Effectiveness of interferon beta treatment in relapsing-remitting multiple sclerosis: An Italian cohort study

Pierluigi Russo, Andrea Paolillo, Luciano Caprino, Stefano Bastianello, Placido Bramanti

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Rationale, aims and objectives: Randomized clinical trials (RCTs) have provided evidence for the efficacy of interferon beta (IFNβ) in the treatment of relapsing-remitting multiple sclerosis (RRMS). The aim of this study was to evaluate the effectiveness of IFNβ treatment in clinical practice. Methods: This was a national, multicentre, observational study of patients with confirmed RRMS. Demographic, clinical and therapeutic data were retrospectively collected for each patient enrolled in the study. Results: The study cohort consisted of 427 patients exposed to and 245 never exposed to IFNβ treatment during the study period (for a total 2297 patient-years of follow-up). Among the exposed patients, 215 were initially untreated and then began IFNβ later in the follow-up period; 137 of these patients were exposed to IFNβ for more than 2 years. In these patients, IFNβ treatment reduced the mean relapse rate by 24.2% [95% confidence interval (CI): 5.8-42.5%]. For 640 of the 672 patients enrolled in the study, it was possible to calculate the area under the disability/time curve compared to that present at baseline. A total of 117 (18.3%) patients displayed disability progression. Adjustment of the disability progression rates for potential confounders and/or for propensity scores by Poisson regression model resulted in relative risks for patients exposed to IFNβ treatment compared to those never exposed to IFNβ of 0.87 (95% CI: 0.56-1.34) after an exposure of ≤2 years, and of 0.35 (95% CI: 0.21-0.60) after an exposure of >2 years. Conclusions: These findings suggest that the evidence from RCTs on the treatment of RRMS with IFNβ has been effectively translated into routine clinical practice.

Original languageEnglish
Pages (from-to)511-518
Number of pages8
JournalJournal of Evaluation in Clinical Practice
Issue number4
Publication statusPublished - Nov 2004


  • Cohort study
  • Interferon beta
  • Propensity score
  • Relapsing-remitting multiple sclerosis
  • Treatment effectiveness

ASJC Scopus subject areas

  • Public Health, Environmental and Occupational Health
  • Health Information Management
  • Nursing(all)


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