Defining endoscopic response and remission in ulcerative colitis clinical trials: an international consensus.
Identifieur interne : 000E67 ( PubMed/Checkpoint ); précédent : 000E66; suivant : 000E68Defining endoscopic response and remission in ulcerative colitis clinical trials: an international consensus.
Auteurs : L. Vuitton [France] ; L. Peyrin-Biroulet [France] ; J F Colombel [États-Unis] ; B. Pariente [France] ; G. Pineton De Chambrun [France] ; A J Walsh [Australie] ; J. Panes [Espagne] ; S P L. Travis [Royaume-Uni] ; J Y Mary [France] ; P. Marteau [France]Source :
- Alimentary pharmacology & therapeutics [ 1365-2036 ] ; 2017.
Abstract
Recently, endpoints for clinical trials have been changing from measuring clinical response to mucosal healing in ulcerative colitis. Endoscopic evaluation is the current gold standard to assess mucosal lesions and has become a major measure of therapeutic efficacy in addition to patients reported outcomes.
DOI: 10.1111/apt.13948
PubMed: 28112419
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Vuitton</name><affiliation wicri:level="1"><nlm:affiliation>Besançon, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Besançon</wicri:regionArea></affiliation></author><author><name sortKey="Peyrin Biroulet, L" sort="Peyrin Biroulet, L" uniqKey="Peyrin Biroulet L" first="L" last="Peyrin-Biroulet">L. Peyrin-Biroulet</name><affiliation wicri:level="1"><nlm:affiliation>Vandoeuvre-lès-Nancy, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Vandoeuvre-lès-Nancy</wicri:regionArea></affiliation></author><author><name sortKey="Colombel, J F" sort="Colombel, J F" uniqKey="Colombel J" first="J F" last="Colombel">J F Colombel</name><affiliation wicri:level="2"><nlm:affiliation>New York, NY, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>New York, NY</wicri:regionArea><placeName><region type="state">État de New York</region></placeName></affiliation></author><author><name sortKey="Pariente, B" sort="Pariente, B" uniqKey="Pariente B" first="B" last="Pariente">B. Pariente</name><affiliation wicri:level="1"><nlm:affiliation>Lille, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Lille</wicri:regionArea></affiliation></author><author><name sortKey="Pineton De Chambrun, G" sort="Pineton De Chambrun, G" uniqKey="Pineton De Chambrun G" first="G" last="Pineton De Chambrun">G. Pineton De Chambrun</name><affiliation wicri:level="1"><nlm:affiliation>Montpellier, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Montpellier</wicri:regionArea></affiliation></author><author><name sortKey="Walsh, A J" sort="Walsh, A J" uniqKey="Walsh A" first="A J" last="Walsh">A J Walsh</name><affiliation wicri:level="1"><nlm:affiliation>Sydney, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Sydney</wicri:regionArea></affiliation></author><author><name sortKey="Panes, J" sort="Panes, J" uniqKey="Panes J" first="J" last="Panes">J. Panes</name><affiliation wicri:level="1"><nlm:affiliation>Barcelona, Spain.</nlm:affiliation><country xml:lang="fr">Espagne</country><wicri:regionArea>Barcelona</wicri:regionArea></affiliation></author><author><name sortKey="Travis, S P L" sort="Travis, S P L" uniqKey="Travis S" first="S P L" last="Travis">S P L. Travis</name><affiliation wicri:level="1"><nlm:affiliation>Oxford, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Oxford</wicri:regionArea></affiliation></author><author><name sortKey="Mary, J Y" sort="Mary, J Y" uniqKey="Mary J" first="J Y" last="Mary">J Y Mary</name><affiliation wicri:level="1"><nlm:affiliation>Paris, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Paris</wicri:regionArea></affiliation></author><author><name sortKey="Marteau, P" sort="Marteau, P" uniqKey="Marteau P" first="P" last="Marteau">P. Marteau</name><affiliation wicri:level="1"><nlm:affiliation>Paris, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Paris</wicri:regionArea></affiliation></author></analytic><series><title level="j">Alimentary pharmacology & therapeutics</title><idno type="eISSN">1365-2036</idno><imprint><date when="2017" type="published">2017</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Recently, endpoints for clinical trials have been changing from measuring clinical response to mucosal healing in ulcerative colitis. Endoscopic evaluation is the current gold standard to assess mucosal lesions and has become a major measure of therapeutic efficacy in addition to patients reported outcomes.</div></front></TEI><pubmed><MedlineCitation Status="In-Process" Owner="NLM"><PMID Version="1">28112419</PMID><DateCreated><Year>2017</Year><Month>01</Month><Day>23</Day></DateCreated><DateRevised><Year>2017</Year><Month>02</Month><Day>17</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1365-2036</ISSN><JournalIssue CitedMedium="Internet"><Volume>45</Volume><Issue>6</Issue><PubDate><Year>2017</Year><Month>Mar</Month></PubDate></JournalIssue><Title>Alimentary pharmacology & therapeutics</Title><ISOAbbreviation>Aliment. Pharmacol. Ther.</ISOAbbreviation></Journal><ArticleTitle>Defining endoscopic response and remission in ulcerative colitis clinical trials: an international consensus.</ArticleTitle><Pagination><MedlinePgn>801-813</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1111/apt.13948</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">Recently, endpoints for clinical trials have been changing from measuring clinical response to mucosal healing in ulcerative colitis. Endoscopic evaluation is the current gold standard to assess mucosal lesions and has become a major measure of therapeutic efficacy in addition to patients reported outcomes.</AbstractText><AbstractText Label="AIM" NlmCategory="OBJECTIVE">To achieve consensus on endoscopic definitions of remission and response for clinical trials in patients with ulcerative colitis.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">In reaching the current international recommendations on an International Organization For the Study of Inflammatory Bowel Disease (IOIBD) initiative, we first performed a systematic review of technical aspects of endoscopic scoring systems. Then, to achieve consensus on endoscopic definitions of remission and response for clinical trials, we conducted a two-round vote using a Delphi-style process among fifteen specialists in the field of inflammatory bowel diseases.</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">The literature review showed that many endoscopic indices have been proposed to evaluate disease activity in ulcerative colitis; most are unvalidated and arbitrary definitions have been used in clinical trials for defining endoscopic response or remission. At the end of the voting process, the investigators ranked initially the Ulcerative Colitis Endoscopic Index of Severity (UCEIS) 0 for the definition of endoscopic remission, and a decrease in Mayo endoscopic score ≥1 grade or a decrease in UCEIS ≥2 points for the definition of endoscopic response in ulcerative colitis.</AbstractText><AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">These international recommendations represent the first consensus on measurement indices for endoscopic outcomes in ulcerative colitis. They should be subject to prospective testing in clinical trials of ulcerative colitis.</AbstractText><CopyrightInformation>© 2017 John Wiley & Sons Ltd.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Vuitton</LastName><ForeName>L</ForeName><Initials>L</Initials><Identifier Source="ORCID">http://orcid.org/0000-0001-9845-6572</Identifier><AffiliationInfo><Affiliation>Besançon, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Peyrin-Biroulet</LastName><ForeName>L</ForeName><Initials>L</Initials><AffiliationInfo><Affiliation>Vandoeuvre-lès-Nancy, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Colombel</LastName><ForeName>J F</ForeName><Initials>JF</Initials><AffiliationInfo><Affiliation>New York, NY, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Pariente</LastName><ForeName>B</ForeName><Initials>B</Initials><AffiliationInfo><Affiliation>Lille, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Pineton de Chambrun</LastName><ForeName>G</ForeName><Initials>G</Initials><AffiliationInfo><Affiliation>Montpellier, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Walsh</LastName><ForeName>A J</ForeName><Initials>AJ</Initials><AffiliationInfo><Affiliation>Sydney, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Panes</LastName><ForeName>J</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Barcelona, Spain.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Travis</LastName><ForeName>S P L</ForeName><Initials>SP</Initials><AffiliationInfo><Affiliation>Oxford, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Mary</LastName><ForeName>J Y</ForeName><Initials>JY</Initials><AffiliationInfo><Affiliation>Paris, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Marteau</LastName><ForeName>P</ForeName><Initials>P</Initials><AffiliationInfo><Affiliation>Paris, France.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2017</Year><Month>01</Month><Day>23</Day></ArticleDate></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>Aliment Pharmacol Ther</MedlineTA><NlmUniqueID>8707234</NlmUniqueID><ISSNLinking>0269-2813</ISSNLinking></MedlineJournalInfo></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2016</Year><Month>08</Month><Day>27</Day></PubMedPubDate><PubMedPubDate PubStatus="revised"><Year>2016</Year><Month>09</Month><Day>07</Day></PubMedPubDate><PubMedPubDate PubStatus="revised"><Year>2016</Year><Month>11</Month><Day>22</Day></PubMedPubDate><PubMedPubDate PubStatus="revised"><Year>2016</Year><Month>12</Month><Day>20</Day></PubMedPubDate><PubMedPubDate PubStatus="revised"><Year>2016</Year><Month>12</Month><Day>26</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2016</Year><Month>12</Month><Day>27</Day></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2017</Year><Month>1</Month><Day>24</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2017</Year><Month>1</Month><Day>24</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2017</Year><Month>1</Month><Day>24</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">28112419</ArticleId><ArticleId IdType="doi">10.1111/apt.13948</ArticleId></ArticleIdList></PubmedData></pubmed><affiliations><list><country><li>Australie</li><li>Espagne</li><li>France</li><li>Royaume-Uni</li><li>États-Unis</li></country><region><li>État de New York</li></region></list><tree><country name="France"><noRegion><name sortKey="Vuitton, L" sort="Vuitton, L" uniqKey="Vuitton L" first="L" last="Vuitton">L. Vuitton</name></noRegion><name sortKey="Marteau, P" sort="Marteau, P" uniqKey="Marteau P" first="P" last="Marteau">P. Marteau</name><name sortKey="Mary, J Y" sort="Mary, J Y" uniqKey="Mary J" first="J Y" last="Mary">J Y Mary</name><name sortKey="Pariente, B" sort="Pariente, B" uniqKey="Pariente B" first="B" last="Pariente">B. Pariente</name><name sortKey="Peyrin Biroulet, L" sort="Peyrin Biroulet, L" uniqKey="Peyrin Biroulet L" first="L" last="Peyrin-Biroulet">L. Peyrin-Biroulet</name><name sortKey="Pineton De Chambrun, G" sort="Pineton De Chambrun, G" uniqKey="Pineton De Chambrun G" first="G" last="Pineton De Chambrun">G. Pineton De Chambrun</name></country><country name="États-Unis"><region name="État de New York"><name sortKey="Colombel, J F" sort="Colombel, J F" uniqKey="Colombel J" first="J F" last="Colombel">J F Colombel</name></region></country><country name="Australie"><noRegion><name sortKey="Walsh, A J" sort="Walsh, A J" uniqKey="Walsh A" first="A J" last="Walsh">A J Walsh</name></noRegion></country><country name="Espagne"><noRegion><name sortKey="Panes, J" sort="Panes, J" uniqKey="Panes J" first="J" last="Panes">J. Panes</name></noRegion></country><country name="Royaume-Uni"><noRegion><name sortKey="Travis, S P L" sort="Travis, S P L" uniqKey="Travis S" first="S P L" last="Travis">S P L. Travis</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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