Long-term (up to 22 years), open-label, compassionate-use study of glatiramer acetate (Copaxone) in relapsing remitting multiple sclerosis.
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,
o relapses were reported at occurrence and
o 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 pre-treatment 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.
Mount Sinai School of Medicine,