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Long-term (up to 22 years), open-label, compassionate-use study of glatiramer acetate in relapsing—remitting multiple sclerosis

Mount Sinai School of Medicine, New York, NY, USA, aaron.miller{at}mssm.edu

Vincent Spada

Teva Neuroscience Inc., Horsham, PA, USA

Dorothy Beerkircher

Teva Neuroscience Inc., Horsham, PA, USA

Rivka Riven Kreitman

Teva Neuroscience Inc., Horsham, PA, USA

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 4.0 and 8/34 (24%) with entry EDSS < 6.0 reached EDSS 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 4.0 and 28% with baseline scores < 6.0 reached EDSS 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. Multiple Sclerosis 2008; 14: 494—499. http://msj.sagepub.com

Key Words: disability • disease modifying therapy • EDSS • glatiramer acetate • immunomodulator • relapse • relapsing-remitting multiple sclerosis

This version was published on May 1, 2008

Multiple Sclerosis, Vol. 14, No. 4, 494-499 (2008)
DOI: 10.1177/1352458507085029


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