P537 Real-world long-term effectiveness of ustekinumab in Crohn’s disease: Results from the ENEIDA registry

Autor: M I Iborra Colomino, B Beltrán, A Fernández-Clotet, E Iglesias Flores, P Navarro, M Rivero, A Gutiérrez, M Sierra-Ausin, F Mesonero, R Ferreiro-Iglesias, J Hinojosa, X Calvet, B Sicilia, C González-Muñoza, B Antolín, M González Vivo, A Y Carbajo, S García, A Martín-Cardona, G Surís Marín, M D Martín-Arranz, R De Francisco, F Cañete, T Carlos, F Gomollón, R Lorente, I Rodríguez-Lago, A Forés-Bosch, E Bernardos, L Ramos, P Delgado, A Hernández, M Van Domselaar, D Hervás, E Domènech, P Nos
Rok vydání: 2020
Předmět:
Zdroj: Journal of Crohn's and Colitis. 14:S458-S460
ISSN: 1876-4479
1873-9946
DOI: 10.1093/ecco-jcc/jjz203.665
Popis: Background There are limited data of long-term ustekinumab administered according to the doses recommended in the UNITI studies. The objective of this study was to assess the real-world, long-term effectiveness of ustekinumab in refractory Crohn’s disease (CD) (LONG-CROHNUSK Study). Methods Multicentre study of CD patients starting ustekinumab at the recommended dose based on weight ~6 mg/kg IV week 0, 90 mg SC week 8 and maintenance 90 mg SC every 8 or 12 weeks and with 1 year of follow-up. Values for Harvey-Bradshaw Index (HBI), endoscopic activity, C reactive protein (CRP) and faecal calprotectin (FC) were recorded at baseline and at weeks 26 and 52. Demographic and clinical data, previous treatments, adverse events (AEs), surgeries and hospitalisations were documented. Potential predictors of clinical and endoscopic remission were examined. Results Four hundred and seven patients were analysed (Table 1). For the maintenance dose, ustekinumab 90 mg was administered SC every 12, 8 and 4 weeks in 56 (14%), 318 (84.5%) and 7 (1.5%) patients, respectively. An interval reduction was applied for 118 patients (29%). Before 52 weeks, treatment discontinuation occurred in 71 patients (17%). At baseline, 295 (72%) had an HBI >4 points. Of these, 169 (57%) and 190 (64%) achieved clinical remission at weeks 26 and 52, respectively. FC levels returned to normal ( Conclusion This is the first study to show the real-world long-term effectiveness, endoscopic improvement and safety of ustekinumab administered according to the recommended induction regimen in a cohort of highly refractory CD patients.
Databáze: OpenAIRE
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