A Randomized Trial of Teriflunomide Added to Glatiramer Acetate in Relapsing Multiple Sclerosis

Overview

Journal Mult Scler J Exp Transl Clin

Date 2017 Jun 14

PMID 28607708

Citations 2

Authors

M S Freedman

J S Wolinsky

P Truffinet

G Comi

L Kappos

A E Miller

T P Olsson

M Benamor

S Chambers

P W OConnor

Affiliations

Soon will be listed here.

Abstract

Background: Teriflunomide is a once-daily oral immunomodulator for the treatment of relapsing-remitting MS.

Objective: To evaluate the safety and tolerability of teriflunomide as add-on therapy to a stable dose of glatiramer acetate (GA) in patients with relapsing forms of MS (RMS).

Methods: Phase II, randomized, double-blind, add-on, placebo-controlled study. The primary objective was to assess safety and tolerability; secondary objectives were to evaluate effects of treatment on disease activity assessed by MRI and relapse.

Results: Patients with RMS on GA ( = 123) were randomized 1:1:1 to receive teriflunomide 14 mg ( = 40), 7 mg ( = 42), or placebo ( = 41) for 24 weeks; 96 patients entered the 24-week extension, remaining on original treatment allocation. Teriflunomide was well tolerated over 48 weeks. The frequency of adverse events (AEs) was low across all groups; 5 (12.2%), 3 (7.1%), and 2 (5.0%) patients in the 14 mg, 7 mg, and placebo groups, respectively, discontinued treatment due to AEs. Teriflunomide reduced the number of T1-Gd lesions vs placebo (14 mg: 46.6% relative reduction, = 0.1931; 7 mg: 64.0%: relative reduction, = 0.0306).

Conclusions: Teriflunomide added to stable-dose GA had acceptable safety and tolerability, and reduced some MRI markers of disease activity compared with GA alone. NCT00475865 (core study); NCT00811395 (extension).

Citing Articles

Adverse effects of immunotherapies for multiple sclerosis: a network meta-analysis.

Tramacere I, Virgili G, Perduca V, Lucenteforte E, Benedetti M, Capobussi M Cochrane Database Syst Rev. 2023; 11:CD012186.

PMID: 38032059 PMC: 10687854. DOI: 10.1002/14651858.CD012186.pub2.

Enduring Clinical Value of Copaxone® (Glatiramer Acetate) in Multiple Sclerosis after 20 Years of Use.

Wynn D Mult Scler Int. 2019; 2019:7151685.

PMID: 30775037 PMC: 6350531. DOI: 10.1155/2019/7151685.

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