Long-Term Outcomes of Biological Therapy in Crohn's Disease Complicated With Internal Fistulizing Disease: BIOSCOPE Study From GETECCU
Authors: Barreiro-de Acosta Manuel , Fernández-Clotet Agnès , Mesonero Francisco , García-Alonso Francisco Javier , Casanova María José , Fernández-de la Varga Margarita , Cañete Fiorella , de Castro Luisa , Gutiérrez Ana , Sicilia Beatriz , Cano Victoria , Merino Olga , de Francisco Ruth , González-Partida Irene , Surís Gerard , Torrealba Leyanira , Ferreiro-Iglesias Rocío , Castro Beatriz , Márquez Lucía , Sobrino Ana , Elorza Ainara , Calvet Xavier , Varela Pilar , Vicente Raquel , Bujanda Luis , Lario Laura , Manceñido Noemí , García-Sepulcre Mariana F. , Iglesias Eva , Rodríguez Cristina , Piqueras Marta , Ferrer Rosique Juan Ángel , Lucendo Alfredo J. , Benítez Olga , García Melody , Olivares David , González-Muñoza Carlos , López-Cauce Beatriz , Morales Alvarado Victor Jair , Spicakova Katerina , Brotons Alicia , Bermejo Fernando , Almela Pedro , Ispízua Nahia , Gilabert Pau , Tardillo Carlos , Muñoz Fernando , Navarro Pablo , Madrigal Domínguez Rosa Eva , Sendra Pau , Hinojosa Esther , Sáinz Empar , Martín-Arranz María Dolores , Carpio Daniel , Ricart Elena , Caballol Berta , Núñez Laura , Barrio Jesús , Gisbert Javier P. , Iborra Marisa , Calafat Margalida , Hernández Vicent , Muñoz Pérez Roser , Cabriada José Luis , Domènech Eugeni , Rodríguez-Lago Iago ,   on behalf of the BIOSCOPE study group from the ENEIDA registry
Published: December 2022

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.