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

Autor: Norman J Kachuck, Lawrence W. Myers, Robert P. Lisak, Jana Lizrova Preiningerova, John W. Rose, Corey C. Ford, Jerry S. Wolinsky, Andrew D. Goodman, Christopher Luzzio, Kenneth P. Johnson, J. W. Lindsey, Hillel Panitch, Horea Rus, A. A. Pruitt
Rok vydání: 2010
Předmět:
Male
Time Factors
Kaplan-Meier Estimate
Severity of Illness Index
Disability Evaluation
0302 clinical medicine
Prospective Studies
10. No inequality
Prospective cohort study
Randomized Controlled Trials as Topic
0303 health sciences
Cross-Over Studies
Evidence-Based Medicine
3. Good health
Expanded Disability Status Scale
Treatment Outcome
Neurology
Cohort
Female
Research Paper
medicine.drug
Adult
secondary progressive multiple sclerosis
medicine.medical_specialty
Patient Dropouts
relapsing-remitting multiple sclerosis
Drug Administration Schedule
03 medical and health sciences
Multiple Sclerosis
Relapsing-Remitting
Double-Blind Method
Internal medicine
Severity of illness
medicine
Humans
Immunologic Factors
Glatiramer acetate
Propensity Score
030304 developmental biology
long-term
Chi-Square Distribution
business.industry
Multiple sclerosis
Glatiramer Acetate
medicine.disease
Crossover study
United States
Surgery
Logistic Models
disability
Neurology (clinical)
Peptides
business
Chi-squared distribution
030217 neurology & neurosurgery
Zdroj: Multiple Sclerosis (Houndmills, Basingstoke, England)
ISSN: 1477-0970
1352-4585
DOI: 10.1177/1352458509358088
Popis: 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were 8.6 ± 5.2, 4.81 ± 3.69, and 13.6 ± 1.3 years and mean disease durations were 17, 13, and 22 years for mITT, Withdrawn and Ongoing cohorts, respectively.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 ≤ 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.
Databáze: OpenAIRE
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