1. Persistence, effectiveness and safety of ustekinumab and vedolizumab therapy for complex perianal fistula in Crohn's disease: The HEAL study from GETECCU.
- Author
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Casanova MJ, Caballol B, García MJ, Mesonero F, Rubín de Célix C, Suárez-Álvarez P, Ferreiro-Iglesias R, Martín-Rodríguez MDM, de Francisco R, Varela-Trastoy P, Bastida G, Carrillo-Palau M, Núñez-Ortiz A, Ramírez-de la Piscina P, Ceballos D, Hervías-Cruz D, Muñoz-Pérez R, Velayos B, Bermejo F, Busquets D, Cabacino M, Camo-Monterde P, Marín-Jiménez I, Muñoz C, de la Peña-Negro LC, Sierra-Moros E, Barrio J, Brunet-Mas E, Bujanda L, Cañete F, Gomollón F, Manceñido-Marcos N, Rodríguez-Lago I, Rodríguez-Grau MC, Sicilia B, Torra-Alsina S, Arranz-Hernández L, Carpio D, García-Sepulcre MF, González-Muñoza C, Huguet JM, Márquez-Mosquera L, López-Serrano MP, Ponferrada-Díaz Á, Chaparro M, and Gisbert JP
- Subjects
- Humans, Female, Male, Adult, Middle Aged, Recurrence, Treatment Outcome, Multivariate Analysis, Crohn Disease drug therapy, Crohn Disease complications, Antibodies, Monoclonal, Humanized therapeutic use, Antibodies, Monoclonal, Humanized adverse effects, Ustekinumab therapeutic use, Ustekinumab adverse effects, Rectal Fistula drug therapy, Rectal Fistula etiology, Gastrointestinal Agents therapeutic use, Remission Induction
- Abstract
Background: The efficacy of ustekinumab and vedolizumab for treating complex perianal fistula in Crohn's disease has been barely studied. We aimed to assess treatment persistence, clinical remission, and safety of these drugs in this context., Methods: Crohn's disease patients who had received ustekinumab or vedolizumab for the indication of active complex perianal fistula, were included. Clinical remission was defined according to Fistula Drainage Assessment Index (no drainage through the fistula upon gentle pressure) based on physicians' assessment., Results: Of 155 patients, 136 received ustekinumab, and 35 vedolizumab (16 received both). Median follow-up for ustekinumab was 27 months. Among those on ustekinumab, 54 % achieved remission, and within this group, 27 % relapsed during follow-up. The incidence rate of relapse was 11 % per patient-year. Multivariate analysis found no variables associated with treatment discontinuation or relapse. Median follow-up time for patients receiving vedolizumab was 19 months. Remission was achieved in 46 % of the patients receiving vedolizumab, and among them, 20 % relapsed during follow-up. The incidence rate of relapse was 7 % per patient-year. Adverse events were mild in 6 % on ustekinumab and 8 % on vedolizumab., Conclusion: Ustekinumab and vedolizumab appear effective, achieving remission in around half of complex perianal fistula patients, with favorable safety profiles., Competing Interests: Declaration of funding interests None, (Copyright © 2024 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.)
- Published
- 2024
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