Continuous long-term immunomodulatory therapy in relapsing multiple sclerosis: results from the 15-year analysis of the US prospective open-label study of glatiramer acetate.
The ongoing US Glatiramer Acetate (GA) Trial is the longest evaluation of continuous immunomodulatory therapy in relapsing-remitting multiple sclerosis (RRMS). The objective of this study was to evaluate up to 15 years of GA as a sole disease-modifying therapy. Two hundred and thirty-two patients received at least one GA dose since study initiation in 1991 (mITT cohort), and 100 (43%, Ongoing cohort) continued as of February 2008. Patients were evaluated every 6 months using the Expanded Disability Status Scale (EDSS). Mean GA exposures were 8.6 +/- 5.2, 4.81 +/- 3.69, and 13.6 +/- 1.3 years and mean disease durations were 17, 13, and 22 years for mITT, Withdrawn and Ongoing cohorts, respectively. For Ongoing patients, annual relapse rates (ARRs) maintained a decline from 1.12 +/- 0.82 at baseline to 0.25 +/- 0.34 per year; 57% had stable/improved EDSS scores (change < or = 0.5 points); 65% had not transitioned to secondary progressive multiple sclerosis (SPMS); 38%, 18%, and 3% reached EDSS 4, 6, and 8. For all patients on GA therapy (the mITT cohort), ARRs declined from 1.18 +/- 0.82 to 0.43 +/- 0.58 per year; 54% had stable/improved EDSS scores; 75% had not transitioned to SPMS; 39%, 23%, and 5% reached EDSS 4, 6, and 8. In conclusion, multiple sclerosis patients with mean disease duration of 22 years administering GA for up to 15 years had reduced relapse rates, and decreased disability progression and transition to SPMS. There were no long-term safety issues.
Ford
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C
Department of Neurology and the Clinical and Magnetic Resonance Research Center and Multiple Sclerosis Specialty Clinic, University of New Mexico Health Sciences Center, University of New Mexico School of Medicine, Pete and Nancy Domenici Hall, 1101 Yale Boulevard NE, Albuquerque, NM 87131, USA. cford@salud.unm.edu
Goodman
A D
AD
Johnson
K
K
Kachuck
N
N
Lindsey
J W
JW
Lisak
R
R
Luzzio
C
C
Myers
L
L
Panitch
H
H
Preiningerova
J
J
Pruitt
A
A
Rose
J
J
Rus
H
H
Wolinsky
J
J
D000328:Adult; D016009:Chi-Square Distribution; D018592:Cross-Over Studies; D004185:Disability Evaluation; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D000068717:Glatiramer Acetate; D006801:Humans; D007155:Immunologic Factors / Q000008:administration & dosage* / Q000009:adverse effects; D053208:Kaplan-Meier Estimate; D016015:Logistic Models; D008297:Male; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000175:diagnosis / Q000188:drug therapy*; D010352:Patient Dropouts; D010455:Peptides / Q000008:administration & dosage* / Q000009:adverse effects; D057216:Propensity Score; D011446:Prospective Studies; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States
D007155:Immunologic Factors; D010455:Peptides; D000068717:Glatiramer Acetate