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Ustekinumab: “Real-world” outcomes and potential predictors of nonresponse in treatment-refractory Crohn’s disease

BACKGROUND: Ustekinumab was approved in Europe for the treatment of adults with moderate to severe Crohn's disease (CD) in 2016, and there is an urgent need for data on its everyday use. AIM: To obtain data on the daily use of ustekinumab. METHODS: This is a retrospective monocentric study. Pat...

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Autores principales: Hoffmann, Peter, Krisam, Johannes, Wehling, Cyrill, Kloeters-Plachky, Petra, Leopold, Yvonne, Belling, Nina, Gauss, Annika
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Baishideng Publishing Group Inc 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6710179/
https://www.ncbi.nlm.nih.gov/pubmed/31496626
http://dx.doi.org/10.3748/wjg.v25.i31.4481
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author Hoffmann, Peter
Krisam, Johannes
Wehling, Cyrill
Kloeters-Plachky, Petra
Leopold, Yvonne
Belling, Nina
Gauss, Annika
author_facet Hoffmann, Peter
Krisam, Johannes
Wehling, Cyrill
Kloeters-Plachky, Petra
Leopold, Yvonne
Belling, Nina
Gauss, Annika
author_sort Hoffmann, Peter
collection PubMed
description BACKGROUND: Ustekinumab was approved in Europe for the treatment of adults with moderate to severe Crohn's disease (CD) in 2016, and there is an urgent need for data on its everyday use. AIM: To obtain data on the daily use of ustekinumab. METHODS: This is a retrospective monocentric study. Patients with moderate to severe CD who began ustekinumab therapy at the inflammatory bowel diseases outpatient clinic of the Heidelberg University Hospital between December 2016 and March 2018 were selected based on electronic patient files. The primary study endpoint was combined steroid-free clinical remission or steroid-free clinical response at 24 ± 6 wk of ustekinumab therapy. Secondary study endpoints were: achievement of mucosal healing, sonographic and magnetic resonance imaging response, biochemical response, the need for intestinal surgery within 24 ± 6 wk after treatment initiation, the occurrence of adverse events, treatment discontinuation due to nonresponse or adverse events, improvement of extraintestinal manifestations, clinical response at 48 ± 6 wk of therapy, and association of response with nucleotid oligodimerisation domain 2 mutations. RESULTS: Fifty-seven patients with CD (5.3% anti-tumour necrosis factor α naïve, 63.2% having undergone at least one intestinal surgery) were included in the study. Twenty patients (35.1%) achieved steroid-free clinical remission, 6 (10.5%) steroid-free clinical response and 31 (54.4%) were non-responders. Treatment discontinuation due to adverse events occurred in two patients (3.5%). Male sex, the presence of extraintestinal manifestations and the use of steroids at baseline were predictors of nonresponse to ustekinumab therapy. CONCLUSION: In a “real-world” treatment-refractory cohort of patients with CD, ustekinumab appeared efficacious and safe.
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spelling pubmed-67101792019-09-06 Ustekinumab: “Real-world” outcomes and potential predictors of nonresponse in treatment-refractory Crohn’s disease Hoffmann, Peter Krisam, Johannes Wehling, Cyrill Kloeters-Plachky, Petra Leopold, Yvonne Belling, Nina Gauss, Annika World J Gastroenterol Retrospective Study BACKGROUND: Ustekinumab was approved in Europe for the treatment of adults with moderate to severe Crohn's disease (CD) in 2016, and there is an urgent need for data on its everyday use. AIM: To obtain data on the daily use of ustekinumab. METHODS: This is a retrospective monocentric study. Patients with moderate to severe CD who began ustekinumab therapy at the inflammatory bowel diseases outpatient clinic of the Heidelberg University Hospital between December 2016 and March 2018 were selected based on electronic patient files. The primary study endpoint was combined steroid-free clinical remission or steroid-free clinical response at 24 ± 6 wk of ustekinumab therapy. Secondary study endpoints were: achievement of mucosal healing, sonographic and magnetic resonance imaging response, biochemical response, the need for intestinal surgery within 24 ± 6 wk after treatment initiation, the occurrence of adverse events, treatment discontinuation due to nonresponse or adverse events, improvement of extraintestinal manifestations, clinical response at 48 ± 6 wk of therapy, and association of response with nucleotid oligodimerisation domain 2 mutations. RESULTS: Fifty-seven patients with CD (5.3% anti-tumour necrosis factor α naïve, 63.2% having undergone at least one intestinal surgery) were included in the study. Twenty patients (35.1%) achieved steroid-free clinical remission, 6 (10.5%) steroid-free clinical response and 31 (54.4%) were non-responders. Treatment discontinuation due to adverse events occurred in two patients (3.5%). Male sex, the presence of extraintestinal manifestations and the use of steroids at baseline were predictors of nonresponse to ustekinumab therapy. CONCLUSION: In a “real-world” treatment-refractory cohort of patients with CD, ustekinumab appeared efficacious and safe. Baishideng Publishing Group Inc 2019-08-21 2019-08-21 /pmc/articles/PMC6710179/ /pubmed/31496626 http://dx.doi.org/10.3748/wjg.v25.i31.4481 Text en ©The Author(s) 2019. Published by Baishideng Publishing Group Inc. All rights reserved. http://creativecommons.org/licenses/by-nc/4.0/ This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial.
spellingShingle Retrospective Study
Hoffmann, Peter
Krisam, Johannes
Wehling, Cyrill
Kloeters-Plachky, Petra
Leopold, Yvonne
Belling, Nina
Gauss, Annika
Ustekinumab: “Real-world” outcomes and potential predictors of nonresponse in treatment-refractory Crohn’s disease
title Ustekinumab: “Real-world” outcomes and potential predictors of nonresponse in treatment-refractory Crohn’s disease
title_full Ustekinumab: “Real-world” outcomes and potential predictors of nonresponse in treatment-refractory Crohn’s disease
title_fullStr Ustekinumab: “Real-world” outcomes and potential predictors of nonresponse in treatment-refractory Crohn’s disease
title_full_unstemmed Ustekinumab: “Real-world” outcomes and potential predictors of nonresponse in treatment-refractory Crohn’s disease
title_short Ustekinumab: “Real-world” outcomes and potential predictors of nonresponse in treatment-refractory Crohn’s disease
title_sort ustekinumab: “real-world” outcomes and potential predictors of nonresponse in treatment-refractory crohn’s disease
topic Retrospective Study
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6710179/
https://www.ncbi.nlm.nih.gov/pubmed/31496626
http://dx.doi.org/10.3748/wjg.v25.i31.4481
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