Natalizumab versus fingolimod for patients with active relapsing-remitting multiple sclerosis: results from REVEAL, a prospective, randomised head-to-head study.

ABSTRACT:

Objective

To directly compare the efficacy of natalizumab and fingolimod in patients with active relapsing-remitting multiple sclerosis.

Methods

This phase 4, randomised, rater- and sponsor-blinded, prospective, parallel-group, clinic-based head-to-head study was conducted at 43 sites in nine countries. Patients were randomised (1:1) to intravenous natalizumab 300 mg every 4 weeks or oral fingolimod 0.5 mg once daily for ≤52 weeks. Enrolment-related early study termination precluded assessment of the primary endpoint (evolution of new on-treatment gadolinium-enhancing (Gd+) lesions to persistent black holes). Unplanned exploratory analyses of secondary endpoints evaluated the effects of treatment on the development of new T1 Gd+ lesions and new/newly enlarging T2 lesions, le

SUBMITTER: Butzkueven H 

PROVIDER: S-EPMC7577060 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature