This Article Full Text (OnlineFirst PDF) All Versions of this Article: 1352458507085029v1 14/4/494    most recent Alert me when this article is cited Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Add to Saved Citations Download to citation manager Request Permissions Request Reprints Add to My Marked Citations Citing Articles Citing Articles via Google Scholar Citing Articles via Scopus Google Scholar Articles by Miller, A. Articles by Kreitman, R. R. Search for Related Content PubMed PubMed Citation Articles by Miller, A. Articles by Kreitman, R. R. Social Bookmarking                   What's this?

Long-term (up to 22 years), open-label,compassionate-use study of glatiramer acetatein relapsingremitting multiple sclerosis

¹ Mount Sinai School of Medicine, New York, NY, USA
² Teva Neuroscience Inc., Horsham, PA, USA

^* To whom correspondence should be addressed.

	Abstract

To evaluate the safety and efficacy of long-term glatiramer acetate (GA) therapy, 46 patients with relapsingremitting 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 020 years (median 6.0 years) and at data cut-off (October 2004), GA therapy duration ranged from 122 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.

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

CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this?