Real-World Evidence Comparing Vedolizumab and Ustekinumab in Antitumor Necrosis Factor-Experienced Patients With Crohn's Disease.
Journal
The American journal of gastroenterology
ISSN: 1572-0241
Titre abrégé: Am J Gastroenterol
Pays: United States
ID NLM: 0421030
Informations de publication
Date de publication:
01 04 2023
01 04 2023
Historique:
received:
27
07
2022
accepted:
06
10
2022
medline:
31
3
2023
pubmed:
13
12
2022
entrez:
12
12
2022
Statut:
ppublish
Résumé
Many patients with Crohn's disease (CD) lose response or become intolerant to antitumor necrosis factor (TNF) therapy and subsequently switch out of class. We compared the effectiveness and safety of ustekinumab to vedolizumab in a large, geographically diverse US population of TNF-experienced patients with CD. We conducted a retrospective cohort study using longitudinal claims data from a large US insurer (Anthem, Inc.). We identified patients with CD initiating vedolizumab or ustekinumab with anti-TNF treatment in the prior 6 months. Our primary outcome was treatment persistence for >52 weeks. Secondary outcomes included (i) all-cause hospitalization, (ii) hospitalization for CD with surgery, (iii) hospitalization for CD without surgery, and (iv) hospitalization for infection. Propensity score fine stratification was used to control for demographic and baseline clinical characteristics and prior treatments. Among 885 new users of ustekinumab and 490 new users of vedolizumab, we observed no difference in treatment persistence (adjusted risk ratio 1.09 [95% confidence interval 0.95-1.25]). Ustekinumab was associated with a lower rate of all-cause hospitalization (adjusted hazard ratio 0.73 [0.59-0.91]), nonsurgical CD hospitalization (adjusted hazard ratio 0.58 [0.40-0.83]), and hospitalization for infection (adjusted hazard ratio 0.56 [0.34-0.92]). This real-world comparative effectiveness study of anti-TNF-experienced patients with CD initiating vedolizumab or ustekinumab showed similar treatment persistence rates beyond 52 weeks, although secondary outcomes such as all-cause hospitalizations, nonsurgical CD hospitalizations, and hospitalizations for infection favored ustekinumab initiation. We, therefore, advocate for individualized decision making in this medically refractory population, considering patient preference and other factors such as cost and route of administration.
Identifiants
pubmed: 36508681
doi: 10.14309/ajg.0000000000002068
pii: 00000434-202304000-00022
doi:
Substances chimiques
Ustekinumab
FU77B4U5Z0
vedolizumab
9RV78Q2002
Tumor Necrosis Factor Inhibitors
0
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
674-684Informations de copyright
Copyright © 2022 by The American College of Gastroenterology.
Références
Gomollon F, Dignass A, Annese V, et al. 3rd European evidence-based consensus on the diagnosis and management of Crohn's disease 2016: Part 1: Diagnosis and medical management. J Crohns Colitis 2017;11(1):3–25.
Dassopoulos T, Sultan S, Falck-Ytter YT, et al. American Gastroenterological Association Institute technical review on the use of thiopurines, methotrexate, and anti-TNF-alpha biologic drugs for the induction and maintenance of remission in inflammatory Crohn's disease. Gastroenterology 2013;145(6):1464–78.e5.
Harbord M, Eliakim R, Bettenworth D, et al. Third European evidence-based consensus on diagnosis and management of ulcerative colitis. Part 2: Current management. J Crohns Colitis 2017;11(7):769–84.
Dassopoulos T, Cohen RD, Scherl EJ, et al. Ulcerative colitis care pathway. Gastroenterology 2015;149(1):238–45.
Bressler B, Marshall JK, Bernstein CN, et al. Clinical practice guidelines for the medical management of nonhospitalized ulcerative colitis: The toronto consensus. Gastroenterology 2015;148(5):1035–58 e3.
Burisch J, Kiudelis G, Kupcinskas L, et al. Natural disease course of Crohn's disease during the first 5 years after diagnosis in a European population-based inception cohort: An epi-IBD study. Gut 2019;68(3):423–33.
Feuerstein JD, Ho EY, Shmidt E, et al. AGA clinical practice guidelines on the medical management of moderate to severe luminal and perianal fistulizing Crohn's disease. Gastroenterology 2021;160(7):2496–508.
Billioud V, Sandborn WJ, Peyrin-Biroulet L. Loss of response and need for adalimumab dose intensification in Crohn's disease: A systematic review. Am J Gastroenterol 2011;106(4):674–84.
Karmiris K, Paintaud G, Noman M, et al. Influence of trough serum levels and immunogenicity on long-term outcome of adalimumab therapy in Crohn's disease. Gastroenterology 2009;137(5):1628–40.
Schnitzler F, Fidder H, Ferrante M, et al. Long-term outcome of treatment with infliximab in 614 patients with Crohn's disease: Results from a single-centre cohort. Gut 2009;58(4):492–500.
Feagan BG, Rubin DT, Danese S, et al. Efficacy of vedolizumab induction and maintenance therapy in patients with ulcerative colitis, regardless of prior exposure to tumor necrosis factor antagonists. Clin Gastroenterol Hepatol 2017;15(2):229–39.e5.
Sands BE, Sandborn WJ, Van Assche G, et al. Vedolizumab as induction and maintenance therapy for Crohn's disease in patients naive to or who have failed tumor necrosis factor antagonist therapy. Inflamm Bowel Dis 2017;23(1):97–106.
Feagan BG, Sandborn WJ, Gasink C, et al. Ustekinumab as induction and maintenance therapy for Crohn's disease. New Engl J Med 2016;375(20):1946–60.
Sandborn WJ, van Assche G, Reinisch W, et al. Adalimumab induces and maintains clinical remission in patients with moderate-to-severe ulcerative colitis. Gastroenterology 2012;142(2):257–65.e3.
Sandborn WJ, Su C, Sands BE, et al. Tofacitinib as induction and maintenance therapy for ulcerative colitis. New Engl J Med 2017;376(18):1723–36.
Townsend T, Razanskaite V, Dodd S, et al. Comparative effectiveness of ustekinumab or vedolizumab after one year in 130 patients with anti-TNF-refractory Crohn's disease. Aliment Pharmacol Ther 2020;52(8):1341–52.
Alric H, Amiot A, Kirchgesner J, et al. The effectiveness of either ustekinumab or vedolizumab in 239 patients with Crohn's disease refractory to anti-tumour necrosis factor. Aliment Pharmacol Ther 2020;51(10):948–57.
Parrot L, Dong C, Carbonnel F, et al. Systematic review with meta-analysis: The effectiveness of either ustekinumab or vedolizumab in patients with Crohn's disease refractory to anti-tumour necrosis factor. Aliment Pharmacol Ther 2022;55(4):380–8.
Biemans VBC, van der Woude CJ, Dijkstra G, et al. Ustekinumab is associated with superior effectiveness outcomes compared to vedolizumab in Crohn's disease patients with prior failure to anti-TNF treatment. Aliment Pharmacol Ther 2020;52(1):123–34.
Manlay L, Boschetti G, Pereira B, et al. Comparison of short- and long-term effectiveness between ustekinumab and vedolizumab in patients with Crohn's disease refractory to anti-tumour necrosis factor therapy. Aliment Pharmacol Ther 2021;53(12):1289–99.
Lenti MV, Dolby V, Clark T, et al. A propensity score-matched, real-world comparison of ustekinumab vs vedolizumab as a second-line treatment for Crohn's disease. The Cross Pennine study II. Aliment Pharmacol Ther 2022;55(7):856–66.
Onali S, Pugliese D, Caprioli FA, et al. An objective comparison of vedolizumab and ustekinumab effectiveness in Crohn's disease patients' failure to TNF-alpha inhibitors. Am J Gastroenterol 2022;117(8):1279–87.
Lund JL, Richardson DB, Stürmer T. The active comparator, new user study design in pharmacoepidemiology: Historical foundations and contemporary application. Curr Epidemiol Rep 2015;2(4):221–8.
Sentinel Common Data Model ( https://www.sentinelinitiative.org/methods-data-tools/sentinel-common-data-model ). Accessed June 1, 2022.
Jones DW, Finlayson SRG. Trends in surgery for Crohn's disease in the era of infliximab. Ann Surg 2010;252(2):307–12.
Lo Re V III, Carbonari DM, Jacob J, et al. Validity of ICD-10-CM diagnoses to identify hospitalizations for serious infections among patients treated with biologic therapies. Pharmacoepidemiol Drug Saf 2021;30(7):899–909.
Poizeau F, Nowak E, Kerbrat S, et al. Association between early severe cardiovascular events and the initiation of treatment with the anti-interleukin 12/23p40 antibody ustekinumab. JAMA Dermatol 2020;156(11):1208–15.
Tamariz L, Harkins T, Nair V. A systematic review of validated methods for identifying venous thromboembolism using administrative and claims data. Pharmacoepidemiol Drug Saf 2012;21(Suppl 1):154–62.
Sun JW, Rogers JR, Her Q, et al. Adaptation and validation of the combined comorbidity score for ICD-10-CM. Med Care 2017;55(12):1046–51.
Cheng AG, Oxford EC, Sauk J, et al. Impact of mode of delivery on outcomes in patients with perianal Crohn's disease. Inflamm Bowel Dis 2014;20:1391–8.
Ma GK, Brensinger CM, Wu Q, et al. Increasing incidence of multiply recurrent Clostridium difficile infection in the United States: A cohort study. Ann Intern Med 2017;167(3):152–8.
Desai RJ, Rothman KJ, Bateman BT, et al. A propensity-score-based fine stratification approach for confounding adjustment when exposure is infrequent. Epidemiology 2017;28(2):249–57.
Desai RJ, Franklin JM. Alternative approaches for confounding adjustment in observational studies using weighting based on the propensity score: A primer for practitioners. BMJ 2019;367:l5657.
Austin PC. Using the standardized difference to compare the prevalence of a binary variable between two groups in observational research. Commun Stat Simulation Comput 2009;38(6):1228–34.
The SAS METAANAL Macro by Hertzmark H and Spiegelman D ( https://cdn1.sph.harvard.edu/wp-content/uploads/sites/271/2012/09/metaanal_user_manual_-_5-24-2012.pdf ). Accessed June 1, 2022.
Shu D, Yoshida K, Fireman BH, et al. Inverse probability weighted Cox model in multi-site studies without sharing individual-level data. Stat Methods Med Res 2020;29(6):1668–81.
Propensity Score Analysis (PSA) Module Introduction ( https://dev.sentinelsystem.org/projects/SENTINEL/repos/sentinel-routine-querying-tool-documentation/browse/files/file170-type0204-psaintro.md ). Accessed June 2, 2022.