Comparing Patient-Reported Outcomes Among Anti-TNF Experienced Patients With Ulcerative Colitis Initiating Vedolizumab Versus Tofacitinib.
Ulcerative colitis
comparative effectiveness research
patient-reported outcomes
tofacitinib
vedolizumab
Journal
Crohn's & colitis 360
ISSN: 2631-827X
Titre abrégé: Crohns Colitis 360
Pays: England
ID NLM: 101752188
Informations de publication
Date de publication:
Jul 2023
Jul 2023
Historique:
received:
20
03
2023
medline:
23
6
2023
pubmed:
23
6
2023
entrez:
23
6
2023
Statut:
epublish
Résumé
Primary and secondary nonresponse to anti-tumor necrosis factor (TNF) therapy is common in patients with ulcerative colitis (UC), yet limited research has compared the effectiveness of subsequent biological therapy. We sought to compare the effectiveness of vedolizumab and tofacitinib in anti-TNF experienced patients with UC, focusing on patient-prioritized patient-reported outcomes (PROs). We conducted a prospective cohort study nested within the Crohn's & Colitis Foundation's IBD Partners and SPARC IBD initiatives. We identified anti-TNF experienced patients with UC initiating vedolizumab or tofacitinib and analyzed PROs reported approximately 6 months later (minimum 4 months, maximum 10 months). Co-primary outcomes were Patient Reported Outcome Measurement Information System (PROMIS) domains of Fatigue and Pain Interference. Secondary outcomes included PRO2, treatment persistence, and need for colectomy. We compared 72 vedolizumab initiators and 33 tofacitinib initiators. At follow-up, Pain Interference ( Among anti-TNF experienced patients with UC, Pain Interference 4-10 months after treatment initiation was lower among tofacitinib users as compared with vedolizumab users. Many, but not all, secondary endpoints and subanalyses also favored tofacitinib. Future studies with larger sample sizes are needed to further evaluate these findings.
Sections du résumé
Background
UNASSIGNED
Primary and secondary nonresponse to anti-tumor necrosis factor (TNF) therapy is common in patients with ulcerative colitis (UC), yet limited research has compared the effectiveness of subsequent biological therapy.
Objective
UNASSIGNED
We sought to compare the effectiveness of vedolizumab and tofacitinib in anti-TNF experienced patients with UC, focusing on patient-prioritized patient-reported outcomes (PROs).
Methods
UNASSIGNED
We conducted a prospective cohort study nested within the Crohn's & Colitis Foundation's IBD Partners and SPARC IBD initiatives. We identified anti-TNF experienced patients with UC initiating vedolizumab or tofacitinib and analyzed PROs reported approximately 6 months later (minimum 4 months, maximum 10 months). Co-primary outcomes were Patient Reported Outcome Measurement Information System (PROMIS) domains of Fatigue and Pain Interference. Secondary outcomes included PRO2, treatment persistence, and need for colectomy.
Results
UNASSIGNED
We compared 72 vedolizumab initiators and 33 tofacitinib initiators. At follow-up, Pain Interference (
Conclusions
UNASSIGNED
Among anti-TNF experienced patients with UC, Pain Interference 4-10 months after treatment initiation was lower among tofacitinib users as compared with vedolizumab users. Many, but not all, secondary endpoints and subanalyses also favored tofacitinib. Future studies with larger sample sizes are needed to further evaluate these findings.
Identifiants
pubmed: 37350775
doi: 10.1093/crocol/otad031
pii: otad031
pmc: PMC10284045
doi:
Types de publication
Journal Article
Langues
eng
Pagination
otad031Informations de copyright
© The Author(s) 2023. Published by Oxford University Press on behalf of Crohn's & Colitis Foundation.
Déclaration de conflit d'intérêts
M.D.K. has consulted for AbbVie, Janssen, Pfizer, Takeda, and Lilly, is a shareholder in Johnson & Johnson, and has received research support from Pfizer, Takeda, Janssen, AbbVie, Lilly, Genentech, Boehringer Ingelheim, Bristol Myers Squibb, Celtrion, and Arenapharm. M.D.L. consulting for AbbVie, Janssen, Pfizer, Takeda, Lilly, BMS, Prometheus, Target Pharmasolutions, Calibr, Roche, Genentech, Theravance, Research support Takeda, and Pfizer. X.Z., F.-C.L., L.W., W.C., J.B., C.M.B., V.N., A.F.K., and A.D. report no conflicts of interest. J.D. is a shareholder in Pfizer. L.E.P. is employed by HealthCore/Anthem. K.H. was employed by Anthem at the time of the research and is currently an employee of Janssen Research & Development. J.D.L. has served as a consultant for Janssen Pharmaceuticals, Samsung Bioepis, Bristol-Myers Squibb, Merck, Celgene, AbbVie, Entasis Therapeutics, and Bridge Biotherapeutics. J.D.L. has served as a paid member of a data monitoring committee for Pfizer, UCB, Gilead, Galapagos, Arena Pharmaceuticals, Protagonist Therapeutics, Sanofi, and Amgen. J.D.L. has received research funding from Janssen Pharmaceuticals, AbbVie, and Takeda Pharmaceuticals. J.D.L. has received educational grant funding from Takeda Pharmaceuticals and Janssen.
Références
J Crohns Colitis. 2017 Mar 1;11(suppl_2):S567-S575
pubmed: 27660343
Inflamm Bowel Dis. 2012 Nov;18(11):2099-106
pubmed: 22287300
Autoimmun Rev. 2014 Jan;13(1):24-30
pubmed: 23792214
Gastrointest Endosc. 2004 Oct;60(4):505-12
pubmed: 15472670
Dig Dis Sci. 2013 Feb;58(2):519-25
pubmed: 22926499
Clin Gastroenterol Hepatol. 2023 Jan;21(1):182-191.e2
pubmed: 35644343
N Engl J Med. 2017 May 4;376(18):1723-1736
pubmed: 28467869
Inflamm Bowel Dis. 2022 Feb 1;28(2):192-199
pubmed: 34436563
Aliment Pharmacol Ther. 2002 Sep;16(9):1603-9
pubmed: 12197839
Clin Gastroenterol Hepatol. 2020 Sep;18(10):2179-2191.e6
pubmed: 31945470
Aliment Pharmacol Ther. 2017 Jul;46(1):68-69
pubmed: 28589588
Gastroenterology. 2015 Jul;149(1):238-45
pubmed: 26025078
Lancet Gastroenterol Hepatol. 2020 Jan;5(1):17-30
pubmed: 31648971
Inflamm Bowel Dis. 2014 Mar;20(3):541-4
pubmed: 24451221
Inflamm Bowel Dis. 2008 Dec;14(12):1660-6
pubmed: 18623174
Gut. 2021 Dec 22;:
pubmed: 34937767
Am J Gastroenterol. 2003 May;98(5):1064-72
pubmed: 12809829
Aliment Pharmacol Ther. 2015 Nov;42(10):1200-10
pubmed: 26388424
Aliment Pharmacol Ther. 2023 Mar;57(6):676-688
pubmed: 36401585
J Am Med Inform Assoc. 2016 May;23(3):485-90
pubmed: 26911821
J Crohns Colitis. 2017 Jul 1;11(7):769-784
pubmed: 28513805
Clin Gastroenterol Hepatol. 2017 Feb;15(2):229-239.e5
pubmed: 27639327
Gut. 1994 May;35(5):665-8
pubmed: 8200562
Clin Gastroenterol Hepatol. 2014 Aug;12(8):1315-23.e2
pubmed: 24183956
Gastroenterology. 2008 Dec;135(6):1907-13
pubmed: 18854185