Details

Autor(en) / Beteiligte

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

Titel

Early versus delayed treatment with glatiramer acetate: Analysis of up to 27 years of continuous follow-up in a US open-label extension study

Ist Teil von

• Multiple sclerosis, 2022-10, Vol.28 (11), p.1729-1743

Ort / Verlag

London, England: SAGE Publications

Erscheinungsjahr

2022

Link zum Volltext

Quelle

Alma/SFX Local Collection

Beschreibungen/Notizen

• 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 (p = 0.0858: full study; p = 0.002; Year 5). Participants with improved/stable EDSS was consistently higher with ES versus DS: 40.3% versus 31.6% (p = 0.1590; full study); 70.8% versus 55.6% (p = 0.015; Year 5). ES prolonged time-to-6-month confirmed disease worsening (CDW) versus DS (9.8 vs 6.7 years), time-to-12-month CDW (18.9 vs 11.6 years), and significantly reduced time-to-second-6-month CDW (p = 0.0441). No new safety concerns arose. 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.