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 re...

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Veröffentlicht in:Multiple sclerosis 2010-03, Vol.16 (3), p.342-350
Hauptverfasser: Ford, C., Goodman, AD, Johnson, K., Kachuck, N., Lindsey, JW, Lisak, R., Luzzio, C., Myers, L., Panitch, H., Preiningerova, J., Pruitt, A., Rose, J., Rus, H., Wolinsky, J.
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container_end_page 350
container_issue 3
container_start_page 342
container_title Multiple sclerosis
container_volume 16
creator Ford, C.
Goodman, AD
Johnson, K.
Kachuck, N.
Lindsey, JW
Lisak, R.
Luzzio, C.
Myers, L.
Panitch, H.
Preiningerova, J.
Pruitt, A.
Rose, J.
Rus, H.
Wolinsky, J.
description 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were 8.6 ± 5.2, 4.81 ± 3.69, and 13.6 ± 1.3 years and mean disease durations were 17, 13, and 22 years for mITT, Withdrawn and Ongoing cohorts, respectively.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.
doi_str_mv 10.1177/1352458509358088
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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.</description><identifier>ISSN: 1352-4585</identifier><identifier>EISSN: 1477-0970</identifier><identifier>DOI: 10.1177/1352458509358088</identifier><identifier>PMID: 20106943</identifier><identifier>CODEN: MUSCFZ</identifier><language>eng</language><publisher>London, England: SAGE Publications</publisher><subject>Adult ; Chi-Square Distribution ; Cross-Over Studies ; Disability Evaluation ; Double-Blind Method ; Drug Administration Schedule ; Female ; Glatiramer Acetate ; Humans ; Immunologic Factors - administration &amp; dosage ; Immunologic Factors - adverse effects ; Kaplan-Meier Estimate ; Logistic Models ; Male ; Multiple Sclerosis, Relapsing-Remitting - diagnosis ; Multiple Sclerosis, Relapsing-Remitting - drug therapy ; Patient Dropouts ; Peptides - administration &amp; dosage ; Peptides - adverse effects ; Propensity Score ; Prospective Studies ; Research Paper ; Severity of Illness Index ; Time Factors ; Treatment Outcome ; United States</subject><ispartof>Multiple sclerosis, 2010-03, Vol.16 (3), p.342-350</ispartof><rights>The Author(s) 2010</rights><rights>SAGE Publications © Mar 2010</rights><rights>2010 The Author(s) 2010 The Author(s)</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c526t-5e6408ff8d68c9e6a6434cf4f03abe2310f488673091efab0d9a76773d6e544e3</citedby><cites>FETCH-LOGICAL-c526t-5e6408ff8d68c9e6a6434cf4f03abe2310f488673091efab0d9a76773d6e544e3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://journals.sagepub.com/doi/pdf/10.1177/1352458509358088$$EPDF$$P50$$Gsage$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://journals.sagepub.com/doi/10.1177/1352458509358088$$EHTML$$P50$$Gsage$$Hfree_for_read</linktohtml><link.rule.ids>230,314,776,780,881,21798,27901,27902,43597,43598</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/20106943$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Ford, C.</creatorcontrib><creatorcontrib>Goodman, AD</creatorcontrib><creatorcontrib>Johnson, K.</creatorcontrib><creatorcontrib>Kachuck, N.</creatorcontrib><creatorcontrib>Lindsey, JW</creatorcontrib><creatorcontrib>Lisak, R.</creatorcontrib><creatorcontrib>Luzzio, C.</creatorcontrib><creatorcontrib>Myers, L.</creatorcontrib><creatorcontrib>Panitch, H.</creatorcontrib><creatorcontrib>Preiningerova, J.</creatorcontrib><creatorcontrib>Pruitt, A.</creatorcontrib><creatorcontrib>Rose, J.</creatorcontrib><creatorcontrib>Rus, H.</creatorcontrib><creatorcontrib>Wolinsky, J.</creatorcontrib><title>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</title><title>Multiple sclerosis</title><addtitle>Mult Scler</addtitle><description>The ongoing US Glatiramer Acetate (GA) Trial is the longest evaluation of continuous immunomodulatory therapy in relapsing—remitting multiple sclerosis (RRMS). 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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. 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subjects Adult
Chi-Square Distribution
Cross-Over Studies
Disability Evaluation
Double-Blind Method
Drug Administration Schedule
Female
Glatiramer Acetate
Humans
Immunologic Factors - administration & dosage
Immunologic Factors - adverse effects
Kaplan-Meier Estimate
Logistic Models
Male
Multiple Sclerosis, Relapsing-Remitting - diagnosis
Multiple Sclerosis, Relapsing-Remitting - drug therapy
Patient Dropouts
Peptides - administration & dosage
Peptides - adverse effects
Propensity Score
Prospective Studies
Research Paper
Severity of Illness Index
Time Factors
Treatment Outcome
United States
title 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
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