1. Long-term follow up of glatiramer acetate compassionate use in Belgium.
- Author
-
Sindic CJ, Seeldrayers P, Vande Gaer L, De Smet E, Nagels G, De Deyn PP, Medaer R, Guillaume D, D'Hooghe MB, Deville MC, Decoo D, Sadzot B, Van Landegem W, Strauven T, Pepin J, Merckx H, Caekebeke J, and van der Tool MA
- Subjects
- Adolescent, Adult, Belgium, Disease Progression, Female, Follow-Up Studies, Glatiramer Acetate, Health Surveys, Humans, Immunosuppressive Agents adverse effects, Luxembourg, Male, Middle Aged, Multiple Sclerosis, Relapsing-Remitting physiopathology, Netherlands, Patient Compliance, Peptides adverse effects, Secondary Prevention, Time Factors, Treatment Outcome, Immunosuppressive Agents administration & dosage, Multiple Sclerosis, Relapsing-Remitting drug therapy, Peptides administration & dosage
- Abstract
Between June 1995 and November 1998, 228 patients with relapsing-remitting Multiple Sclerosis started treatment with glatiramer acetate (Copaxone) 20 mg once daily in the frame of a "compassionate use" protocol in 15 Belgian centers. Following an average treatment period of 5.8 years, treating neurologists were requested to fill in follow-up forms indicating neurological disability status and side effects during the previous 6 months. These data were available for 134 patients. In this group, the Expanded Disability Status Scale (EDSS) improved in 26.3% of patients. An additional 36.8% of patients remained neurologically stable. The Ambulation Index (AI) showed similar results: 12.5% of patients improved, 50% of patients remained stable, and 37.5% worsened. Only 10% of patients dropped out due to several reasons. The adverse events occurring in the period preceding the follow-up survey were non-serious and consistent with the current product information of glatiramer acetate. Among the 94 patients no longer followed-up in the compassionate program, reasons for lost to follow-up were obtained for 63; most of them (41) had stopped GA treatment or switched to another disease-modifying treatment. Overall these results are very similar to the ones reported in the extension study of the pivotal trial (Johnson et al., 2000), and indicate that patients treated with glatiramer acetate have a better outcome than expected on the basis of the natural course of the disease. Despite limitations of the study design, this report confirms the sustained efficacy of glatiramer acetate in reducing the disease progression in patients with relapsing-remitting multiple sclerosis treated in day-to-day clinical practice.
- Published
- 2005