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

Background: Fingolimod demonstrated superior efficacy compared with interferon beta-1 a 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 beta-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 beta-la 30 mu g 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 beta-la intramuscular, fingolimod 0.5 mg significantly reduced annualized relapse rate in patients who were treatment naive, received prior interferon-beta 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-beta-treated patients. Conclusions: This analysis demonstrates superiority of fingolimod over interferon intramuscular regardless of prior (interferon-beta) treatment and prior treatment efficacy and duration. ClinicalTrials. gov identifier: NCT00340834. (C) 2014 Published by Elsevier By.