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Ocrelizumab versus Interferon Beta-1a in Relapsing Multiple Sclerosis.

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The New England Journal of Medicine
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Ocrelizumab significantly reduced relapse rates and disability progression in relapsing multiple sclerosis patients compared to interferon beta-1a. Further long-term safety studies of ocrelizumab are needed.

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Area of Science:

  • Neuroimmunology
  • Pharmacology

Background:

  • B cells play a critical role in multiple sclerosis pathogenesis.
  • Ocrelizumab is a targeted therapy designed to deplete CD20-expressing B cells.

Purpose of the Study:

  • To evaluate the efficacy and safety of ocrelizumab compared to interferon beta-1a in patients with relapsing multiple sclerosis.

Main Methods:

  • Two identical Phase 3 trials (OPERA I and II) randomized 1656 patients with relapsing multiple sclerosis.
  • Patients received either ocrelizumab (600 mg IV every 24 weeks) or interferon beta-1a (44 μg SC three times weekly) for 96 weeks.

Main Results:

  • Ocrelizumab demonstrated significantly lower annualized relapse rates (46-47% reduction) versus interferon beta-1a.
  • Ocrelizumab significantly reduced disability progression (12- and 24-week confirmed) and the number of gadolinium-enhancing MRI lesions.
  • While ocrelizumab improved the Multiple Sclerosis Functional Composite score in one trial, infusion reactions were more common; serious infections and neoplasms were infrequent.

Conclusions:

  • Ocrelizumab offers superior efficacy over interferon beta-1a in reducing disease activity and progression in relapsing multiple sclerosis over 96 weeks.
  • Longer-term studies are necessary to fully assess the safety profile of ocrelizumab.