Relapse Outcomes in Patients Treated with Fingolimod According to Disease Duration

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 subgroups with varying duration either of disease or of previous exposure to disease-modifying therapies (DMTs).

Objectives: To report the effects of oral fingolimod treatment on ARRs in patients with RRMS according to disease duration and duration of treatment with previous DMTs.

Methods: Patient subgroups were defined by time since first symptom (≥ 3 versus < 3 years before randomization) and number of years of previous treatment (0, ≤ 1, > 1–3, and > 3 years before randomization).

Results: In patients with less than 3 years since first symptom, fingolimod 0.5 mg significantly reduced ARR by 69% (ARR ratio: 0.31, n = 163, P < .001) versus placebo and by 50% (ARR ratio: 0.50, n = 140, P = .002) versus IFN. In patients with 3 or more years since first symptom, reductions in ARR were 49% (ARR ratio: 0.51, n = 610, P < .001) versus placebo and 46% (ARR ratio: 0.54, n = 291, P < .001) versus IFN. Fingolimod 0.5 mg significantly reduced ARR in patients with 0, >1–3, and more than 3 years of treatment before randomization compared with placebo and IFN, but not in patients in the IFN group previously treated for 1 year or less (relative reduction: 35%, [ARR ratio: 0.65, n = 64, P = .108]).

Conclusions: Fingolimod 0.5 mg demonstrated consistent efficacy benefits over placebo and IFN beta-1a in patients with RRMS, irrespective of time since first symptom or number of years of previous treatment, with the exception of patients in the IFN beta-1a subgroup previously treated for 1 year or less.