title: Long-term (up to 22 years), open-label, compassionate-use study of glatiramer acetate in relapsing-remitting multiple sclerosis.
abstract: To evaluate the safety and efficacy of long-term glatiramer acetate (GA) therapy, 46 patients with relapsing-remitting multiple sclerosis (RRMS) were treated for up to 22 years in an ongoing, open-label study. Kurtzke expanded disability status scale (EDSS) was measured every six months, relapses were reported at occurrence and patients self-reported adverse events (AEs). At GA initiation, disease durations ranged from 0-20 years (median 6.0 years) and at data cut-off (October 2004), GA therapy duration ranged from 1-22 years (median 12.0 years). Mean EDSS score increased 0.9 +/- 1.9 from the pretreatment score (3.0 +/- 1.8; P = 0.076). Only 10/28 (36%) patients with baseline EDSS <4.0 had a last observed value >or= 4.0 and 8/34 (24%) with entry EDSS < 6.0 reached EDSS >or= 6.0. A majority (57%) maintained improved or unchanged EDSS scores. Annualized relapse rate decreased to 0.1 +/- 0.2 from 2.9 +/- 1.4 prestudy (P < 0.0001). Of the 18 remaining patients in October 2004 (average disease duration 23 years), 17% with baseline EDSS scores < 4.0 reached EDSS >or= 4.0 and 28% with baseline scores < 6.0 reached EDSS >or= 6.0. Adverse events were similar to those reported in short-term clinical trials. This study shows a low rate of relapses and EDSS progression in RRMS patients on GA for up to 22 years.
authors.affiliation: Mount Sinai School of Medicine, New York, NY, USA. aaron.miller@mssm.edu
authors.forename: Aaron
authors.initials: A
authors.lastname: Miller
authors.forename: Vincent
authors.initials: V
authors.lastname: Spada
authors.forename: Dorothy
authors.initials: D
authors.lastname: Beerkircher
authors.forename: Rivka Riven
authors.initials: RR
authors.lastname: Kreitman
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D004185:Disability Evaluation; D018450:Disease Progression; D005260:Female; D000068717:Glatiramer Acetate; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000188:drug therapy*; D010455:Peptides / Q000008:administration & dosage* / Q000009:adverse effects; D011446:Prospective Studies; D055502:Secondary Prevention; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D007166:Immunosuppressive Agents; D010455:Peptides; D000068717:Glatiramer Acetate