Long-Term Outcomes of Biological Therapy in Crohn's Disease Complicated With Internal Fistulizing Disease: BIOSCOPE Study From GETECCU
Manuel Barreiro‐de Acosta, A Fernández-Clotet, Francisco Mesonero, Francisco Javier García‐Alonso, María José Casanova, Margarita Fernández-de la Varga, Fiorella Cañete, Luisa de Castro, Ana Gutiérrez, Beatriz Sicilia, Victoria Cano, Olga Merino, Ruth de Francisco, Irene González-Partida, Gerard Surís, Leyanira Torrealba, Rocío Ferreiro‐Iglesias, Beatriz Castro, Lucía Márquez, A Sobrino, Ainara Elorza, Xavier Calvet, Pilar Varela, Raquel Vicente, Luís Bujanda, Laura Lario, Noemí Manceñido, Mariana Fe García-Sepulcre, Eva Iglesias, Cristina Rodríguez, Marta Piqueras, Juan Ángel Ferrer Rosique, Alfredo J. Lucendo, Olga Benítez, M Ibáñez García, David Olivares, Carlos González‐Muñoza, Beatriz López-Cauce, Víctor Jair Morales-Alvarado, Kateřina Špičáková, Alicia Brotons, Fernando Bermejo, Pedro Almela, Nahia Ispízua, Pau Gilabert, Carlos Tardillo, Fernándo Muñoz, Pablo Navarro, Rosa Eva Madrigal Domínguez, Pau Sendra, Esther Hinojosa, Empar Sáinz, María Dolores Martín‐Arranz, Daniel Carpio, Elena Ricart, Berta Caballol, Laura Núñez, Jésus Barrio, Javier P. Gisbert, Marisa Iborra, Margalida Calafat, Vicent Hernández, Roser Muñoz Pérez, José Luis Cabriada, Eugeni Domènech, Iago Rodríguez–Lago, on behalf of the BIOSCOPE study group from the ENEIDA registry
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.