Anti-IP-10 antibody (BMS-936557) for ulcerative colitis: a phase II randomised study
Identifieur interne : 000336 ( Main/Exploration ); précédent : 000335; suivant : 000337Anti-IP-10 antibody (BMS-936557) for ulcerative colitis: a phase II randomised study
Auteurs : Lloyd Mayer [États-Unis] ; William J. Sandborn [États-Unis] ; Yuriy Stepanov [Ukraine] ; Karel Geboes [Belgique] ; Robert Hardi [États-Unis] ; Michael Yellin [États-Unis] ; Xiaolu Tao [États-Unis] ; Li An Xu [États-Unis] ; Luisa Salter-Cid [États-Unis] ; Sheila Gujrathi [États-Unis] ; Richard Aranda [États-Unis] ; Allison Y. Luo [États-Unis]Source :
- Gut [ 0017-5749 ] ; 2013.
Abstract
Interferon-γ-inducible protein-10 (IP-10 or CXCL10) plays a role in inflammatory cell migration and epithelial cell survival and migration. It is expressed in higher levels in the colonic tissue and plasma of patients with ulcerative colitis (UC). This phase II study assessed the efficacy and safety of BMS-936557, a fully human, monoclonal antibody to IP-10, in the treatment of moderately-to-severely active UC.
In this 8-week, phase II, double-blind, multicentre, randomised study, patients with active UC received placebo or BMS-936557 (10 mg/kg) intravenously every other week. The primary endpoint was the rate of clinical response at Day 57; clinical remission and mucosal healing rates were secondary endpoints. Post hoc analyses evaluated the drug exposure–response relationship and histological improvement.
109 patients were included (BMS-936557: n=55; placebo: n=54). Prespecified primary and secondary endpoints were not met; clinical response rate at Day 57 was 52.7% versus 35.2% for BMS-936557 versus placebo (p=0.083), and clinical remission and mucosal healing rates were 18.2% versus 16.7% (p=1.00) and 41.8% versus 35.2% (p=0.556), respectively. However, higher BMS-936557 steady-state trough concentration (Cminss) was associated with increased clinical response (87.5% vs 37.0% (p<0.001) for patients with Cminss 108–235 μg/ml vs placebo) and histological improvements (73.0% vs 41.0%; p=0.004). Infections occurred in 7 (12.7%) BMS-936557-treated patients and 3 (5.8%) placebo-treated patients. 2 (3.6%) BMS-936557 patients discontinued due to adverse events.
Anti-IP-10 antibody, BMS-936557, is a potentially effective therapy for moderately-to-severely active UC. Higher drug exposure correlated with increasing clinical response and histological improvement. Further dose–response studies are warranted.
ClinicalTrials.gov NCT00656890.
Url:
DOI: 10.1136/gutjnl-2012-303424
PubMed: 23461895
PubMed Central: 3933070
Affiliations:
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Sandborn</name><affiliation wicri:level="1"><nlm:aff id="af2"><addr-line>Division of Gastroenterology</addr-line>,<institution>University of California San Diego</institution>,<addr-line>La Jolla, California</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Stepanov, Yuriy" sort="Stepanov, Yuriy" uniqKey="Stepanov Y" first="Yuriy" last="Stepanov">Yuriy Stepanov</name><affiliation wicri:level="1"><nlm:aff id="af3"><institution>Dnipropetrovsk State Medical Academy</institution>,<addr-line>Dnipropetrovsk</addr-line>,<country>Ukraine</country></nlm:aff><country xml:lang="fr">Ukraine</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Geboes, Karel" sort="Geboes, Karel" uniqKey="Geboes K" first="Karel" last="Geboes">Karel Geboes</name><affiliation wicri:level="1"><nlm:aff id="af4"><addr-line>Department of Pathologie</addr-line>,<institution>University Hospital KU Leuven</institution>,<addr-line>Leuven</addr-line>,<country>Belgium</country></nlm:aff><country xml:lang="fr">Belgique</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Hardi, Robert" sort="Hardi, Robert" uniqKey="Hardi R" first="Robert" last="Hardi">Robert Hardi</name><affiliation wicri:level="1"><nlm:aff id="af5"><institution>Chevy Chase Clinical Research</institution>,<addr-line>Chevy Chase, Maryland</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Yellin, Michael" sort="Yellin, Michael" uniqKey="Yellin M" first="Michael" last="Yellin">Michael Yellin</name><affiliation wicri:level="1"><nlm:aff id="af6"><institution>Medarex Inc</institution>,<addr-line>Bloomsbury, New Jersey</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Tao, Xiaolu" sort="Tao, Xiaolu" uniqKey="Tao X" first="Xiaolu" last="Tao">Xiaolu Tao</name><affiliation wicri:level="1"><nlm:aff id="af7"><institution>Bristol-Myers Squibb</institution>,<addr-line>Princeton, New Jersey</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Xu, Li An" sort="Xu, Li An" uniqKey="Xu L" first="Li An" last="Xu">Li An Xu</name><affiliation wicri:level="1"><nlm:aff id="af7"><institution>Bristol-Myers Squibb</institution>,<addr-line>Princeton, New Jersey</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Salter Cid, Luisa" sort="Salter Cid, Luisa" uniqKey="Salter Cid L" first="Luisa" last="Salter-Cid">Luisa Salter-Cid</name><affiliation wicri:level="1"><nlm:aff id="af7"><institution>Bristol-Myers Squibb</institution>,<addr-line>Princeton, New Jersey</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Gujrathi, Sheila" sort="Gujrathi, Sheila" uniqKey="Gujrathi S" first="Sheila" last="Gujrathi">Sheila Gujrathi</name><affiliation wicri:level="1"><nlm:aff id="af7"><institution>Bristol-Myers Squibb</institution>,<addr-line>Princeton, New Jersey</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Aranda, Richard" sort="Aranda, Richard" uniqKey="Aranda R" first="Richard" last="Aranda">Richard Aranda</name><affiliation wicri:level="1"><nlm:aff id="af7"><institution>Bristol-Myers Squibb</institution>,<addr-line>Princeton, New Jersey</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Luo, Allison Y" sort="Luo, Allison Y" uniqKey="Luo A" first="Allison Y" last="Luo">Allison Y. Luo</name><affiliation wicri:level="1"><nlm:aff id="af7"><institution>Bristol-Myers Squibb</institution>,<addr-line>Princeton, New Jersey</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">23461895</idno><idno type="pmc">3933070</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3933070</idno><idno type="RBID">PMC:3933070</idno><idno type="doi">10.1136/gutjnl-2012-303424</idno><date when="2013">2013</date><idno type="wicri:Area/Pmc/Corpus">000367</idno><idno type="wicri:Area/Pmc/Curation">000367</idno><idno type="wicri:Area/Pmc/Checkpoint">000290</idno><idno type="wicri:Area/Ncbi/Merge">000164</idno><idno type="wicri:Area/Ncbi/Curation">000164</idno><idno type="wicri:Area/Ncbi/Checkpoint">000164</idno><idno type="wicri:doubleKey">0017-5749:2013:Mayer L:anti:ip:antibody</idno><idno type="wicri:Area/Main/Merge">000336</idno><idno type="wicri:Area/Main/Curation">000336</idno><idno type="wicri:Area/Main/Exploration">000336</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Anti-IP-10 antibody (BMS-936557) for ulcerative colitis: a phase II randomised study</title><author><name sortKey="Mayer, Lloyd" sort="Mayer, Lloyd" uniqKey="Mayer L" first="Lloyd" last="Mayer">Lloyd Mayer</name><affiliation wicri:level="1"><nlm:aff id="af1"><institution>Immunology Institute</institution>,<institution>Mount Sinai School of Medicine</institution>,<addr-line>New York, New York</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Sandborn, William J" sort="Sandborn, William J" uniqKey="Sandborn W" first="William J" last="Sandborn">William J. Sandborn</name><affiliation wicri:level="1"><nlm:aff id="af2"><addr-line>Division of Gastroenterology</addr-line>,<institution>University of California San Diego</institution>,<addr-line>La Jolla, California</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Stepanov, Yuriy" sort="Stepanov, Yuriy" uniqKey="Stepanov Y" first="Yuriy" last="Stepanov">Yuriy Stepanov</name><affiliation wicri:level="1"><nlm:aff id="af3"><institution>Dnipropetrovsk State Medical Academy</institution>,<addr-line>Dnipropetrovsk</addr-line>,<country>Ukraine</country></nlm:aff><country xml:lang="fr">Ukraine</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Geboes, Karel" sort="Geboes, Karel" uniqKey="Geboes K" first="Karel" last="Geboes">Karel Geboes</name><affiliation wicri:level="1"><nlm:aff id="af4"><addr-line>Department of Pathologie</addr-line>,<institution>University Hospital KU Leuven</institution>,<addr-line>Leuven</addr-line>,<country>Belgium</country></nlm:aff><country xml:lang="fr">Belgique</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Hardi, Robert" sort="Hardi, Robert" uniqKey="Hardi R" first="Robert" last="Hardi">Robert Hardi</name><affiliation wicri:level="1"><nlm:aff id="af5"><institution>Chevy Chase Clinical Research</institution>,<addr-line>Chevy Chase, Maryland</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Yellin, Michael" sort="Yellin, Michael" uniqKey="Yellin M" first="Michael" last="Yellin">Michael Yellin</name><affiliation wicri:level="1"><nlm:aff id="af6"><institution>Medarex Inc</institution>,<addr-line>Bloomsbury, New Jersey</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Tao, Xiaolu" sort="Tao, Xiaolu" uniqKey="Tao X" first="Xiaolu" last="Tao">Xiaolu Tao</name><affiliation wicri:level="1"><nlm:aff id="af7"><institution>Bristol-Myers Squibb</institution>,<addr-line>Princeton, New Jersey</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Xu, Li An" sort="Xu, Li An" uniqKey="Xu L" first="Li An" last="Xu">Li An Xu</name><affiliation wicri:level="1"><nlm:aff id="af7"><institution>Bristol-Myers Squibb</institution>,<addr-line>Princeton, New Jersey</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Salter Cid, Luisa" sort="Salter Cid, Luisa" uniqKey="Salter Cid L" first="Luisa" last="Salter-Cid">Luisa Salter-Cid</name><affiliation wicri:level="1"><nlm:aff id="af7"><institution>Bristol-Myers Squibb</institution>,<addr-line>Princeton, New Jersey</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Gujrathi, Sheila" sort="Gujrathi, Sheila" uniqKey="Gujrathi S" first="Sheila" last="Gujrathi">Sheila Gujrathi</name><affiliation wicri:level="1"><nlm:aff id="af7"><institution>Bristol-Myers Squibb</institution>,<addr-line>Princeton, New Jersey</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Aranda, Richard" sort="Aranda, Richard" uniqKey="Aranda R" first="Richard" last="Aranda">Richard Aranda</name><affiliation wicri:level="1"><nlm:aff id="af7"><institution>Bristol-Myers Squibb</institution>,<addr-line>Princeton, New Jersey</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Luo, Allison Y" sort="Luo, Allison Y" uniqKey="Luo A" first="Allison Y" last="Luo">Allison Y. Luo</name><affiliation wicri:level="1"><nlm:aff id="af7"><institution>Bristol-Myers Squibb</institution>,<addr-line>Princeton, New Jersey</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author></analytic><series><title level="j">Gut</title><idno type="ISSN">0017-5749</idno><idno type="eISSN">1468-3288</idno><imprint><date when="2013">2013</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Objective</title><p>Interferon-γ-inducible protein-10 (IP-10 or CXCL10) plays a role in inflammatory cell migration and epithelial cell survival and migration. It is expressed in higher levels in the colonic tissue and plasma of patients with ulcerative colitis (UC). This phase II study assessed the efficacy and safety of BMS-936557, a fully human, monoclonal antibody to IP-10, in the treatment of moderately-to-severely active UC.</p></sec><sec><title>Design</title><p>In this 8-week, phase II, double-blind, multicentre, randomised study, patients with active UC received placebo or BMS-936557 (10 mg/kg) intravenously every other week. The primary endpoint was the rate of clinical response at Day 57; clinical remission and mucosal healing rates were secondary endpoints. Post hoc analyses evaluated the drug exposure–response relationship and histological improvement.</p></sec><sec><title>Results</title><p>109 patients were included (BMS-936557: n=55; placebo: n=54). Prespecified primary and secondary endpoints were not met; clinical response rate at Day 57 was 52.7% versus 35.2% for BMS-936557 versus placebo (p=0.083), and clinical remission and mucosal healing rates were 18.2% versus 16.7% (p=1.00) and 41.8% versus 35.2% (p=0.556), respectively. However, higher BMS-936557 steady-state trough concentration (C<sub>minss</sub>) was associated with increased clinical response (87.5% vs 37.0% (p<0.001) for patients with C<sub>minss</sub> 108–235 μg/ml vs placebo) and histological improvements (73.0% vs 41.0%; p=0.004). Infections occurred in 7 (12.7%) BMS-936557-treated patients and 3 (5.8%) placebo-treated patients. 2 (3.6%) BMS-936557 patients discontinued due to adverse events.</p></sec><sec><title>Conclusions</title><p>Anti-IP-10 antibody, BMS-936557, is a potentially effective therapy for moderately-to-severely active UC. Higher drug exposure correlated with increasing clinical response and histological improvement. Further dose–response studies are warranted.</p></sec><sec><title>Clinical Trial Registration Number:</title><p>ClinicalTrials.gov NCT00656890.</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Ordas, I" uniqKey="Ordas I">I Ordas</name></author><author><name sortKey="Eckmann, L" uniqKey="Eckmann L">L Eckmann</name></author><author><name sortKey="Talimini, M" uniqKey="Talimini M">M Talimini</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Kornbluth, A" uniqKey="Kornbluth A">A Kornbluth</name></author><author><name sortKey="Sachar, Db" uniqKey="Sachar D">DB Sachar</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Travis, Sp" uniqKey="Travis S">SP Travis</name></author><author><name sortKey="Stange, Ef" uniqKey="Stange E">EF Stange</name></author><author><name sortKey="Lemann, M" uniqKey="Lemann M">M 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uniqKey="Marano C">C Marano</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Yellin, M" uniqKey="Yellin M">M Yellin</name></author><author><name sortKey="Paliienko, I" uniqKey="Paliienko I">I Paliienko</name></author><author><name sortKey="Balanescu, A" uniqKey="Balanescu A">A Balanescu</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Afif, W" uniqKey="Afif W">W Afif</name></author><author><name sortKey="Leighton, Ja" uniqKey="Leighton J">JA Leighton</name></author><author><name sortKey="Hanauer, Sb" uniqKey="Hanauer S">SB Hanauer</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Baumgart, Dc" uniqKey="Baumgart D">DC Baumgart</name></author><author><name sortKey="Targan, Sr" uniqKey="Targan S">SR Targan</name></author><author><name sortKey="Dignass, Au" uniqKey="Dignass A">AU Dignass</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Rutgeerts, P" uniqKey="Rutgeerts P">P Rutgeerts</name></author><author><name sortKey="Sandborn, Wj" uniqKey="Sandborn W">WJ Sandborn</name></author><author><name sortKey="Feagan, Bg" uniqKey="Feagan B">BG Feagan</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Sandborn, W" uniqKey="Sandborn W">W Sandborn</name></author><author><name sortKey="Colombel, J F" uniqKey="Colombel J">J-F Colombel</name></author><author><name sortKey="Hanauer, S" uniqKey="Hanauer S">S Hanauer</name></author></analytic></biblStruct></listBibl></div1></back></TEI><affiliations><list><country><li>Belgique</li><li>Ukraine</li><li>États-Unis</li></country></list><tree><country name="États-Unis"><noRegion><name sortKey="Mayer, Lloyd" sort="Mayer, Lloyd" uniqKey="Mayer L" first="Lloyd" last="Mayer">Lloyd Mayer</name></noRegion><name sortKey="Aranda, Richard" sort="Aranda, Richard" uniqKey="Aranda R" first="Richard" last="Aranda">Richard Aranda</name><name sortKey="Gujrathi, Sheila" sort="Gujrathi, Sheila" uniqKey="Gujrathi S" first="Sheila" last="Gujrathi">Sheila Gujrathi</name><name sortKey="Hardi, Robert" sort="Hardi, Robert" uniqKey="Hardi R" first="Robert" last="Hardi">Robert Hardi</name><name sortKey="Luo, Allison Y" sort="Luo, Allison Y" uniqKey="Luo A" first="Allison Y" last="Luo">Allison Y. Luo</name><name sortKey="Salter Cid, Luisa" sort="Salter Cid, Luisa" uniqKey="Salter Cid L" first="Luisa" last="Salter-Cid">Luisa Salter-Cid</name><name sortKey="Sandborn, William J" sort="Sandborn, William J" uniqKey="Sandborn W" first="William J" last="Sandborn">William J. Sandborn</name><name sortKey="Tao, Xiaolu" sort="Tao, Xiaolu" uniqKey="Tao X" first="Xiaolu" last="Tao">Xiaolu Tao</name><name sortKey="Xu, Li An" sort="Xu, Li An" uniqKey="Xu L" first="Li An" last="Xu">Li An Xu</name><name sortKey="Yellin, Michael" sort="Yellin, Michael" uniqKey="Yellin M" first="Michael" last="Yellin">Michael Yellin</name></country><country name="Ukraine"><noRegion><name sortKey="Stepanov, Yuriy" sort="Stepanov, Yuriy" uniqKey="Stepanov Y" first="Yuriy" last="Stepanov">Yuriy Stepanov</name></noRegion></country><country name="Belgique"><noRegion><name sortKey="Geboes, Karel" sort="Geboes, Karel" uniqKey="Geboes K" first="Karel" last="Geboes">Karel Geboes</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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