Impact of intravenous abatacept on synovitis, osteitis and structural damage in patients with rheumatoid arthritis and an inadequate response to methotrexate: the ASSET randomised controlled trial
Identifieur interne : 000311 ( Pmc/Curation ); précédent : 000310; suivant : 000312Impact of intravenous abatacept on synovitis, osteitis and structural damage in patients with rheumatoid arthritis and an inadequate response to methotrexate: the ASSET randomised controlled trial
Auteurs : Philip G. Conaghan [Royaume-Uni] ; Patrick Durez [Belgique] ; Rieke E. Alten [Allemagne] ; Gerd-Rüdiger Burmester [Allemagne] ; Paul P. Tak [Pays-Bas, Royaume-Uni] ; Lars Klareskog [Suède] ; Anca Irinel Catrina [Suède] ; Julie Dicarlo [États-Unis] ; Corine Gaillez [France] ; Manuela Le Bars [France] ; Xianhuang Zhou [États-Unis] ; Charles Peterfy [États-Unis]Source :
- Annals of the Rheumatic Diseases [ 0003-4967 ] ; 2012.
Abstract
This randomised, double-blind, placebo-controlled phase IIIb study evaluated the impact of abatacept on MRI pathology as a primary outcome in methotrexate (MTX)-refractory patients with rheumatoid arthritis.
Patients received intravenous abatacept (∼10 mg/kg) or placebo, on background MTX, for 4 months, followed by an 8-month open-label extension (OLE; all patients received abatacept plus MTX). Patients had 1.5T MRI with intravenous contrast at baseline, Months 4 and 12; wrist synovitis (three locations assessed), and wrist and hand (15 and eight locations assessed, respectively) osteitis and erosion were scored using OMERACT-RAMRIS.
26/27 abatacept- and 23/23 placebo-randomised patients completed Month 4 and entered the OLE; 26 and 21 completed Month 12. The primary endpoint was not achieved; mean change (SD) from baseline in synovitis was −0.44 (1.47) for abatacept versus 0.52 (1.38) for placebo (p=0.103) at Month 4. For mean change in synovitis adjusted for baseline score (sensitivity analysis), the difference between groups was −0.69, p=0.078. Adjusted mean changes (SE) in osteitis and erosion were −1.94 (0.86) and 0.45 (0.43) for abatacept, and 1.54 (0.90) and 0.95 (0.45) for placebo. Further MRI improvements were observed up to Month 12 for abatacept and from Months 4 to 12 for placebo-treated patients switched to abatacept at Month 4. Clinical efficacy was shown with abatacept and sustained to Month 12.
Despite small patient numbers, MRI detected structural and synovial benefit, sustained to Month 12 in abatacept+MTX-treated patients, and improvements in structural and inflammatory outcomes for placebo+MTX-treated patients following addition of abatacept.
Clinicaltrials.gov NCT00420199.
Url:
DOI: 10.1136/annrheumdis-2012-201611
PubMed: 22915624
PubMed Central: 3711370
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Conaghan</name><affiliation wicri:level="1"><nlm:aff id="af1">Section of Musculoskeletal Disease, University of Leeds & NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Section of Musculoskeletal Disease, University of Leeds & NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds</wicri:regionArea></affiliation></author><author><name sortKey="Durez, Patrick" sort="Durez, Patrick" uniqKey="Durez P" first="Patrick" last="Durez">Patrick Durez</name><affiliation wicri:level="1"><nlm:aff id="af2">Cliniques Universitaires Saint Luc, Université Catholique de Louvain, Brussels, Belgium</nlm:aff><country xml:lang="fr">Belgique</country><wicri:regionArea>Cliniques Universitaires Saint Luc, Université Catholique de Louvain, Brussels</wicri:regionArea></affiliation></author><author><name sortKey="Alten, Rieke E" sort="Alten, Rieke E" uniqKey="Alten R" first="Rieke E" last="Alten">Rieke E. Alten</name><affiliation wicri:level="1"><nlm:aff id="af3">Schlosspark-Klinik, University Medicine, Berlin, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Schlosspark-Klinik, University Medicine, Berlin</wicri:regionArea></affiliation></author><author><name sortKey="Burmester, Gerd Rudiger" sort="Burmester, Gerd Rudiger" uniqKey="Burmester G" first="Gerd-Rüdiger" last="Burmester">Gerd-Rüdiger Burmester</name><affiliation wicri:level="1"><nlm:aff id="af4">Department of Rheumatology and Clinical Immunology, Charité-Universitatsmedizin, Berlin, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of Rheumatology and Clinical Immunology, Charité-Universitatsmedizin, Berlin</wicri:regionArea></affiliation></author><author><name sortKey="Tak, Paul P" sort="Tak, Paul P" uniqKey="Tak P" first="Paul P" last="Tak">Paul P. Tak</name><affiliation wicri:level="1"><nlm:aff id="af5">Department of Clinical Immunology and Rheumatology, F4-105, Academic Medical Center/University of Amsterdam, Amsterdam, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Department of Clinical Immunology and Rheumatology, F4-105, Academic Medical Center/University of Amsterdam, Amsterdam</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="af6">GlaxoSmithKine, Stevenage, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>GlaxoSmithKine, Stevenage</wicri:regionArea></affiliation></author><author><name sortKey="Klareskog, Lars" sort="Klareskog, Lars" uniqKey="Klareskog L" first="Lars" last="Klareskog">Lars Klareskog</name><affiliation wicri:level="1"><nlm:aff id="af7">Rheumatology Unit, Department of Medicine, Karolinska Institute and Karolinska University Hospital, Stockholm, Sweden</nlm:aff><country xml:lang="fr">Suède</country><wicri:regionArea>Rheumatology Unit, Department of Medicine, Karolinska Institute and Karolinska University Hospital, Stockholm</wicri:regionArea></affiliation></author><author><name sortKey="Catrina, Anca Irinel" sort="Catrina, Anca Irinel" uniqKey="Catrina A" first="Anca Irinel" last="Catrina">Anca Irinel Catrina</name><affiliation wicri:level="1"><nlm:aff id="af7">Rheumatology Unit, Department of Medicine, Karolinska Institute and Karolinska University Hospital, Stockholm, Sweden</nlm:aff><country xml:lang="fr">Suède</country><wicri:regionArea>Rheumatology Unit, Department of Medicine, Karolinska Institute and Karolinska University Hospital, Stockholm</wicri:regionArea></affiliation></author><author><name sortKey="Dicarlo, Julie" sort="Dicarlo, Julie" uniqKey="Dicarlo J" first="Julie" last="Dicarlo">Julie Dicarlo</name><affiliation wicri:level="1"><nlm:aff id="af8">Spire Sciences LCC, San Francisco, California, USA</nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Spire Sciences LCC, San Francisco, California</wicri:regionArea></affiliation></author><author><name sortKey="Gaillez, Corine" sort="Gaillez, Corine" uniqKey="Gaillez C" first="Corine" last="Gaillez">Corine Gaillez</name><affiliation wicri:level="1"><nlm:aff id="af9">Bristol-Myers Squibb, Rueil-Malmaison, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Bristol-Myers Squibb, Rueil-Malmaison</wicri:regionArea></affiliation></author><author><name sortKey="Le Bars, Manuela" sort="Le Bars, Manuela" uniqKey="Le Bars M" first="Manuela" last="Le Bars">Manuela Le Bars</name><affiliation wicri:level="1"><nlm:aff id="af9">Bristol-Myers Squibb, Rueil-Malmaison, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Bristol-Myers Squibb, Rueil-Malmaison</wicri:regionArea></affiliation></author><author><name sortKey="Zhou, Xianhuang" sort="Zhou, Xianhuang" uniqKey="Zhou X" first="Xianhuang" last="Zhou">Xianhuang Zhou</name><affiliation wicri:level="1"><nlm:aff id="af10">Bristol-Myers Squibb, Princeton, New Jersey, USA</nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Bristol-Myers Squibb, Princeton, New Jersey</wicri:regionArea></affiliation></author><author><name sortKey="Peterfy, Charles" sort="Peterfy, Charles" uniqKey="Peterfy C" first="Charles" last="Peterfy">Charles Peterfy</name><affiliation wicri:level="1"><nlm:aff id="af8">Spire Sciences LCC, San Francisco, California, USA</nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Spire Sciences LCC, San Francisco, California</wicri:regionArea></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">22915624</idno><idno type="pmc">3711370</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3711370</idno><idno type="RBID">PMC:3711370</idno><idno type="doi">10.1136/annrheumdis-2012-201611</idno><date when="2012">2012</date><idno type="wicri:Area/Pmc/Corpus">000311</idno><idno type="wicri:Area/Pmc/Curation">000311</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Impact of intravenous abatacept on synovitis, osteitis and structural damage in patients with rheumatoid arthritis and an inadequate response to methotrexate: the ASSET randomised controlled trial</title><author><name sortKey="Conaghan, Philip G" sort="Conaghan, Philip G" uniqKey="Conaghan P" first="Philip G" last="Conaghan">Philip G. Conaghan</name><affiliation wicri:level="1"><nlm:aff id="af1">Section of Musculoskeletal Disease, University of Leeds & NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Section of Musculoskeletal Disease, University of Leeds & NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds</wicri:regionArea></affiliation></author><author><name sortKey="Durez, Patrick" sort="Durez, Patrick" uniqKey="Durez P" first="Patrick" last="Durez">Patrick Durez</name><affiliation wicri:level="1"><nlm:aff id="af2">Cliniques Universitaires Saint Luc, Université Catholique de Louvain, Brussels, Belgium</nlm:aff><country xml:lang="fr">Belgique</country><wicri:regionArea>Cliniques Universitaires Saint Luc, Université Catholique de Louvain, Brussels</wicri:regionArea></affiliation></author><author><name sortKey="Alten, Rieke E" sort="Alten, Rieke E" uniqKey="Alten R" first="Rieke E" last="Alten">Rieke E. Alten</name><affiliation wicri:level="1"><nlm:aff id="af3">Schlosspark-Klinik, University Medicine, Berlin, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Schlosspark-Klinik, University Medicine, Berlin</wicri:regionArea></affiliation></author><author><name sortKey="Burmester, Gerd Rudiger" sort="Burmester, Gerd Rudiger" uniqKey="Burmester G" first="Gerd-Rüdiger" last="Burmester">Gerd-Rüdiger Burmester</name><affiliation wicri:level="1"><nlm:aff id="af4">Department of Rheumatology and Clinical Immunology, Charité-Universitatsmedizin, Berlin, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of Rheumatology and Clinical Immunology, Charité-Universitatsmedizin, Berlin</wicri:regionArea></affiliation></author><author><name sortKey="Tak, Paul P" sort="Tak, Paul P" uniqKey="Tak P" first="Paul P" last="Tak">Paul P. Tak</name><affiliation wicri:level="1"><nlm:aff id="af5">Department of Clinical Immunology and Rheumatology, F4-105, Academic Medical Center/University of Amsterdam, Amsterdam, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Department of Clinical Immunology and Rheumatology, F4-105, Academic Medical Center/University of Amsterdam, Amsterdam</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="af6">GlaxoSmithKine, Stevenage, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>GlaxoSmithKine, Stevenage</wicri:regionArea></affiliation></author><author><name sortKey="Klareskog, Lars" sort="Klareskog, Lars" uniqKey="Klareskog L" first="Lars" last="Klareskog">Lars Klareskog</name><affiliation wicri:level="1"><nlm:aff id="af7">Rheumatology Unit, Department of Medicine, Karolinska Institute and Karolinska University Hospital, Stockholm, Sweden</nlm:aff><country xml:lang="fr">Suède</country><wicri:regionArea>Rheumatology Unit, Department of Medicine, Karolinska Institute and Karolinska University Hospital, Stockholm</wicri:regionArea></affiliation></author><author><name sortKey="Catrina, Anca Irinel" sort="Catrina, Anca Irinel" uniqKey="Catrina A" first="Anca Irinel" last="Catrina">Anca Irinel Catrina</name><affiliation wicri:level="1"><nlm:aff id="af7">Rheumatology Unit, Department of Medicine, Karolinska Institute and Karolinska University Hospital, Stockholm, Sweden</nlm:aff><country xml:lang="fr">Suède</country><wicri:regionArea>Rheumatology Unit, Department of Medicine, Karolinska Institute and Karolinska University Hospital, Stockholm</wicri:regionArea></affiliation></author><author><name sortKey="Dicarlo, Julie" sort="Dicarlo, Julie" uniqKey="Dicarlo J" first="Julie" last="Dicarlo">Julie Dicarlo</name><affiliation wicri:level="1"><nlm:aff id="af8">Spire Sciences LCC, San Francisco, California, USA</nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Spire Sciences LCC, San Francisco, California</wicri:regionArea></affiliation></author><author><name sortKey="Gaillez, Corine" sort="Gaillez, Corine" uniqKey="Gaillez C" first="Corine" last="Gaillez">Corine Gaillez</name><affiliation wicri:level="1"><nlm:aff id="af9">Bristol-Myers Squibb, Rueil-Malmaison, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Bristol-Myers Squibb, Rueil-Malmaison</wicri:regionArea></affiliation></author><author><name sortKey="Le Bars, Manuela" sort="Le Bars, Manuela" uniqKey="Le Bars M" first="Manuela" last="Le Bars">Manuela Le Bars</name><affiliation wicri:level="1"><nlm:aff id="af9">Bristol-Myers Squibb, Rueil-Malmaison, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Bristol-Myers Squibb, Rueil-Malmaison</wicri:regionArea></affiliation></author><author><name sortKey="Zhou, Xianhuang" sort="Zhou, Xianhuang" uniqKey="Zhou X" first="Xianhuang" last="Zhou">Xianhuang Zhou</name><affiliation wicri:level="1"><nlm:aff id="af10">Bristol-Myers Squibb, Princeton, New Jersey, USA</nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Bristol-Myers Squibb, Princeton, New Jersey</wicri:regionArea></affiliation></author><author><name sortKey="Peterfy, Charles" sort="Peterfy, Charles" uniqKey="Peterfy C" first="Charles" last="Peterfy">Charles Peterfy</name><affiliation wicri:level="1"><nlm:aff id="af8">Spire Sciences LCC, San Francisco, California, USA</nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Spire Sciences LCC, San Francisco, California</wicri:regionArea></affiliation></author></analytic><series><title level="j">Annals of the Rheumatic Diseases</title><idno type="ISSN">0003-4967</idno><idno type="eISSN">1468-2060</idno><imprint><date when="2012">2012</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Objectives</title><p>This randomised, double-blind, placebo-controlled phase IIIb study evaluated the impact of abatacept on MRI pathology as a primary outcome in methotrexate (MTX)-refractory patients with rheumatoid arthritis.</p></sec><sec><title>Methods</title><p>Patients received intravenous abatacept (∼10 mg/kg) or placebo, on background MTX, for 4 months, followed by an 8-month open-label extension (OLE; all patients received abatacept plus MTX). Patients had 1.5T MRI with intravenous contrast at baseline, Months 4 and 12; wrist synovitis (three locations assessed), and wrist and hand (15 and eight locations assessed, respectively) osteitis and erosion were scored using OMERACT-RAMRIS.</p></sec><sec><title>Results</title><p>26/27 abatacept- and 23/23 placebo-randomised patients completed Month 4 and entered the OLE; 26 and 21 completed Month 12. The primary endpoint was not achieved; mean change (SD) from baseline in synovitis was −0.44 (1.47) for abatacept versus 0.52 (1.38) for placebo (p=0.103) at Month 4. For mean change in synovitis adjusted for baseline score (sensitivity analysis), the difference between groups was −0.69, p=0.078. Adjusted mean changes (SE) in osteitis and erosion were −1.94 (0.86) and 0.45 (0.43) for abatacept, and 1.54 (0.90) and 0.95 (0.45) for placebo. Further MRI improvements were observed up to Month 12 for abatacept and from Months 4 to 12 for placebo-treated patients switched to abatacept at Month 4. Clinical efficacy was shown with abatacept and sustained to Month 12.</p></sec><sec><title>Conclusions</title><p>Despite small patient numbers, MRI detected structural and synovial benefit, sustained to Month 12 in abatacept+MTX-treated patients, and improvements in structural and inflammatory outcomes for placebo+MTX-treated patients following addition of abatacept.</p></sec><sec><title>Clinical trial registration</title><p>Clinicaltrials.gov NCT00420199.</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Mcgonagle, D" uniqKey="Mcgonagle D">D McGonagle</name></author><author><name sortKey="Conaghan, Pg" uniqKey="Conaghan P">PG Conaghan</name></author><author><name sortKey="O Connor, P" uniqKey="O Connor P">P O'Connor</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Brown, Ak" uniqKey="Brown A">AK Brown</name></author><author><name sortKey="Wakefield, Rj" uniqKey="Wakefield R">RJ 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<front><journal-meta><journal-id journal-id-type="nlm-ta">Ann Rheum Dis</journal-id><journal-id journal-id-type="iso-abbrev">Ann. Rheum. Dis</journal-id><journal-id journal-id-type="hwp">annrheumdis</journal-id><journal-id journal-id-type="publisher-id">ard</journal-id><journal-title-group><journal-title>Annals of the Rheumatic Diseases</journal-title></journal-title-group><issn pub-type="ppub">0003-4967</issn><issn pub-type="epub">1468-2060</issn><publisher><publisher-name>BMJ Publishing Group</publisher-name><publisher-loc>BMA House, Tavistock Square, London, WC1H 9JR</publisher-loc></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">22915624</article-id><article-id pub-id-type="pmc">3711370</article-id><article-id pub-id-type="publisher-id">annrheumdis-2012-201611</article-id><article-id pub-id-type="doi">10.1136/annrheumdis-2012-201611</article-id><article-categories><subj-group subj-group-type="hwp-journal-coll"><subject>1506</subject></subj-group><subj-group subj-group-type="heading"><subject>Clinical and Epidemiological Research</subject></subj-group><series-title>Extended report</series-title></article-categories><title-group><article-title>Impact of intravenous abatacept on synovitis, osteitis and structural damage in patients with rheumatoid arthritis and an inadequate response to methotrexate: the ASSET randomised controlled trial</article-title><alt-title alt-title-type="short">Clinical and epidemiological research</alt-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>Conaghan</surname><given-names>Philip G</given-names></name><xref ref-type="aff" rid="af1">1</xref></contrib><contrib contrib-type="author"><name><surname>Durez</surname><given-names>Patrick</given-names></name><xref ref-type="aff" rid="af2">2</xref></contrib><contrib contrib-type="author"><name><surname>Alten</surname><given-names>Rieke E</given-names></name><xref ref-type="aff" rid="af3">3</xref></contrib><contrib contrib-type="author"><name><surname>Burmester</surname><given-names>Gerd-Rüdiger</given-names></name><xref ref-type="aff" rid="af4">4</xref></contrib><contrib contrib-type="author"><name><surname>Tak</surname><given-names>Paul P</given-names></name><xref ref-type="aff" rid="af5">5</xref><xref ref-type="aff" rid="af6">6</xref></contrib><contrib contrib-type="author"><name><surname>Klareskog</surname><given-names>Lars</given-names></name><xref ref-type="aff" rid="af7">7</xref></contrib><contrib contrib-type="author"><name><surname>Catrina</surname><given-names>Anca Irinel</given-names></name><xref ref-type="aff" rid="af7">7</xref></contrib><contrib contrib-type="author"><name><surname>DiCarlo</surname><given-names>Julie</given-names></name><xref ref-type="aff" rid="af8">8</xref></contrib><contrib contrib-type="author"><name><surname>Gaillez</surname><given-names>Corine</given-names></name><xref ref-type="aff" rid="af9">9</xref></contrib><contrib contrib-type="author"><name><surname>Le Bars</surname><given-names>Manuela</given-names></name><xref ref-type="aff" rid="af9">9</xref></contrib><contrib contrib-type="author"><name><surname>Zhou</surname><given-names>Xianhuang</given-names></name><xref ref-type="aff" rid="af10">10</xref></contrib><contrib contrib-type="author"><name><surname>Peterfy</surname><given-names>Charles</given-names></name><xref ref-type="aff" rid="af8">8</xref></contrib></contrib-group><aff id="af1"><label>1</label>Section of Musculoskeletal Disease, University of Leeds & NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds, UK</aff><aff id="af2"><label>2</label>Cliniques Universitaires Saint Luc, Université Catholique de Louvain, Brussels, Belgium</aff><aff id="af3"><label>3</label>Schlosspark-Klinik, University Medicine, Berlin, Germany</aff><aff id="af4"><label>4</label>Department of Rheumatology and Clinical Immunology, Charité-Universitatsmedizin, Berlin, Germany</aff><aff id="af5"><label>5</label>Department of Clinical Immunology and Rheumatology, F4-105, Academic Medical Center/University of Amsterdam, Amsterdam, The Netherlands</aff><aff id="af6"><label>6</label>GlaxoSmithKine, Stevenage, UK</aff><aff id="af7"><label>7</label>Rheumatology Unit, Department of Medicine, Karolinska Institute and Karolinska University Hospital, Stockholm, Sweden</aff><aff id="af8"><label>8</label>Spire Sciences LCC, San Francisco, California, USA</aff><aff id="af9"><label>9</label>Bristol-Myers Squibb, Rueil-Malmaison, France</aff><aff id="af10"><label>10</label>Bristol-Myers Squibb, Princeton, New Jersey, USA</aff><author-notes><fn><p><bold>Handling editor</bold> Tore K Kvien </p></fn><corresp><label>Correspondence to</label> Professor PG Conaghan, Division of Musculoskeletal Disease, Chapel Allerton Hospital, Leeds LS7 4SA, UK; <email>p.conaghan@leeds.ac.uk</email></corresp></author-notes><pub-date pub-type="ppub"><month>8</month><year>2013</year></pub-date><pub-date pub-type="epub"><day>21</day><month>8</month><year>2012</year></pub-date><volume>72</volume><issue>8</issue><fpage>1287</fpage><lpage>1294</lpage><history><date date-type="received"><day>29</day><month>2</month><year>2012</year></date><date date-type="accepted"><day>19</day><month>7</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"><license-p>This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 3.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. 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></license-p></license></permissions><self-uri xlink:title="pdf" xlink:type="simple" xlink:href="annrheumdis-2012-201611.pdf"></self-uri><abstract><sec><title>Objectives</title><p>This randomised, double-blind, placebo-controlled phase IIIb study evaluated the impact of abatacept on MRI pathology as a primary outcome in methotrexate (MTX)-refractory patients with rheumatoid arthritis.</p></sec><sec><title>Methods</title><p>Patients received intravenous abatacept (∼10 mg/kg) or placebo, on background MTX, for 4 months, followed by an 8-month open-label extension (OLE; all patients received abatacept plus MTX). Patients had 1.5T MRI with intravenous contrast at baseline, Months 4 and 12; wrist synovitis (three locations assessed), and wrist and hand (15 and eight locations assessed, respectively) osteitis and erosion were scored using OMERACT-RAMRIS.</p></sec><sec><title>Results</title><p>26/27 abatacept- and 23/23 placebo-randomised patients completed Month 4 and entered the OLE; 26 and 21 completed Month 12. The primary endpoint was not achieved; mean change (SD) from baseline in synovitis was −0.44 (1.47) for abatacept versus 0.52 (1.38) for placebo (p=0.103) at Month 4. For mean change in synovitis adjusted for baseline score (sensitivity analysis), the difference between groups was −0.69, p=0.078. Adjusted mean changes (SE) in osteitis and erosion were −1.94 (0.86) and 0.45 (0.43) for abatacept, and 1.54 (0.90) and 0.95 (0.45) for placebo. Further MRI improvements were observed up to Month 12 for abatacept and from Months 4 to 12 for placebo-treated patients switched to abatacept at Month 4. Clinical efficacy was shown with abatacept and sustained to Month 12.</p></sec><sec><title>Conclusions</title><p>Despite small patient numbers, MRI detected structural and synovial benefit, sustained to Month 12 in abatacept+MTX-treated patients, and improvements in structural and inflammatory outcomes for placebo+MTX-treated patients following addition of abatacept.</p></sec><sec><title>Clinical trial registration</title><p>Clinicaltrials.gov NCT00420199.</p></sec></abstract><kwd-group><kwd>Magnetic Resonance Imaging</kwd><kwd>Rheumatoid Arthritis</kwd><kwd>Synovitis</kwd><kwd>T Cells</kwd><kwd>Disease Activity</kwd></kwd-group><custom-meta-group><custom-meta><meta-name>special-feature</meta-name><meta-value>unlocked</meta-value></custom-meta></custom-meta-group></article-meta></front></pmc></record>Pour manipuler ce document sous Unix (Dilib)
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