Real-world short-term effectiveness of ustekinumab in 305 patients with Crohn’s disease: results from the ENEIDA registry.

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Real-world short-term effectiveness of ustekinumab in 305 patients with Crohn’s disease: results from the ENEIDA registry.

Aliment Pharmacol Ther. 2019 Jun 20;:

Authors: Iborra M, Beltrán B, Fernández-Clotet A, Gutiérrez A, Antolín B, Huguet JM, De Francisco R, Merino O, Carpio D, García-López S, Mesonero F, Navarro P, Ferreiro-Iglesias R, Carbajo AY, Rivero M, Gisbert JP, Piñero-Pérez MC, Monfort D, Bujanda L, García-Sepulcre MF, Martín-Cardona A, Cañete F, Taxonera C, Domènech E, Nos A, GETECCU Group (Grupo Español de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa)

Abstract
BACKGROUND: There are limited data of ustekinumab administered according to the doses recommended in the UNITI studies.
AIM: To assess the real-world, short-term effectiveness of ustekinumab in refractory Crohn’s disease (CD).
METHODS: Multicentre study of CD patients starting ustekinumab after June 2017 at the recommend dose (260, 390 or 520 mg based on weight ~6 mg/kg IV week 0 and 90 mg subcutaneously week 8). Values for Harvey-Bradshaw Index (HBI), C-reactive protein (CRP) and faecal calprotectin (FC) were recorded at baseline and at weeks 8 and 14. Demographic and clinical data, previous treatments, AEs and hospitalisations were documented. Possible predictors of clinical remission were examined.
RESULTS: Three hundred and five patients were analysed (≥2 previous anti-TNFα therapies 64% and vedolizumab 29%). At baseline, 217 (72%) had an HBI >4 points. Of these, 101 (47%) and 126 (58%) achieved clinical remission at weeks 8 and 14, respectively. FC levels returned to normal (<250 µg/g) in 46% and 54% of the patients at weeks 8 and 14 respectively. CRP returned to normal (<3 mg/L) in the 35% and 41% of the patients at week 8 and 14 respectively. AEs were recorded in 38, and 40 patients were hospitalised. Intolerance to the most recent anti-TNF agent and fewer previous anti-TNF agents were associated with clinical remission at week 14. Endoscopic severity was associated with poor response.
CONCLUSION: This is the first study to show the real-world effectiveness and safety of ustekinumab administered according to the recommended induction regimen in a cohort of highly refractory CD patients.

PMID: 31222872 [PubMed – as supplied by publisher]

PubMed Link: https://www.ncbi.nlm.nih.gov/pubmed/31222872?dopt=Abstract