Eldelumab [Anti-IP-10] Induction Therapy for Ulcerative Colitis: A Randomised, Placebo-Controlled, Phase 2b Study
Identifieur interne : 002E61 ( Main/Exploration ); précédent : 002E60; suivant : 002E62Eldelumab [Anti-IP-10] Induction Therapy for Ulcerative Colitis: A Randomised, Placebo-Controlled, Phase 2b Study
Auteurs : William J. Sandborn [États-Unis] ; Jean-Frédéric Colombel [États-Unis] ; Subrata Ghosh [Canada] ; Bruce E. Sands [États-Unis] ; Gerald Dryden [États-Unis] ; Xavier Hébuterne [France] ; Rupert W. Leong [Australie] ; Brian Bressler [Canada] ; Thomas Ullman [États-Unis] ; Peter L. Lakatos [Hongrie] ; Walter Reinisch [Canada] ; Li-An Xu [États-Unis] ; Allison Luo [États-Unis]Source :
- Journal of Crohn's & Colitis [ 1873-9946 ] ; 2015.
Descripteurs français
- KwdFr :
- Adolescent, Adulte, Adulte d'âge moyen, Agents gastro-intestinaux (administration et posologie), Agents gastro-intestinaux (usage thérapeutique), Anticorps monoclonaux (usage thérapeutique), Chimiokine CXCL10 (antagonistes et inhibiteurs), Femelle, Humains, Induction de rémission, Jeune adulte, Mâle, Perfusions veineuses, Rectocolite hémorragique (traitement médicamenteux), Sujet âgé.
- MESH :
- administration et posologie : Agents gastro-intestinaux.
- antagonistes et inhibiteurs : Chimiokine CXCL10.
- traitement médicamenteux : Rectocolite hémorragique.
- usage thérapeutique : Agents gastro-intestinaux, Anticorps monoclonaux.
- Adolescent, Adulte, Adulte d'âge moyen, Femelle, Humains, Induction de rémission, Jeune adulte, Mâle, Perfusions veineuses, Sujet âgé.
English descriptors
- KwdEn :
- Adolescent, Adult, Aged, Antibodies, Monoclonal (therapeutic use), Chemokine CXCL10 (antagonists & inhibitors), Colitis, Ulcerative (drug therapy), Female, Gastrointestinal Agents (administration & dosage), Gastrointestinal Agents (therapeutic use), Humans, Infusions, Intravenous, Male, Middle Aged, Remission Induction, Young Adult.
- MESH :
- chemical , administration & dosage : Gastrointestinal Agents.
- chemical , antagonists & inhibitors : Chemokine CXCL10.
- chemical , therapeutic use : Antibodies, Monoclonal, Gastrointestinal Agents.
- drug therapy : Colitis, Ulcerative.
- Adolescent, Adult, Aged, Female, Humans, Infusions, Intravenous, Male, Middle Aged, Remission Induction, Young Adult.
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
Affiliations:
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Le document en format XML
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Sandborn</name><affiliation wicri:level="1"><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><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></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 wicri:level="1"><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><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Ghosh, Subrata" sort="Ghosh, Subrata" uniqKey="Ghosh S" first="Subrata" last="Ghosh">Subrata Ghosh</name><affiliation wicri:level="1"><nlm:aff id="AF0003"><institution>Department of Medicine, University of Calgary</institution>,<addr-line>Calgary, AB</addr-line>,<country>Canada</country></nlm:aff><country xml:lang="fr">Canada</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></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 wicri:level="1"><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><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Dryden, Gerald" sort="Dryden, Gerald" uniqKey="Dryden G" first="Gerald" last="Dryden">Gerald Dryden</name><affiliation wicri:level="1"><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><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Hebuterne, Xavier" sort="Hebuterne, Xavier" uniqKey="Hebuterne X" first="Xavier" last="Hébuterne">Xavier Hébuterne</name><affiliation wicri:level="1"><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><country xml:lang="fr">France</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></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 wicri:level="1"><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><country xml:lang="fr">Australie</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Bressler, Brian" sort="Bressler, Brian" uniqKey="Bressler B" first="Brian" last="Bressler">Brian Bressler</name><affiliation wicri:level="1"><nlm:aff id="AF0007"><institution>Division of Gastroenterology, St Paul’s Hospital</institution>,<addr-line>Vancouver, BC</addr-line>,<country>Canada</country></nlm:aff><country xml:lang="fr">Canada</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Ullman, Thomas" sort="Ullman, Thomas" uniqKey="Ullman T" first="Thomas" last="Ullman">Thomas Ullman</name><affiliation wicri:level="1"><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><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></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 wicri:level="1"><nlm:aff id="AF0008"><institution>1st Department of Medicine, Semmelweis University</institution>,<addr-line>Budapest</addr-line>,<country>Hungary</country></nlm:aff><country xml:lang="fr">Hongrie</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Reinisch, Walter" sort="Reinisch, Walter" uniqKey="Reinisch W" first="Walter" last="Reinisch">Walter Reinisch</name><affiliation wicri:level="1"><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><country xml:lang="fr">Canada</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="AF0010"><institution>Bristol-Myers Squibb</institution>,<addr-line>Lawrenceville, NJ</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" sort="Luo, Allison" uniqKey="Luo A" first="Allison" last="Luo">Allison Luo</name><affiliation wicri:level="1"><nlm:aff id="AF0011"><institution>Formerly of Bristol-Myers Squibb</institution>,<addr-line>Lawrenceville, NJ</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">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><keywords scheme="KwdEn" xml:lang="en"><term>Adolescent</term><term>Adult</term><term>Aged</term><term>Antibodies, Monoclonal (therapeutic use)</term><term>Chemokine CXCL10 (antagonists & inhibitors)</term><term>Colitis, Ulcerative (drug therapy)</term><term>Female</term><term>Gastrointestinal Agents (administration & dosage)</term><term>Gastrointestinal Agents (therapeutic use)</term><term>Humans</term><term>Infusions, Intravenous</term><term>Male</term><term>Middle Aged</term><term>Remission Induction</term><term>Young Adult</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Adolescent</term><term>Adulte</term><term>Adulte d'âge moyen</term><term>Agents gastro-intestinaux (administration et posologie)</term><term>Agents gastro-intestinaux (usage thérapeutique)</term><term>Anticorps monoclonaux (usage thérapeutique)</term><term>Chimiokine CXCL10 (antagonistes et inhibiteurs)</term><term>Femelle</term><term>Humains</term><term>Induction de rémission</term><term>Jeune adulte</term><term>Mâle</term><term>Perfusions veineuses</term><term>Rectocolite hémorragique (traitement médicamenteux)</term><term>Sujet âgé</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Gastrointestinal Agents</term></keywords><keywords scheme="MESH" type="chemical" qualifier="antagonists & inhibitors" xml:lang="en"><term>Chemokine CXCL10</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Antibodies, Monoclonal</term><term>Gastrointestinal Agents</term></keywords><keywords scheme="MESH" qualifier="administration et posologie" xml:lang="fr"><term>Agents gastro-intestinaux</term></keywords><keywords scheme="MESH" qualifier="antagonistes et inhibiteurs" xml:lang="fr"><term>Chimiokine CXCL10</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Colitis, Ulcerative</term></keywords><keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr"><term>Rectocolite hémorragique</term></keywords><keywords scheme="MESH" qualifier="usage thérapeutique" xml:lang="fr"><term>Agents gastro-intestinaux</term><term>Anticorps monoclonaux</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adolescent</term><term>Adult</term><term>Aged</term><term>Female</term><term>Humans</term><term>Infusions, Intravenous</term><term>Male</term><term>Middle Aged</term><term>Remission Induction</term><term>Young Adult</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Adolescent</term><term>Adulte</term><term>Adulte d'âge moyen</term><term>Femelle</term><term>Humains</term><term>Induction de rémission</term><term>Jeune adulte</term><term>Mâle</term><term>Perfusions veineuses</term><term>Sujet âgé</term></keywords></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><affiliations><list><country><li>Australie</li><li>Canada</li><li>France</li><li>Hongrie</li><li>États-Unis</li></country></list><tree><country name="États-Unis"><noRegion><name sortKey="Sandborn, William J" sort="Sandborn, William J" uniqKey="Sandborn W" first="William J." last="Sandborn">William J. Sandborn</name></noRegion><name sortKey="Colombel, Jean Frederic" sort="Colombel, Jean Frederic" uniqKey="Colombel J" first="Jean-Frédéric" last="Colombel">Jean-Frédéric Colombel</name><name sortKey="Dryden, Gerald" sort="Dryden, Gerald" uniqKey="Dryden G" first="Gerald" last="Dryden">Gerald Dryden</name><name sortKey="Luo, Allison" sort="Luo, Allison" uniqKey="Luo A" first="Allison" last="Luo">Allison Luo</name><name sortKey="Sands, Bruce E" sort="Sands, Bruce E" uniqKey="Sands B" first="Bruce E." last="Sands">Bruce E. Sands</name><name sortKey="Ullman, Thomas" sort="Ullman, Thomas" uniqKey="Ullman T" first="Thomas" last="Ullman">Thomas Ullman</name><name sortKey="Xu, Li An" sort="Xu, Li An" uniqKey="Xu L" first="Li-An" last="Xu">Li-An Xu</name></country><country name="Canada"><noRegion><name sortKey="Ghosh, Subrata" sort="Ghosh, Subrata" uniqKey="Ghosh S" first="Subrata" last="Ghosh">Subrata Ghosh</name></noRegion><name sortKey="Bressler, Brian" sort="Bressler, Brian" uniqKey="Bressler B" first="Brian" last="Bressler">Brian Bressler</name><name sortKey="Reinisch, Walter" sort="Reinisch, Walter" uniqKey="Reinisch W" first="Walter" last="Reinisch">Walter Reinisch</name></country><country name="France"><noRegion><name sortKey="Hebuterne, Xavier" sort="Hebuterne, Xavier" uniqKey="Hebuterne X" first="Xavier" last="Hébuterne">Xavier Hébuterne</name></noRegion></country><country name="Australie"><noRegion><name sortKey="Leong, Rupert W" sort="Leong, Rupert W" uniqKey="Leong R" first="Rupert W." last="Leong">Rupert W. Leong</name></noRegion></country><country name="Hongrie"><noRegion><name sortKey="Lakatos, Peter L" sort="Lakatos, Peter L" uniqKey="Lakatos P" first="Peter L." last="Lakatos">Peter L. Lakatos</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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