  - SL Hauser
AU  - F Lublin
AU  - K Selmaj
AU  - A Traboulsee
AU  - L Kappos
AU  - on behalf of the OPERA I and II clinical investigators
TI  - OCRELIZUMAB VS INTERFERON β-1A IN RELAPSING MS: TWO STUDIES
AID  - 10.1136/jnnp-2016-315106.144
DP  - 2016 Dec 01
TA  - Journal of Neurology, Neurosurgery & Psychiatry
PG  - e1--e1
VI  - 87
IP  - 12
4099  - http://jnnp.bmj.com/content/87/12/e1.51.short
4100  - http://jnnp.bmj.com/content/87/12/e1.51.full
SO  - J Neurol Neurosurg Psychiatry2016 Dec 01; 87
AB  - 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.