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Three times weekly glatiramer acetate in relapsing-remitting multiple sclerosis
Objective To assess the efficacy and safety of glatiramer acetate (GA) 40mg administered 3× weekly (tiw) compared with placebo in patients with relapsing–remitting multiple sclerosis (RRMS). Methods This randomized, double‐blind study was conducted in 142 sites in 17 countries. Patients with RRMS wi...
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| Published in: | Annals of neurology 2013-06, Vol.73 (6), p.705-713 |
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| Main Authors: | , , , , |
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| container_end_page | 713 |
| container_issue | 6 |
| container_start_page | 705 |
| container_title | Annals of neurology |
| container_volume | 73 |
| creator | Khan, Omar Rieckmann, Peter Boyko, Alexey Selmaj, Krzysztof Zivadinov, Robert |
| description | Objective
To assess the efficacy and safety of glatiramer acetate (GA) 40mg administered 3× weekly (tiw) compared with placebo in patients with relapsing–remitting multiple sclerosis (RRMS).
Methods
This randomized, double‐blind study was conducted in 142 sites in 17 countries. Patients with RRMS with at least 1 documented relapse in the 12 months before screening, or at least 2 documented relapses in the 24 months before screening, and an Expanded Disability Status Scale score ≤ 5.5, were randomized 2:1 to receive either subcutaneous (sc) GA 40mg tiw (1ml) or placebo for 12 months.
Results
Of 1,524 patients screened, 1,404 were randomized to receive GA 40mg sc tiw (n = 943) or placebo (n = 461). Ninety‐three percent and 91% of patients in the placebo and GA groups, respectively, completed the 12‐month study. GA 40mg tiw was associated with a 34.0% reduction in risk of confirmed relapses compared with placebo (mean annualized relapse rate = 0.331 vs 0.505; p < 0.0001). Patients who received GA 40mg tiw experienced highly significant reduction (p < 0.0001) in the cumulative number of gadolinium‐enhancing T1 (44.8%) and new or newly enlarging T2 lesions (34.7%) at months 6 and 12. GA 40mg tiw was safe and well tolerated. The most common adverse events in the GA group were injection site reactions (35.5% with GA vs 5.0% with placebo).
Interpretation
GA 40mg sc tiw is a safe and effective regimen for the treatment of RRMS, providing the convenience of fewer sc injections per week. ANN NEUROL 2013;73:705–713 |
| doi_str_mv | 10.1002/ana.23938 |
| format | article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_1434013037</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>1411626993</sourcerecordid><originalsourceid>FETCH-LOGICAL-c4248-afdcfdeddaeefaad3b65ea11278cef5119c4e88ef7074d0446aacf02d5269c1c3</originalsourceid><addsrcrecordid>eNqN0U1P3DAQBmCroioL9MAfqCJxKYeAv-McV4hCqxUcoOJoDc4EDE52azui--9rWOBQqVJPM4dnXmn0ErLP6BGjlB_DCEdctMJ8IDOmBKsNl-0WmVGhZa2YkNtkJ6UHSmmrGf1EtrnQRhvOZuTy-j4iVtkPmKonxMewru4CZB9hwFiBwwwZKz9WEQOskh_v6oiDz7ls1TCF7FcBq-QCxmXyaY987CEk_Pw6d8nPb6fXJ-f14vLs-8l8UTvJpamh71zfYdcBYg_QiVutEBjjjXHYK8ZaJ9EY7BvayI5KqQFcT3mnuG4dc2KXfN3kruLy14Qp28EnhyHAiMspWSaFpExQ0fwHZUyX2FYUevAXfVhOcSyPFEWpVsrIZ3W4Ua68nCL2dhX9AHFtGbXPhdhSiH0ppNgvr4nT7YDdu3xroIDjDXjyAdf_TrLzi_lbZL258Cnj7_cLiI9WN6JR9ubizF4tbrjiPxZWij_GWqRu</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1400655843</pqid></control><display><type>article</type><title>Three times weekly glatiramer acetate in relapsing-remitting multiple sclerosis</title><source>Wiley-Blackwell Journals</source><creator>Khan, Omar ; Rieckmann, Peter ; Boyko, Alexey ; Selmaj, Krzysztof ; Zivadinov, Robert</creator><creatorcontrib>Khan, Omar ; Rieckmann, Peter ; Boyko, Alexey ; Selmaj, Krzysztof ; Zivadinov, Robert ; GALA Study Group</creatorcontrib><description>Objective
To assess the efficacy and safety of glatiramer acetate (GA) 40mg administered 3× weekly (tiw) compared with placebo in patients with relapsing–remitting multiple sclerosis (RRMS).
Methods
This randomized, double‐blind study was conducted in 142 sites in 17 countries. Patients with RRMS with at least 1 documented relapse in the 12 months before screening, or at least 2 documented relapses in the 24 months before screening, and an Expanded Disability Status Scale score ≤ 5.5, were randomized 2:1 to receive either subcutaneous (sc) GA 40mg tiw (1ml) or placebo for 12 months.
Results
Of 1,524 patients screened, 1,404 were randomized to receive GA 40mg sc tiw (n = 943) or placebo (n = 461). Ninety‐three percent and 91% of patients in the placebo and GA groups, respectively, completed the 12‐month study. GA 40mg tiw was associated with a 34.0% reduction in risk of confirmed relapses compared with placebo (mean annualized relapse rate = 0.331 vs 0.505; p < 0.0001). Patients who received GA 40mg tiw experienced highly significant reduction (p < 0.0001) in the cumulative number of gadolinium‐enhancing T1 (44.8%) and new or newly enlarging T2 lesions (34.7%) at months 6 and 12. GA 40mg tiw was safe and well tolerated. The most common adverse events in the GA group were injection site reactions (35.5% with GA vs 5.0% with placebo).
Interpretation
GA 40mg sc tiw is a safe and effective regimen for the treatment of RRMS, providing the convenience of fewer sc injections per week. ANN NEUROL 2013;73:705–713</description><identifier>ISSN: 0364-5134</identifier><identifier>EISSN: 1531-8249</identifier><identifier>DOI: 10.1002/ana.23938</identifier><identifier>PMID: 23686821</identifier><language>eng</language><publisher>United States: Blackwell Publishing Ltd</publisher><subject>Adult ; Double-Blind Method ; Drug Administration Schedule ; Female ; Glatiramer Acetate ; Humans ; Immunosuppressive Agents - administration & dosage ; Male ; Middle Aged ; Multiple Sclerosis, Relapsing-Remitting - drug therapy ; Multiple Sclerosis, Relapsing-Remitting - epidemiology ; Peptides - administration & dosage ; Prospective Studies ; Treatment Outcome</subject><ispartof>Annals of neurology, 2013-06, Vol.73 (6), p.705-713</ispartof><rights>2013 American Neurological Association</rights><rights>2013 American Neurological Association.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4248-afdcfdeddaeefaad3b65ea11278cef5119c4e88ef7074d0446aacf02d5269c1c3</citedby><cites>FETCH-LOGICAL-c4248-afdcfdeddaeefaad3b65ea11278cef5119c4e88ef7074d0446aacf02d5269c1c3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1002%2Fana.23938$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1002%2Fana.23938$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>315,786,790,27957,27958,50923,51032</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/23686821$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Khan, Omar</creatorcontrib><creatorcontrib>Rieckmann, Peter</creatorcontrib><creatorcontrib>Boyko, Alexey</creatorcontrib><creatorcontrib>Selmaj, Krzysztof</creatorcontrib><creatorcontrib>Zivadinov, Robert</creatorcontrib><creatorcontrib>GALA Study Group</creatorcontrib><title>Three times weekly glatiramer acetate in relapsing-remitting multiple sclerosis</title><title>Annals of neurology</title><addtitle>Ann Neurol</addtitle><description>Objective
To assess the efficacy and safety of glatiramer acetate (GA) 40mg administered 3× weekly (tiw) compared with placebo in patients with relapsing–remitting multiple sclerosis (RRMS).
Methods
This randomized, double‐blind study was conducted in 142 sites in 17 countries. Patients with RRMS with at least 1 documented relapse in the 12 months before screening, or at least 2 documented relapses in the 24 months before screening, and an Expanded Disability Status Scale score ≤ 5.5, were randomized 2:1 to receive either subcutaneous (sc) GA 40mg tiw (1ml) or placebo for 12 months.
Results
Of 1,524 patients screened, 1,404 were randomized to receive GA 40mg sc tiw (n = 943) or placebo (n = 461). Ninety‐three percent and 91% of patients in the placebo and GA groups, respectively, completed the 12‐month study. GA 40mg tiw was associated with a 34.0% reduction in risk of confirmed relapses compared with placebo (mean annualized relapse rate = 0.331 vs 0.505; p < 0.0001). Patients who received GA 40mg tiw experienced highly significant reduction (p < 0.0001) in the cumulative number of gadolinium‐enhancing T1 (44.8%) and new or newly enlarging T2 lesions (34.7%) at months 6 and 12. GA 40mg tiw was safe and well tolerated. The most common adverse events in the GA group were injection site reactions (35.5% with GA vs 5.0% with placebo).
Interpretation
GA 40mg sc tiw is a safe and effective regimen for the treatment of RRMS, providing the convenience of fewer sc injections per week. ANN NEUROL 2013;73:705–713</description><subject>Adult</subject><subject>Double-Blind Method</subject><subject>Drug Administration Schedule</subject><subject>Female</subject><subject>Glatiramer Acetate</subject><subject>Humans</subject><subject>Immunosuppressive Agents - administration & dosage</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Multiple Sclerosis, Relapsing-Remitting - drug therapy</subject><subject>Multiple Sclerosis, Relapsing-Remitting - epidemiology</subject><subject>Peptides - administration & dosage</subject><subject>Prospective Studies</subject><subject>Treatment Outcome</subject><issn>0364-5134</issn><issn>1531-8249</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2013</creationdate><recordtype>article</recordtype><recordid>eNqN0U1P3DAQBmCroioL9MAfqCJxKYeAv-McV4hCqxUcoOJoDc4EDE52azui--9rWOBQqVJPM4dnXmn0ErLP6BGjlB_DCEdctMJ8IDOmBKsNl-0WmVGhZa2YkNtkJ6UHSmmrGf1EtrnQRhvOZuTy-j4iVtkPmKonxMewru4CZB9hwFiBwwwZKz9WEQOskh_v6oiDz7ls1TCF7FcBq-QCxmXyaY987CEk_Pw6d8nPb6fXJ-f14vLs-8l8UTvJpamh71zfYdcBYg_QiVutEBjjjXHYK8ZaJ9EY7BvayI5KqQFcT3mnuG4dc2KXfN3kruLy14Qp28EnhyHAiMspWSaFpExQ0fwHZUyX2FYUevAXfVhOcSyPFEWpVsrIZ3W4Ua68nCL2dhX9AHFtGbXPhdhSiH0ppNgvr4nT7YDdu3xroIDjDXjyAdf_TrLzi_lbZL258Cnj7_cLiI9WN6JR9ubizF4tbrjiPxZWij_GWqRu</recordid><startdate>201306</startdate><enddate>201306</enddate><creator>Khan, Omar</creator><creator>Rieckmann, Peter</creator><creator>Boyko, Alexey</creator><creator>Selmaj, Krzysztof</creator><creator>Zivadinov, Robert</creator><general>Blackwell Publishing Ltd</general><general>Wiley Subscription Services, Inc</general><scope>BSCLL</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>7TK</scope><scope>7U7</scope><scope>C1K</scope><scope>K9.</scope><scope>7X8</scope></search><sort><creationdate>201306</creationdate><title>Three times weekly glatiramer acetate in relapsing-remitting multiple sclerosis</title><author>Khan, Omar ; Rieckmann, Peter ; Boyko, Alexey ; Selmaj, Krzysztof ; Zivadinov, Robert</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4248-afdcfdeddaeefaad3b65ea11278cef5119c4e88ef7074d0446aacf02d5269c1c3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2013</creationdate><topic>Adult</topic><topic>Double-Blind Method</topic><topic>Drug Administration Schedule</topic><topic>Female</topic><topic>Glatiramer Acetate</topic><topic>Humans</topic><topic>Immunosuppressive Agents - administration & dosage</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Multiple Sclerosis, Relapsing-Remitting - drug therapy</topic><topic>Multiple Sclerosis, Relapsing-Remitting - epidemiology</topic><topic>Peptides - administration & dosage</topic><topic>Prospective Studies</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Khan, Omar</creatorcontrib><creatorcontrib>Rieckmann, Peter</creatorcontrib><creatorcontrib>Boyko, Alexey</creatorcontrib><creatorcontrib>Selmaj, Krzysztof</creatorcontrib><creatorcontrib>Zivadinov, Robert</creatorcontrib><creatorcontrib>GALA Study Group</creatorcontrib><collection>Istex</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Neurosciences Abstracts</collection><collection>Toxicology Abstracts</collection><collection>Environmental Sciences and Pollution Management</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>MEDLINE - Academic</collection><jtitle>Annals of neurology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Khan, Omar</au><au>Rieckmann, Peter</au><au>Boyko, Alexey</au><au>Selmaj, Krzysztof</au><au>Zivadinov, Robert</au><aucorp>GALA Study Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Three times weekly glatiramer acetate in relapsing-remitting multiple sclerosis</atitle><jtitle>Annals of neurology</jtitle><addtitle>Ann Neurol</addtitle><date>2013-06</date><risdate>2013</risdate><volume>73</volume><issue>6</issue><spage>705</spage><epage>713</epage><pages>705-713</pages><issn>0364-5134</issn><eissn>1531-8249</eissn><notes>istex:0BD929E873C03721FA87A06E14787B77E339625F</notes><notes>ArticleID:ANA23938</notes><notes>ark:/67375/WNG-SLW252JL-4</notes><notes>Members of the GALA Study Group are listed in the Appendix on page 8.</notes><notes>ObjectType-Article-1</notes><notes>SourceType-Scholarly Journals-1</notes><notes>ObjectType-Feature-2</notes><notes>ObjectType-News-3</notes><notes>content type line 23</notes><notes>ObjectType-Article-2</notes><notes>ObjectType-Feature-1</notes><abstract>Objective
To assess the efficacy and safety of glatiramer acetate (GA) 40mg administered 3× weekly (tiw) compared with placebo in patients with relapsing–remitting multiple sclerosis (RRMS).
Methods
This randomized, double‐blind study was conducted in 142 sites in 17 countries. Patients with RRMS with at least 1 documented relapse in the 12 months before screening, or at least 2 documented relapses in the 24 months before screening, and an Expanded Disability Status Scale score ≤ 5.5, were randomized 2:1 to receive either subcutaneous (sc) GA 40mg tiw (1ml) or placebo for 12 months.
Results
Of 1,524 patients screened, 1,404 were randomized to receive GA 40mg sc tiw (n = 943) or placebo (n = 461). Ninety‐three percent and 91% of patients in the placebo and GA groups, respectively, completed the 12‐month study. GA 40mg tiw was associated with a 34.0% reduction in risk of confirmed relapses compared with placebo (mean annualized relapse rate = 0.331 vs 0.505; p < 0.0001). Patients who received GA 40mg tiw experienced highly significant reduction (p < 0.0001) in the cumulative number of gadolinium‐enhancing T1 (44.8%) and new or newly enlarging T2 lesions (34.7%) at months 6 and 12. GA 40mg tiw was safe and well tolerated. The most common adverse events in the GA group were injection site reactions (35.5% with GA vs 5.0% with placebo).
Interpretation
GA 40mg sc tiw is a safe and effective regimen for the treatment of RRMS, providing the convenience of fewer sc injections per week. ANN NEUROL 2013;73:705–713</abstract><cop>United States</cop><pub>Blackwell Publishing Ltd</pub><pmid>23686821</pmid><doi>10.1002/ana.23938</doi><tpages>9</tpages></addata></record> |
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| identifier | ISSN: 0364-5134 |
| ispartof | Annals of neurology, 2013-06, Vol.73 (6), p.705-713 |
| issn | 0364-5134 1531-8249 |
| language | eng |
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| source | Wiley-Blackwell Journals |
| subjects | Adult Double-Blind Method Drug Administration Schedule Female Glatiramer Acetate Humans Immunosuppressive Agents - administration & dosage Male Middle Aged Multiple Sclerosis, Relapsing-Remitting - drug therapy Multiple Sclerosis, Relapsing-Remitting - epidemiology Peptides - administration & dosage Prospective Studies Treatment Outcome |
| title | Three times weekly glatiramer acetate in relapsing-remitting multiple sclerosis |
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