Comparative Risk of Serious Infections With Tumor Necrosis Factor α Antagonists vs Vedolizumab in Patients With Inflammatory Bowel Diseases.
Biologics
Choice
Colitis
Infections
Safety
Journal
Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association
ISSN: 1542-7714
Titre abrégé: Clin Gastroenterol Hepatol
Pays: United States
ID NLM: 101160775
Informations de publication
Date de publication:
02 2022
02 2022
Historique:
received:
06
10
2020
revised:
21
01
2021
accepted:
08
02
2021
pubmed:
1
3
2021
medline:
17
3
2022
entrez:
28
2
2021
Statut:
ppublish
Résumé
We conducted a retrospective cohort study comparing the risk of serious infections between patients treated with tumor necrosis factor-a (TNFa) antagonists vs. vedolizumab in patients with inflammatory bowel diseases (IBD). Using an administrative claims database, we identified patients with IBD who were new-users of either TNFa antagonists or vedolizumab between 2014-2018 and had insurance coverage for at least 1y before and after treatment initiation. We compared the risk of serious infections (infections requiring hospitalization) between patients treated with vedolizumab or TNFa antagonists using marginal structural Cox proportional hazard models adjusted for baseline disease characteristics, healthcare utilization, comorbidities, and time-varying use of corticosteroids, immunomodulators and opiates. We included 4881 patients treated with TNFa antagonists (age, 41 ± 15y, 60% with Crohn's disease [CD]) of whom 434 developed serious infections over 5786 person-year [PY] follow-up, and 1106 patients treated with vedolizumab (age, 44 ± 16y, 39% with CD) of whom 86 developed serious infections over 1040-PY follow-up. Vedolizumab was associated with 46% lower risk of serious infections as compared with TNFa antagonists in patients with ulcerative colitis (HR,0.54 [95% CI,0.35-0.83), but no significant differences were observed in patients with CD (HR,1.30 [0.80-2.11]). Vedolizumab was associated with lower risk of extra-intestinal serious infections in patients with UC, but higher risk of gastrointestinal serious infections in patients with CD. In an observational study of patients with IBD, vedolizumab was associated with lower risk of serious infections as compared with TNFa antagonists, in patients with UC, but not in patients with CD.
Sections du résumé
BACKGROUND AND AIMS
We conducted a retrospective cohort study comparing the risk of serious infections between patients treated with tumor necrosis factor-a (TNFa) antagonists vs. vedolizumab in patients with inflammatory bowel diseases (IBD).
METHODS
Using an administrative claims database, we identified patients with IBD who were new-users of either TNFa antagonists or vedolizumab between 2014-2018 and had insurance coverage for at least 1y before and after treatment initiation. We compared the risk of serious infections (infections requiring hospitalization) between patients treated with vedolizumab or TNFa antagonists using marginal structural Cox proportional hazard models adjusted for baseline disease characteristics, healthcare utilization, comorbidities, and time-varying use of corticosteroids, immunomodulators and opiates.
RESULTS
We included 4881 patients treated with TNFa antagonists (age, 41 ± 15y, 60% with Crohn's disease [CD]) of whom 434 developed serious infections over 5786 person-year [PY] follow-up, and 1106 patients treated with vedolizumab (age, 44 ± 16y, 39% with CD) of whom 86 developed serious infections over 1040-PY follow-up. Vedolizumab was associated with 46% lower risk of serious infections as compared with TNFa antagonists in patients with ulcerative colitis (HR,0.54 [95% CI,0.35-0.83), but no significant differences were observed in patients with CD (HR,1.30 [0.80-2.11]). Vedolizumab was associated with lower risk of extra-intestinal serious infections in patients with UC, but higher risk of gastrointestinal serious infections in patients with CD.
CONCLUSIONS
In an observational study of patients with IBD, vedolizumab was associated with lower risk of serious infections as compared with TNFa antagonists, in patients with UC, but not in patients with CD.
Identifiants
pubmed: 33640480
pii: S1542-3565(21)00210-X
doi: 10.1016/j.cgh.2021.02.032
pmc: PMC8384969
mid: NIHMS1677961
pii:
doi:
Substances chimiques
Antibodies, Monoclonal, Humanized
0
Gastrointestinal Agents
0
Tumor Necrosis Factor Inhibitors
0
Tumor Necrosis Factor-alpha
0
vedolizumab
9RV78Q2002
Types de publication
Journal Article
Observational Study
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
e74-e88Subventions
Organisme : NIDDK NIH HHS
ID : K23 DK117058
Pays : United States
Organisme : NIDDK NIH HHS
ID : P30 DK120515
Pays : United States
Organisme : NIDDK NIH HHS
ID : R03 DK129631
Pays : United States
Informations de copyright
Copyright © 2022 AGA Institute. Published by Elsevier Inc. All rights reserved.
Références
Am J Gastroenterol. 2012 Sep;107(9):1409-22
pubmed: 22890223
J Crohns Colitis. 2017 Jun 1;11(6):680-689
pubmed: 28025307
Gastroenterology. 2020 Apr;158(5):1450-1461
pubmed: 31945371
Clin Gastroenterol Hepatol. 2016 Oct;14(10):1385-1397.e10
pubmed: 27189910
Aliment Pharmacol Ther. 2020 Aug;52(4):669-681
pubmed: 32656800
Gastroenterology. 2018 Aug;155(2):337-346.e10
pubmed: 29655835
Clin Gastroenterol Hepatol. 2020 Sep;18(10):2179-2191.e6
pubmed: 31945470
J Gastroenterol Hepatol. 2021 Jan;36(1):105-111
pubmed: 32428981
Pharmacoepidemiol Drug Saf. 2008 Sep;17(9):890-5
pubmed: 18543352
Clin Gastroenterol Hepatol. 2020 Jan;18(1):69-81.e3
pubmed: 30876964
N Engl J Med. 2019 Sep 26;381(13):1215-1226
pubmed: 31553834
Gastroenterology. 2020 Apr;158(5):1465-1496.e17
pubmed: 31945351
Gut. 2017 May;66(5):839-851
pubmed: 26893500
Gut. 2015 Jan;64(1):77-83
pubmed: 24763133
Am J Gastroenterol. 2018 Jun;113(6):872-882
pubmed: 29867173
Am J Epidemiol. 2008 Sep 15;168(6):656-64
pubmed: 18682488
Clin Gastroenterol Hepatol. 2016 Aug;14(8):1120-1129.e6
pubmed: 27058635
J Clin Epidemiol. 2009 Mar;62(3):321-7, 327.e1-7
pubmed: 18834713
Clin Gastroenterol Hepatol. 2022 Feb;20(2):314-324.e16
pubmed: 33387667
Clin Gastroenterol Hepatol. 2022 Jan;20(1):126-135
pubmed: 33039584
Health Aff (Millwood). 2014 Jul;33(7):1187-94
pubmed: 25006145
Clin Gastroenterol Hepatol. 2017 Aug;15(8):1218-1225.e7
pubmed: 27913244
Med Care. 1998 Jan;36(1):8-27
pubmed: 9431328
Aliment Pharmacol Ther. 2018 Aug;48(4):394-409
pubmed: 29920733
Lancet. 2018 May 5;391(10132):1775-1782
pubmed: 29706364
Expert Rev Clin Immunol. 2019 Sep;15(9):969-979
pubmed: 31322018
Aliment Pharmacol Ther. 2018 Mar;47(5):596-604
pubmed: 29239001