Intravenous golimumab is effective in patients with active rheumatoid arthritis despite methotrexate therapy with responses as early as week 2: results of the phase 3, randomised, multicentre, double-blind, placebo-controlled GO-FURTHER trial
Identifieur interne : 000793 ( Istex/Corpus ); précédent : 000792; suivant : 000794Intravenous golimumab is effective in patients with active rheumatoid arthritis despite methotrexate therapy with responses as early as week 2: results of the phase 3, randomised, multicentre, double-blind, placebo-controlled GO-FURTHER trial
Auteurs : Michael E. Weinblatt ; Clifton O. Bingham ; Alan M. Mendelsohn ; Lilianne Kim ; Michael Mack ; Jiandong Lu ; Daniel Baker ; Rene WesthovensSource :
- Annals of the Rheumatic Diseases [ 0003-4967 ] ; 2013-03.
Abstract
Objectives Evaluate the efficacy of intravenous golimumab 2 mg/kg+methotrexate (MTX) in patients with active rheumatoid arthritis (RA) receiving MTX. Methods Patients (n=592) with active disease (≥6/66 swollen, ≥6/68 tender joints, C-reactive protein ≥1.0 mg/dl, rheumatoid factor positive and/or anticyclic citrullinated protein antibody positive at screening) despite MTX (15–25 mg/week) participated in this double-blind, placebo-controlled, phase 3 study. Patients were randomised (2:1) to receive intravenous golimumab 2 mg/kg, or placebo infusions at weeks 0 and 4 and every (q) 8 weeks; patients continued MTX. Placebo patients with <10% improvement in combined swollen/tender joint counts at week 16 could early escape to intravenous golimumab 2 mg/kg. The primary endpoint was week 14 American College of Rheumatology 20% (ACR20) response. Analyses employed non-responder imputation and last-observation-carried-forward. Results At week 14, significantly (p<0.001) larger proportions of golimumab+MTX than placebo+MTX patients achieved ACR20 response (59% vs 25%, respectively), a disease activity score of good/moderate (EULAR) response (81% vs 40%), and greater median improvement in health assessment questionnaire scores (0.500 vs 0.125). Improvements versus placebo+MTX were observed by week 2. Similar proportions of patients receiving golimumab+MTX and placebo+MTX, respectively, reported adverse events through week 16 (47% and 44%) and week 24 (53% and 49%). Serious adverse events were reported by more golimumab+MTX (4.1%) than placebo+MTX (2%) patients at week 24. Conclusion The addition of intravenous golimumab rapidly and significantly improved signs and symptoms in patients with active RA despite ongoing MTX, in some patients by week 2.
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DOI: 10.1136/annrheumdis-2012-201411
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<record><TEI wicri:istexFullTextTei="biblStruct"><teiHeader><fileDesc><titleStmt><title>Intravenous golimumab is effective in patients with active rheumatoid arthritis despite methotrexate therapy with responses as early as week 2: results of the phase 3, randomised, multicentre, double-blind, placebo-controlled GO-FURTHER trial</title><author><name sortKey="Weinblatt, Michael E" sort="Weinblatt, Michael E" uniqKey="Weinblatt M" first="Michael E" last="Weinblatt">Michael E. Weinblatt</name><affiliation><mods:affiliation>Department of Rheumatology, Brigham and Women's Hospital, Boston, Massachusetts, USA</mods:affiliation></affiliation></author><author><name sortKey="Bingham, Clifton O" sort="Bingham, Clifton O" uniqKey="Bingham C" first="Clifton O" last="Bingham">Clifton O. Bingham</name><affiliation><mods:affiliation>Department of Rheumatology, Johns Hopkins, Baltimore, Maryland, USA</mods:affiliation></affiliation></author><author><name sortKey="Mendelsohn, Alan M" sort="Mendelsohn, Alan M" uniqKey="Mendelsohn A" first="Alan M" last="Mendelsohn">Alan M. Mendelsohn</name><affiliation><mods:affiliation>Janssen Research & Development, LLC, Spring House, Pennsylvania, USA</mods:affiliation></affiliation></author><author><name sortKey="Kim, Lilianne" sort="Kim, Lilianne" uniqKey="Kim L" first="Lilianne" last="Kim">Lilianne Kim</name><affiliation><mods:affiliation>Janssen Research & Development, LLC, Spring House, Pennsylvania, USA</mods:affiliation></affiliation></author><author><name sortKey="Mack, Michael" sort="Mack, Michael" uniqKey="Mack M" first="Michael" last="Mack">Michael Mack</name><affiliation><mods:affiliation>Janssen Research & Development, LLC, Spring House, Pennsylvania, USA</mods:affiliation></affiliation></author><author><name sortKey="Lu, Jiandong" sort="Lu, Jiandong" uniqKey="Lu J" first="Jiandong" last="Lu">Jiandong Lu</name><affiliation><mods:affiliation>Janssen Research & Development, LLC, Spring House, Pennsylvania, USA</mods:affiliation></affiliation></author><author><name sortKey="Baker, Daniel" sort="Baker, Daniel" uniqKey="Baker D" first="Daniel" last="Baker">Daniel Baker</name><affiliation><mods:affiliation>Janssen Research & Development, LLC, Spring House, Pennsylvania, USA</mods:affiliation></affiliation></author><author><name sortKey="Westhovens, Rene" sort="Westhovens, Rene" uniqKey="Westhovens R" first="Rene" last="Westhovens">Rene Westhovens</name><affiliation><mods:affiliation>Department of Musculoskeletal Sciences, KU Leuven, Leuven, Belgium</mods:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">ISTEX</idno><idno type="RBID">ISTEX:8C82496D8FDCA14361BC889CC7A7A2C6B18D92F2</idno><date when="2013" year="2013">2013</date><idno type="doi">10.1136/annrheumdis-2012-201411</idno><idno type="url">https://api.istex.fr/document/8C82496D8FDCA14361BC889CC7A7A2C6B18D92F2/fulltext/pdf</idno><idno type="wicri:Area/Istex/Corpus">000793</idno></publicationStmt><sourceDesc><biblStruct><analytic><title level="a">Intravenous golimumab is effective in patients with active rheumatoid arthritis despite methotrexate therapy with responses as early as week 2: results of the phase 3, randomised, multicentre, double-blind, placebo-controlled GO-FURTHER trial</title><author><name sortKey="Weinblatt, Michael E" sort="Weinblatt, Michael E" uniqKey="Weinblatt M" first="Michael E" last="Weinblatt">Michael E. Weinblatt</name><affiliation><mods:affiliation>Department of Rheumatology, Brigham and Women's Hospital, Boston, Massachusetts, USA</mods:affiliation></affiliation></author><author><name sortKey="Bingham, Clifton O" sort="Bingham, Clifton O" uniqKey="Bingham C" first="Clifton O" last="Bingham">Clifton O. Bingham</name><affiliation><mods:affiliation>Department of Rheumatology, Johns Hopkins, Baltimore, Maryland, USA</mods:affiliation></affiliation></author><author><name sortKey="Mendelsohn, Alan M" sort="Mendelsohn, Alan M" uniqKey="Mendelsohn A" first="Alan M" last="Mendelsohn">Alan M. Mendelsohn</name><affiliation><mods:affiliation>Janssen Research & Development, LLC, Spring House, Pennsylvania, USA</mods:affiliation></affiliation></author><author><name sortKey="Kim, Lilianne" sort="Kim, Lilianne" uniqKey="Kim L" first="Lilianne" last="Kim">Lilianne Kim</name><affiliation><mods:affiliation>Janssen Research & Development, LLC, Spring House, Pennsylvania, USA</mods:affiliation></affiliation></author><author><name sortKey="Mack, Michael" sort="Mack, Michael" uniqKey="Mack M" first="Michael" last="Mack">Michael Mack</name><affiliation><mods:affiliation>Janssen Research & Development, LLC, Spring House, Pennsylvania, USA</mods:affiliation></affiliation></author><author><name sortKey="Lu, Jiandong" sort="Lu, Jiandong" uniqKey="Lu J" first="Jiandong" last="Lu">Jiandong Lu</name><affiliation><mods:affiliation>Janssen Research & Development, LLC, Spring House, Pennsylvania, USA</mods:affiliation></affiliation></author><author><name sortKey="Baker, Daniel" sort="Baker, Daniel" uniqKey="Baker D" first="Daniel" last="Baker">Daniel Baker</name><affiliation><mods:affiliation>Janssen Research & Development, LLC, Spring House, Pennsylvania, USA</mods:affiliation></affiliation></author><author><name sortKey="Westhovens, Rene" sort="Westhovens, Rene" uniqKey="Westhovens R" first="Rene" last="Westhovens">Rene Westhovens</name><affiliation><mods:affiliation>Department of Musculoskeletal Sciences, KU Leuven, Leuven, Belgium</mods:affiliation></affiliation></author></analytic><monogr></monogr><series><title level="j">Annals of the Rheumatic Diseases</title><title level="j" type="abbrev">Ann Rheum Dis</title><idno type="ISSN">0003-4967</idno><idno type="eISSN">1468-2060</idno><imprint><publisher>BMJ Publishing Group Ltd and European League Against Rheumatism</publisher><date type="published" when="2013-03">2013-03</date><biblScope unit="volume">72</biblScope><biblScope unit="issue">3</biblScope><biblScope unit="page" from="381">381</biblScope></imprint><idno type="ISSN">0003-4967</idno></series><idno type="istex">8C82496D8FDCA14361BC889CC7A7A2C6B18D92F2</idno><idno type="DOI">10.1136/annrheumdis-2012-201411</idno><idno type="href">annrheumdis-72-381.pdf</idno><idno type="ArticleID">annrheumdis-2012-201411</idno><idno type="PMID">22661646</idno><idno type="local">annrheumdis;72/3/381</idno></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0003-4967</idno></seriesStmt></fileDesc><profileDesc><textClass></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract">Objectives Evaluate the efficacy of intravenous golimumab 2 mg/kg+methotrexate (MTX) in patients with active rheumatoid arthritis (RA) receiving MTX. Methods Patients (n=592) with active disease (≥6/66 swollen, ≥6/68 tender joints, C-reactive protein ≥1.0 mg/dl, rheumatoid factor positive and/or anticyclic citrullinated protein antibody positive at screening) despite MTX (15–25 mg/week) participated in this double-blind, placebo-controlled, phase 3 study. Patients were randomised (2:1) to receive intravenous golimumab 2 mg/kg, or placebo infusions at weeks 0 and 4 and every (q) 8 weeks; patients continued MTX. Placebo patients with <10% improvement in combined swollen/tender joint counts at week 16 could early escape to intravenous golimumab 2 mg/kg. The primary endpoint was week 14 American College of Rheumatology 20% (ACR20) response. Analyses employed non-responder imputation and last-observation-carried-forward. Results At week 14, significantly (p<0.001) larger proportions of golimumab+MTX than placebo+MTX patients achieved ACR20 response (59% vs 25%, respectively), a disease activity score of good/moderate (EULAR) response (81% vs 40%), and greater median improvement in health assessment questionnaire scores (0.500 vs 0.125). Improvements versus placebo+MTX were observed by week 2. Similar proportions of patients receiving golimumab+MTX and placebo+MTX, respectively, reported adverse events through week 16 (47% and 44%) and week 24 (53% and 49%). Serious adverse events were reported by more golimumab+MTX (4.1%) than placebo+MTX (2%) patients at week 24. Conclusion The addition of intravenous golimumab rapidly and significantly improved signs and symptoms in patients with active RA despite ongoing MTX, in some patients by week 2.</div></front></TEI><istex><corpusName>bmj</corpusName><author><json:item><name>Michael E Weinblatt</name><affiliations><json:string>Department of Rheumatology, Brigham and Women's Hospital, Boston, Massachusetts, USA</json:string></affiliations></json:item><json:item><name>Clifton O Bingham III</name><affiliations><json:string>Department of Rheumatology, Johns Hopkins, Baltimore, Maryland, USA</json:string></affiliations></json:item><json:item><name>Alan M Mendelsohn</name><affiliations><json:string>Janssen Research & Development, LLC, Spring House, Pennsylvania, USA</json:string></affiliations></json:item><json:item><name>Lilianne Kim</name><affiliations><json:string>Janssen Research & Development, LLC, Spring House, Pennsylvania, USA</json:string></affiliations></json:item><json:item><name>Michael Mack</name><affiliations><json:string>Janssen Research & Development, LLC, Spring House, Pennsylvania, USA</json:string></affiliations></json:item><json:item><name>Jiandong Lu</name><affiliations><json:string>Janssen Research & Development, LLC, Spring House, Pennsylvania, USA</json:string></affiliations></json:item><json:item><name>Daniel Baker</name><affiliations><json:string>Janssen Research & Development, LLC, Spring House, Pennsylvania, USA</json:string></affiliations></json:item><json:item><name>Rene Westhovens</name><affiliations><json:string>Department of Musculoskeletal Sciences, KU Leuven, Leuven, Belgium</json:string></affiliations></json:item></author><subject><json:item><lang><json:string>eng</json:string></lang><value>Open access</value></json:item></subject><articleId><json:string>annrheumdis-2012-201411</json:string></articleId><language><json:string>eng</json:string></language><originalGenre><json:string>research-article</json:string></originalGenre><abstract>Objectives Evaluate the efficacy of intravenous golimumab 2 mg/kg+methotrexate (MTX) in patients with active rheumatoid arthritis (RA) receiving MTX. Methods Patients (n=592) with active disease (≥6/66 swollen, ≥6/68 tender joints, C-reactive protein ≥1.0 mg/dl, rheumatoid factor positive and/or anticyclic citrullinated protein antibody positive at screening) despite MTX (15–25 mg/week) participated in this double-blind, placebo-controlled, phase 3 study. Patients were randomised (2:1) to receive intravenous golimumab 2 mg/kg, or placebo infusions at weeks 0 and 4 and every (q) 8 weeks; patients continued MTX. Placebo patients with >10% improvement in combined swollen/tender joint counts at week 16 could early escape to intravenous golimumab 2 mg/kg. The primary endpoint was week 14 American College of Rheumatology 20% (ACR20) response. Analyses employed non-responder imputation and last-observation-carried-forward. Results At week 14, significantly (p>0.001) larger proportions of golimumab+MTX than placebo+MTX patients achieved ACR20 response (59% vs 25%, respectively), a disease activity score of good/moderate (EULAR) response (81% vs 40%), and greater median improvement in health assessment questionnaire scores (0.500 vs 0.125). Improvements versus placebo+MTX were observed by week 2. Similar proportions of patients receiving golimumab+MTX and placebo+MTX, respectively, reported adverse events through week 16 (47% and 44%) and week 24 (53% and 49%). Serious adverse events were reported by more golimumab+MTX (4.1%) than placebo+MTX (2%) patients at week 24. Conclusion The addition of intravenous golimumab rapidly and significantly improved signs and symptoms in patients with active RA despite ongoing MTX, in some patients by week 2.</abstract><qualityIndicators><score>9.392</score><pdfVersion>1.6</pdfVersion><pdfPageSize>595.276 x 793.701 pts</pdfPageSize><refBibsNative>true</refBibsNative><keywordCount>1</keywordCount><abstractCharCount>1764</abstractCharCount><pdfWordCount>5154</pdfWordCount><pdfCharCount>38012</pdfCharCount><pdfPageCount>9</pdfPageCount><abstractWordCount>241</abstractWordCount></qualityIndicators><title>Intravenous golimumab is effective in patients with active rheumatoid arthritis despite methotrexate therapy with responses as early as week 2: results of the phase 3, randomised, multicentre, double-blind, placebo-controlled GO-FURTHER 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multicentre, double-blind, placebo-controlled GO-FURTHER trial</title></titleStmt><publicationStmt><authority>ISTEX</authority><publisher>BMJ Publishing Group Ltd and European League Against Rheumatism</publisher><availability status="free"><p>Open Access</p></availability><date>2012-06-01</date></publicationStmt><sourceDesc><biblStruct type="inbook"><analytic><title level="a">Intravenous golimumab is effective in patients with active rheumatoid arthritis despite methotrexate therapy with responses as early as week 2: results of the phase 3, randomised, multicentre, double-blind, placebo-controlled GO-FURTHER trial</title><author xml:id="author-1"><persName><forename type="first">Michael E</forename><surname>Weinblatt</surname></persName><affiliation>Department of Rheumatology, Brigham and Women's Hospital, Boston, Massachusetts, USA</affiliation></author><author xml:id="author-2"><persName><forename type="first">Clifton O</forename><surname>Bingham</surname></persName><roleName type="degree">III</roleName><affiliation>Department of Rheumatology, Johns Hopkins, Baltimore, Maryland, USA</affiliation></author><author xml:id="author-3"><persName><forename type="first">Alan M</forename><surname>Mendelsohn</surname></persName><affiliation>Janssen Research & Development, LLC, Spring House, Pennsylvania, USA</affiliation></author><author xml:id="author-4"><persName><forename type="first">Lilianne</forename><surname>Kim</surname></persName><affiliation>Janssen Research & Development, LLC, Spring House, Pennsylvania, USA</affiliation></author><author xml:id="author-5"><persName><forename type="first">Michael</forename><surname>Mack</surname></persName><affiliation>Janssen Research & Development, LLC, Spring House, Pennsylvania, USA</affiliation></author><author xml:id="author-6"><persName><forename type="first">Jiandong</forename><surname>Lu</surname></persName><affiliation>Janssen Research & Development, LLC, Spring House, Pennsylvania, USA</affiliation></author><author xml:id="author-7"><persName><forename type="first">Daniel</forename><surname>Baker</surname></persName><affiliation>Janssen Research & Development, LLC, Spring House, Pennsylvania, USA</affiliation></author><author xml:id="author-8"><persName><forename type="first">Rene</forename><surname>Westhovens</surname></persName><affiliation>Department of Musculoskeletal Sciences, KU Leuven, Leuven, Belgium</affiliation></author></analytic><monogr><title level="j">Annals of the Rheumatic Diseases</title><title level="j" type="abbrev">Ann Rheum Dis</title><idno type="pISSN">0003-4967</idno><idno type="eISSN">1468-2060</idno><imprint><publisher>BMJ Publishing Group Ltd and European League Against Rheumatism</publisher><date type="published" when="2013-03"></date><biblScope unit="volume">72</biblScope><biblScope unit="issue">3</biblScope><biblScope unit="page" from="381">381</biblScope></imprint></monogr><idno type="istex">8C82496D8FDCA14361BC889CC7A7A2C6B18D92F2</idno><idno type="DOI">10.1136/annrheumdis-2012-201411</idno><idno type="href">annrheumdis-72-381.pdf</idno><idno type="ArticleID">annrheumdis-2012-201411</idno><idno type="PMID">22661646</idno><idno type="local">annrheumdis;72/3/381</idno></biblStruct></sourceDesc></fileDesc><profileDesc><creation><date>2012-06-01</date></creation><langUsage><language ident="en">en</language></langUsage><abstract><p>Objectives Evaluate the efficacy of intravenous golimumab 2 mg/kg+methotrexate (MTX) in patients with active rheumatoid arthritis (RA) receiving MTX. Methods Patients (n=592) with active disease (≥6/66 swollen, ≥6/68 tender joints, C-reactive protein ≥1.0 mg/dl, rheumatoid factor positive and/or anticyclic citrullinated protein antibody positive at screening) despite MTX (15–25 mg/week) participated in this double-blind, placebo-controlled, phase 3 study. Patients were randomised (2:1) to receive intravenous golimumab 2 mg/kg, or placebo infusions at weeks 0 and 4 and every (q) 8 weeks; patients continued MTX. Placebo patients with <10% improvement in combined swollen/tender joint counts at week 16 could early escape to intravenous golimumab 2 mg/kg. The primary endpoint was week 14 American College of Rheumatology 20% (ACR20) response. Analyses employed non-responder imputation and last-observation-carried-forward. Results At week 14, significantly (p<0.001) larger proportions of golimumab+MTX than placebo+MTX patients achieved ACR20 response (59% vs 25%, respectively), a disease activity score of good/moderate (EULAR) response (81% vs 40%), and greater median improvement in health assessment questionnaire scores (0.500 vs 0.125). Improvements versus placebo+MTX were observed by week 2. Similar proportions of patients receiving golimumab+MTX and placebo+MTX, respectively, reported adverse events through week 16 (47% and 44%) and week 24 (53% and 49%). Serious adverse events were reported by more golimumab+MTX (4.1%) than placebo+MTX (2%) patients at week 24. Conclusion The addition of intravenous golimumab rapidly and significantly improved signs and symptoms in patients with active RA despite ongoing MTX, in some patients by week 2.</p></abstract><textClass><keywords scheme="keyword"><list><head>hwp-journal-coll</head><item><term>Open access</term></item></list></keywords></textClass></profileDesc><revisionDesc><change when="2012-06-01">Created</change><change when="2013-03">Published</change></revisionDesc></teiHeader></istex:fulltextTEI><json:item><original>false</original><mimetype>text/plain</mimetype><extension>txt</extension><uri>https://api.istex.fr/document/8C82496D8FDCA14361BC889CC7A7A2C6B18D92F2/fulltext/txt</uri></json:item></fulltext><metadata><istex:metadataXml wicri:clean="corpus bmj" wicri:toSee="no header"><istex:xmlDeclaration>version="1.0" encoding="UTF-8" standalone="no"</istex:xmlDeclaration><istex:docType PUBLIC="-//NLM//DTD Journal Archiving and Interchange DTD v2.3 20070202//EN" URI="archivearticle.dtd" name="istex:docType"></istex:docType><istex:document><article article-type="research-article"><front><journal-meta><journal-id journal-id-type="hwp">annrheumdis</journal-id><journal-id journal-id-type="nlm-ta">Ann Rheum Dis</journal-id><journal-id journal-id-type="publisher-id">ard</journal-id><journal-title>Annals of the Rheumatic Diseases</journal-title><abbrev-journal-title abbrev-type="publisher">Ann Rheum Dis</abbrev-journal-title><abbrev-journal-title>Ann Rheum Dis</abbrev-journal-title><issn pub-type="ppub">0003-4967</issn><issn pub-type="epub">1468-2060</issn><publisher><publisher-name>BMJ Publishing Group Ltd and European League Against Rheumatism</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="publisher-id">annrheumdis-2012-201411</article-id><article-id pub-id-type="doi">10.1136/annrheumdis-2012-201411</article-id><article-id pub-id-type="other">annrheumdis;72/3/381</article-id><article-id pub-id-type="other">annrheumdis;annrheumdis-2012-201411</article-id><article-id pub-id-type="pmid">22661646</article-id><article-id pub-id-type="other">381</article-id><article-id pub-id-type="other">annrheumdis-2012-201411</article-id><article-categories><subj-group subj-group-type="heading"><subject>Clinical and epidemiological research</subject></subj-group><subj-group subj-group-type="hwp-journal-coll"><subject>Open access</subject></subj-group><series-title>Extended report</series-title></article-categories><title-group><article-title>Intravenous golimumab is effective in patients with active rheumatoid arthritis despite methotrexate therapy with responses as early as week 2: results of the phase 3, randomised, multicentre, double-blind, placebo-controlled GO-FURTHER trial</article-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>Weinblatt</surname><given-names>Michael E</given-names></name><xref ref-type="aff" rid="A1">1</xref></contrib><contrib contrib-type="author"><name><surname>Bingham</surname><given-names>Clifton O</given-names><suffix>III</suffix></name><xref ref-type="aff" rid="A2">2</xref></contrib><contrib contrib-type="author"><name><surname>Mendelsohn</surname><given-names>Alan M</given-names></name><xref ref-type="aff" rid="A3">3</xref></contrib><contrib contrib-type="author"><name><surname>Kim</surname><given-names>Lilianne</given-names></name><xref ref-type="aff" rid="A3">3</xref></contrib><contrib contrib-type="author"><name><surname>Mack</surname><given-names>Michael</given-names></name><xref ref-type="aff" rid="A3">3</xref></contrib><contrib contrib-type="author"><name><surname>Lu</surname><given-names>Jiandong</given-names></name><xref ref-type="aff" rid="A3">3</xref></contrib><contrib contrib-type="author"><name><surname>Baker</surname><given-names>Daniel</given-names></name><xref ref-type="aff" rid="A3">3</xref></contrib><contrib contrib-type="author"><name><surname>Westhovens</surname><given-names>Rene</given-names></name><xref ref-type="aff" rid="A4">4</xref></contrib></contrib-group><aff id="A1"><label>1</label>Department of Rheumatology, Brigham and Women's Hospital, Boston, Massachusetts, USA</aff><aff id="A2"><label>2</label>Department of Rheumatology, Johns Hopkins, Baltimore, Maryland, USA</aff><aff id="A3"><label>3</label>Janssen Research & Development, LLC, Spring House, Pennsylvania, USA</aff><aff id="A4"><label>4</label>Department of Musculoskeletal Sciences, KU Leuven, Leuven, Belgium</aff><author-notes><corresp><label>Correspondence to</label> Dr Michael E Weinblatt, Department of Rheumatology, Brigham and Women's Hospital, 75 Francis St, Boston, Massachusetts MA 02115, USA; <email xlink:type="simple">mweinblatt@partners.org</email></corresp></author-notes><pub-date pub-type="ppub"><month>3</month><year>2013</year></pub-date><pub-date pub-type="epub-original"><day>1</day><month>6</month><year>2012</year></pub-date><pub-date pub-type="epub"><day>1</day><month>6</month><year>2012</year></pub-date><volume>72</volume><volume-id pub-id-type="other">72</volume-id><volume-id pub-id-type="other">72</volume-id><issue>3</issue><issue-id pub-id-type="other">annrheumdis;72/3</issue-id><issue-id pub-id-type="other">3</issue-id><issue-id pub-id-type="other">72/3</issue-id><fpage>381</fpage><history><date date-type="accepted"><day>9</day><month>4</month><year>2012</year></date></history><permissions><copyright-statement>Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions</copyright-statement><copyright-year>2013</copyright-year><license license-type="open-access" xlink:href="http://creativecommons.org/licenses/"><p>This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits use, distribution, and reproduction in any medium, provided the original work is properly cited, the use is non commercial and is otherwise in compliance with the license. See: <ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/licenses/by-nc/3.0/">http://creativecommons.org/licenses/by-nc/3.0/</ext-link> and <ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/licenses/by-nc/3.0/legalcode">http://creativecommons.org/licenses/by-nc/3.0/legalcode</ext-link></p></license></permissions><self-uri content-type="pdf" xlink:role="full-text" xlink:href="annrheumdis-72-381.pdf"></self-uri><abstract><sec><title>Objectives</title><p>Evaluate the efficacy of intravenous golimumab 2 mg/kg+methotrexate (MTX) in patients with active rheumatoid arthritis (RA) receiving MTX.</p></sec><sec><title>Methods</title><p>Patients (n=592) with active disease (≥6/66 swollen, ≥6/68 tender joints, C-reactive protein ≥1.0 mg/dl, rheumatoid factor positive and/or anticyclic citrullinated protein antibody positive at screening) despite MTX (15–25 mg/week) participated in this double-blind, placebo-controlled, phase 3 study. Patients were randomised (2:1) to receive intravenous golimumab 2 mg/kg, or placebo infusions at weeks 0 and 4 and every (q) 8 weeks; patients continued MTX. Placebo patients with <10% improvement in combined swollen/tender joint counts at week 16 could early escape to intravenous golimumab 2 mg/kg. The primary endpoint was week 14 American College of Rheumatology 20% (ACR20) response. Analyses employed non-responder imputation and last-observation-carried-forward.</p></sec><sec><title>Results</title><p>At week 14, significantly (p<0.001) larger proportions of golimumab+MTX than placebo+MTX patients achieved ACR20 response (59% vs 25%, respectively), a disease activity score of good/moderate (EULAR) response (81% vs 40%), and greater median improvement in health assessment questionnaire scores (0.500 vs 0.125). Improvements versus placebo+MTX were observed by week 2. Similar proportions of patients receiving golimumab+MTX and placebo+MTX, respectively, reported adverse events through week 16 (47% and 44%) and week 24 (53% and 49%). Serious adverse events were reported by more golimumab+MTX (4.1%) than placebo+MTX (2%) patients at week 24.</p></sec><sec><title>Conclusion</title><p>The addition of intravenous golimumab rapidly and significantly improved signs and symptoms in patients with active RA despite ongoing MTX, in some patients by week 2.</p></sec></abstract></article-meta></front></article></istex:document></istex:metadataXml><mods version="3.6"><titleInfo><title>Intravenous golimumab is effective in patients with active rheumatoid arthritis despite methotrexate therapy with responses as early as week 2: results of the phase 3, randomised, multicentre, double-blind, placebo-controlled GO-FURTHER trial</title><partName>Extended report</partName></titleInfo><titleInfo type="alternative" contentType="CDATA"><title>Intravenous golimumab is effective in patients with active rheumatoid arthritis despite methotrexate therapy with responses as early as week 2: results of the phase 3, randomised, multicentre, double-blind, placebo-controlled GO-FURTHER trial</title><partName>Extended report</partName></titleInfo><name type="personal"><namePart type="given">Michael E</namePart><namePart type="family">Weinblatt</namePart><affiliation>Department of Rheumatology, Brigham and Women's Hospital, Boston, Massachusetts, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Clifton O</namePart><namePart type="family">Bingham</namePart><namePart type="termsOfAddress">III</namePart><affiliation>Department of Rheumatology, Johns Hopkins, Baltimore, Maryland, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Alan M</namePart><namePart type="family">Mendelsohn</namePart><affiliation>Janssen Research & Development, LLC, Spring House, Pennsylvania, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Lilianne</namePart><namePart type="family">Kim</namePart><affiliation>Janssen Research & Development, LLC, Spring House, Pennsylvania, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Michael</namePart><namePart type="family">Mack</namePart><affiliation>Janssen Research & Development, LLC, Spring House, Pennsylvania, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Jiandong</namePart><namePart type="family">Lu</namePart><affiliation>Janssen Research & Development, LLC, Spring House, Pennsylvania, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Daniel</namePart><namePart type="family">Baker</namePart><affiliation>Janssen Research & Development, LLC, Spring House, Pennsylvania, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Rene</namePart><namePart type="family">Westhovens</namePart><affiliation>Department of Musculoskeletal Sciences, KU Leuven, Leuven, Belgium</affiliation><role><roleTerm type="text">author</roleTerm></role></name><typeOfResource>text</typeOfResource><genre type="research-article" displayLabel="research-article"></genre><subject><genre>hwp-journal-coll</genre><topic>Open access</topic></subject><originInfo><publisher>BMJ Publishing Group Ltd and European League Against Rheumatism</publisher><dateIssued encoding="w3cdtf">2013-03</dateIssued><dateCreated encoding="w3cdtf">2012-06-01</dateCreated><copyrightDate encoding="w3cdtf">2013</copyrightDate></originInfo><language><languageTerm type="code" authority="iso639-2b">eng</languageTerm><languageTerm type="code" authority="rfc3066">en</languageTerm></language><physicalDescription><internetMediaType>text/html</internetMediaType></physicalDescription><abstract>Objectives Evaluate the efficacy of intravenous golimumab 2 mg/kg+methotrexate (MTX) in patients with active rheumatoid arthritis (RA) receiving MTX. Methods Patients (n=592) with active disease (≥6/66 swollen, ≥6/68 tender joints, C-reactive protein ≥1.0 mg/dl, rheumatoid factor positive and/or anticyclic citrullinated protein antibody positive at screening) despite MTX (15–25 mg/week) participated in this double-blind, placebo-controlled, phase 3 study. Patients were randomised (2:1) to receive intravenous golimumab 2 mg/kg, or placebo infusions at weeks 0 and 4 and every (q) 8 weeks; patients continued MTX. Placebo patients with <10% improvement in combined swollen/tender joint counts at week 16 could early escape to intravenous golimumab 2 mg/kg. The primary endpoint was week 14 American College of Rheumatology 20% (ACR20) response. Analyses employed non-responder imputation and last-observation-carried-forward. Results At week 14, significantly (p<0.001) larger proportions of golimumab+MTX than placebo+MTX patients achieved ACR20 response (59% vs 25%, respectively), a disease activity score of good/moderate (EULAR) response (81% vs 40%), and greater median improvement in health assessment questionnaire scores (0.500 vs 0.125). Improvements versus placebo+MTX were observed by week 2. Similar proportions of patients receiving golimumab+MTX and placebo+MTX, respectively, reported adverse events through week 16 (47% and 44%) and week 24 (53% and 49%). Serious adverse events were reported by more golimumab+MTX (4.1%) than placebo+MTX (2%) patients at week 24. Conclusion The addition of intravenous golimumab rapidly and significantly improved signs and symptoms in patients with active RA despite ongoing MTX, in some patients by week 2.</abstract><relatedItem type="host"><titleInfo><title>Annals of the Rheumatic Diseases</title></titleInfo><titleInfo type="abbreviated"><title>Ann Rheum Dis</title></titleInfo><genre type="journal">journal</genre><identifier type="ISSN">0003-4967</identifier><identifier type="eISSN">1468-2060</identifier><identifier type="PublisherID">ard</identifier><identifier type="PublisherID-hwp">annrheumdis</identifier><identifier type="PublisherID-nlm-ta">Ann Rheum Dis</identifier><part><date>2013</date><detail type="volume"><caption>vol.</caption><number>72</number></detail><detail type="issue"><caption>no.</caption><number>3</number></detail><extent unit="pages"><start>381</start></extent></part></relatedItem><identifier type="istex">8C82496D8FDCA14361BC889CC7A7A2C6B18D92F2</identifier><identifier type="DOI">10.1136/annrheumdis-2012-201411</identifier><identifier type="href">annrheumdis-72-381.pdf</identifier><identifier type="ArticleID">annrheumdis-2012-201411</identifier><identifier type="PMID">22661646</identifier><identifier type="local">annrheumdis;72/3/381</identifier><accessCondition type="use and reproduction" contentType="open-access">This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits use, distribution, and reproduction in any medium, provided the original work is properly cited, the use is non commercial and is otherwise in compliance with the license. See: http://creativecommons.org/licenses/by-nc/3.0/ and http://creativecommons.org/licenses/by-nc/3.0/legalcode</accessCondition><recordInfo><recordContentSource>BMJ</recordContentSource></recordInfo></mods></metadata><annexes><json:item><original>true</original><mimetype>image/jpeg</mimetype><extension>jpeg</extension><uri>https://api.istex.fr/document/8C82496D8FDCA14361BC889CC7A7A2C6B18D92F2/annexes/jpeg</uri></json:item></annexes><enrichments><json:item><type>multicat</type><uri>https://api.istex.fr/document/8C82496D8FDCA14361BC889CC7A7A2C6B18D92F2/enrichments/multicat</uri></json:item></enrichments><serie></serie></istex></record>Pour manipuler ce document sous Unix (Dilib)
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