1. P263 Influence of Crohn′s Disease phenotype in the retention rate of ustekinumab treatment: SUSTAIN Study
- Author
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C Novella, E Vispo, María García, A Gutiérrez Casbas, I Bastón Rey, C Dueñas Sadornil, J Martínez Cadilla, E Iyo, O. Merino Ochoa, M Cabelo, J González García, C Quílez Ivorra, F Argüelles, Javier P. Gisbert, B David, Jordi Gordillo, Mara Charro, S Rubio Iturria, M. Barreiro-de Acosta, P Ramírez de la Piscina, E. Iglesias Flores, B Velayos Jiménez, E Hinojosa, P Martínez Montiel, M Chaparro, M Boscá-Watts, Francisco Javier Bermejo, José María Huguet, Y. Gonzalez Lama, J M Vázque morón, A I Muñagorri Santos, V M Amo, P Fradejas Salazar, A Núñez Ortiz, M D Martín Arranz, Daniel Ginard, L Ramos, M T Diz-Lois Palomares, E Fernández-Salgado, and Maite Arroyo
- Subjects
medicine.medical_specialty ,Crohn's disease ,business.industry ,Gastroenterology ,General Medicine ,Retention rate ,medicine.disease ,Inflammatory bowel disease ,Phenotype ,Log-rank test ,Internal medicine ,Ustekinumab ,medicine ,Predictor variable ,business ,Survival analysis ,medicine.drug - Abstract
Background Crohn′s disease (CD) is a progressive inflammatory bowel disease that can lead to complications such as strictures or penetrating disease, and ultimately surgery, representing a complex clinical challenge in the care of patients. We aimed to evaluate the influence of CD phenotype in the retention rate of ustekinumab in the Sustain study. Methods Retrospective, multicentre study (>60 sites) including patients with active CD [(Harvey-Bradshaw (HBI)>4)] who received ≥1 dose of ustekinumab intravenously before July 2018. Clinical remission was defined as HBI≤4 and response as ≥3 points decrease from baseline. Loss of response (LoR) was defined as reappearance of symptoms that led to intensifying the treatment dose, adding another medication to control CD, switching or surgery in patients with short-term remission. Disease characteristics were collected (date of diagnosis; location; behaviour: inflammatory, stenosing or penetrating; presence of perianal disease or extraintestinal manifestations; previous surgeries, etc.). The retention rates in patients on ustekinumab depending of their disease phenotype were evaluated by descriptive analysis and Kaplan-Meier survival curves. Survival curves were compared using the log-rank test. Predictive factors were assessed by Cox-regression. Data quality was assured by remote monitoring. Results 463 CD patients were included (Table 1). 87 patients (18.6%) had penetrating CD in our cohort. The probability of maintaining UST treatment was 91% at 6, 83% at 12, 76% at 18 and 73% at 24 months. Similar retention rates were observed in patients with inflammatory (77.6%), stricturing (76.4%) and penetrating (79%) disease behaviour (p>0.05). Figure 1. Conclusion Ustekinumab has shown to be equally effective in the treatment of inflammatory, stricturing and penetrating CD phenotype in Sustain, the largest study evaluating its use in CD in clinical practice, having the longest follow-up period reported to date.
- Published
- 2021