Comparison of first-line and second-line use of fingolimod in relapsing MS: The open-label EARLIMS study.

Background Treatment of MS often begins with low-efficacy injectable disease-modifying therapy (iDMT). Objectives To compare the effect of fingolimod 0.5 mg/day on clinical, MRI, patient-reported, and safety outcomes, in treatment-naive and previously treated (≥1 iDMT) patients with early MS. Methods EARLIMS was a multicentre, open-label, non-randomized, parallel-group phase 3 b/4 study in Australia and Spain. Patients with relapsing-remitting MS, Expanded Disability Status Scale (EDSS) score 1 iDMT.