Racial Difference in Efficacy of Golimumab in Ulcerative Colitis
Abstract Background Observational studies have described racial differences in inflammatory bowel disease (IBD) genetics, clinical manifestations, and outcomes. Whether race impacts response to biologics in IBD is unclear. We conducted a post hoc analysis of phase 2 and 3 randomized clinical trials...
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| Veröffentlicht in: | Inflammatory bowel diseases 2023-06, Vol.29 (6), p.843-849 |
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| creator | Greywoode, Ruby Petralia, Francesca Ullman, Thomas A Frederic Colombel, Jean Ungaro, Ryan C |
| description | Abstract
Background
Observational studies have described racial differences in inflammatory bowel disease (IBD) genetics, clinical manifestations, and outcomes. Whether race impacts response to biologics in IBD is unclear. We conducted a post hoc analysis of phase 2 and 3 randomized clinical trials in ulcerative colitis to evaluate the effect of race on response to golimumab.
Methods
We analyzed pooled individual-level data from induction and maintenance trials of golimumab through the Yale Open Data Access Project. The primary outcome was clinical response. Secondary outcomes were clinical remission and endoscopic healing. Multivariable logistic regression was performed comparing White vs racial minority groups (Asian, Black, or other race), adjusting for potential confounders.
Results
There were 1006 participants in the induction (18% racial minority) and 783 participants in the maintenance (17% racial minority) trials. Compared with White participants, participants from racial minority groups had significantly lower clinical response (adjusted odds ratio [aOR], 0.43; 95% confidence interval [CI], 0.28-0.66), clinical remission (aOR, 0.41; 95% CI, 0.22-0.77), and endoscopic healing (aOR, 0.48; 95% CI, 0.31-0.74) at week 6. Participants from racial minority groups also had significantly lower clinical remission (aOR, 0.46; 95% CI, 0.28-0.74) and endoscopic healing (aOR, 0.63; 95% CI, 0.41-0.96) at week 30. There were no racial differences in placebo response rates.
Conclusions
Ulcerative colitis participants from racial minority groups were less likely to achieve clinical response, clinical remission, and endoscopic healing with golimumab compared with White participants in induction and maintenance trials. Further studies are needed to understand the impact of race on therapeutic response in IBD.
Lay Summary
Racial disparities exist in inflammatory bowel disease, but the influence of race on response to biologic therapy is unclear. In pooled analysis of golimumab clinical trials, participants from racial minority groups were less likely to achieve clinical efficacy compared with White participants. |
| doi_str_mv | 10.1093/ibd/izac161 |
| format | Article |
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Background
Observational studies have described racial differences in inflammatory bowel disease (IBD) genetics, clinical manifestations, and outcomes. Whether race impacts response to biologics in IBD is unclear. We conducted a post hoc analysis of phase 2 and 3 randomized clinical trials in ulcerative colitis to evaluate the effect of race on response to golimumab.
Methods
We analyzed pooled individual-level data from induction and maintenance trials of golimumab through the Yale Open Data Access Project. The primary outcome was clinical response. Secondary outcomes were clinical remission and endoscopic healing. Multivariable logistic regression was performed comparing White vs racial minority groups (Asian, Black, or other race), adjusting for potential confounders.
Results
There were 1006 participants in the induction (18% racial minority) and 783 participants in the maintenance (17% racial minority) trials. Compared with White participants, participants from racial minority groups had significantly lower clinical response (adjusted odds ratio [aOR], 0.43; 95% confidence interval [CI], 0.28-0.66), clinical remission (aOR, 0.41; 95% CI, 0.22-0.77), and endoscopic healing (aOR, 0.48; 95% CI, 0.31-0.74) at week 6. Participants from racial minority groups also had significantly lower clinical remission (aOR, 0.46; 95% CI, 0.28-0.74) and endoscopic healing (aOR, 0.63; 95% CI, 0.41-0.96) at week 30. There were no racial differences in placebo response rates.
Conclusions
Ulcerative colitis participants from racial minority groups were less likely to achieve clinical response, clinical remission, and endoscopic healing with golimumab compared with White participants in induction and maintenance trials. Further studies are needed to understand the impact of race on therapeutic response in IBD.
Lay Summary
Racial disparities exist in inflammatory bowel disease, but the influence of race on response to biologic therapy is unclear. In pooled analysis of golimumab clinical trials, participants from racial minority groups were less likely to achieve clinical efficacy compared with White participants.</description><identifier>ISSN: 1078-0998</identifier><identifier>ISSN: 1536-4844</identifier><identifier>EISSN: 1536-4844</identifier><identifier>DOI: 10.1093/ibd/izac161</identifier><identifier>PMID: 35913121</identifier><language>eng</language><publisher>US: Oxford University Press</publisher><subject>Antibodies, Monoclonal - therapeutic use ; Colitis, Ulcerative - drug therapy ; Editor's Choice ; Humans ; Inflammatory Bowel Diseases - drug therapy ; Leading Off ; Remission Induction</subject><ispartof>Inflammatory bowel diseases, 2023-06, Vol.29 (6), p.843-849</ispartof><rights>The Author(s) 2022. Published by Oxford University Press on behalf of Crohn’s & Colitis Foundation. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com 2022</rights><rights>The Author(s) 2022. Published by Oxford University Press on behalf of Crohn’s & Colitis Foundation. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c413t-dcf9da0eeaf77811b4c67d7b6e8447004a5da707f19bc89353d2ebf3ab98aad23</citedby><cites>FETCH-LOGICAL-c413t-dcf9da0eeaf77811b4c67d7b6e8447004a5da707f19bc89353d2ebf3ab98aad23</cites><orcidid>0000-0002-1725-1370</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/35913121$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Greywoode, Ruby</creatorcontrib><creatorcontrib>Petralia, Francesca</creatorcontrib><creatorcontrib>Ullman, Thomas A</creatorcontrib><creatorcontrib>Frederic Colombel, Jean</creatorcontrib><creatorcontrib>Ungaro, Ryan C</creatorcontrib><title>Racial Difference in Efficacy of Golimumab in Ulcerative Colitis</title><title>Inflammatory bowel diseases</title><addtitle>Inflamm Bowel Dis</addtitle><description>Abstract
Background
Observational studies have described racial differences in inflammatory bowel disease (IBD) genetics, clinical manifestations, and outcomes. Whether race impacts response to biologics in IBD is unclear. We conducted a post hoc analysis of phase 2 and 3 randomized clinical trials in ulcerative colitis to evaluate the effect of race on response to golimumab.
Methods
We analyzed pooled individual-level data from induction and maintenance trials of golimumab through the Yale Open Data Access Project. The primary outcome was clinical response. Secondary outcomes were clinical remission and endoscopic healing. Multivariable logistic regression was performed comparing White vs racial minority groups (Asian, Black, or other race), adjusting for potential confounders.
Results
There were 1006 participants in the induction (18% racial minority) and 783 participants in the maintenance (17% racial minority) trials. Compared with White participants, participants from racial minority groups had significantly lower clinical response (adjusted odds ratio [aOR], 0.43; 95% confidence interval [CI], 0.28-0.66), clinical remission (aOR, 0.41; 95% CI, 0.22-0.77), and endoscopic healing (aOR, 0.48; 95% CI, 0.31-0.74) at week 6. Participants from racial minority groups also had significantly lower clinical remission (aOR, 0.46; 95% CI, 0.28-0.74) and endoscopic healing (aOR, 0.63; 95% CI, 0.41-0.96) at week 30. There were no racial differences in placebo response rates.
Conclusions
Ulcerative colitis participants from racial minority groups were less likely to achieve clinical response, clinical remission, and endoscopic healing with golimumab compared with White participants in induction and maintenance trials. Further studies are needed to understand the impact of race on therapeutic response in IBD.
Lay Summary
Racial disparities exist in inflammatory bowel disease, but the influence of race on response to biologic therapy is unclear. In pooled analysis of golimumab clinical trials, participants from racial minority groups were less likely to achieve clinical efficacy compared with White participants.</description><subject>Antibodies, Monoclonal - therapeutic use</subject><subject>Colitis, Ulcerative - drug therapy</subject><subject>Editor's Choice</subject><subject>Humans</subject><subject>Inflammatory Bowel Diseases - drug therapy</subject><subject>Leading Off</subject><subject>Remission Induction</subject><issn>1078-0998</issn><issn>1536-4844</issn><issn>1536-4844</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kN9LwzAQx4Mobv548l36JILUJU3bJE8qc05hIIh7Dtc00UjbzKYdzL_ejM2hL3IPd9x9-N6XL0JnBF8TLOjIFuXIfoEiOdlDQ5LRPE55mu6HGTMeYyH4AB15_4FxEkocogHNBKEkIUN0-wLKQhXdW2N0qxulI9tEE2OsArWKnImmrrJ1X0OxPswrpVvo7FJH47DvrD9BBwYqr0-3_RjNHyav48d49jx9Gt_NYpUS2sWlMqIErDUYxjghRapyVrIi18EqwziFrASGmSGiUFzQjJaJLgyFQnCAMqHH6Gaju-iLWpdKN10LlVy0toZ2JR1Y-ffS2Hf55paS4ITSFOOgcLlVaN1nr30na-uVripotOu9THLBsEgzzgN6tUFV67xvtdn9IViuQ5chdLkNPdDnv63t2J-UA3CxAVy_-FfpG3JxjFk</recordid><startdate>20230601</startdate><enddate>20230601</enddate><creator>Greywoode, Ruby</creator><creator>Petralia, Francesca</creator><creator>Ullman, Thomas A</creator><creator>Frederic Colombel, Jean</creator><creator>Ungaro, Ryan C</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>7X8</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0002-1725-1370</orcidid></search><sort><creationdate>20230601</creationdate><title>Racial Difference in Efficacy of Golimumab in Ulcerative Colitis</title><author>Greywoode, Ruby ; Petralia, Francesca ; Ullman, Thomas A ; Frederic Colombel, Jean ; Ungaro, Ryan C</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c413t-dcf9da0eeaf77811b4c67d7b6e8447004a5da707f19bc89353d2ebf3ab98aad23</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>Antibodies, Monoclonal - therapeutic use</topic><topic>Colitis, Ulcerative - drug therapy</topic><topic>Editor's Choice</topic><topic>Humans</topic><topic>Inflammatory Bowel Diseases - drug therapy</topic><topic>Leading Off</topic><topic>Remission Induction</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Greywoode, Ruby</creatorcontrib><creatorcontrib>Petralia, Francesca</creatorcontrib><creatorcontrib>Ullman, Thomas A</creatorcontrib><creatorcontrib>Frederic Colombel, Jean</creatorcontrib><creatorcontrib>Ungaro, Ryan C</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</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>Greywoode, Ruby</au><au>Petralia, Francesca</au><au>Ullman, Thomas A</au><au>Frederic Colombel, Jean</au><au>Ungaro, Ryan C</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Racial Difference in Efficacy of Golimumab in Ulcerative Colitis</atitle><jtitle>Inflammatory bowel diseases</jtitle><addtitle>Inflamm Bowel Dis</addtitle><date>2023-06-01</date><risdate>2023</risdate><volume>29</volume><issue>6</issue><spage>843</spage><epage>849</epage><pages>843-849</pages><issn>1078-0998</issn><issn>1536-4844</issn><eissn>1536-4844</eissn><abstract>Abstract
Background
Observational studies have described racial differences in inflammatory bowel disease (IBD) genetics, clinical manifestations, and outcomes. Whether race impacts response to biologics in IBD is unclear. We conducted a post hoc analysis of phase 2 and 3 randomized clinical trials in ulcerative colitis to evaluate the effect of race on response to golimumab.
Methods
We analyzed pooled individual-level data from induction and maintenance trials of golimumab through the Yale Open Data Access Project. The primary outcome was clinical response. Secondary outcomes were clinical remission and endoscopic healing. Multivariable logistic regression was performed comparing White vs racial minority groups (Asian, Black, or other race), adjusting for potential confounders.
Results
There were 1006 participants in the induction (18% racial minority) and 783 participants in the maintenance (17% racial minority) trials. Compared with White participants, participants from racial minority groups had significantly lower clinical response (adjusted odds ratio [aOR], 0.43; 95% confidence interval [CI], 0.28-0.66), clinical remission (aOR, 0.41; 95% CI, 0.22-0.77), and endoscopic healing (aOR, 0.48; 95% CI, 0.31-0.74) at week 6. Participants from racial minority groups also had significantly lower clinical remission (aOR, 0.46; 95% CI, 0.28-0.74) and endoscopic healing (aOR, 0.63; 95% CI, 0.41-0.96) at week 30. There were no racial differences in placebo response rates.
Conclusions
Ulcerative colitis participants from racial minority groups were less likely to achieve clinical response, clinical remission, and endoscopic healing with golimumab compared with White participants in induction and maintenance trials. Further studies are needed to understand the impact of race on therapeutic response in IBD.
Lay Summary
Racial disparities exist in inflammatory bowel disease, but the influence of race on response to biologic therapy is unclear. In pooled analysis of golimumab clinical trials, participants from racial minority groups were less likely to achieve clinical efficacy compared with White participants.</abstract><cop>US</cop><pub>Oxford University Press</pub><pmid>35913121</pmid><doi>10.1093/ibd/izac161</doi><tpages>7</tpages><orcidid>https://orcid.org/0000-0002-1725-1370</orcidid><oa>free_for_read</oa></addata></record> |
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| source | MEDLINE; Oxford University Press Journals All Titles (1996-Current) |
| subjects | Antibodies, Monoclonal - therapeutic use Colitis, Ulcerative - drug therapy Editor's Choice Humans Inflammatory Bowel Diseases - drug therapy Leading Off Remission Induction |
| title | Racial Difference in Efficacy of Golimumab in Ulcerative Colitis |
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