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 |
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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were 8.6 ± 5.2, 4.81 ± 3.69, and 13.6 ± 1.3 years and mean disease durations were 17, 13, and 22 years for mITT, Withdrawn and Ongoing cohorts, respectively.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 & 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</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). 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><subject>Adult</subject><subject>Chi-Square Distribution</subject><subject>Cross-Over Studies</subject><subject>Disability Evaluation</subject><subject>Double-Blind Method</subject><subject>Drug Administration Schedule</subject><subject>Female</subject><subject>Glatiramer Acetate</subject><subject>Humans</subject><subject>Immunologic Factors - administration & dosage</subject><subject>Immunologic Factors - adverse effects</subject><subject>Kaplan-Meier Estimate</subject><subject>Logistic Models</subject><subject>Male</subject><subject>Multiple Sclerosis, Relapsing-Remitting - diagnosis</subject><subject>Multiple Sclerosis, Relapsing-Remitting - drug therapy</subject><subject>Patient Dropouts</subject><subject>Peptides - administration & dosage</subject><subject>Peptides - adverse effects</subject><subject>Propensity Score</subject><subject>Prospective Studies</subject><subject>Research Paper</subject><subject>Severity of Illness Index</subject><subject>Time Factors</subject><subject>Treatment Outcome</subject><subject>United States</subject><issn>1352-4585</issn><issn>1477-0970</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2010</creationdate><recordtype>article</recordtype><sourceid>AFRWT</sourceid><sourceid>EIF</sourceid><sourceid>BENPR</sourceid><recordid>eNp1UUuL1TAUDqI4D927kuC-mjSPpi4EufiCARc665LbnnQypEnNY6A_av7j5HrH8QGuEs73OpwPoReUvKa0695QJloulCA9E4oo9QidUt51Dek78rj-K9wc8BN0ltI1IaTrmHiKTlpCiew5O0W3u-Cz9SWUhF3wc5MhLtguS_FhCVNxOoe44XwFUa8bth5HcHpN1s94KS7b1QFOo4MYkk1vK5rqNGETw3JQYSqaDXTE2mu3VQoO5uf88hteq2aFMdsbwGEF3zi9B4dTLtN2oM013Ea9QFWPkHWGZ-iJ0S7B8_v3HF1-_PB997m5-Prpy-79RTOKVuZGgOREGaMmqcYepJac8dFwQ1hNaBklhislO0Z6CkbvydTrTtbbTBIE58DO0buj71r2C0wj-By1G9ZoFx23IWg7_I14ezXM4WZoaxdCqWrw6t4ghh8FUh6uQ4n1BGloacU5bdtKIkfSWA-RIpiHAEqGQ7_Dv_1Wycs_F3sQ_Cq0EpojIekZfof-1_AOezGy3g</recordid><startdate>20100301</startdate><enddate>20100301</enddate><creator>Ford, C.</creator><creator>Goodman, AD</creator><creator>Johnson, K.</creator><creator>Kachuck, N.</creator><creator>Lindsey, JW</creator><creator>Lisak, R.</creator><creator>Luzzio, C.</creator><creator>Myers, L.</creator><creator>Panitch, H.</creator><creator>Preiningerova, J.</creator><creator>Pruitt, A.</creator><creator>Rose, J.</creator><creator>Rus, H.</creator><creator>Wolinsky, J.</creator><general>SAGE Publications</general><general>Sage Publications Ltd</general><scope>AFRWT</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7T5</scope><scope>7TK</scope><scope>7U9</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>H94</scope><scope>K9-</scope><scope>K9.</scope><scope>M0R</scope><scope>M0S</scope><scope>M1P</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>5PM</scope></search><sort><creationdate>20100301</creationdate><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><author>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.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c526t-5e6408ff8d68c9e6a6434cf4f03abe2310f488673091efab0d9a76773d6e544e3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2010</creationdate><topic>Adult</topic><topic>Chi-Square Distribution</topic><topic>Cross-Over Studies</topic><topic>Disability Evaluation</topic><topic>Double-Blind Method</topic><topic>Drug Administration Schedule</topic><topic>Female</topic><topic>Glatiramer Acetate</topic><topic>Humans</topic><topic>Immunologic Factors - administration & dosage</topic><topic>Immunologic Factors - adverse effects</topic><topic>Kaplan-Meier Estimate</topic><topic>Logistic Models</topic><topic>Male</topic><topic>Multiple Sclerosis, Relapsing-Remitting - diagnosis</topic><topic>Multiple Sclerosis, Relapsing-Remitting - drug therapy</topic><topic>Patient Dropouts</topic><topic>Peptides - administration & dosage</topic><topic>Peptides - adverse effects</topic><topic>Propensity Score</topic><topic>Prospective Studies</topic><topic>Research Paper</topic><topic>Severity of Illness Index</topic><topic>Time Factors</topic><topic>Treatment Outcome</topic><topic>United States</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><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><collection>Sage Journals GOLD Open Access 2024</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Immunology Abstracts</collection><collection>Neurosciences Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>Consumer Health Database (Alumni Edition)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Consumer Health Database</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Multiple sclerosis</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Ford, C.</au><au>Goodman, AD</au><au>Johnson, K.</au><au>Kachuck, N.</au><au>Lindsey, JW</au><au>Lisak, R.</au><au>Luzzio, C.</au><au>Myers, L.</au><au>Panitch, H.</au><au>Preiningerova, J.</au><au>Pruitt, A.</au><au>Rose, J.</au><au>Rus, H.</au><au>Wolinsky, J.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>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</atitle><jtitle>Multiple sclerosis</jtitle><addtitle>Mult Scler</addtitle><date>2010-03-01</date><risdate>2010</risdate><volume>16</volume><issue>3</issue><spage>342</spage><epage>350</epage><pages>342-350</pages><issn>1352-4585</issn><eissn>1477-0970</eissn><coden>MUSCFZ</coden><abstract>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.</abstract><cop>London, England</cop><pub>SAGE Publications</pub><pmid>20106943</pmid><doi>10.1177/1352458509358088</doi><tpages>9</tpages><oa>free_for_read</oa></addata></record> |
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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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