: Relapse Outcomes in Patients with Multiple Sclerosis Treated with Fingolimod after Previous Treatment with Injectable Disease-Modifying Therapies

Background: In phase 3 clinical trials, fingolimod significantly reduced annualized relapse rates (ARRs) in patients with relapsing–remitting multiple sclerosis (RRMS) in comparison with placebo and intramuscular interferon (IFN) beta-1a. This post hoc subgroup analysis of pooled data from the FREEDOMS, FREEDOMS II, and TRANSFORMS patient populations investigated the efficacy of fingolimod in individuals with suboptimal response to previous disease-modifying therapies (DMTs).

Objectives: To assess the effects of oral fingolimod treatment on ARRs in patients with RRMS who were naïve to previous treatment with IFN beta-1a or glatiramer acetate (GA) or had discontinued previous treatment with these agents.

Methods: Subgroups included patients who had received injectable treatment for multiple sclerosis before study entry (IFN vs IFN-naïve, GA vs GA-naïve). Further subgroups were defined by reasons for discontinuation of previous treatment (unsatisfactory therapeutic effect vs other reasons, and adverse event [AE] versus other reasons).

Results: Compared with placebo and IFN, fingolimod 0.5 mg significantly reduced ARRs in patients who were IFN-naïve (relative reductions: 59%, n = 449; and 42%, n = 225, respectively; both P < .001), had previously received IFN (49%, n = 324; and 49%, n = 206, respectively; both P < .001), were GA-naïve (58%, n = 583; and 46%, n = 365, respectively; both P < .001), had previously received GA (42%, n = 190, p < 0.001; and 44%, n = 66, P = .015, respectively), had previously discontinued DMT owing to unsatisfactory therapeutic effect (54%, n = 112, p < 0.001; and 53%, n = 45, P = .009, respectively), and had previously discontinued DMT owing to an AE (37%, n = 222, P = .002; and 36%, n = 50, P = .090, respectively).

Conclusions: Fingolimod 0.5 mg demonstrated consistent efficacy benefits over placebo and IFN beta-1a in patients with RRMS, regardless of previous therapy or reasons for discontinuing previous therapy.