WillowV1, Main, Exploration, bibRecord, 000416

Randomised trial and open-label extension study of an anti-interleukin-6 antibody in Crohn's disease (ANDANTE I and II).

Identifieur interne : 000416 ( Main/Exploration ); précédent : 000415; suivant : 000417

Randomised trial and open-label extension study of an anti-interleukin-6 antibody in Crohn's disease (ANDANTE I and II).

Auteurs : Silvio Danese [Italie] ; Séverine Vermeire [Belgique] ; Paul Hellstern [États-Unis] ; Remo Panaccione [Canada] ; Gerhard Rogler [Suisse] ; Gerald Fraser [Israël] ; Anna Kohn [Italie] ; Pierre Desreumaux [France] ; Rupert W. Leong [Australie] ; Gail M. Comer [États-Unis] ; Fabio Cataldi [États-Unis] ; Anindita Banerjee [États-Unis] ; Mary K. Maguire [États-Unis] ; Cheryl Li [États-Unis] ; Natalie Rath [États-Unis] ; Jean Beebe [États-Unis] ; Stefan Schreiber [Allemagne]

Source :

Gut [ 1468-3288 ] ; 2019.

RBID : pubmed:29247068

Descripteurs français

KwdFr :
- Adolescent (MeSH), Adulte (MeSH), Adulte d'âge moyen (MeSH), Anticorps monoclonaux humanisés (administration et posologie), Anticorps monoclonaux humanisés (effets indésirables), Anticorps monoclonaux humanisés (usage thérapeutique), Femelle (MeSH), Humains (MeSH), Indice de gravité de la maladie (MeSH), Maladie de Crohn (traitement médicamenteux), Mâle (MeSH), Méthode en double aveugle (MeSH), Résultat thérapeutique (MeSH), Sujet âgé (MeSH).
MESH :
- administration et posologie : Anticorps monoclonaux humanisés.
- effets indésirables : Anticorps monoclonaux humanisés.
- traitement médicamenteux : Maladie de Crohn.
- usage thérapeutique : Anticorps monoclonaux humanisés.
- Adolescent, Adulte, Adulte d'âge moyen, Femelle, Humains, Indice de gravité de la maladie, Mâle, Méthode en double aveugle, Résultat thérapeutique, Sujet âgé.

English descriptors

KwdEn :
- Adolescent (MeSH), Adult (MeSH), Aged (MeSH), Antibodies, Monoclonal, Humanized (administration & dosage), Antibodies, Monoclonal, Humanized (adverse effects), Antibodies, Monoclonal, Humanized (therapeutic use), Crohn Disease (drug therapy), Double-Blind Method (MeSH), Female (MeSH), Humans (MeSH), Male (MeSH), Middle Aged (MeSH), Severity of Illness Index (MeSH), Treatment Outcome (MeSH).
MESH :
- chemical , administration & dosage : Antibodies, Monoclonal, Humanized.
- chemical , adverse effects : Antibodies, Monoclonal, Humanized.
- chemical , therapeutic use : Antibodies, Monoclonal, Humanized.
- drug therapy : Crohn Disease.
- Adolescent, Adult, Aged, Double-Blind Method, Female, Humans, Male, Middle Aged, Severity of Illness Index, Treatment Outcome.

Abstract

OBJECTIVE

Neutralising pro-inflammatory interleukin-6 (IL-6) may effectively treat Crohn's disease (CD). Effects of PF-04236921, an anti-IL-6 antibody, in adults with CD are reported.

DESIGN

Parallel-group, dose-ranging, double-blind trial with 4-week screening and 12-week treatment periods. After induction, patients entered 28-week follow-up or 48-week open-label extension (OLE) with 28-week follow-up. Adults with confirmed CD and inadequate response to anti-tumour necrosis factor (TNF) therapy were included.

RESULTS

247 patients were randomised and received treatment in the induction study. The 200 mg dose was discontinued due to safety findings in another study (NCT01405196) and was not included in the primary efficacy analysis. Crohn's Disease Activity Index (CDAI)-70 response rates with PF-04236921 50 mg were significantly greater than placebo at weeks 8 (49.3% vs 30.6%, P<0.05) and 12 (47.4% vs 28.6%, P<0.05) and met the primary end point. Week 12 CDAI remission rates with PF-04236921 50 mg and placebo were 27.4% and 10.9%, respectively (16.5% difference; P<0.05). 191 subjects received treatment in the OLE. Common treatment-emergent and serious adverse events in both studies included worsening CD, abdominal pain and nasopharyngitis.

CONCLUSIONS

PF-04236921 50 mg induced clinical response and remission in refractory patients with moderate-to-severe CD following failure of anti-TNF therapy. GI abscess and perforation were observed, a specific focus of attention during future clinical development.

TRIAL REGISTRATION NUMBER

NCT01287897 and NCT01345318.

DOI: 10.1136/gutjnl-2017-314562
PubMed: 29247068
PubMed Central: PMC6839832

Affiliations:

Allemagne, Australie, Belgique, Canada, France, Israël, Italie, Suisse, États-Unis
Alberta, Canton de Zurich, Floride, Hauts-de-France, Latium, Lombardie, Massachusetts, Nord-Pas-de-Calais, Pennsylvanie, Schleswig-Holstein
Calgary, Kiel, Lille, Milan, Rome, Zurich
Université de Calgary, Université de Zurich

Links toward previous steps (curation, corpus...)

to stream Main, to step Corpus: 000812
to stream Main, to step Curation: 000812

Le document en format XML

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<sourceDesc><biblStruct><analytic><title xml:lang="en">Randomised trial and open-label extension study of an anti-interleukin-6 antibody in Crohn's disease (ANDANTE I and II).</title>
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<author><name sortKey="Fraser, Gerald" sort="Fraser, Gerald" uniqKey="Fraser G" first="Gerald" last="Fraser">Gerald Fraser</name>
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<country xml:lang="fr">Israël</country>
<wicri:regionArea>Division of Gastroenterology, Rabin Medical Center, University of Tel-Aviv, Petah Tikva</wicri:regionArea>
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<author><name sortKey="Kohn, Anna" sort="Kohn, Anna" uniqKey="Kohn A" first="Anna" last="Kohn">Anna Kohn</name>
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<country xml:lang="fr">Italie</country>
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</author>
<author><name sortKey="Desreumaux, Pierre" sort="Desreumaux, Pierre" uniqKey="Desreumaux P" first="Pierre" last="Desreumaux">Pierre Desreumaux</name>
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<country xml:lang="fr">France</country>
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<region type="old region">Nord-Pas-de-Calais</region>
<settlement type="city">Lille</settlement>
</placeName>
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</author>
<author><name sortKey="Leong, Rupert W" sort="Leong, Rupert W" uniqKey="Leong R" first="Rupert W" last="Leong">Rupert W. Leong</name>
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<country xml:lang="fr">Australie</country>
<wicri:regionArea>Inflammatory Bowel Diseases Service, Concord Hospital, Sydney, New South Wales</wicri:regionArea>
<wicri:noRegion>New South Wales</wicri:noRegion>
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</author>
<author><name sortKey="Comer, Gail M" sort="Comer, Gail M" uniqKey="Comer G" first="Gail M" last="Comer">Gail M. Comer</name>
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<author><name sortKey="Cataldi, Fabio" sort="Cataldi, Fabio" uniqKey="Cataldi F" first="Fabio" last="Cataldi">Fabio Cataldi</name>
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</placeName>
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<author><name sortKey="Banerjee, Anindita" sort="Banerjee, Anindita" uniqKey="Banerjee A" first="Anindita" last="Banerjee">Anindita Banerjee</name>
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<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Worldwide Research and Development, Pfizer Inc, Cambridge, Massachusetts</wicri:regionArea>
<placeName><region type="state">Massachusetts</region>
</placeName>
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<author><name sortKey="Maguire, Mary K" sort="Maguire, Mary K" uniqKey="Maguire M" first="Mary K" last="Maguire">Mary K. Maguire</name>
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</placeName>
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<author><name sortKey="Li, Cheryl" sort="Li, Cheryl" uniqKey="Li C" first="Cheryl" last="Li">Cheryl Li</name>
<affiliation wicri:level="2"><nlm:affiliation>Worldwide Research and Development, Pfizer Inc, Cambridge, Massachusetts, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Worldwide Research and Development, Pfizer Inc, Cambridge, Massachusetts</wicri:regionArea>
<placeName><region type="state">Massachusetts</region>
</placeName>
</affiliation>
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<author><name sortKey="Rath, Natalie" sort="Rath, Natalie" uniqKey="Rath N" first="Natalie" last="Rath">Natalie Rath</name>
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<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Worldwide Research and Development, Pfizer Inc, Collegeville, Pennsylvania</wicri:regionArea>
<placeName><region type="state">Pennsylvanie</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Beebe, Jean" sort="Beebe, Jean" uniqKey="Beebe J" first="Jean" last="Beebe">Jean Beebe</name>
<affiliation wicri:level="2"><nlm:affiliation>Worldwide Research and Development, Pfizer Inc, Cambridge, Massachusetts, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Worldwide Research and Development, Pfizer Inc, Cambridge, Massachusetts</wicri:regionArea>
<placeName><region type="state">Massachusetts</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Schreiber, Stefan" sort="Schreiber, Stefan" uniqKey="Schreiber S" first="Stefan" last="Schreiber">Stefan Schreiber</name>
<affiliation wicri:level="3"><nlm:affiliation>Department of Medicine I, Christian-Albrechts-University and University Hospital Schleswig-Holstein, Kiel, Germany.</nlm:affiliation>
<country xml:lang="fr">Allemagne</country>
<wicri:regionArea>Department of Medicine I, Christian-Albrechts-University and University Hospital Schleswig-Holstein, Kiel</wicri:regionArea>
<placeName><region type="land" nuts="2">Schleswig-Holstein</region>
<settlement type="city">Kiel</settlement>
</placeName>
</affiliation>
</author>
</analytic>
<series><title level="j">Gut</title>
<idno type="eISSN">1468-3288</idno>
<imprint><date when="2019" type="published">2019</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
</fileDesc>
<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adolescent (MeSH)</term>
<term>Adult (MeSH)</term>
<term>Aged (MeSH)</term>
<term>Antibodies, Monoclonal, Humanized (administration & dosage)</term>
<term>Antibodies, Monoclonal, Humanized (adverse effects)</term>
<term>Antibodies, Monoclonal, Humanized (therapeutic use)</term>
<term>Crohn Disease (drug therapy)</term>
<term>Double-Blind Method (MeSH)</term>
<term>Female (MeSH)</term>
<term>Humans (MeSH)</term>
<term>Male (MeSH)</term>
<term>Middle Aged (MeSH)</term>
<term>Severity of Illness Index (MeSH)</term>
<term>Treatment Outcome (MeSH)</term>
</keywords>
<keywords scheme="KwdFr" xml:lang="fr"><term>Adolescent (MeSH)</term>
<term>Adulte (MeSH)</term>
<term>Adulte d'âge moyen (MeSH)</term>
<term>Anticorps monoclonaux humanisés (administration et posologie)</term>
<term>Anticorps monoclonaux humanisés (effets indésirables)</term>
<term>Anticorps monoclonaux humanisés (usage thérapeutique)</term>
<term>Femelle (MeSH)</term>
<term>Humains (MeSH)</term>
<term>Indice de gravité de la maladie (MeSH)</term>
<term>Maladie de Crohn (traitement médicamenteux)</term>
<term>Mâle (MeSH)</term>
<term>Méthode en double aveugle (MeSH)</term>
<term>Résultat thérapeutique (MeSH)</term>
<term>Sujet âgé (MeSH)</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Antibodies, Monoclonal, Humanized</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Antibodies, Monoclonal, Humanized</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Antibodies, Monoclonal, Humanized</term>
</keywords>
<keywords scheme="MESH" qualifier="administration et posologie" xml:lang="fr"><term>Anticorps monoclonaux humanisés</term>
</keywords>
<keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Crohn Disease</term>
</keywords>
<keywords scheme="MESH" qualifier="effets indésirables" xml:lang="fr"><term>Anticorps monoclonaux humanisés</term>
</keywords>
<keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr"><term>Maladie de Crohn</term>
</keywords>
<keywords scheme="MESH" qualifier="usage thérapeutique" xml:lang="fr"><term>Anticorps monoclonaux humanisés</term>
</keywords>
<keywords scheme="MESH" xml:lang="en"><term>Adolescent</term>
<term>Adult</term>
<term>Aged</term>
<term>Double-Blind Method</term>
<term>Female</term>
<term>Humans</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Severity of Illness Index</term>
<term>Treatment Outcome</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>Indice de gravité de la maladie</term>
<term>Mâle</term>
<term>Méthode en double aveugle</term>
<term>Résultat thérapeutique</term>
<term>Sujet âgé</term>
</keywords>
</textClass>
</profileDesc>
</teiHeader>
<front><div type="abstract" xml:lang="en"><p><b>OBJECTIVE</b>
</p>
<p>Neutralising pro-inflammatory interleukin-6 (IL-6) may effectively treat Crohn's disease (CD). Effects of PF-04236921, an anti-IL-6 antibody, in adults with CD are reported.</p>
</div>
<div type="abstract" xml:lang="en"><p><b>DESIGN</b>
</p>
<p>Parallel-group, dose-ranging, double-blind trial with 4-week screening and 12-week treatment periods. After induction, patients entered 28-week follow-up or 48-week open-label extension (OLE) with 28-week follow-up. Adults with confirmed CD and inadequate response to anti-tumour necrosis factor (TNF) therapy were included. </p>
</div>
<div type="abstract" xml:lang="en"><p><b>RESULTS</b>
</p>
<p>247 patients were randomised and received treatment in the induction study. The 200 mg dose was discontinued due to safety findings in another study (NCT01405196) and was not included in the primary efficacy analysis. Crohn's Disease Activity Index (CDAI)-70 response rates with PF-04236921 50 mg were significantly greater than placebo at weeks 8 (49.3% vs 30.6%, P<0.05) and 12 (47.4% vs 28.6%, P<0.05) and met the primary end point. Week 12 CDAI remission rates with PF-04236921 50 mg and placebo were 27.4% and 10.9%, respectively (16.5% difference; P<0.05). 191 subjects received treatment in the OLE. Common treatment-emergent and serious adverse events in both studies included worsening CD, abdominal pain and nasopharyngitis.</p>
</div>
<div type="abstract" xml:lang="en"><p><b>CONCLUSIONS</b>
</p>
<p>PF-04236921 50 mg induced clinical response and remission in refractory patients with moderate-to-severe CD following failure of anti-TNF therapy. GI abscess and perforation were observed, a specific focus of attention during future clinical development.</p>
</div>
<div type="abstract" xml:lang="en"><p><b>TRIAL REGISTRATION NUMBER</b>
</p>
<p>NCT01287897 and NCT01345318.</p>
</div>
</front>
</TEI>
<pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">29247068</PMID>
<DateCompleted><Year>2018</Year>
<Month>12</Month>
<Day>31</Day>
</DateCompleted>
<DateRevised><Year>2019</Year>
<Month>12</Month>
<Day>10</Day>
</DateRevised>
<Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1468-3288</ISSN>
<JournalIssue CitedMedium="Internet"><Volume>68</Volume>
<Issue>1</Issue>
<PubDate><Year>2019</Year>
<Month>01</Month>
</PubDate>
</JournalIssue>
<Title>Gut</Title>
<ISOAbbreviation>Gut</ISOAbbreviation>
</Journal>
<ArticleTitle>Randomised trial and open-label extension study of an anti-interleukin-6 antibody in Crohn's disease (ANDANTE I and II).</ArticleTitle>
<Pagination><MedlinePgn>40-48</MedlinePgn>
</Pagination>
<ELocationID EIdType="doi" ValidYN="Y">10.1136/gutjnl-2017-314562</ELocationID>
<Abstract><AbstractText Label="OBJECTIVE">Neutralising pro-inflammatory interleukin-6 (IL-6) may effectively treat Crohn's disease (CD). Effects of PF-04236921, an anti-IL-6 antibody, in adults with CD are reported.</AbstractText>
<AbstractText Label="DESIGN">Parallel-group, dose-ranging, double-blind trial with 4-week screening and 12-week treatment periods. After induction, patients entered 28-week follow-up or 48-week open-label extension (OLE) with 28-week follow-up. Adults with confirmed CD and inadequate response to anti-tumour necrosis factor (TNF) therapy were included. <i>Induction study</i>
: 249 patients randomised 1:1:1:1 to placebo, PF-04236921 10, 50 or 200 mg by subcutaneous injection on days 1 and 28. <i>OLE study</i>
: PF-04236921 50 mg every 8 weeks up to six doses followed by 28-week follow-up.</AbstractText>
<AbstractText Label="RESULTS">247 patients were randomised and received treatment in the induction study. The 200 mg dose was discontinued due to safety findings in another study (NCT01405196) and was not included in the primary efficacy analysis. Crohn's Disease Activity Index (CDAI)-70 response rates with PF-04236921 50 mg were significantly greater than placebo at weeks 8 (49.3% vs 30.6%, P<0.05) and 12 (47.4% vs 28.6%, P<0.05) and met the primary end point. Week 12 CDAI remission rates with PF-04236921 50 mg and placebo were 27.4% and 10.9%, respectively (16.5% difference; P<0.05). 191 subjects received treatment in the OLE. Common treatment-emergent and serious adverse events in both studies included worsening CD, abdominal pain and nasopharyngitis.</AbstractText>
<AbstractText Label="CONCLUSIONS">PF-04236921 50 mg induced clinical response and remission in refractory patients with moderate-to-severe CD following failure of anti-TNF therapy. GI abscess and perforation were observed, a specific focus of attention during future clinical development.</AbstractText>
<AbstractText Label="TRIAL REGISTRATION NUMBER">NCT01287897 and NCT01345318.</AbstractText>
<CopyrightInformation>© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2019. All rights reserved. No commercial use is permitted unless otherwise expressly granted.</CopyrightInformation>
</Abstract>
<AuthorList CompleteYN="Y"><Author ValidYN="Y" EqualContrib="Y"><LastName>Danese</LastName>
<ForeName>Silvio</ForeName>
<Initials>S</Initials>
<AffiliationInfo><Affiliation>Gastrointestinal Immunopathology Lab and IBD Unit, Humanitas Clinical and Research Center and Humanitas University, Milan, Italy.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Vermeire</LastName>
<ForeName>Séverine</ForeName>
<Initials>S</Initials>
<AffiliationInfo><Affiliation>Department of Gastroenterology, University Hospitals Leuven, Leuven, Belgium.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Hellstern</LastName>
<ForeName>Paul</ForeName>
<Initials>P</Initials>
<AffiliationInfo><Affiliation>Nature Coast Clinical Research, Inverness, Florida, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Panaccione</LastName>
<ForeName>Remo</ForeName>
<Initials>R</Initials>
<AffiliationInfo><Affiliation>Inflammatory Bowel Disease Clinic, University of Calgary, Calgary, Canada.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Rogler</LastName>
<ForeName>Gerhard</ForeName>
<Initials>G</Initials>
<AffiliationInfo><Affiliation>Department of Gastroenterology and Hepatology, University of Zürich, Zürich, Switzerland.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Fraser</LastName>
<ForeName>Gerald</ForeName>
<Initials>G</Initials>
<AffiliationInfo><Affiliation>Division of Gastroenterology, Rabin Medical Center, University of Tel-Aviv, Petah Tikva, Israel.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Kohn</LastName>
<ForeName>Anna</ForeName>
<Initials>A</Initials>
<AffiliationInfo><Affiliation>UOC Gastroenterologia, AO San Camillo Forlanini, Rome, Italy.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Desreumaux</LastName>
<ForeName>Pierre</ForeName>
<Initials>P</Initials>
<AffiliationInfo><Affiliation>Lille University School of Medicine, University of Lille, Inserm U995, Lille, France.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Leong</LastName>
<ForeName>Rupert W</ForeName>
<Initials>RW</Initials>
<Identifier Source="ORCID">0000-0001-5944-3488</Identifier>
<AffiliationInfo><Affiliation>Inflammatory Bowel Diseases Service, Concord Hospital, Sydney, New South Wales, Australia.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Comer</LastName>
<ForeName>Gail M</ForeName>
<Initials>GM</Initials>
<AffiliationInfo><Affiliation>Formerly of Worldwide Research and Development, Pfizer Inc, Cambridge, Massachusetts, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Cataldi</LastName>
<ForeName>Fabio</ForeName>
<Initials>F</Initials>
<AffiliationInfo><Affiliation>Formerly of Worldwide Research and Development, Pfizer Inc, Cambridge, Massachusetts, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Banerjee</LastName>
<ForeName>Anindita</ForeName>
<Initials>A</Initials>
<AffiliationInfo><Affiliation>Worldwide Research and Development, Pfizer Inc, Cambridge, Massachusetts, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Maguire</LastName>
<ForeName>Mary K</ForeName>
<Initials>MK</Initials>
<AffiliationInfo><Affiliation>Worldwide Research and Development, Pfizer Inc, Collegeville, Pennsylvania, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Li</LastName>
<ForeName>Cheryl</ForeName>
<Initials>C</Initials>
<AffiliationInfo><Affiliation>Worldwide Research and Development, Pfizer Inc, Cambridge, Massachusetts, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Rath</LastName>
<ForeName>Natalie</ForeName>
<Initials>N</Initials>
<AffiliationInfo><Affiliation>Worldwide Research and Development, Pfizer Inc, Collegeville, Pennsylvania, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Beebe</LastName>
<ForeName>Jean</ForeName>
<Initials>J</Initials>
<AffiliationInfo><Affiliation>Worldwide Research and Development, Pfizer Inc, Cambridge, Massachusetts, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y" EqualContrib="Y"><LastName>Schreiber</LastName>
<ForeName>Stefan</ForeName>
<Initials>S</Initials>
<AffiliationInfo><Affiliation>Department of Medicine I, Christian-Albrechts-University and University Hospital Schleswig-Holstein, Kiel, Germany.</Affiliation>
</AffiliationInfo>
</Author>
</AuthorList>
<Language>eng</Language>
<DataBankList CompleteYN="Y"><DataBank><DataBankName>ClinicalTrials.gov</DataBankName>
<AccessionNumberList><AccessionNumber>NCT01287897</AccessionNumber>
<AccessionNumber>NCT01345318</AccessionNumber>
</AccessionNumberList>
</DataBank>
</DataBankList>
<PublicationTypeList><PublicationType UI="D017427">Clinical Trial, Phase II</PublicationType>
<PublicationType UI="D016428">Journal Article</PublicationType>
<PublicationType UI="D016448">Multicenter Study</PublicationType>
<PublicationType UI="D016449">Randomized Controlled Trial</PublicationType>
<PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType>
</PublicationTypeList>
<ArticleDate DateType="Electronic"><Year>2017</Year>
<Month>12</Month>
<Day>15</Day>
</ArticleDate>
</Article>
<MedlineJournalInfo><Country>England</Country>
<MedlineTA>Gut</MedlineTA>
<NlmUniqueID>2985108R</NlmUniqueID>
<ISSNLinking>0017-5749</ISSNLinking>
</MedlineJournalInfo>
<ChemicalList><Chemical><RegistryNumber>0</RegistryNumber>
<NameOfSubstance UI="D061067">Antibodies, Monoclonal, Humanized</NameOfSubstance>
</Chemical>
<Chemical><RegistryNumber>2NHW9AKY9C</RegistryNumber>
<NameOfSubstance UI="C000620303">PF-04236921</NameOfSubstance>
</Chemical>
</ChemicalList>
<CitationSubset>AIM</CitationSubset>
<CitationSubset>IM</CitationSubset>
<MeshHeadingList><MeshHeading><DescriptorName UI="D000293" MajorTopicYN="N">Adolescent</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D000328" MajorTopicYN="N">Adult</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D000368" MajorTopicYN="N">Aged</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D061067" MajorTopicYN="N">Antibodies, Monoclonal, Humanized</DescriptorName>
<QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName>
<QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName>
<QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D003424" MajorTopicYN="N">Crohn Disease</DescriptorName>
<QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D004311" MajorTopicYN="N">Double-Blind Method</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D008875" MajorTopicYN="N">Middle Aged</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D012720" MajorTopicYN="N">Severity of Illness Index</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D016896" MajorTopicYN="N">Treatment Outcome</DescriptorName>
</MeshHeading>
</MeshHeadingList>
<KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="Y">anti-IL6 antibody</Keyword>
<Keyword MajorTopicYN="Y">anti-TNF</Keyword>
<Keyword MajorTopicYN="Y">crohn’s disease</Keyword>
<Keyword MajorTopicYN="Y">inadequate response</Keyword>
</KeywordList>
<CoiStatement>Competing interests: SD is a speaker, consultant and advisory board member for Abbott Laboratories, AbbVie, Actelion, Alphawasserman, AstraZeneca, Cellerix, Cosmo Pharmaceuticals, Ferring, Genentech, Grunenthal, Hospira, Johnson and Johnson, Merck & Co, Millennium Takeda, Mundipharma, Novo Nordisk, Nycomed, Pharmacosmos, Pfizer, Schering-Plough, UCB Pharma and Vifor. SV received research support from AbbVie, MSD and Takeda and received consultancy and/or speaker honoraria from AbbVie, Celgene, Centocor, Ferring, Galapagos, Genentech/Roche, Hospira, MSD, Mundipharma, Pfizer, Shire and Takeda. PH is a consultant and/or advisory board participant for, and/or has received speaker honoraria, research support and/or educational grants from, Cubist, Evoke, Ferring, Forest, Furiex, Gilead, GlaxoSmithKline, Intercept, Ironwood, Menarini, Nature Coast Clinical Research, Pfizer, Rhythm, Salix, Synergy, Takeda, Theravance and Vivus. RP is a consultant for and/or received lecture fees from Abbott, AbbVie, Allergan, Amgen, AstraZeneca, Axcan Pharma, Biogen Idec, Bristol-Myers Squibb, Centocor, ChemoCentryx, Eisai Medical Research, ELAN, Ferring, Genentech, GlaxoSmithKline, Janssen, Millennium, MSD, Ocera Therapeutics, Otsuka America Pharmaceuticals, Pfizer, Shire Pharmaceuticals, Prometheus, Robarts Clinical Trials, Schering-Plough, Synta Pharmaceuticals, Takeda, Teva, UCB Pharma and Warner Chilcott. GR is a consultant for Abbott, AbbVie, Augurix, Boehringer, Calypso, FALK, Ferring, Fisher, Genentech, Essex/MSD, Novartis, Pfizer, Phadia, Roche, Takeda, Tillots, UCB, Vifor, Vital Solutions and Zeller; received speaker honoraria from AstraZeneca, Abbott, AbbVie, FALK, MSD, Phadia, Tillots, UCB and Vifor; and received educational grants and research grants from Abbot, AbbVie, Ardeypharm, Augurix, Calypso, Essex/MSD, FALK, Flamentera, Novartis, Roche, Takeda, Tillots, UCB and Zeller. AK received educational grants from AbbVie, MSD and Takeda. PD participated in advisory boards for, and received fees and grants from, AbbVie, Biofortis, BioMérieux Danone, Ferring, Genfit, Intralytix, Kitozyme, Lesaffre, MSD, Norgine, OmegaPharma International, Pileje, PPM, Roquette, Takeda and TxCell. RWL participated in advisory boards for AbbVie, Aspen, Ferring, Janssen, Hospira and Takeda and received research support from Janssen, NHMRC Career Development Fellowship and Shire. SS received consultancy fees from AbbVie, Bristol-Myers Squibb, Boehringer, Ferring, Genentech/Roche, Pfizer, MSD/Janssen, Takeda and UCB and lecture fees from AbbVie, MSD/Janssen, Takeda and UCB. AB, MKM, CL, NR and JB are all employees of Pfizer Inc and hold stock or options in Pfizer Inc. GMC and FC are former employees of Pfizer Inc and FC is a current employee of Shire Pharmaceuticals. GF has no conflicts of interest to report. GMC has been a consultant for Adare, Albireo, AstraZeneca, CinRx, Cutis, OrphoMed, Second Genome, Strongbridge and Zealand.</CoiStatement>
</MedlineCitation>
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<PubMedPubDate PubStatus="revised"><Year>2017</Year>
<Month>11</Month>
<Day>20</Day>
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<PubMedPubDate PubStatus="accepted"><Year>2017</Year>
<Month>11</Month>
<Day>22</Day>
</PubMedPubDate>
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<Month>12</Month>
<Day>17</Day>
<Hour>6</Hour>
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<ReferenceList><Reference><Citation>Aliment Pharmacol Ther. 2016 Jan;43(1):30-51</Citation>
<ArticleIdList><ArticleId IdType="pubmed">26515897</ArticleId>
</ArticleIdList>
</Reference>
<Reference><Citation>N Engl J Med. 2016 Nov 17;375(20):1946-1960</Citation>
<ArticleIdList><ArticleId IdType="pubmed">27959607</ArticleId>
</ArticleIdList>
</Reference>
<Reference><Citation>N Engl J Med. 2007 Jul 19;357(3):228-38</Citation>
<ArticleIdList><ArticleId IdType="pubmed">17634458</ArticleId>
</ArticleIdList>
</Reference>
<Reference><Citation>Gastroenterology. 2007 Jan;132(1):52-65</Citation>
<ArticleIdList><ArticleId IdType="pubmed">17241859</ArticleId>
</ArticleIdList>
</Reference>
<Reference><Citation>Semin Arthritis Rheum. 2015 Feb;44(4):381-8</Citation>
<ArticleIdList><ArticleId IdType="pubmed">25300699</ArticleId>
</ArticleIdList>
</Reference>
<Reference><Citation>N Engl J Med. 2013 Aug 22;369(8):711-21</Citation>
<ArticleIdList><ArticleId IdType="pubmed">23964933</ArticleId>
</ArticleIdList>
</Reference>
<Reference><Citation>Curr Drug Targets. 2013 Nov;14(12):1508-21</Citation>
<ArticleIdList><ArticleId IdType="pubmed">24102406</ArticleId>
</ArticleIdList>
</Reference>
<Reference><Citation>Lancet. 2002 May 4;359(9317):1541-9</Citation>
<ArticleIdList><ArticleId IdType="pubmed">12047962</ArticleId>
</ArticleIdList>
</Reference>
<Reference><Citation>Gastroenterology. 2007 May;132(5):1672-83</Citation>
<ArticleIdList><ArticleId IdType="pubmed">17484865</ArticleId>
</ArticleIdList>
</Reference>
<Reference><Citation>Am Fam Physician. 2011 Dec 15;84(12):1365-75</Citation>
<ArticleIdList><ArticleId IdType="pubmed">22230271</ArticleId>
</ArticleIdList>
</Reference>
<Reference><Citation>Gastroenterology. 2004 Apr;126(4):989-96; discussion 947</Citation>
<ArticleIdList><ArticleId IdType="pubmed">15057738</ArticleId>
</ArticleIdList>
</Reference>
<Reference><Citation>Clin Rheumatol. 2011 Nov;30(11):1471-4</Citation>
<ArticleIdList><ArticleId IdType="pubmed">21833686</ArticleId>
</ArticleIdList>
</Reference>
<Reference><Citation>Ann Rheum Dis. 2017 Mar;76(3):534-542</Citation>
<ArticleIdList><ArticleId IdType="pubmed">27672124</ArticleId>
</ArticleIdList>
</Reference>
</ReferenceList>
</PubmedData>
</pubmed>
<affiliations><list><country><li>Allemagne</li>
<li>Australie</li>
<li>Belgique</li>
<li>Canada</li>
<li>France</li>
<li>Israël</li>
<li>Italie</li>
<li>Suisse</li>
<li>États-Unis</li>
</country>
<region><li>Alberta</li>
<li>Canton de Zurich</li>
<li>Floride</li>
<li>Hauts-de-France</li>
<li>Latium</li>
<li>Lombardie</li>
<li>Massachusetts</li>
<li>Nord-Pas-de-Calais</li>
<li>Pennsylvanie</li>
<li>Schleswig-Holstein</li>
</region>
<settlement><li>Calgary</li>
<li>Kiel</li>
<li>Lille</li>
<li>Milan</li>
<li>Rome</li>
<li>Zurich</li>
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<orgName><li>Université de Calgary</li>
<li>Université de Zurich</li>
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</list>
<tree><country name="Italie"><region name="Lombardie"><name sortKey="Danese, Silvio" sort="Danese, Silvio" uniqKey="Danese S" first="Silvio" last="Danese">Silvio Danese</name>
</region>
<name sortKey="Kohn, Anna" sort="Kohn, Anna" uniqKey="Kohn A" first="Anna" last="Kohn">Anna Kohn</name>
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   |texte=   Randomised trial and open-label extension study of an anti-interleukin-6 antibody in Crohn's disease (ANDANTE I and II).
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Randomised trial and open-label extension study of an anti-interleukin-6 antibody in Crohn's disease (ANDANTE I and II).

Randomised trial and open-label extension study of an anti-interleukin-6 antibody in Crohn's disease (ANDANTE I and II).

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