Effect of prior treatment status and reasons for discontinuation on the efficacy and safety of fingolimod vs. interferon β-1a intramuscular: Subgroup analyses of the Trial Assessing Injectable Interferon vs. Fingolimod Oral in Relapsing-Remitting Multiple Sclerosis (TRANSFORMS)

B. O. Khatri, J. Pelletier, L. Kappos, H. P. Hartung, G. Comi, F. Barkhof, P. Von Rosenstiel, X. Meng, A. Grinspan, R. Hashmonay, J. A. Cohen

Research output: Contribution to journalArticle

Abstract

Background: Fingolimod demonstrated superior efficacy compared with interferon β-1a intramuscular in relapsing multiple sclerosis. The impact of treatment history on fingolimod efficacy is unknown. Objectives: This post-hoc analysis of phase 3 TRANSFORMS data compared the efficacy and safety of fingolimod and interferon β-1a intramuscular among patient subgroups defined by prior treatment history. Methods: Annualized relapse rate and safety of once-daily oral fingolimod 0.5 mg, 1.25 mg, or once-weekly interferon β-1a 30 μg intramuscular for 12 months were analyzed in 1292 patients with relapsing multiple sclerosis according to prior disease-modifying therapy, reason for prior disease-modifying therapy discontinuation (adverse events or unsatisfactory therapeutic effect), and prior disease-modifying therapy duration. Results: Compared with interferon β-1a intramuscular, fingolimod 0.5 mg significantly reduced annualized relapse rate in patients who were treatment naive, received prior interferon-β treatment, discontinued prior disease-modifying therapy for unsatisfactory therapeutic effect, or had prior disease-modifying therapy duration of ≥1 year (P≤0.05, all comparisons). Similar trends were observed in patients with prior glatiramer acetate treatment. Significant reductions were also seen with fingolimod 1.25 mg for treatment-naive and prior interferon-β-treated patients. Conclusions: This analysis demonstrates superiority of fingolimod over interferon β-1a intramuscular regardless of prior (interferon-β) treatment and prior treatment efficacy and duration. ClinicalTrials.gov identifier: NCT00340834.

Original languageEnglish
Pages (from-to)355-363
Number of pages9
JournalMultiple Sclerosis and Related Disorders
Volume3
Issue number3
DOIs
Publication statusPublished - 2014

Keywords

  • Disease-modifying therapy
  • Fingolimod
  • Interferon
  • Multiple sclerosis
  • Relapse rate
  • Sphingosine 1-phosphate receptor modulator

ASJC Scopus subject areas

  • Clinical Neurology
  • Neurology

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