Decision Support Tool Identifies Ulcerative Colitis Patients Most Likely to Achieve Remission With Vedolizumab vs Adalimumab
Abstract Background & Aims We have previously validated a clinical decision support tool (CDST) (vedolizumab CDST [VDZ-CDST]) for clinical and endoscopic remission with VDZ in ulcerative colitis (UC). We aim to expand the validation for predicting histoendoscopic mucosal improvement (HEMI) with...
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| Veröffentlicht in: | Inflammatory bowel diseases 2022-10, Vol.28 (10), p.1555-1564 |
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| creator | Dulai, Parambir S Wong, Emily C L Reinisch, Walter Colombel, Jean-Frederic Marshall, John K Narula, Neeraj |
| description | Abstract
Background & Aims
We have previously validated a clinical decision support tool (CDST) (vedolizumab CDST [VDZ-CDST]) for clinical and endoscopic remission with VDZ in ulcerative colitis (UC). We aim to expand the validation for predicting histoendoscopic mucosal improvement (HEMI) with VDZ vs adalimumab (ADA).
Methods
In a post hoc analysis of a clinical trial for VDZ vs ADA in moderate to severe UC (VARSITY trial; NCT02497469), comparative accuracy was evaluated for the VDZ-CDST among an external validation cohort of VDZ- and ADA-treated patients for week 52 HEMI (Mayo endoscopic subscore 0-1 and Geboes score |
| doi_str_mv | 10.1093/ibd/izab310 |
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| fullrecord | <record><control><sourceid>oup_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_9527604</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><oup_id>10.1093/ibd/izab310</oup_id><sourcerecordid>10.1093/ibd/izab310</sourcerecordid><originalsourceid>FETCH-LOGICAL-c412t-f7a5f0ec0a7bb980990c16a6a2f96b2607e0bac939d514b1a4f61ab1fb4113693</originalsourceid><addsrcrecordid>eNp9kT1PwzAQhi0EolCY2JEnFhRqJ65TL0hV-apUBIIWxsh2HHqQ1FGcVGrFj8elpYIFeTif7r3n7HsROqHkghIRdUClHVhKFVGygw5oN-IB6zG26-8k7gVEiF4LHTr3Tkjoj9hHrYgJHkciPkCfV0aDAzvDz01Z2qrGY2tzPEzNrIYMjMOTXJtK1jA3eGBzqMHhR5_6usP31tV4BB8mX-Da4r6egvG6J1OA-4a-Qj3FLyb1jcumkArPHe6nModilR2hvUzmzhxvYhtNbq7Hg7tg9HA7HPRHgWY0rIMslt2MGE1krJTo-Q8RTbnkMswEVyEnsSFKahGJtEuZopJlnEpFM8UojbiI2uhyzS0bVZhU-7dXMk_KCgpZLRIrIflbmcE0ebPzRHTDmBPmAedrgK6sc5XJtr2UJCsTEm9CsjHBq09_j9tqf7buBWdrgW3Kf0lfk3eUyA</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype></control><display><type>article</type><title>Decision Support Tool Identifies Ulcerative Colitis Patients Most Likely to Achieve Remission With Vedolizumab vs Adalimumab</title><source>MEDLINE</source><source>Oxford University Press Journals All Titles (1996-Current)</source><creator>Dulai, Parambir S ; Wong, Emily C L ; Reinisch, Walter ; Colombel, Jean-Frederic ; Marshall, John K ; Narula, Neeraj</creator><creatorcontrib>Dulai, Parambir S ; Wong, Emily C L ; Reinisch, Walter ; Colombel, Jean-Frederic ; Marshall, John K ; Narula, Neeraj</creatorcontrib><description>Abstract
Background & Aims
We have previously validated a clinical decision support tool (CDST) (vedolizumab CDST [VDZ-CDST]) for clinical and endoscopic remission with VDZ in ulcerative colitis (UC). We aim to expand the validation for predicting histoendoscopic mucosal improvement (HEMI) with VDZ vs adalimumab (ADA).
Methods
In a post hoc analysis of a clinical trial for VDZ vs ADA in moderate to severe UC (VARSITY trial; NCT02497469), comparative accuracy was evaluated for the VDZ-CDST among an external validation cohort of VDZ- and ADA-treated patients for week 52 HEMI (Mayo endoscopic subscore 0-1 and Geboes score <3.2). Comparative effectiveness of VDZ and ADA was assessed after stratifying the cohort by baseline probability of response to VDZ using the VDZ-CDST.
Results
A total of 419 patients were included. The majority of patients enrolled in the VARSITY trial had a high (61%) or intermediate (29%) baseline predicted probability of response to VDZ. The baseline VDZ-CDST score was significantly more likely to predict week 52 HEMI for VDZ (area under the curve , 0.712; 95% confidence interval, 0.636-0.787) relative to ADA-treated patients (area under the curve, 0.538; 95% confidence interval, 0.377-0.700; P < .001 for AUC comparison). A significant (P < .001) association was observed between the VDZ-CDST and measured VDZ drug exposure over 52 weeks. Superiority of VDZ to ADA was only observed in patients with a high baseline predicted probability of response to VDZ.
Conclusions
Superiority of VDZ to ADA is dependent on baseline probability of response, and a VDZ-CDST is capable of identifying UC patients most appropriate for VDZ vs ADA.</description><identifier>ISSN: 1078-0998</identifier><identifier>EISSN: 1536-4844</identifier><identifier>DOI: 10.1093/ibd/izab310</identifier><identifier>PMID: 34967397</identifier><language>eng</language><publisher>US: Oxford University Press</publisher><subject>Adalimumab - therapeutic use ; Antibodies, Monoclonal, Humanized - therapeutic use ; Clinical Research ; Colitis, Ulcerative - chemically induced ; Colitis, Ulcerative - drug therapy ; Gastrointestinal Agents - therapeutic use ; Humans ; Remission Induction ; Retrospective Studies ; Treatment Outcome</subject><ispartof>Inflammatory bowel diseases, 2022-10, Vol.28 (10), p.1555-1564</ispartof><rights>The Author(s) 2021. Published by Oxford University Press on behalf of Crohn’s & Colitis Foundation. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com 2021</rights><rights>2021 Crohn’s & Colitis Foundation. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.</rights><rights>2021 Crohn’s & Colitis Foundation. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com. 2021</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c412t-f7a5f0ec0a7bb980990c16a6a2f96b2607e0bac939d514b1a4f61ab1fb4113693</citedby><cites>FETCH-LOGICAL-c412t-f7a5f0ec0a7bb980990c16a6a2f96b2607e0bac939d514b1a4f61ab1fb4113693</cites><orcidid>0000-0001-6472-249X ; 0000-0002-1536-8436 ; 0000-0002-9514-2321</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,780,784,885,1584,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/34967397$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Dulai, Parambir S</creatorcontrib><creatorcontrib>Wong, Emily C L</creatorcontrib><creatorcontrib>Reinisch, Walter</creatorcontrib><creatorcontrib>Colombel, Jean-Frederic</creatorcontrib><creatorcontrib>Marshall, John K</creatorcontrib><creatorcontrib>Narula, Neeraj</creatorcontrib><title>Decision Support Tool Identifies Ulcerative Colitis Patients Most Likely to Achieve Remission With Vedolizumab vs Adalimumab</title><title>Inflammatory bowel diseases</title><addtitle>Inflamm Bowel Dis</addtitle><description>Abstract
Background & Aims
We have previously validated a clinical decision support tool (CDST) (vedolizumab CDST [VDZ-CDST]) for clinical and endoscopic remission with VDZ in ulcerative colitis (UC). We aim to expand the validation for predicting histoendoscopic mucosal improvement (HEMI) with VDZ vs adalimumab (ADA).
Methods
In a post hoc analysis of a clinical trial for VDZ vs ADA in moderate to severe UC (VARSITY trial; NCT02497469), comparative accuracy was evaluated for the VDZ-CDST among an external validation cohort of VDZ- and ADA-treated patients for week 52 HEMI (Mayo endoscopic subscore 0-1 and Geboes score <3.2). Comparative effectiveness of VDZ and ADA was assessed after stratifying the cohort by baseline probability of response to VDZ using the VDZ-CDST.
Results
A total of 419 patients were included. The majority of patients enrolled in the VARSITY trial had a high (61%) or intermediate (29%) baseline predicted probability of response to VDZ. The baseline VDZ-CDST score was significantly more likely to predict week 52 HEMI for VDZ (area under the curve , 0.712; 95% confidence interval, 0.636-0.787) relative to ADA-treated patients (area under the curve, 0.538; 95% confidence interval, 0.377-0.700; P < .001 for AUC comparison). A significant (P < .001) association was observed between the VDZ-CDST and measured VDZ drug exposure over 52 weeks. Superiority of VDZ to ADA was only observed in patients with a high baseline predicted probability of response to VDZ.
Conclusions
Superiority of VDZ to ADA is dependent on baseline probability of response, and a VDZ-CDST is capable of identifying UC patients most appropriate for VDZ vs ADA.</description><subject>Adalimumab - therapeutic use</subject><subject>Antibodies, Monoclonal, Humanized - therapeutic use</subject><subject>Clinical Research</subject><subject>Colitis, Ulcerative - chemically induced</subject><subject>Colitis, Ulcerative - drug therapy</subject><subject>Gastrointestinal Agents - therapeutic use</subject><subject>Humans</subject><subject>Remission Induction</subject><subject>Retrospective Studies</subject><subject>Treatment Outcome</subject><issn>1078-0998</issn><issn>1536-4844</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2022</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kT1PwzAQhi0EolCY2JEnFhRqJ65TL0hV-apUBIIWxsh2HHqQ1FGcVGrFj8elpYIFeTif7r3n7HsROqHkghIRdUClHVhKFVGygw5oN-IB6zG26-8k7gVEiF4LHTr3Tkjoj9hHrYgJHkciPkCfV0aDAzvDz01Z2qrGY2tzPEzNrIYMjMOTXJtK1jA3eGBzqMHhR5_6usP31tV4BB8mX-Da4r6egvG6J1OA-4a-Qj3FLyb1jcumkArPHe6nModilR2hvUzmzhxvYhtNbq7Hg7tg9HA7HPRHgWY0rIMslt2MGE1krJTo-Q8RTbnkMswEVyEnsSFKahGJtEuZopJlnEpFM8UojbiI2uhyzS0bVZhU-7dXMk_KCgpZLRIrIflbmcE0ebPzRHTDmBPmAedrgK6sc5XJtr2UJCsTEm9CsjHBq09_j9tqf7buBWdrgW3Kf0lfk3eUyA</recordid><startdate>20221003</startdate><enddate>20221003</enddate><creator>Dulai, Parambir S</creator><creator>Wong, Emily C L</creator><creator>Reinisch, Walter</creator><creator>Colombel, Jean-Frederic</creator><creator>Marshall, John K</creator><creator>Narula, Neeraj</creator><general>Oxford University Press</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0001-6472-249X</orcidid><orcidid>https://orcid.org/0000-0002-1536-8436</orcidid><orcidid>https://orcid.org/0000-0002-9514-2321</orcidid></search><sort><creationdate>20221003</creationdate><title>Decision Support Tool Identifies Ulcerative Colitis Patients Most Likely to Achieve Remission With Vedolizumab vs Adalimumab</title><author>Dulai, Parambir S ; Wong, Emily C L ; Reinisch, Walter ; Colombel, Jean-Frederic ; Marshall, John K ; Narula, Neeraj</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c412t-f7a5f0ec0a7bb980990c16a6a2f96b2607e0bac939d514b1a4f61ab1fb4113693</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2022</creationdate><topic>Adalimumab - therapeutic use</topic><topic>Antibodies, Monoclonal, Humanized - therapeutic use</topic><topic>Clinical Research</topic><topic>Colitis, Ulcerative - chemically induced</topic><topic>Colitis, Ulcerative - drug therapy</topic><topic>Gastrointestinal Agents - therapeutic use</topic><topic>Humans</topic><topic>Remission Induction</topic><topic>Retrospective Studies</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Dulai, Parambir S</creatorcontrib><creatorcontrib>Wong, Emily C L</creatorcontrib><creatorcontrib>Reinisch, Walter</creatorcontrib><creatorcontrib>Colombel, Jean-Frederic</creatorcontrib><creatorcontrib>Marshall, John K</creatorcontrib><creatorcontrib>Narula, Neeraj</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Inflammatory bowel diseases</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Dulai, Parambir S</au><au>Wong, Emily C L</au><au>Reinisch, Walter</au><au>Colombel, Jean-Frederic</au><au>Marshall, John K</au><au>Narula, Neeraj</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Decision Support Tool Identifies Ulcerative Colitis Patients Most Likely to Achieve Remission With Vedolizumab vs Adalimumab</atitle><jtitle>Inflammatory bowel diseases</jtitle><addtitle>Inflamm Bowel Dis</addtitle><date>2022-10-03</date><risdate>2022</risdate><volume>28</volume><issue>10</issue><spage>1555</spage><epage>1564</epage><pages>1555-1564</pages><issn>1078-0998</issn><eissn>1536-4844</eissn><abstract>Abstract
Background & Aims
We have previously validated a clinical decision support tool (CDST) (vedolizumab CDST [VDZ-CDST]) for clinical and endoscopic remission with VDZ in ulcerative colitis (UC). We aim to expand the validation for predicting histoendoscopic mucosal improvement (HEMI) with VDZ vs adalimumab (ADA).
Methods
In a post hoc analysis of a clinical trial for VDZ vs ADA in moderate to severe UC (VARSITY trial; NCT02497469), comparative accuracy was evaluated for the VDZ-CDST among an external validation cohort of VDZ- and ADA-treated patients for week 52 HEMI (Mayo endoscopic subscore 0-1 and Geboes score <3.2). Comparative effectiveness of VDZ and ADA was assessed after stratifying the cohort by baseline probability of response to VDZ using the VDZ-CDST.
Results
A total of 419 patients were included. The majority of patients enrolled in the VARSITY trial had a high (61%) or intermediate (29%) baseline predicted probability of response to VDZ. The baseline VDZ-CDST score was significantly more likely to predict week 52 HEMI for VDZ (area under the curve , 0.712; 95% confidence interval, 0.636-0.787) relative to ADA-treated patients (area under the curve, 0.538; 95% confidence interval, 0.377-0.700; P < .001 for AUC comparison). A significant (P < .001) association was observed between the VDZ-CDST and measured VDZ drug exposure over 52 weeks. Superiority of VDZ to ADA was only observed in patients with a high baseline predicted probability of response to VDZ.
Conclusions
Superiority of VDZ to ADA is dependent on baseline probability of response, and a VDZ-CDST is capable of identifying UC patients most appropriate for VDZ vs ADA.</abstract><cop>US</cop><pub>Oxford University Press</pub><pmid>34967397</pmid><doi>10.1093/ibd/izab310</doi><tpages>10</tpages><orcidid>https://orcid.org/0000-0001-6472-249X</orcidid><orcidid>https://orcid.org/0000-0002-1536-8436</orcidid><orcidid>https://orcid.org/0000-0002-9514-2321</orcidid><oa>free_for_read</oa></addata></record> |
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| ispartof | Inflammatory bowel diseases, 2022-10, Vol.28 (10), p.1555-1564 |
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| source | MEDLINE; Oxford University Press Journals All Titles (1996-Current) |
| subjects | Adalimumab - therapeutic use Antibodies, Monoclonal, Humanized - therapeutic use Clinical Research Colitis, Ulcerative - chemically induced Colitis, Ulcerative - drug therapy Gastrointestinal Agents - therapeutic use Humans Remission Induction Retrospective Studies Treatment Outcome |
| title | Decision Support Tool Identifies Ulcerative Colitis Patients Most Likely to Achieve Remission With Vedolizumab vs Adalimumab |
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