Vedolizumab Versus Other Biologics and the Risk of Venous Thromboembolism in Patients with Pediatric-Onset Inflammatory Bowel Diseases: A Target Trial Emulation Study

Atia O, Shavit-Brunschwig Z, Lev-Tzion R, Stein R, Broide E, Urlep D, et al. Maintenance treatment with vedolizumab in paediatric inflammatory bowel disease (VEDOKIDS): 54-week outcomes of a multicentre, prospective, cohort study. Lancet Gastroenterol Hepatol. 2025;10:234–47. https://doi.org/10.1016/S2468-1253(24)00319-4.

Article  CAS  PubMed  Google Scholar 

Meserve J, Aniwan S, Koliani-Pace JL, Shashi P, Weiss A, Faleck D, et al. Retrospective analysis of safety of vedolizumab in patients with inflammatory bowel diseases. Clin Gastroenterol Hepatol. 2019;17:1533-1540.e2. https://doi.org/10.1016/j.cgh.2018.09.035.

Article  CAS  PubMed  Google Scholar 

Fang S, Zhang S, Zhang C, Wang L. Effectiveness and safety of ustekinumab for pediatric inflammatory bowel disease: a systematic review. Paediatr Drugs. 2023;25:499–513. https://doi.org/10.1007/s40272-023-00586-7.

Article  PubMed  Google Scholar 

Singh N, Rabizadeh S, Jossen J, Pittman N, Check M, Hashemi G, et al. Multi-center experience of vedolizumab effectiveness in pediatric inflammatory bowel disease. Inflamm Bowel Dis. 2016;22:2121–6. https://doi.org/10.1097/MIB.0000000000000865.

Article  PubMed  Google Scholar 

Herrinton LJ, Liu L, Lewis JD, Griffin PM, Allison J. Incidence and prevalence of inflammatory bowel disease in a Northern California managed care organization, 1996–2002. Am J Gastroenterol. 2008;103:1998–2006. https://doi.org/10.1111/j.1572-0241.2008.01960.x.

Article  PubMed  Google Scholar 

Chhibba T, Gros B, King JA, Windsor JW, Gorospe J, Leibovitzh H, et al. Environmental risk factors of inflammatory bowel disease: toward a strategy of preventative health. J Crohns Colitis. 2025;19:jjaf042. https://doi.org/10.1093/ecco-jcc/jjaf042.

Article  PubMed  PubMed Central  Google Scholar 

Atia O, Harel S, Ledderman N, Greenfeld S, Kariv R, Dotan I, et al. Risk of cancer in paediatric onset inflammatory bowel diseases: a nation-wide study from the epi-IIRN. J Crohns Colitis. 2022;16:786–95. https://doi.org/10.1093/ecco-jcc/jjab205.

Article  PubMed  Google Scholar 

Argollo M, Gilardi D, Peyrin-Biroulet C, Chabot J-F, Peyrin-Biroulet L, Danese S. Comorbidities in inflammatory bowel disease: a call for action. Lancet Gastroenterol Hepatol. 2019;4:643–54. https://doi.org/10.1016/S2468-1253(19)30173-6.

Article  PubMed  Google Scholar 

Yarur AJ, Deshpande AR, Pechman DM, Tamariz L, Abreu MT, Sussman DA. Inflammatory bowel disease is associated with an increased incidence of cardiovascular events. Am J Gastroenterol. 2011;106:741. https://doi.org/10.1038/ajg.2011.63.

Article  PubMed  Google Scholar 

Cheng K, Faye AS. Venous thromboembolism in inflammatory bowel disease. World J Gastroenterol. 2020;26(12):1231–41. https://doi.org/10.3748/wjg.v26.i12.1231.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Stadnicki A, Stadnicka I. Venous and arterial thromboembolism in patients with inflammatory bowel diseases. World J Gastroenterol. 2021;27(40):6757–74. https://doi.org/10.3748/wjg.v27.i40.6757.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Kim SY, Cho YS, Kim H-S, Lee JK, Kim HM, Park HJ, et al. Venous thromboembolism risk in Asian patients with inflammatory bowel disease: a population-based nationwide inception cohort study. Gut Liver. 2022;16:555–66. https://doi.org/10.5009/gnl210190.

Article  CAS  PubMed  Google Scholar 

Klomberg RCW, Hellendoorn AE, Kemos P, Rizopoulos D, Ruemmele FM, Croft NM, et al. Rare and severe adverse events in children with inflammatory bowel disease: analysis of data from the PIBD-SETquality safety registry. Lancet Child Adolesc Health. 2024;8:422–32. https://doi.org/10.1016/S2352-4642(24)00078-6.

Article  PubMed  Google Scholar 

Harvey PR, McNulty D, Coupland B, Kemos P, Croft NM, Trudgill NJ. The risk of venous thromboembolism in children with inflammatory bowel disease. Inflamm Bowel Dis. 2024. https://doi.org/10.1093/ibd/izae249.

Article  Google Scholar 

Sarlos P, Szemes K, Hegyi P, Garami A, Szabo I, Illes A, et al. Steroid but not biological therapy elevates the risk of venous thromboembolic events in inflammatory bowel disease: a meta-analysis. J Crohns Colitis. 2018;12:489–98. https://doi.org/10.1093/ecco-jcc/jjx162.

Article  PubMed  Google Scholar 

Higgins PDR, Skup M, Mulani PM, Lin J, Chao J. Increased risk of venous thromboembolic events with corticosteroid vs biologic therapy for inflammatory bowel disease. Clin Gastroenterol Hepatol. 2015;13:316–21. https://doi.org/10.1016/j.cgh.2014.07.017.

Article  PubMed  Google Scholar 

Dragoni G, Innocenti T, Amiot A, Castiglione F, Melotti L, Festa S, et al. Rates of adverse events in patients with ulcerative colitis undergoing colectomy during treatment with tofacitinib vs biologics: a multicenter observational study. Am J Gastroenterol. 2024;119:1525–35. https://doi.org/10.14309/ajg.0000000000002676.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Hernán MA, Wang W, Leaf DE. Target trial emulation: a framework for causal inference from observational data. JAMA. 2022;328:2446–7. https://doi.org/10.1001/jama.2022.21383.

Article  PubMed  Google Scholar 

Hubbard RA, Gatsonis CA, Hogan JW, Hunter DJ, Normand S-LT, Troxel AB. “Target trial emulation” for observational studies—potential and pitfalls. N Engl J Med. 2024;391:1975–7. https://doi.org/10.1056/NEJMp2407586.

Article  PubMed  Google Scholar 

Honap S, Danese S, Peyrin-Biroulet L. Target trial emulation: improving the quality of observational studies in inflammatory bowel disease using the principles of randomized trials. Inflamm Bowel Dis. 2024;31:843–9. https://doi.org/10.1093/ibd/izae131.

Article  PubMed Central  Google Scholar 

Khorana AA, Mackman N, Falanga A, Pabinger I, Noble S, Ageno W, et al. Cancer-associated venous thromboembolism. Nat Rev Dis Primers. 2022;8:11. https://doi.org/10.1038/s41572-022-00336-y.

Article  PubMed  Google Scholar 

van Vlijmen EFW, Wiewel-Verschueren S, Monster TBM, Meijer K. Combined oral contraceptives, thrombophilia and the risk of venous thromboembolism: a systematic review and meta-analysis. J Thromb Haemost. 2016;14:1393–403. https://doi.org/10.1111/jth.13349.

Article  PubMed  Google Scholar 

Austin PC. An introduction to propensity score methods for reducing the effects of confounding in observational studies. Multivar Behav Res. 2011;46:399–424. https://doi.org/10.1080/00273171.2011.568786.

Article  Google Scholar 

Cross RK, Chiorean M, Vekeman F, Xiao Y, Wu E, Chao J, et al. Assessment of the real-world safety profile of vedolizumab using the United States Food and Drug Administration adverse event reporting system. PLoS ONE. 2019;14:e0225572. https://doi.org/10.1371/journal.pone.0225572.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Cross RK, Osterman MT, Panaccione R, Afzali A, Song X, Shi N, et al. The Incidence of cardiovascular events in patients with Crohn’s disease treated with vedolizumab and anti-TNF therapies. Gastroenterology. 2017;152:S577–8. https://doi.org/10.1016/S0016-5085(17)32086-3.

Article  Google Scholar 

Olivera PA, Zuily S, Kotze PG, Regnault V, Al Awadhi S, Bossuyt P, et al. International consensus on the prevention of venous and arterial thrombotic events in patients with inflammatory bowel disease. Nat Rev Gastroenterol Hepatol. 2021;18:857–73. https://doi.org/10.1038/s41575-021-00492-8.

Article  PubMed  PubMed Central  Google Scholar 

deFonseka AM, Tuskey A, Conaway MR, Behm BW. Antitumor necrosis factor-α therapy is associated with reduced risk of thromboembolic events in hospitalized patients with inflammatory bowel disease. J Clin Gastroenterol. 2016;50:578–83. https://doi.org/10.1097/MCG.0000000000000408.

Article  CAS  PubMed  Google Scholar 

Detrez I, Thomas D, Van Steen K, Ballet V, Peeters M, Hoylaerts MF, et al. Successful infliximab treatment is associated with reversal of clotting abnormalities in inflammatory bowel disease patients. J Clin Gastroenterol. 2020;54:819. https://doi.org/10.1097/MCG.0000000000001290.

Article  CAS  PubMed  Google Scholar 

Su K, Xiao S, Wang M, Wang K, Fan Q, Sha S, et al. Predictive value of albumin to fibrinogen ratio and CALLY index for diagnosis of ulcerative colitis and mucosal healing after vedolizumab treatment. J Inflamm Res. 2025;18:589–600. https://doi.org/10.2147/JIR.S500600.

Article  PubMed  PubMed Central 

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