Early versus delayed treatment with glatiramer acetate: Analysis of up to 27 years of continuous follow-up in a US open-label extension study.
Mult Scler
; 28(11): 1729-1743, 2022 10.
Article
em En
| MEDLINE
| ID: mdl-35768939
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 (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.Palavras-chave
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Base de dados:
MEDLINE
Assunto principal:
Esclerose Múltipla Recidivante-Remitente
/
Esclerose Múltipla
Tipo de estudo:
Clinical_trials
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Observational_studies
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Prognostic_studies
Limite:
Humans
Idioma:
En
Ano de publicação:
2022
Tipo de documento:
Article