Racial Difference in Efficacy of Golimumab in Ulcerative Colitis.
TNF antagonist
biologics
inflammatory bowel disease
race
Journal
Inflammatory bowel diseases
ISSN: 1536-4844
Titre abrégé: Inflamm Bowel Dis
Pays: England
ID NLM: 9508162
Informations de publication
Date de publication:
01 06 2023
01 06 2023
Historique:
received:
20
01
2022
medline:
2
6
2023
pubmed:
2
8
2022
entrez:
1
8
2022
Statut:
ppublish
Résumé
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. 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. 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. 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. 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.
Sections du résumé
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.
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.
Autres résumés
Type: plain-language-summary
(eng)
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.
Identifiants
pubmed: 35913121
pii: 6652811
doi: 10.1093/ibd/izac161
pmc: PMC10233400
doi:
Substances chimiques
Antibodies, Monoclonal
0
golimumab
91X1KLU43E
Types de publication
Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Langues
eng
Sous-ensembles de citation
IM
Pagination
843-849Subventions
Organisme : NIH HHS
ID : K23KD111995
Pays : United States
Organisme : NCATS NIH HHS
ID : UL1TR001073
Pays : United States
Commentaires et corrections
Type : CommentIn
Informations de copyright
© 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.
Références
Gastroenterology. 2016 Jan;150(1):86-95.e3; quiz e13-4
pubmed: 26385074
Pharmacogenomics J. 2015 Feb;15(1):101-108
pubmed: 25069476
Gastroenterology. 2021 Feb;160(3):677-689
pubmed: 33098884
J Gastroenterol. 2017 Oct;52(10):1101-1111
pubmed: 28324167
Dig Dis Sci. 2014 Feb;59(2):287-94
pubmed: 24173809
Inflamm Bowel Dis. 2012 Jun;18(6):1164-76
pubmed: 21887729
Inflamm Bowel Dis. 2013 Mar;19(3):627-43
pubmed: 22623078
Lancet Gastroenterol Hepatol. 2020 Jan;5(1):17-30
pubmed: 31648971
Nat Rev Gastroenterol Hepatol. 2015 Apr;12(4):205-17
pubmed: 25732745
Nat Genet. 2015 Sep;47(9):979-986
pubmed: 26192919
Onco Targets Ther. 2018 Nov 23;11:8309-8317
pubmed: 30538500
PLoS One. 2015 Sep 23;10(9):e0138511
pubmed: 26398658
Clin Gastroenterol Hepatol. 2018 Feb;16(2):190-197.e11
pubmed: 28603049
N Engl J Med. 2004 Nov 11;351(20):2049-57
pubmed: 15533851
Gastroenterology. 2017 Jan;152(1):206-217.e2
pubmed: 27693347
Gastroenterology. 2022 Jan;162(1):17-21
pubmed: 34562464
Pharmacogenomics J. 2014 Jun;14(3):217-22
pubmed: 23835662
Am J Transplant. 2021 Oct;21(10):3491-3493
pubmed: 33890411
Am J Gastroenterol. 2006 May;101(5):1012-23
pubmed: 16696785
Clin Gastroenterol Hepatol. 2021 Jul;19(7):1377-1386.e5
pubmed: 32526341
Am J Hum Genet. 2021 Mar 4;108(3):431-445
pubmed: 33600772
Inflamm Bowel Dis. 2016 Aug;22(8):2023-40
pubmed: 27379446
Inflamm Bowel Dis. 2009 Aug;15(8):1233-9
pubmed: 19177509
Inflamm Bowel Dis. 2018 Nov 29;24(12):2634-2640
pubmed: 29788063
N Engl J Med. 2021 Feb 4;384(5):474-480
pubmed: 33406325
Dig Dis Sci. 2020 Jun;65(6):1790-1799
pubmed: 31655907
Clin Gastroenterol Hepatol. 2020 Feb;18(2):304-312
pubmed: 31252191
Am J Gastroenterol. 2013 Feb;108(2):231-9
pubmed: 23247580
Cancer. 2014 Apr 1;120 Suppl 7:1091-6
pubmed: 24643646
N Engl J Med. 2010 Oct 14;363(16):1551-8
pubmed: 20942671
JAMA. 2004 Jun 9;291(22):2720-6
pubmed: 15187053
Inflamm Bowel Dis. 2009 May;15(5):726-33
pubmed: 19067416
Ann Thorac Surg. 2021 Sep;112(3):726-735
pubmed: 33189670
JAMA. 2016 Apr 26;315(16):1750-66
pubmed: 27063997
Ethn Dis. 2015 Aug 07;25(3):245-54
pubmed: 26675362
J Gastroenterol. 2014 Feb;49(2):283-94
pubmed: 24363029
Lancet. 2018 Dec 23;390(10114):2769-2778
pubmed: 29050646