Early Versus Delayed Treatment With Glatiramer Acetate: Analysis of up to 27 Years of Continuous Follow-up in a US Open-Label Extension Study

Authors

Corey C Ford
Jeffrey A Cohen
Andrew D Goodman
John W Lindsey
Robert P Lisak
Christopher Luzzio
Amy Pruitt
John Rose
Horea Rus
Jerry S Wolinsky
Shaul E Kadosh
Emily Bernstein-Hanlon
Yafit Stark
Jessica K Alexander

Publication Date

10-1-2022

Journal

Multiple Sclerosis Journal

Abstract

BACKGROUND: Glatiramer acetate (GA) is US-approved for relapsing multiple sclerosis.

OBJECTIVES: To describe GA long-term clinical profile. To compare effectiveness of early start (ES) versus delayed start (DS; up to 3 years) with GA.

METHODS: Phase 3 trial participants entered a randomized placebo-controlled period then an open-label extension (OLE) with GA.

RESULTS: Overall, 208 out of 251 (82.9%) randomized participants entered the OLE; 24 out of 101 (23.8%, ES) and 28 out of 107 (26.2%, DS) participants completed the OLE. Median GA treatment was 9.8 (0.1-26.3) years. Annualized change in Expanded Disability Status Scale (EDSS) score was lower with ES versus DS (

CONCLUSION: GA long-term treatment maintained clinical benefit with a similar safety profile to phase 3 results; a key limitation was that only 25% of participants completed the OLE. Early initiation of GA had sustained benefits versus delayed treatment.

Keywords

Clinical trial, disease-modifying therapies, glatiramer acetate, multiple sclerosis, quality of life, relapsing/remitting