OPERA I and II: Identical, head-to-head clinical trials vs Rebif over 2 years 2,3,5

The efficacy and safety of OCREVUS in RMS were studied vs Rebif in 2 double-blind, double-dummy trials evaluating over 1600 patients for 2 years

  • Patients receiving OCREVUS (ocrelizumab) were given a 600 mg IV dose every 24 weeks (dose 1 administered as two 300 mg IV infusions 2 weeks apart) and placebo subcutaneous injections 3 times a week
  • Patients receiving Rebif® (interferon β-1a) were given 44 μg subcutaneous injections 3 times per week and placebo IV infusions every 24 weeks
  • Additional endpoints studied included proportion of patients with confirmed disability improvement and mean number of new T1 hypointense lesions (chronic black holes) per MRI

OCREVUS: OPERA I, n=410; OPERA II, n=417.
Rebif: OPERA I, n=411; OPERA II, n=418.

Three years of data in the OLE period 2

Over 90% of patients who completed the controlled period entered the OLE, and of those, ≈90% completed Year 3 of the OLE

Over 90% of patients who completed the controlled period entered the OLE, and of those, 90% completed Year 3 of the OLE.
  • Patients who received Rebif during the controlled period continued to receive Rebif during the OLE screening period until their first infusion of OCREVUS
  • In the OLE phase, the first 600 mg dose of OCREVUS was administered as two 300 mg infusions given 2 weeks apart

Limitations of OLE data

  • The OLE is an open-label and uncontrolled study period
  • Patients in the OLE period successfully completed the controlled period and are subject to continued dropout; they may represent an enriched population
  • The endpoints measured were not prespecified nor powered to conclude statistical significance; they only convey numerical trends
  • Conclusions regarding the treatment effect of OCREVUS cannot be drawn on the basis of OLE data

The OCREVUS RMS patient 2,5,10

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Review efficacy and safety data in controlled head-to-head trials vs Rebif.

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EDSS=Expanded Disability Status Scale; Gd+=gadolinium-enhancing.