Long-Term Outcomes of Biological Therapy in Crohn's Disease Complicated With Internal Fistulizing Disease: BIOSCOPE Study From GETECCU.
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 06 2023
01 06 2023
Historique:
received:
11
07
2022
accepted:
14
11
2022
medline:
2
6
2023
pubmed:
15
12
2022
entrez:
14
12
2022
Statut:
ppublish
Résumé
The prevalence of penetrating complications in Crohn's disease (CD) increases progressively over time, but evidence on the medical treatment in this setting is limited. The aim of this study was to evaluate the effectiveness of biologic agents in CD complicated with internal fistulizing disease. Adult patients with CD-related fistulae who received at least 1 biologic agent for this condition from the prospectively maintained ENEIDA registry were included. Exclusion criteria involved those receiving biologics for perianal disease, enterocutaneous, rectovaginal, anastomotic, or peristomal fistulae. The primary end point was fistula-related surgery. Predictive factors associated with surgery and fistula closure were evaluated by multivariate logistic regression and survival analyses. A total of 760 patients from 53 hospitals (673 receiving anti-tumor necrosis factors, 69 ustekinumab, and 18 vedolizumab) were included. After a median follow-up of 56 months (interquartile range, 26-102 months), 240 patients required surgery, with surgery rates of 32%, 41%, and 24% among those under anti-tumor necrosis factor, vedolizumab, or ustekinumab, respectively. Fistula closure was observed in 24% of patients. Older patients, ileocolonic disease, entero-urinary fistulae, or an intestinal stricture distal to the origin of the fistula were associated with a higher risk of surgery, whereas nonsmokers and combination therapy with an immunomodulator reduced this risk. Biologic therapy is beneficial in approximately three-quarters of patients with fistulizing CD, achieving fistula closure in 24%. However, around one-third still undergo surgery due to refractory disease. Some patient- and lesion-related factors can identify patients who will obtain more benefit from these drugs.
Identifiants
pubmed: 36516073
doi: 10.14309/ajg.0000000000002152
pii: 00000434-202306000-00024
doi:
Substances chimiques
Ustekinumab
FU77B4U5Z0
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1036-1046Informations de copyright
Copyright © 2023 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.
Satsangi J, Silverberg MS, Vermeire S, et al. The Montreal classification of inflammatory bowel disease: Controversies, consensus, and implications. Gut 2006;55(6):749–53.
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.
Schwartz DA, Loftus EV Jr., Tremaine WJ, et al. The natural history of fistulizing Crohn's disease in Olmsted County, Minnesota. Gastroenterology 2002;122(4):875–80.
Thia KT, Sandborn WJ, Harmsen WS, et al. Risk factors associated with progression to intestinal complications of Crohn's disease in a population-based cohort. Gastroenterology 2010;139(4):1147–55.
Tjandra D, Garg M, Behrenbruch C, et al. Review article: Investigation and management of internal fistulae in Crohn's disease. Aliment Pharmacol Ther 2021;53(10):1064–79.
Hirten RP, Shah S, Sachar DB, et al. The management of intestinal penetrating Crohn's disease. Inflamm Bowel Dis 2018;24(4):752–65.
Poritz LS, Rowe WA, Koltun WA. Remicade does not abolish the need for surgery in fistulizing Crohn's disease. Dis Colon Rectum 2002;45(6):771–5.
Taxonera C, Barreiro-de-Acosta M, Bastida G, et al. Outcomes of medical and surgical therapy for entero-urinary fistulas in Crohn's disease. J Crohns Colitis 2016;10(6):657–62.
Kobayashi T, Hishida A, Tanaka H, et al. Real-world experience of anti-tumor necrosis factor therapy for internal fistulas in Crohn's disease: A retrospective multicenter cohort study. Inflamm Bowel Dis 2017;23(12):2245–51.
Bouguen G, Huguet A, Amiot A, et al. Efficacy and safety of tumor necrosis factor antagonists in treatment of internal fistulizing Crohn's disease. Clin Gastroenterol Hepatol 2020;18(3):628–36.
Zabana Y, Panes J, Nos P, et al. The ENEIDA registry (Nationwide study on genetic and environmental determinants of inflammatory bowel disease) by GETECCU: Design, monitoring and functions. Gastroenterol Hepatol 2020;43(9):551–8.
Harris PA, Taylor R, Thielke R, et al. Research electronic data capture (REDCap): A metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform 2009;42(2):377–81.
El Ouali S, Click B, Holubar SD, et al. Natural history, diagnosis and treatment approach to fibrostenosing Crohn's disease. United European Gastroenterol J 2020;8(3):263–70.
Rodriguez-Lago I, Gisbert JP. The role of immunomodulators and biologics in the medical management of stricturing Crohn's disease. J Crohns Colitis 2020;14(4):557–66.
Colombel JF, Adedokun OJ, Gasink C, et al. Combination therapy with infliximab and azathioprine improves infliximab pharmacokinetic features and efficacy: A post hoc analysis. Clin Gastroenterol Hepatol 2019;17(8):1525–32 e1.
Ananthakrishnan AN, Sakuraba A, Barnes EL, et al. The benefit of combination therapy depends on disease phenotype and duration in Crohn's disease. Aliment Pharmacol Ther 2017;46(2):162–8.
Vuyyuru SK, Desai D, Kedia S, et al. Long-term outcomes of anti-tumor necrosis factor therapy and surgery in nonperianal fistulizing Crohn's disease. JGH Open 2021;5(4):420–7.
Miehsler W, Reinisch W, Kazemi-Shirazi L, et al. Infliximab: Lack of efficacy on perforating complications in Crohn's disease. Inflamm Bowel Dis 2004;10(1):36–40.
Ricart E, Panaccione R, Loftus EV, et al. Infliximab for Crohn's disease in clinical practice at the Mayo Clinic: The first 100 patients. Am J Gastroenterol 2001;96(3):722–9.
Ardizzone S, Maconi G, Colombo E, et al. Perianal fistulae following infliximab treatment: Clinical and endosonographic outcome. Inflamm Bowel Dis 2004;10(2):91–6.
Schroder O, Blumenstein I, Schulte-Bockholt A, et al. Combining infliximab and methotrexate in fistulizing Crohn's disease resistant or intolerant to azathioprine. Aliment Pharmacol Ther 2004;19(3):295–301.
Miheller P, Lakatos PL, Horvath G, et al. Efficacy and safety of infliximab induction therapy in Crohn's Disease in Central Europe--a Hungarian nationwide observational study. BMC Gastroenterol 2009;9(1):66.
Mañosa M, Calafat M, de Francisco R, et al. Phenotype and natural history of elderly onset inflammatory bowel disease: A multicentre, case-control study. Aliment Pharmacol Ther 2018;47(5):605–14.
Feagan BG, Sandborn WJ, Gasink C, et al. Ustekinumab as induction and maintenance therapy for Crohn's disease. N Engl J Med 2016;375(20):1946–60.
Sandborn WJ, Feagan BG, Rutgeerts P, et al. Vedolizumab as induction and maintenance therapy for Crohn's disease. N Engl J Med 2013;369(8):711–21.
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.