WillowV1, Main, Exploration, bibRecord, 000411

Responsiveness of histological disease activity indices in ulcerative colitis: a post hoc analysis using data from the TOUCHSTONE randomised controlled trial.

Identifieur interne : 000411 ( Main/Exploration ); précédent : 000410; suivant : 000412

Responsiveness of histological disease activity indices in ulcerative colitis: a post hoc analysis using data from the TOUCHSTONE randomised controlled trial.

Auteurs : Vipul Jairath [Canada] ; Laurent Peyrin-Biroulet [France] ; Guangyong Zou [Canada] ; Mahmoud Mosli [Arabie saoudite] ; Niels Vande Casteele [Canada] ; Reetesh K. Pai [États-Unis] ; Mark A. Valasek [États-Unis] ; Aude Marchal-Bressenot [France] ; Larry W. Stitt [Canada] ; Lisa M. Shackelton [Canada] ; Reena Khanna [Canada] ; Geert R. D'Haens [Canada] ; William J. Sandborn [Canada] ; Allan Olson [États-Unis] ; Brian G. Feagan [Canada] ; Rish K. Pai [États-Unis]

Source :

Gut [ 1468-3288 ] ; 2019.

RBID : pubmed:30076171

Descripteurs français

KwdFr :
- Adulte d'âge moyen (MeSH), Biopsie (MeSH), Courbe ROC (MeSH), Femelle (MeSH), Humains (MeSH), Indanes (usage thérapeutique), Indice de gravité de la maladie (MeSH), Mâle (MeSH), Oxadiazoles (usage thérapeutique), Rectocolite hémorragique (anatomopathologie), Rectocolite hémorragique (traitement médicamenteux), Reproductibilité des résultats (MeSH), Échelle visuelle analogique (MeSH).
MESH :
- anatomopathologie : Rectocolite hémorragique.
- traitement médicamenteux : Rectocolite hémorragique.
- usage thérapeutique : Indanes, Oxadiazoles.
- Adulte d'âge moyen, Biopsie, Courbe ROC, Femelle, Humains, Indice de gravité de la maladie, Mâle, Reproductibilité des résultats, Échelle visuelle analogique.

English descriptors

KwdEn :
- Biopsy (MeSH), Colitis, Ulcerative (drug therapy), Colitis, Ulcerative (pathology), Female (MeSH), Humans (MeSH), Indans (therapeutic use), Male (MeSH), Middle Aged (MeSH), Oxadiazoles (therapeutic use), ROC Curve (MeSH), Reproducibility of Results (MeSH), Severity of Illness Index (MeSH), Visual Analog Scale (MeSH).
MESH :
- chemical , therapeutic use : Indans, Oxadiazoles.
- drug therapy : Colitis, Ulcerative.
- pathology : Colitis, Ulcerative.
- Biopsy, Female, Humans, Male, Middle Aged, ROC Curve, Reproducibility of Results, Severity of Illness Index, Visual Analog Scale.

Abstract

OBJECTIVE

We evaluated the reliability and responsiveness of available but incompletely validated UC histological disease activity indices using standardised rules for centralised assessment.

DESIGN

Disease activity was assessed in biopsies collected in a phase II placebo-controlled ozanimod trial by four blinded pathologists using the Geboes (GS) and modified Riley (MRS) scores, the Robarts Histopathology (RHI) and Nancy Histological (NHI) indices and a Visual Analogue Scale. Reliability was assessed with intraclass correlation coefficients (ICCs). Index responsiveness was evaluated by assessing longitudinal validity (Pearson correlations of changes in index scores and other disease measures), and effect size estimates (standardised effect size (SES)) using two criteria for change (treatment assignment and >2 point decrease in total Mayo Clinic score). Area under the receiver operating characteristic (AUROC) curve estimates evaluated the probability of the indices to discriminate between treatment and placebo.

RESULTS

Inter-rater reliability of the histological indices was substantial to almost perfect (ICC>0.61), and responsiveness was moderate to large (SES estimates>0.5); 0.81 (0.52, 1.10), 0.87 (0.58, 1.17), 0.57 (0.30, 0.84) and 0.81 (0.52, 1.09) when treatment assignment was the criterion for change and 1.05 (0.80, 1.31), 1.13 (0.87, 1.39), 0.88 (0.64, 1.12) and 1.06 (0.80, 1.31) for the change in Mayo score criterion for the GS, MRS, RHI and NHI, respectively. The indices had similar drisciminative ability based on AUROC estimates (range 0.608-0.649).

CONCLUSION

All four existing histological indices were similarly reliable and responsive based on this dataset.

DOI: 10.1136/gutjnl-2018-316702
PubMed: 30076171

Affiliations:

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

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Le document en format XML

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<author><name sortKey="Marchal Bressenot, Aude" sort="Marchal Bressenot, Aude" uniqKey="Marchal Bressenot A" first="Aude" last="Marchal-Bressenot">Aude Marchal-Bressenot</name>
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<sourceDesc><biblStruct><analytic><title xml:lang="en">Responsiveness of histological disease activity indices in ulcerative colitis: a post hoc analysis using data from the TOUCHSTONE randomised controlled trial.</title>
<author><name sortKey="Jairath, Vipul" sort="Jairath, Vipul" uniqKey="Jairath V" first="Vipul" last="Jairath">Vipul Jairath</name>
<affiliation wicri:level="1"><nlm:affiliation>Robarts Clinical Trials Inc., London, Ontario, Canada.</nlm:affiliation>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>Robarts Clinical Trials Inc., London, Ontario</wicri:regionArea>
<wicri:noRegion>Ontario</wicri:noRegion>
</affiliation>
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<author><name sortKey="Peyrin Biroulet, Laurent" sort="Peyrin Biroulet, Laurent" uniqKey="Peyrin Biroulet L" first="Laurent" last="Peyrin-Biroulet">Laurent Peyrin-Biroulet</name>
<affiliation wicri:level="3"><nlm:affiliation>Department of Gastroenterology, Lorraine University, Vandoeuvre-lès-Nancy, France.</nlm:affiliation>
<country xml:lang="fr">France</country>
<wicri:regionArea>Department of Gastroenterology, Lorraine University, Vandoeuvre-lès-Nancy</wicri:regionArea>
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<region type="old region" nuts="2">Lorraine (région)</region>
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<author><name sortKey="Zou, Guangyong" sort="Zou, Guangyong" uniqKey="Zou G" first="Guangyong" last="Zou">Guangyong Zou</name>
<affiliation wicri:level="1"><nlm:affiliation>Robarts Clinical Trials Inc., London, Ontario, Canada.</nlm:affiliation>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>Robarts Clinical Trials Inc., London, Ontario</wicri:regionArea>
<wicri:noRegion>Ontario</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Mosli, Mahmoud" sort="Mosli, Mahmoud" uniqKey="Mosli M" first="Mahmoud" last="Mosli">Mahmoud Mosli</name>
<affiliation wicri:level="1"><nlm:affiliation>Department of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia.</nlm:affiliation>
<country xml:lang="fr">Arabie saoudite</country>
<wicri:regionArea>Department of Medicine, King Abdulaziz University, Jeddah</wicri:regionArea>
<wicri:noRegion>Jeddah</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Vande Casteele, Niels" sort="Vande Casteele, Niels" uniqKey="Vande Casteele N" first="Niels" last="Vande Casteele">Niels Vande Casteele</name>
<affiliation wicri:level="1"><nlm:affiliation>Robarts Clinical Trials Inc., London, Ontario, Canada.</nlm:affiliation>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>Robarts Clinical Trials Inc., London, Ontario</wicri:regionArea>
<wicri:noRegion>Ontario</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Pai, Reetesh K" sort="Pai, Reetesh K" uniqKey="Pai R" first="Reetesh K" last="Pai">Reetesh K. Pai</name>
<affiliation wicri:level="2"><nlm:affiliation>Department of Pathology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Department of Pathology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania</wicri:regionArea>
<placeName><region type="state">Pennsylvanie</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Valasek, Mark A" sort="Valasek, Mark A" uniqKey="Valasek M" first="Mark A" last="Valasek">Mark A. Valasek</name>
<affiliation wicri:level="2"><nlm:affiliation>Department of Pathology, University of California, San Diego, La Jolla, California, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Department of Pathology, University of California, San Diego, La Jolla, California</wicri:regionArea>
<placeName><region type="state">Californie</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Marchal Bressenot, Aude" sort="Marchal Bressenot, Aude" uniqKey="Marchal Bressenot A" first="Aude" last="Marchal-Bressenot">Aude Marchal-Bressenot</name>
<affiliation wicri:level="3"><nlm:affiliation>Department of Pathology, University of Reims et Champagne-Ardenne, Reims, France.</nlm:affiliation>
<country xml:lang="fr">France</country>
<wicri:regionArea>Department of Pathology, University of Reims et Champagne-Ardenne, Reims</wicri:regionArea>
<placeName><region type="region">Grand Est</region>
<region type="old region">Champagne-Ardenne</region>
<settlement type="city">Reims</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Stitt, Larry W" sort="Stitt, Larry W" uniqKey="Stitt L" first="Larry W" last="Stitt">Larry W. Stitt</name>
<affiliation wicri:level="1"><nlm:affiliation>Robarts Clinical Trials Inc., London, Ontario, Canada.</nlm:affiliation>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>Robarts Clinical Trials Inc., London, Ontario</wicri:regionArea>
<wicri:noRegion>Ontario</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Shackelton, Lisa M" sort="Shackelton, Lisa M" uniqKey="Shackelton L" first="Lisa M" last="Shackelton">Lisa M. Shackelton</name>
<affiliation wicri:level="1"><nlm:affiliation>Robarts Clinical Trials Inc., London, Ontario, Canada.</nlm:affiliation>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>Robarts Clinical Trials Inc., London, Ontario</wicri:regionArea>
<wicri:noRegion>Ontario</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Khanna, Reena" sort="Khanna, Reena" uniqKey="Khanna R" first="Reena" last="Khanna">Reena Khanna</name>
<affiliation wicri:level="1"><nlm:affiliation>Robarts Clinical Trials Inc., London, Ontario, Canada.</nlm:affiliation>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>Robarts Clinical Trials Inc., London, Ontario</wicri:regionArea>
<wicri:noRegion>Ontario</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="D Haens, Geert R" sort="D Haens, Geert R" uniqKey="D Haens G" first="Geert R" last="D'Haens">Geert R. D'Haens</name>
<affiliation wicri:level="1"><nlm:affiliation>Robarts Clinical Trials Inc., London, Ontario, Canada.</nlm:affiliation>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>Robarts Clinical Trials Inc., London, Ontario</wicri:regionArea>
<wicri:noRegion>Ontario</wicri:noRegion>
</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:affiliation>Robarts Clinical Trials Inc., London, Ontario, Canada.</nlm:affiliation>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>Robarts Clinical Trials Inc., London, Ontario</wicri:regionArea>
<wicri:noRegion>Ontario</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Olson, Allan" sort="Olson, Allan" uniqKey="Olson A" first="Allan" last="Olson">Allan Olson</name>
<affiliation wicri:level="2"><nlm:affiliation>Celgene, San Diego, California, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Celgene, San Diego, California</wicri:regionArea>
<placeName><region type="state">Californie</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Feagan, Brian G" sort="Feagan, Brian G" uniqKey="Feagan B" first="Brian G" last="Feagan">Brian G. Feagan</name>
<affiliation wicri:level="1"><nlm:affiliation>Robarts Clinical Trials Inc., London, Ontario, Canada.</nlm:affiliation>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>Robarts Clinical Trials Inc., London, Ontario</wicri:regionArea>
<wicri:noRegion>Ontario</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Pai, Rish K" sort="Pai, Rish K" uniqKey="Pai R" first="Rish K" last="Pai">Rish K. Pai</name>
<affiliation wicri:level="2"><nlm:affiliation>Department of Laboratory Medicine and Pathology, Mayo Clinic, Scottsdale, Arizona, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Department of Laboratory Medicine and Pathology, Mayo Clinic, Scottsdale, Arizona</wicri:regionArea>
<placeName><region type="state">Arizona</region>
</placeName>
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<series><title level="j">Gut</title>
<idno type="eISSN">1468-3288</idno>
<imprint><date when="2019" type="published">2019</date>
</imprint>
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<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Biopsy (MeSH)</term>
<term>Colitis, Ulcerative (drug therapy)</term>
<term>Colitis, Ulcerative (pathology)</term>
<term>Female (MeSH)</term>
<term>Humans (MeSH)</term>
<term>Indans (therapeutic use)</term>
<term>Male (MeSH)</term>
<term>Middle Aged (MeSH)</term>
<term>Oxadiazoles (therapeutic use)</term>
<term>ROC Curve (MeSH)</term>
<term>Reproducibility of Results (MeSH)</term>
<term>Severity of Illness Index (MeSH)</term>
<term>Visual Analog Scale (MeSH)</term>
</keywords>
<keywords scheme="KwdFr" xml:lang="fr"><term>Adulte d'âge moyen (MeSH)</term>
<term>Biopsie (MeSH)</term>
<term>Courbe ROC (MeSH)</term>
<term>Femelle (MeSH)</term>
<term>Humains (MeSH)</term>
<term>Indanes (usage thérapeutique)</term>
<term>Indice de gravité de la maladie (MeSH)</term>
<term>Mâle (MeSH)</term>
<term>Oxadiazoles (usage thérapeutique)</term>
<term>Rectocolite hémorragique (anatomopathologie)</term>
<term>Rectocolite hémorragique (traitement médicamenteux)</term>
<term>Reproductibilité des résultats (MeSH)</term>
<term>Échelle visuelle analogique (MeSH)</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Indans</term>
<term>Oxadiazoles</term>
</keywords>
<keywords scheme="MESH" qualifier="anatomopathologie" xml:lang="fr"><term>Rectocolite hémorragique</term>
</keywords>
<keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Colitis, Ulcerative</term>
</keywords>
<keywords scheme="MESH" qualifier="pathology" 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>Indanes</term>
<term>Oxadiazoles</term>
</keywords>
<keywords scheme="MESH" xml:lang="en"><term>Biopsy</term>
<term>Female</term>
<term>Humans</term>
<term>Male</term>
<term>Middle Aged</term>
<term>ROC Curve</term>
<term>Reproducibility of Results</term>
<term>Severity of Illness Index</term>
<term>Visual Analog Scale</term>
</keywords>
<keywords scheme="MESH" xml:lang="fr"><term>Adulte d'âge moyen</term>
<term>Biopsie</term>
<term>Courbe ROC</term>
<term>Femelle</term>
<term>Humains</term>
<term>Indice de gravité de la maladie</term>
<term>Mâle</term>
<term>Reproductibilité des résultats</term>
<term>Échelle visuelle analogique</term>
</keywords>
</textClass>
</profileDesc>
</teiHeader>
<front><div type="abstract" xml:lang="en"><p><b>OBJECTIVE</b>
</p>
<p>We evaluated the reliability and responsiveness of available but incompletely validated UC histological disease activity indices using standardised rules for centralised assessment.</p>
</div>
<div type="abstract" xml:lang="en"><p><b>DESIGN</b>
</p>
<p>Disease activity was assessed in biopsies collected in a phase II placebo-controlled ozanimod trial by four blinded pathologists using the Geboes (GS) and modified Riley (MRS) scores, the Robarts Histopathology (RHI) and Nancy Histological (NHI) indices and a Visual Analogue Scale. Reliability was assessed with intraclass correlation coefficients (ICCs). Index responsiveness was evaluated by assessing longitudinal validity (Pearson correlations of changes in index scores and other disease measures), and effect size estimates (standardised effect size (SES)) using two criteria for change (treatment assignment and >2 point decrease in total Mayo Clinic score). Area under the receiver operating characteristic (AUROC) curve estimates evaluated the probability of the indices to discriminate between treatment and placebo.</p>
</div>
<div type="abstract" xml:lang="en"><p><b>RESULTS</b>
</p>
<p>Inter-rater reliability of the histological indices was substantial to almost perfect (ICC>0.61), and responsiveness was moderate to large (SES estimates>0.5); 0.81 (0.52, 1.10), 0.87 (0.58, 1.17), 0.57 (0.30, 0.84) and 0.81 (0.52, 1.09) when treatment assignment was the criterion for change and 1.05 (0.80, 1.31), 1.13 (0.87, 1.39), 0.88 (0.64, 1.12) and 1.06 (0.80, 1.31) for the change in Mayo score criterion for the GS, MRS, RHI and NHI, respectively. The indices had similar drisciminative ability based on AUROC estimates (range 0.608-0.649).</p>
</div>
<div type="abstract" xml:lang="en"><p><b>CONCLUSION</b>
</p>
<p>All four existing histological indices were similarly reliable and responsive based on this dataset.</p>
</div>
</front>
</TEI>
<pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">30076171</PMID>
<DateCompleted><Year>2019</Year>
<Month>07</Month>
<Day>26</Day>
</DateCompleted>
<DateRevised><Year>2019</Year>
<Month>07</Month>
<Day>26</Day>
</DateRevised>
<Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1468-3288</ISSN>
<JournalIssue CitedMedium="Internet"><Volume>68</Volume>
<Issue>7</Issue>
<PubDate><Year>2019</Year>
<Month>07</Month>
</PubDate>
</JournalIssue>
<Title>Gut</Title>
<ISOAbbreviation>Gut</ISOAbbreviation>
</Journal>
<ArticleTitle>Responsiveness of histological disease activity indices in ulcerative colitis: a post hoc analysis using data from the TOUCHSTONE randomised controlled trial.</ArticleTitle>
<Pagination><MedlinePgn>1162-1168</MedlinePgn>
</Pagination>
<ELocationID EIdType="doi" ValidYN="Y">10.1136/gutjnl-2018-316702</ELocationID>
<Abstract><AbstractText Label="OBJECTIVE">We evaluated the reliability and responsiveness of available but incompletely validated UC histological disease activity indices using standardised rules for centralised assessment.</AbstractText>
<AbstractText Label="DESIGN">Disease activity was assessed in biopsies collected in a phase II placebo-controlled ozanimod trial by four blinded pathologists using the Geboes (GS) and modified Riley (MRS) scores, the Robarts Histopathology (RHI) and Nancy Histological (NHI) indices and a Visual Analogue Scale. Reliability was assessed with intraclass correlation coefficients (ICCs). Index responsiveness was evaluated by assessing longitudinal validity (Pearson correlations of changes in index scores and other disease measures), and effect size estimates (standardised effect size (SES)) using two criteria for change (treatment assignment and >2 point decrease in total Mayo Clinic score). Area under the receiver operating characteristic (AUROC) curve estimates evaluated the probability of the indices to discriminate between treatment and placebo.</AbstractText>
<AbstractText Label="RESULTS">Inter-rater reliability of the histological indices was substantial to almost perfect (ICC>0.61), and responsiveness was moderate to large (SES estimates>0.5); 0.81 (0.52, 1.10), 0.87 (0.58, 1.17), 0.57 (0.30, 0.84) and 0.81 (0.52, 1.09) when treatment assignment was the criterion for change and 1.05 (0.80, 1.31), 1.13 (0.87, 1.39), 0.88 (0.64, 1.12) and 1.06 (0.80, 1.31) for the change in Mayo score criterion for the GS, MRS, RHI and NHI, respectively. The indices had similar drisciminative ability based on AUROC estimates (range 0.608-0.649).</AbstractText>
<AbstractText Label="CONCLUSION">All four existing histological indices were similarly reliable and responsive based on this dataset.</AbstractText>
<CopyrightInformation>© Author(s) (or their employer(s)) 2019. No commercial re-use. See rights and permissions. Published by BMJ.</CopyrightInformation>
</Abstract>
<AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Jairath</LastName>
<ForeName>Vipul</ForeName>
<Initials>V</Initials>
<AffiliationInfo><Affiliation>Robarts Clinical Trials Inc., London, Ontario, Canada.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Peyrin-Biroulet</LastName>
<ForeName>Laurent</ForeName>
<Initials>L</Initials>
<AffiliationInfo><Affiliation>Department of Gastroenterology, Lorraine University, Vandoeuvre-lès-Nancy, France.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Zou</LastName>
<ForeName>Guangyong</ForeName>
<Initials>G</Initials>
<AffiliationInfo><Affiliation>Robarts Clinical Trials Inc., London, Ontario, Canada.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Mosli</LastName>
<ForeName>Mahmoud</ForeName>
<Initials>M</Initials>
<AffiliationInfo><Affiliation>Department of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Vande Casteele</LastName>
<ForeName>Niels</ForeName>
<Initials>N</Initials>
<AffiliationInfo><Affiliation>Robarts Clinical Trials Inc., London, Ontario, Canada.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Pai</LastName>
<ForeName>Reetesh K</ForeName>
<Initials>RK</Initials>
<AffiliationInfo><Affiliation>Department of Pathology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Valasek</LastName>
<ForeName>Mark A</ForeName>
<Initials>MA</Initials>
<AffiliationInfo><Affiliation>Department of Pathology, University of California, San Diego, La Jolla, California, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Marchal-Bressenot</LastName>
<ForeName>Aude</ForeName>
<Initials>A</Initials>
<AffiliationInfo><Affiliation>Department of Pathology, University of Reims et Champagne-Ardenne, Reims, France.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Stitt</LastName>
<ForeName>Larry W</ForeName>
<Initials>LW</Initials>
<AffiliationInfo><Affiliation>Robarts Clinical Trials Inc., London, Ontario, Canada.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Shackelton</LastName>
<ForeName>Lisa M</ForeName>
<Initials>LM</Initials>
<AffiliationInfo><Affiliation>Robarts Clinical Trials Inc., London, Ontario, Canada.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Khanna</LastName>
<ForeName>Reena</ForeName>
<Initials>R</Initials>
<AffiliationInfo><Affiliation>Robarts Clinical Trials Inc., London, Ontario, Canada.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>D'Haens</LastName>
<ForeName>Geert R</ForeName>
<Initials>GR</Initials>
<AffiliationInfo><Affiliation>Robarts Clinical Trials Inc., London, Ontario, Canada.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Sandborn</LastName>
<ForeName>William J</ForeName>
<Initials>WJ</Initials>
<AffiliationInfo><Affiliation>Robarts Clinical Trials Inc., London, Ontario, Canada.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Olson</LastName>
<ForeName>Allan</ForeName>
<Initials>A</Initials>
<AffiliationInfo><Affiliation>Celgene, San Diego, California, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Feagan</LastName>
<ForeName>Brian G</ForeName>
<Initials>BG</Initials>
<AffiliationInfo><Affiliation>Robarts Clinical Trials Inc., London, Ontario, Canada.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Pai</LastName>
<ForeName>Rish K</ForeName>
<Initials>RK</Initials>
<AffiliationInfo><Affiliation>Department of Laboratory Medicine and Pathology, Mayo Clinic, Scottsdale, Arizona, USA.</Affiliation>
</AffiliationInfo>
</Author>
</AuthorList>
<Language>eng</Language>
<PublicationTypeList><PublicationType UI="D017427">Clinical Trial, Phase II</PublicationType>
<PublicationType UI="D016428">Journal Article</PublicationType>
<PublicationType UI="D016449">Randomized Controlled Trial</PublicationType>
<PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType>
</PublicationTypeList>
<ArticleDate DateType="Electronic"><Year>2018</Year>
<Month>08</Month>
<Day>03</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="D007189">Indans</NameOfSubstance>
</Chemical>
<Chemical><RegistryNumber>0</RegistryNumber>
<NameOfSubstance UI="D010069">Oxadiazoles</NameOfSubstance>
</Chemical>
<Chemical><RegistryNumber>Z80293URPV</RegistryNumber>
<NameOfSubstance UI="C000607776">ozanimod</NameOfSubstance>
</Chemical>
</ChemicalList>
<MeshHeadingList><MeshHeading><DescriptorName UI="D001706" MajorTopicYN="N">Biopsy</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D003093" MajorTopicYN="N">Colitis, Ulcerative</DescriptorName>
<QualifierName UI="Q000188" MajorTopicYN="N">drug therapy</QualifierName>
<QualifierName UI="Q000473" MajorTopicYN="Y">pathology</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D007189" MajorTopicYN="N">Indans</DescriptorName>
<QualifierName UI="Q000627" MajorTopicYN="N">therapeutic use</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D008875" MajorTopicYN="N">Middle Aged</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D010069" MajorTopicYN="N">Oxadiazoles</DescriptorName>
<QualifierName UI="Q000627" MajorTopicYN="N">therapeutic use</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D012372" MajorTopicYN="N">ROC Curve</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D015203" MajorTopicYN="N">Reproducibility of Results</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D012720" MajorTopicYN="N">Severity of Illness Index</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D064232" MajorTopicYN="N">Visual Analog Scale</DescriptorName>
</MeshHeading>
</MeshHeadingList>
<KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="Y">histopathology</Keyword>
<Keyword MajorTopicYN="Y">ulcerative colitis</Keyword>
</KeywordList>
<CoiStatement>Competing interests: VJ reports scientific advisory board fees from Abbvie, Sandoz, Ferring and Janssen; speaker’s fees from Takeda and Ferring; and travel support for conference attendance from Vifor Pharmaceuticals. LP-B reports consulting fees from AbbVie, Amgen, Biogaran, Biogen, Boehringer-Ingelheim, Bristol-Myers Squibb, Celgene, Celltrion, Ferring, Forward Pharma, Genentech, H.A.C. Pharma, Hospira, Index Pharmaceuticals, Janssen, Lycera, Merck, Lilly, Mitsubishi, Norgine, Pfizer, Pharmacosmos, Pilège, Samsung Bioepis, Sandoz, Takeda, Therakos, Tillots, UCB Pharma and Vifor; and lecture fees from AbbVie, Ferring, H.A.C. Pharma, Janssen, Merck, Mitsubishi, Norgine, Takeda, Therakos, Tillots and Vifor. GZ is an employee of Robarts Clinical Trials, which was the research organisation that conducted this study. NVC reports consulting fees from Janssen, Pfizer, Takeda and UCB. LWS and LMS report consulting fees from Robarts Clinical Trials, which was the research organisation that conducted this study. RK reports fees from Janssen, AbbVie, Shire, Pfizer and Takeda Canada and from Robarts Clinical Trials outside the submitted work. GRD’H reports consulting fees from Robarts Clinical Trials; personal fees from Ablynx, Amakem, Amgen, AM Pharma, Boehringer-Ingelheim, Bristol Myers Squibb, Cosmo, Celgene, Celtrion, Covidien, Engene, Galapagos, Medimetrics, Mundipharma, Mitsubishi, Novonordisk, Pfizer, Receptos, Salix, Sandoz, Setpoint, Shire, Teva, Tigenix, Topivert, Versant and Vifor; grants and personal fees from Abbvie, Ferring, Glaxo Smith Kline, Jansen Biologics, Hospira, Merck Sharp Dome, Prometheus Labs, Robarts Clinical Trials, Takeda and Tillotts; and grants from Dr Falk Pharma and Photopill, outside the submitted work. WJS reports consulting fees from University of Western Ontario (previous owner of Robarts Clinical Trials, Inc.), Abbvie, Akros Pharma, Allergan, Ambrx Inc., Amgen, Ardelyx, Arena Pharmaceuticals, Atlantic Pharmaceuticals, Avaxia, Biogen, Boehringer-Ingelheim, Bristol Meyers Squibb, Celgene, Conatus, Cosmo Technologies, Escalier Biosciences, Ferring, Ferring Research Institute, Forward Pharma, Galapagos, Genentech, Gilead Sciences, Immune Pharmaceuticals, Index Pharmaceuticals, Janssen, Kyowa Hakko Kirin Pharma, Lilly, Medimmune, Mesoblast, Miraca Life Sciences, Nivalis Therapeutics, Novartis, Nutrition Science Partners, Oppilan Pharma, Otsuka, Palatin, Paul Hastings, Pfizer, Precision IBD, Progenity, Prometheus Laboratories, Qu Biologics, Regeneron, Ritter Pharmaceuticals, Robarts Clinical Trials, Salix, Seattle Genetics, Seres Therapeutics, Shire, Sigmoid Biotechnologies, Takeda, Theradiag, Theravance, Tigenix, Tillotts Pharma, UCB Pharma, Vascular Biogenics and Vivelix; research grants from Atlantic Healthcare Limited, Amgen, Genentech, Gilead Sciences, Abbvie, Janssen, Takeda, Lilly and Celgene/Receptos; payments for lectures/speaker’s bureau from Abbvie, Janssen and Takeda; and stock/stock options in Escalier Biosciences, Oppilan Pharma, Precision IBD, Progenity and Ritter Pharmaceuticals. AO is an employee of Celgene Corporation. BGF reports grant/research support from Millennium Pharmaceuticals, Merck, Tillotts Pharma AG, AbbVie, Novartis Pharmaceuticals, Centocor Inc., Elan/Biogen, UCB Pharma, Bristol-Myers Squibb, Genentech, ActoGenix and Wyeth Pharmaceuticals Inc.; consulting fees from Millennium Pharmaceuticals, Merck, Centocor Inc., Elan/Biogen, Janssen-Ortho, Teva Pharmaceuticals, Bristol-Myers Squibb, Celgene, UCB Pharma, AbbVie, Astra Zeneca, Serono, Genentech, Tillotts Pharma AG, Unity Pharmaceuticals, Albireo Pharma, Given Imaging Inc., Salix Pharmaceuticals, Novonordisk, GSK, Actogenix, Prometheus Therapeutics and Diagnostics, Athersys, Axcan, Gilead, Pfizer, Shire, Wyeth, Zealand Pharma, Zyngenia, GiCare Pharma Inc. and Sigmoid Pharma; and speaker’s bureau fees from UCB, AbbVie and J&J/Janssen. RKP reports fees from Genentech outside the submitted work.</CoiStatement>
</MedlineCitation>
<PubmedData><History><PubMedPubDate PubStatus="received"><Year>2018</Year>
<Month>04</Month>
<Day>26</Day>
</PubMedPubDate>
<PubMedPubDate PubStatus="revised"><Year>2018</Year>
<Month>07</Month>
<Day>02</Day>
</PubMedPubDate>
<PubMedPubDate PubStatus="accepted"><Year>2018</Year>
<Month>07</Month>
<Day>18</Day>
</PubMedPubDate>
<PubMedPubDate PubStatus="pubmed"><Year>2018</Year>
<Month>8</Month>
<Day>5</Day>
<Hour>6</Hour>
<Minute>0</Minute>
</PubMedPubDate>
<PubMedPubDate PubStatus="medline"><Year>2019</Year>
<Month>7</Month>
<Day>28</Day>
<Hour>6</Hour>
<Minute>0</Minute>
</PubMedPubDate>
<PubMedPubDate PubStatus="entrez"><Year>2018</Year>
<Month>8</Month>
<Day>5</Day>
<Hour>6</Hour>
<Minute>0</Minute>
</PubMedPubDate>
</History>
<PublicationStatus>ppublish</PublicationStatus>
<ArticleIdList><ArticleId IdType="pubmed">30076171</ArticleId>
<ArticleId IdType="pii">gutjnl-2018-316702</ArticleId>
<ArticleId IdType="doi">10.1136/gutjnl-2018-316702</ArticleId>
</ArticleIdList>
</PubmedData>
</pubmed>
<affiliations><list><country><li>Arabie saoudite</li>
<li>Canada</li>
<li>France</li>
<li>États-Unis</li>
</country>
<region><li>Arizona</li>
<li>Californie</li>
<li>Champagne-Ardenne</li>
<li>Grand Est</li>
<li>Lorraine (région)</li>
<li>Pennsylvanie</li>
</region>
<settlement><li>Nancy</li>
<li>Reims</li>
<li>Vandœuvre-lès-Nancy</li>
</settlement>
<orgName><li>Centre hospitalier régional et universitaire de Nancy</li>
<li>Université de Lorraine</li>
</orgName>
</list>
<tree><country name="Canada"><noRegion><name sortKey="Jairath, Vipul" sort="Jairath, Vipul" uniqKey="Jairath V" first="Vipul" last="Jairath">Vipul Jairath</name>
</noRegion>
<name sortKey="D Haens, Geert R" sort="D Haens, Geert R" uniqKey="D Haens G" first="Geert R" last="D'Haens">Geert R. D'Haens</name>
<name sortKey="Feagan, Brian G" sort="Feagan, Brian G" uniqKey="Feagan B" first="Brian G" last="Feagan">Brian G. Feagan</name>
<name sortKey="Khanna, Reena" sort="Khanna, Reena" uniqKey="Khanna R" first="Reena" last="Khanna">Reena Khanna</name>
<name sortKey="Sandborn, William J" sort="Sandborn, William J" uniqKey="Sandborn W" first="William J" last="Sandborn">William J. Sandborn</name>
<name sortKey="Shackelton, Lisa M" sort="Shackelton, Lisa M" uniqKey="Shackelton L" first="Lisa M" last="Shackelton">Lisa M. Shackelton</name>
<name sortKey="Stitt, Larry W" sort="Stitt, Larry W" uniqKey="Stitt L" first="Larry W" last="Stitt">Larry W. Stitt</name>
<name sortKey="Vande Casteele, Niels" sort="Vande Casteele, Niels" uniqKey="Vande Casteele N" first="Niels" last="Vande Casteele">Niels Vande Casteele</name>
<name sortKey="Zou, Guangyong" sort="Zou, Guangyong" uniqKey="Zou G" first="Guangyong" last="Zou">Guangyong Zou</name>
</country>
<country name="France"><region name="Grand Est"><name sortKey="Peyrin Biroulet, Laurent" sort="Peyrin Biroulet, Laurent" uniqKey="Peyrin Biroulet L" first="Laurent" last="Peyrin-Biroulet">Laurent Peyrin-Biroulet</name>
</region>
<name sortKey="Marchal Bressenot, Aude" sort="Marchal Bressenot, Aude" uniqKey="Marchal Bressenot A" first="Aude" last="Marchal-Bressenot">Aude Marchal-Bressenot</name>
</country>
<country name="Arabie saoudite"><noRegion><name sortKey="Mosli, Mahmoud" sort="Mosli, Mahmoud" uniqKey="Mosli M" first="Mahmoud" last="Mosli">Mahmoud Mosli</name>
</noRegion>
</country>
<country name="États-Unis"><region name="Pennsylvanie"><name sortKey="Pai, Reetesh K" sort="Pai, Reetesh K" uniqKey="Pai R" first="Reetesh K" last="Pai">Reetesh K. Pai</name>
</region>
<name sortKey="Olson, Allan" sort="Olson, Allan" uniqKey="Olson A" first="Allan" last="Olson">Allan Olson</name>
<name sortKey="Pai, Rish K" sort="Pai, Rish K" uniqKey="Pai R" first="Rish K" last="Pai">Rish K. Pai</name>
<name sortKey="Valasek, Mark A" sort="Valasek, Mark A" uniqKey="Valasek M" first="Mark A" last="Valasek">Mark A. Valasek</name>
</country>
</tree>
</affiliations>
</record>

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Responsiveness of histological disease activity indices in ulcerative colitis: a post hoc analysis using data from the TOUCHSTONE randomised controlled trial.

Responsiveness of histological disease activity indices in ulcerative colitis: a post hoc analysis using data from the TOUCHSTONE randomised controlled trial.

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