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PRISMS: the story of a pivotal clinical trial series in multiple sclerosis

Bruce A Cohen1, Victor M Rivera

  • 1Davee Department of Neurology, Feinberg School of Medicine, Northwestern University, Chicago, Illinois 60611, USA. bac106@northwestern.edu

Current Medical Research and Opinion
|February 4, 2010
PubMed
Abstract

Insights

Subcutaneous interferon beta-1a (IFN beta-1a) is a safe and effective first-line treatment for relapsing-remitting multiple sclerosis (MS). Long-term data show sustained benefits in reducing relapses and disability progression.

Area of Science:

  • Neurology
  • Immunology

Background:

  • The PRISMS study initiated in 1994 provided long-term data on subcutaneous interferon beta-1a (sc IFN beta-1a) for multiple sclerosis (MS).
  • Few disease-modifying drugs were available for MS at the study's inception.
  • This review consolidates clinical, MRI, safety, and immunogenicity data from up to 8 years of the PRISMS studies.

Purpose of the Study:

  • To review and collate published data from the PRISMS study series.
  • To evaluate the long-term efficacy, safety, and immunogenicity of sc IFN beta-1a in relapsing-remitting MS.
  • To provide insights into future studies with new formulations of sc IFN beta-1a.

Main Methods:

  • Systematic review and collation of published efficacy, safety, and immunogenicity data from the PRISMS study series (years 1-8).
  • Inclusion of data from subsequent studies evolving from PRISMS.
  • Analysis of prospectively defined endpoints and post hoc analyses.

Main Results:

  • In the initial 2-year study, sc IFN beta-1a (22 or 44 mcg three times weekly) significantly reduced relapse rates, disability progression, and MRI disease burden compared to placebo.
  • Long-term extension and follow-up (up to 8 years) confirmed sustained efficacy and good safety.
  • The 44 mcg dose demonstrated greater long-term benefit than the 22 mcg dose, with neutralizing antibodies impacting efficacy in the lower dose group.

Conclusions:

  • Long-term data from PRISMS support sc IFN beta-1a three times weekly as a first-line treatment for MS.
  • Sustained efficacy, acceptable safety, and high patient retention rates support its use.
  • The findings support the continued use of sc IFN beta-1a in managing relapsing-remitting MS.

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