Eldelumab [Anti-IP-10] Induction Therapy for Ulcerative Colitis: A Randomised, Placebo-Controlled, Phase 2b Study
Identifieur interne : 000466 ( Pmc/Corpus ); précédent : 000465; suivant : 000467Eldelumab [Anti-IP-10] Induction Therapy for Ulcerative Colitis: A Randomised, Placebo-Controlled, Phase 2b Study
Auteurs : William J. Sandborn ; Jean-Frédéric Colombel ; Subrata Ghosh ; Bruce E. Sands ; Gerald Dryden ; Xavier Hébuterne ; Rupert W. Leong ; Brian Bressler ; Thomas Ullman ; Peter L. Lakatos ; Walter Reinisch ; Li-An Xu ; Allison LuoSource :
- Journal of Crohn's & Colitis [ 1873-9946 ] ; 2015.
Abstract
Interferon-γ-inducible protein-10 [IP-10] mediates immune cell trafficking from the circulation to the inflamed colon and decreases gut epithelial cell survival. IP-10 expression is increased in patients with ulcerative colitis [UC]. We report efficacy and safety results from a dose-ranging induction study of eldelumab, a fully human monoclonal antibody to IP-10, in moderately to severely active UC.
A total of 252 adults with UC [Mayo score ≥ 6 and endoscopic subscore ≥ 2] were randomised 1:1:1 to placebo or eldelumab 15 or 25 mg/kg administered intravenously on Days 1 and 8 and every other week thereafter. The primary endpoint was clinical remission [Mayo score ≤ 2; no individual subscale score > 1] at Week 11. Key secondary endpoints included Mayo score clinical response and mucosal healing at Week 11.
Neither eldelumab 15 or 25 mg/kg resulted in significant increases vs placebo in the proportion of patients achieving Week 11 clinical remission. Remission and response rates were 17.6% and 47.1% with eldelumab 25mg/kg, 13.1% and 44.0% with eldelumab 15mg/kg, and 9.6% and 31.3% with placebo. Clinical remission and response rates were higher in anti-tumour necrosis factor [TNF]-naïve patients treated with eldelumab compared with placebo. Eldelumab treatment was well tolerated and no immunogenicity was observed.
The primary endpoint was not achieved with induction treatment with eldelumab 15 or 25 mg/kg in patients with UC. Trends towards clinical remission and response were observed in the overall population and were more pronounced in anti-TNF naïve patients. Eldelumab safety signals were consistent with those reported previously [ClinicalTrials.gov number, NCT01294410].
Url:
DOI: 10.1093/ecco-jcc/jjv224
PubMed: 26721935
PubMed Central: 4946756
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PMC:4946756Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Eldelumab [Anti-IP-10] Induction Therapy for Ulcerative Colitis: A Randomised, Placebo-Controlled, Phase 2b Study</title><author><name sortKey="Sandborn, William J" sort="Sandborn, William J" uniqKey="Sandborn W" first="William J." last="Sandborn">William J. Sandborn</name><affiliation><nlm:aff id="AF0001"><institution>Inflammatory Bowel Disease Center, University of California San Diego</institution>,<addr-line>La Jolla, CA</addr-line>,<country>USA</country></nlm:aff></affiliation></author><author><name sortKey="Colombel, Jean Frederic" sort="Colombel, Jean Frederic" uniqKey="Colombel J" first="Jean-Frédéric" last="Colombel">Jean-Frédéric Colombel</name><affiliation><nlm:aff id="AF0002"><institution>Dr Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai</institution>,<addr-line>New York, NY</addr-line>,<country>USA</country></nlm:aff></affiliation></author><author><name sortKey="Ghosh, Subrata" sort="Ghosh, Subrata" uniqKey="Ghosh S" first="Subrata" last="Ghosh">Subrata Ghosh</name><affiliation><nlm:aff id="AF0003"><institution>Department of Medicine, University of Calgary</institution>,<addr-line>Calgary, AB</addr-line>,<country>Canada</country></nlm:aff></affiliation></author><author><name sortKey="Sands, Bruce E" sort="Sands, Bruce E" uniqKey="Sands B" first="Bruce E." last="Sands">Bruce E. Sands</name><affiliation><nlm:aff id="AF0002"><institution>Dr Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai</institution>,<addr-line>New York, NY</addr-line>,<country>USA</country></nlm:aff></affiliation></author><author><name sortKey="Dryden, Gerald" sort="Dryden, Gerald" uniqKey="Dryden G" first="Gerald" last="Dryden">Gerald Dryden</name><affiliation><nlm:aff id="AF0004"><institution>Division of Gastroenterology, Hepatology, and Nutrition, University of Louisville School of Medicine</institution>,<addr-line>Louisville, KY</addr-line>,<country>USA</country></nlm:aff></affiliation></author><author><name sortKey="Hebuterne, Xavier" sort="Hebuterne, Xavier" uniqKey="Hebuterne X" first="Xavier" last="Hébuterne">Xavier Hébuterne</name><affiliation><nlm:aff id="AF0005"><institution>Faculté de Médecine, Université de Nice-Sophia Antipolis, Hôpital de l’Archet</institution>,<addr-line>Nice</addr-line>,<country>France</country></nlm:aff></affiliation></author><author><name sortKey="Leong, Rupert W" sort="Leong, Rupert W" uniqKey="Leong R" first="Rupert W." last="Leong">Rupert W. Leong</name><affiliation><nlm:aff id="AF0006"><institution>Concord Hospital, Gastroenterology and Liver Services, University of New South Wales</institution>,<addr-line>Sydney</addr-line>,<country>Australia</country></nlm:aff></affiliation></author><author><name sortKey="Bressler, Brian" sort="Bressler, Brian" uniqKey="Bressler B" first="Brian" last="Bressler">Brian Bressler</name><affiliation><nlm:aff id="AF0007"><institution>Division of Gastroenterology, St Paul’s Hospital</institution>,<addr-line>Vancouver, BC</addr-line>,<country>Canada</country></nlm:aff></affiliation></author><author><name sortKey="Ullman, Thomas" sort="Ullman, Thomas" uniqKey="Ullman T" first="Thomas" last="Ullman">Thomas Ullman</name><affiliation><nlm:aff id="AF0002"><institution>Dr Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai</institution>,<addr-line>New York, NY</addr-line>,<country>USA</country></nlm:aff></affiliation></author><author><name sortKey="Lakatos, Peter L" sort="Lakatos, Peter L" uniqKey="Lakatos P" first="Peter L." last="Lakatos">Peter L. Lakatos</name><affiliation><nlm:aff id="AF0008"><institution>1st Department of Medicine, Semmelweis University</institution>,<addr-line>Budapest</addr-line>,<country>Hungary</country></nlm:aff></affiliation></author><author><name sortKey="Reinisch, Walter" sort="Reinisch, Walter" uniqKey="Reinisch W" first="Walter" last="Reinisch">Walter Reinisch</name><affiliation><nlm:aff id="AF0009"><institution>Department of Internal Medicine III, Medical University of Vienna, Vienna, Austria, and McMaster University, Department of Internal Medicine</institution>,<addr-line>Hamilton, ON</addr-line>,<country>Canada</country></nlm:aff></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><nlm:aff id="AF0010"><institution>Bristol-Myers Squibb</institution>,<addr-line>Lawrenceville, NJ</addr-line>,<country>USA</country></nlm:aff></affiliation></author><author><name sortKey="Luo, Allison" sort="Luo, Allison" uniqKey="Luo A" first="Allison" last="Luo">Allison Luo</name><affiliation><nlm:aff id="AF0011"><institution>Formerly of Bristol-Myers Squibb</institution>,<addr-line>Lawrenceville, NJ</addr-line>,<country>USA</country></nlm:aff></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">26721935</idno><idno type="pmc">4946756</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4946756</idno><idno type="RBID">PMC:4946756</idno><idno type="doi">10.1093/ecco-jcc/jjv224</idno><date when="2015">2015</date><idno type="wicri:Area/Pmc/Corpus">000466</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">000466</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Eldelumab [Anti-IP-10] Induction Therapy for Ulcerative Colitis: A Randomised, Placebo-Controlled, Phase 2b Study</title><author><name sortKey="Sandborn, William J" sort="Sandborn, William J" uniqKey="Sandborn W" first="William J." last="Sandborn">William J. Sandborn</name><affiliation><nlm:aff id="AF0001"><institution>Inflammatory Bowel Disease Center, University of California San Diego</institution>,<addr-line>La Jolla, CA</addr-line>,<country>USA</country></nlm:aff></affiliation></author><author><name sortKey="Colombel, Jean Frederic" sort="Colombel, Jean Frederic" uniqKey="Colombel J" first="Jean-Frédéric" last="Colombel">Jean-Frédéric Colombel</name><affiliation><nlm:aff id="AF0002"><institution>Dr Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai</institution>,<addr-line>New York, NY</addr-line>,<country>USA</country></nlm:aff></affiliation></author><author><name sortKey="Ghosh, Subrata" sort="Ghosh, Subrata" uniqKey="Ghosh S" first="Subrata" last="Ghosh">Subrata Ghosh</name><affiliation><nlm:aff id="AF0003"><institution>Department of Medicine, University of Calgary</institution>,<addr-line>Calgary, AB</addr-line>,<country>Canada</country></nlm:aff></affiliation></author><author><name sortKey="Sands, Bruce E" sort="Sands, Bruce E" uniqKey="Sands B" first="Bruce E." last="Sands">Bruce E. Sands</name><affiliation><nlm:aff id="AF0002"><institution>Dr Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai</institution>,<addr-line>New York, NY</addr-line>,<country>USA</country></nlm:aff></affiliation></author><author><name sortKey="Dryden, Gerald" sort="Dryden, Gerald" uniqKey="Dryden G" first="Gerald" last="Dryden">Gerald Dryden</name><affiliation><nlm:aff id="AF0004"><institution>Division of Gastroenterology, Hepatology, and Nutrition, University of Louisville School of Medicine</institution>,<addr-line>Louisville, KY</addr-line>,<country>USA</country></nlm:aff></affiliation></author><author><name sortKey="Hebuterne, Xavier" sort="Hebuterne, Xavier" uniqKey="Hebuterne X" first="Xavier" last="Hébuterne">Xavier Hébuterne</name><affiliation><nlm:aff id="AF0005"><institution>Faculté de Médecine, Université de Nice-Sophia Antipolis, Hôpital de l’Archet</institution>,<addr-line>Nice</addr-line>,<country>France</country></nlm:aff></affiliation></author><author><name sortKey="Leong, Rupert W" sort="Leong, Rupert W" uniqKey="Leong R" first="Rupert W." last="Leong">Rupert W. Leong</name><affiliation><nlm:aff id="AF0006"><institution>Concord Hospital, Gastroenterology and Liver Services, University of New South Wales</institution>,<addr-line>Sydney</addr-line>,<country>Australia</country></nlm:aff></affiliation></author><author><name sortKey="Bressler, Brian" sort="Bressler, Brian" uniqKey="Bressler B" first="Brian" last="Bressler">Brian Bressler</name><affiliation><nlm:aff id="AF0007"><institution>Division of Gastroenterology, St Paul’s Hospital</institution>,<addr-line>Vancouver, BC</addr-line>,<country>Canada</country></nlm:aff></affiliation></author><author><name sortKey="Ullman, Thomas" sort="Ullman, Thomas" uniqKey="Ullman T" first="Thomas" last="Ullman">Thomas Ullman</name><affiliation><nlm:aff id="AF0002"><institution>Dr Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai</institution>,<addr-line>New York, NY</addr-line>,<country>USA</country></nlm:aff></affiliation></author><author><name sortKey="Lakatos, Peter L" sort="Lakatos, Peter L" uniqKey="Lakatos P" first="Peter L." last="Lakatos">Peter L. Lakatos</name><affiliation><nlm:aff id="AF0008"><institution>1st Department of Medicine, Semmelweis University</institution>,<addr-line>Budapest</addr-line>,<country>Hungary</country></nlm:aff></affiliation></author><author><name sortKey="Reinisch, Walter" sort="Reinisch, Walter" uniqKey="Reinisch W" first="Walter" last="Reinisch">Walter Reinisch</name><affiliation><nlm:aff id="AF0009"><institution>Department of Internal Medicine III, Medical University of Vienna, Vienna, Austria, and McMaster University, Department of Internal Medicine</institution>,<addr-line>Hamilton, ON</addr-line>,<country>Canada</country></nlm:aff></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><nlm:aff id="AF0010"><institution>Bristol-Myers Squibb</institution>,<addr-line>Lawrenceville, NJ</addr-line>,<country>USA</country></nlm:aff></affiliation></author><author><name sortKey="Luo, Allison" sort="Luo, Allison" uniqKey="Luo A" first="Allison" last="Luo">Allison Luo</name><affiliation><nlm:aff id="AF0011"><institution>Formerly of Bristol-Myers Squibb</institution>,<addr-line>Lawrenceville, NJ</addr-line>,<country>USA</country></nlm:aff></affiliation></author></analytic><series><title level="j">Journal of Crohn's & Colitis</title><idno type="ISSN">1873-9946</idno><idno type="eISSN">1876-4479</idno><imprint><date when="2015">2015</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Background and Aims:</title><p>Interferon-γ-inducible protein-10 [IP-10] mediates immune cell trafficking from the circulation to the inflamed colon and decreases gut epithelial cell survival. IP-10 expression is increased in patients with ulcerative colitis [UC]. We report efficacy and safety results from a dose-ranging induction study of eldelumab, a fully human monoclonal antibody to IP-10, in moderately to severely active UC.</p></sec><sec><title>Methods:</title><p>A total of 252 adults with UC [Mayo score ≥ 6 and endoscopic subscore ≥ 2] were randomised 1:1:1 to placebo or eldelumab 15 or 25 mg/kg administered intravenously on Days 1 and 8 and every other week thereafter. The primary endpoint was clinical remission [Mayo score ≤ 2; no individual subscale score > 1] at Week 11. Key secondary endpoints included Mayo score clinical response and mucosal healing at Week 11.</p></sec><sec><title>Results:</title><p>Neither eldelumab 15 or 25 mg/kg resulted in significant increases vs placebo in the proportion of patients achieving Week 11 clinical remission. Remission and response rates were 17.6% and 47.1% with eldelumab 25mg/kg, 13.1% and 44.0% with eldelumab 15mg/kg, and 9.6% and 31.3% with placebo. Clinical remission and response rates were higher in anti-tumour necrosis factor [TNF]-naïve patients treated with eldelumab compared with placebo. Eldelumab treatment was well tolerated and no immunogenicity was observed.</p></sec><sec><title>Conclusions:</title><p>The primary endpoint was not achieved with induction treatment with eldelumab 15 or 25 mg/kg in patients with UC. Trends towards clinical remission and response were observed in the overall population and were more pronounced in anti-TNF naïve patients. Eldelumab safety signals were consistent with those reported previously [ClinicalTrials.gov number, NCT01294410].</p></sec></div></front></TEI><pmc article-type="research-article"><pmc-comment>The publisher of this article does not allow downloading of the full text in XML form.</pmc-comment>
<front><journal-meta><journal-id journal-id-type="nlm-ta">J Crohns Colitis</journal-id><journal-id journal-id-type="iso-abbrev">J Crohns Colitis</journal-id><journal-id journal-id-type="hwp">eccojc</journal-id><journal-id journal-id-type="publisher-id">eccojc</journal-id><journal-title-group><journal-title>Journal of Crohn's & Colitis</journal-title></journal-title-group><issn pub-type="ppub">1873-9946</issn><issn pub-type="epub">1876-4479</issn><publisher><publisher-name>Oxford University Press</publisher-name><publisher-loc>UK</publisher-loc></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">26721935</article-id><article-id pub-id-type="pmc">4946756</article-id><article-id pub-id-type="doi">10.1093/ecco-jcc/jjv224</article-id><article-categories><subj-group subj-group-type="heading"><subject>Original Article</subject></subj-group></article-categories><title-group><article-title>Eldelumab [Anti-IP-10] Induction Therapy for Ulcerative Colitis: A Randomised, Placebo-Controlled, Phase 2b Study</article-title></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><name><surname>Sandborn</surname><given-names>William J.</given-names></name><xref ref-type="aff" rid="AF0001"><sup>a</sup></xref></contrib><contrib contrib-type="author"><name><surname>Colombel</surname><given-names>Jean-Frédéric</given-names></name><xref ref-type="aff" rid="AF0002"><sup>b</sup></xref></contrib><contrib contrib-type="author"><name><surname>Ghosh</surname><given-names>Subrata</given-names></name><xref ref-type="aff" rid="AF0003"><sup>c</sup></xref></contrib><contrib contrib-type="author"><name><surname>Sands</surname><given-names>Bruce E.</given-names></name><xref ref-type="aff" rid="AF0002"><sup>b</sup></xref></contrib><contrib contrib-type="author"><name><surname>Dryden</surname><given-names>Gerald</given-names></name><xref ref-type="aff" rid="AF0004"><sup>d</sup></xref></contrib><contrib contrib-type="author"><name><surname>Hébuterne</surname><given-names>Xavier</given-names></name><xref ref-type="aff" rid="AF0005"><sup>e</sup></xref></contrib><contrib contrib-type="author"><name><surname>Leong</surname><given-names>Rupert W.</given-names></name><xref ref-type="aff" rid="AF0006"><sup>f</sup></xref></contrib><contrib contrib-type="author"><name><surname>Bressler</surname><given-names>Brian</given-names></name><xref ref-type="aff" rid="AF0007"><sup>g</sup></xref></contrib><contrib contrib-type="author"><name><surname>Ullman</surname><given-names>Thomas</given-names></name><xref ref-type="aff" rid="AF0002"><sup>b</sup></xref></contrib><contrib contrib-type="author"><name><surname>Lakatos</surname><given-names>Peter L.</given-names></name><xref ref-type="aff" rid="AF0008"><sup>h</sup></xref></contrib><contrib contrib-type="author"><name><surname>Reinisch</surname><given-names>Walter</given-names></name><xref ref-type="aff" rid="AF0009"><sup>i</sup></xref></contrib><contrib contrib-type="author"><name><surname>Xu</surname><given-names>Li-An</given-names></name><xref ref-type="aff" rid="AF0010"><sup>j</sup></xref></contrib><contrib contrib-type="author"><name><surname>Luo</surname><given-names>Allison</given-names></name><xref ref-type="aff" rid="AF0011"><sup>k</sup></xref></contrib><aff id="AF0001"><sup>a</sup><institution>Inflammatory Bowel Disease Center, University of California San Diego</institution>,<addr-line>La Jolla, CA</addr-line>,<country>USA</country></aff><aff id="AF0002"><sup>b</sup><institution>Dr Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai</institution>,<addr-line>New York, NY</addr-line>,<country>USA</country></aff><aff id="AF0003"><sup>c</sup><institution>Department of Medicine, University of Calgary</institution>,<addr-line>Calgary, AB</addr-line>,<country>Canada</country></aff><aff id="AF0004"><sup>d</sup><institution>Division of Gastroenterology, Hepatology, and Nutrition, University of Louisville School of Medicine</institution>,<addr-line>Louisville, KY</addr-line>,<country>USA</country></aff><aff id="AF0005"><sup>e</sup><institution>Faculté de Médecine, Université de Nice-Sophia Antipolis, Hôpital de l’Archet</institution>,<addr-line>Nice</addr-line>,<country>France</country></aff><aff id="AF0006"><sup>f</sup><institution>Concord Hospital, Gastroenterology and Liver Services, University of New South Wales</institution>,<addr-line>Sydney</addr-line>,<country>Australia</country></aff><aff id="AF0007"><sup>g</sup><institution>Division of Gastroenterology, St Paul’s Hospital</institution>,<addr-line>Vancouver, BC</addr-line>,<country>Canada</country></aff><aff id="AF0008"><sup>h</sup><institution>1st Department of Medicine, Semmelweis University</institution>,<addr-line>Budapest</addr-line>,<country>Hungary</country></aff><aff id="AF0009"><sup>i</sup><institution>Department of Internal Medicine III, Medical University of Vienna, Vienna, Austria, and McMaster University, Department of Internal Medicine</institution>,<addr-line>Hamilton, ON</addr-line>,<country>Canada</country></aff><aff id="AF0010"><sup>j</sup><institution>Bristol-Myers Squibb</institution>,<addr-line>Lawrenceville, NJ</addr-line>,<country>USA</country></aff><aff id="AF0011"><sup>k</sup><institution>Formerly of Bristol-Myers Squibb</institution>,<addr-line>Lawrenceville, NJ</addr-line>,<country>USA</country></aff></contrib-group><author-notes><corresp id="c1">Corresponding author: William J. Sandborn, MD, UCSD Inflammatory Bowel Disease Center, Division of Gastroenterology, UC San Diego Health System, 9500 Gilman Drive, La Jolla, CA 92093-0956, USA. Tel: <phone>+1 858 657 5284</phone>; fax: <fax>+1 858 657 5022;</fax> email: <email>wsandborn@ucsd.edu</email></corresp></author-notes><pub-date pub-type="ppub"><month>4</month><year>2016</year></pub-date><pub-date pub-type="epub"><day>30</day><month>12</month><year>2015</year></pub-date><volume>10</volume><issue>4</issue><fpage>418</fpage><lpage>428</lpage><history><date date-type="received"><day>8</day><month>9</month><year>2015</year></date><date date-type="rev-recd"><day>24</day><month>11</month><year>2015</year></date><date date-type="accepted"><day>30</day><month>11</month><year>2015</year></date></history><permissions><copyright-statement>Copyright © 2015 European Crohn’s and Colitis Organisation (ECCO). Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com</copyright-statement><copyright-year>2015</copyright-year></permissions><abstract><sec><title>Background and Aims:</title><p>Interferon-γ-inducible protein-10 [IP-10] mediates immune cell trafficking from the circulation to the inflamed colon and decreases gut epithelial cell survival. IP-10 expression is increased in patients with ulcerative colitis [UC]. We report efficacy and safety results from a dose-ranging induction study of eldelumab, a fully human monoclonal antibody to IP-10, in moderately to severely active UC.</p></sec><sec><title>Methods:</title><p>A total of 252 adults with UC [Mayo score ≥ 6 and endoscopic subscore ≥ 2] were randomised 1:1:1 to placebo or eldelumab 15 or 25 mg/kg administered intravenously on Days 1 and 8 and every other week thereafter. The primary endpoint was clinical remission [Mayo score ≤ 2; no individual subscale score > 1] at Week 11. Key secondary endpoints included Mayo score clinical response and mucosal healing at Week 11.</p></sec><sec><title>Results:</title><p>Neither eldelumab 15 or 25 mg/kg resulted in significant increases vs placebo in the proportion of patients achieving Week 11 clinical remission. Remission and response rates were 17.6% and 47.1% with eldelumab 25mg/kg, 13.1% and 44.0% with eldelumab 15mg/kg, and 9.6% and 31.3% with placebo. Clinical remission and response rates were higher in anti-tumour necrosis factor [TNF]-naïve patients treated with eldelumab compared with placebo. Eldelumab treatment was well tolerated and no immunogenicity was observed.</p></sec><sec><title>Conclusions:</title><p>The primary endpoint was not achieved with induction treatment with eldelumab 15 or 25 mg/kg in patients with UC. Trends towards clinical remission and response were observed in the overall population and were more pronounced in anti-TNF naïve patients. Eldelumab safety signals were consistent with those reported previously [ClinicalTrials.gov number, NCT01294410].</p></sec></abstract><kwd-group><title>Keywords:</title><kwd>Inflammatory bowel diseases</kwd><kwd>ulcerative colitis</kwd></kwd-group><counts><page-count count="11"></page-count></counts></article-meta></front></pmc></record>Pour manipuler ce document sous Unix (Dilib)
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