Long-term effects of glatiramer acetate in multiple sclerosis |
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| Authors: | Brochet B |
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| Affiliation: | 1. Clinic of Neurology, Clinical Center of Serbia, Faculty of Medicine, University of Belgrade, Dr Subotica 6, 11129 Belgrade, Serbia;2. Institute of Epidemiology, Faculty of Medicine, University of Belgrade, Visegradska 26A, 11129 Belgrade, Serbia;1. Center for Brain/Mind Medicine, Division of Cognitive and Behavioral Neurology, Department of Neurology, Brigham and Women’s Hospital, Harvard Medical School, 221 Longwood Avenue, Boston, MA 02115, USA;2. Department of Psychology, Tufts University, 490 Boston Avenue, Medford, MA 02155, USA;1. Department of Neurology, Northwestern University, 710 North Lake Shore Drive, Abbott Hall 1121, Chicago, IL 60611, USA;2. Department of Neurology, Stony Brook University, Health Sciences Center, T12-020, Stony Brook, NY 11794, USA;3. Comprehensive MS Center, Thomas Jefferson University, 900 Walnut St. #200, Philadelphia, PA 19107, USA;4. Health Outcomes Research Consulting and Writing, Outcomes Scribe, LLC, 664 Wynding Oaks, Kalamazoo, MI 49006, USA;5. Biostatistics, MedNet Solutions, Inc., 110 Cheshire Lane, Ste. 300, Minnetonka, MN 55305, USA;6. Neuroscience Consultants, Comprehensive Multiple Sclerosis Center, 4601 Ponce de Leon Blvd, Ste. 100, Coral Gables, FL 33146, USA;1. Center of Neurology, Division of Neuropsychology, Hertie-Institute for Clinical Brain Research, University of Tübingen, Tübingen, Germany;2. Department of Psychology, University of South Carolina, Columbia, SC, USA;1. Service de neurologie, CHU de Dijon, 3, rue du Faubourg-Raines, 21000 Dijon, France;2. EA 4184, centre d’épidémiologie des populations, 1, boulevard Jeanne-d’Arc, BP 1542, 21079 Dijon, France;3. Maison départementale des solidarités, service de protection maternelle et infantile (PMI), 21, rue de l’Ermitage, 71240 Sennecey-le-Grand, France;4. Inserm, CIE1, 7, boulevard Jeanne-d’Arc, 21079 Dijon, France;5. Centre d’investigation clinique – Épidémiologie clinique/essais thérapeutiques, université de Bourgogne, CHU de Dijon, Bocage Sud, 14, rue Gaffarel, BP 77908, 21079 Dijon cedex, France;6. CNAMTS, 26-50, avenue du Professeur-André-Lemierre, 75986 Paris cedex 20, France;7. CNAMTS, direction du service médical, 38, rue de Cracovie, 21075 Dijon cedex, France |
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| Abstract: | IntroductionMultiple sclerosis is a chronic progressive neurological disorder. For this reason, the clinician needs to have access to treatments that are effective and well-tolerated over decades. However, in the absence of long-term controlled clinical trials, it is difficult to assess the long-term benefit provided by currently available immunomodulatory treatments. The objective of this report is to review the strengths and limitations of available long-term data obtained in different phases of the randomized phase III clinical trial with glatiramer acetate collected over a 10-year period in particular.MethodsData were obtained from six published analyses of data from the phase III randomized clinical trial of glatiramer acetate performed at different times over a 10-year period. Initially patients were randomized to receive glatiramer acetate (n = 125) or placebo (n = 126) for 24 months under a double blind scheme, which was subsequently extended to up to 35 months. All patients were then proposed to continue glatiramer acetate treatment in an open-label prospective extension. Analyses of this extension study were performed at six and eight years after initial randomization. Finally, a pooled analysis was performed after a mean treatment duration of 10 years of all patients who had ever received glatiramer acetate during the study. Data were available for 68% of the original cohort at 10 years. At this stage, 108 patients (46.6%) had been continually treated with glatiramer acetate for a mean duration of 10 years.ResultsAfter one year of treatment, the annualized relapse rate decreased by around 50% from 1.18 relapses/year before inclusion to 0.60 relapses/year. Thereafter, relapse rates continued to decline progressively, reaching less than 0.2 relapses/year from the ninth year of treatment onward. For 65% of patients, EDSS disability scores remained stable or improved over the entire treatment period, and 8% had reached a score of 6 on the EDSS scale (inability to walk unaided) after a mean continuous treatment duration of 10 years. With respect to safety, 23 patients (< 10%) needed to stop treatment due to an adverse event over the 10-year follow-up period. The most frequently encountered adverse events were local injection site reactions and systemic immediate postinjection reactions. No specific safety issue associated with long-term treatment was identified.ConclusionsThe information collected from prospective long-term follow-up of patients treated with glatiramer acetate extending out to 10 years provide clear evidence for the long-term efficacy and adequate safety of this immunomodulatory treatment in the treatment of relapsing-remitting multiple sclerosis over a period of at least 10 years. |
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