Copaxone long-term study
Posted: Wed Jan 23, 2008 8:13 am
Now that's some long-term follow up!
Long-term (up to 22 years), open-label,compassionate-use study of glatiramer acetatein relapsingremitting multiple sclerosis.
Mult Scler. 2008 Jan 21 [Epub ahead of print]
Miller A, Spada V, Beerkircher D, Kreitman RR.
Mount Sinai School of Medicine, New York, NY, USA.
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.
Pubmed link
Long-term (up to 22 years), open-label,compassionate-use study of glatiramer acetatein relapsingremitting multiple sclerosis.
Mult Scler. 2008 Jan 21 [Epub ahead of print]
Miller A, Spada V, Beerkircher D, Kreitman RR.
Mount Sinai School of Medicine, New York, NY, USA.
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.
Pubmed link