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. 2023 Jun 1;118(6):1036-1046.
doi: 10.14309/ajg.0000000000002152. Epub 2022 Dec 14.

Long-Term Outcomes of Biological Therapy in Crohn's Disease Complicated With Internal Fistulizing Disease: BIOSCOPE Study From GETECCU

Manuel Barreiro-de Acosta  1 , Agnès Fernández-Clotet  2   3 , Francisco Mesonero  4 , Francisco Javier García-Alonso  5 , María José Casanova  3   6 , Margarita Fernández-de la Varga  7 , Fiorella Cañete  3   8 , Luisa de Castro  9 , Ana Gutiérrez  3   10 , Beatriz Sicilia  11 , Victoria Cano  12 , Olga Merino  13 , Ruth de Francisco  14 , Irene González-Partida  15 , Gerard Surís  16 , Leyanira Torrealba  17 , Rocío Ferreiro-Iglesias  1 , Beatriz Castro  18 , Lucía Márquez  19 , Ana Sobrino  20 , Ainara Elorza  21 , Xavier Calvet  3   22 , Pilar Varela  23 , Raquel Vicente  24 , Luis Bujanda  3   25 , Laura Lario  26 , Noemí Manceñido  27 , Mariana F García-Sepulcre  28 , Eva Iglesias  29 , Cristina Rodríguez  30 , Marta Piqueras  31 , Juan Ángel Ferrer Rosique  32 , Alfredo J Lucendo  3   33 , Olga Benítez  34 , Melody García  35 , David Olivares  36 , Carlos González-Muñoza  37 , Beatriz López-Cauce  38 , Victor Jair Morales Alvarado  39 , Katerina Spicakova  40 , Alicia Brotons  41 , Fernando Bermejo  42 , Pedro Almela  43 , Nahia Ispízua  44 , Pau Gilabert  45 , Carlos Tardillo  46 , Fernando Muñoz  47 , Pablo Navarro  48 , Rosa Eva Madrigal Domínguez  49 , Pau Sendra  50 , Esther Hinojosa  51 , Empar Sáinz  52 , María Dolores Martín-Arranz  53 , Daniel Carpio  54 , Elena Ricart  2   3 , Berta Caballol  2   3 , Laura Núñez  4 , Jesús Barrio  5 , Javier P Gisbert  3   6 , Marisa Iborra  7 , Margalida Calafat  3   8 , Vicent Hernández  9 , Roser Muñoz Pérez  10 , José Luis Cabriada  21 , Eugeni Domènech  3   8 , Iago Rodríguez-Lago  21 ; BIOSCOPE study group from the ENEIDA registry
Affiliations

Long-Term Outcomes of Biological Therapy in Crohn's Disease Complicated With Internal Fistulizing Disease: BIOSCOPE Study From GETECCU

Manuel Barreiro-de Acosta et al. Am J Gastroenterol. .

Abstract

Introduction: 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.

Methods: 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.

Results: 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.

Discussion: 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.

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