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

ABSTRACT:

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-naïve 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 <4.0, and ≥1-5 years since diagnosis, received daily fingolimod for 48 weeks. The primary endpoint was annualized relapse rate (ARR).

Results

Of 347 patients enrolled at 51 sites (treatment-naïve, 200 [57.6%]; previously treated, 147 [42.4%]), 320 completed the study (trea

SUBMITTER: Fernandez O 

PROVIDER: S-EPMC7493256 | biostudies-literature | 2020 Jul-Sep

REPOSITORIES: biostudies-literature