Hoffmann P, Krisam J, Wehling C, Kloeters-Plachky P, Leopold Y, Belling N, Gauss A. Ustekinumab: “Real-world” outcomes and potential predictors of nonresponse in treatment-refractory Crohn’s disease. World J Gastroenterol 2019; 25(31): 4481-4492 [PMID: 31496626 DOI: 10.3748/wjg.v25.i31.4481]
Corresponding Author of This Article
Peter Hoffmann, MD, Doctor, Department of Gastroenterology and Hepatology, University Hospital Heidelberg, Im Neuenheimer Feld 410, Heidelberg 69120, Germany. peter.hoffmann@med.uni-heidelberg.de
Research Domain of This Article
Gastroenterology & Hepatology
Article-Type of This Article
Retrospective Study
Open-Access Policy of This Article
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. See: http://creativecommons.org/licenses/by-nc/4.0/
World J Gastroenterol. Aug 21, 2019; 25(31): 4481-4492 Published online Aug 21, 2019. doi: 10.3748/wjg.v25.i31.4481
Ustekinumab: “Real-world” outcomes and potential predictors of nonresponse in treatment-refractory Crohn’s disease
Peter Hoffmann, Johannes Krisam, Cyrill Wehling, Petra Kloeters-Plachky, Yvonne Leopold, Nina Belling, Annika Gauss
Peter Hoffmann, Cyrill Wehling, Petra Kloeters-Plachky, Yvonne Leopold, Nina Belling, Annika Gauss, Department of Gastroenterology and Hepatology, University Hospital Heidelberg, Heidelberg 69120, Germany
Johannes Krisam, Department of Medical Biometry, University Hospital Heidelberg, Heidelberg 69120, Germany
Author contributions: Hoffmann P and Gauss A designed research, performed research and wrote the paper; Krisam J analysed data; Kloeters-Plachky P and Leopold Y helped perform research and analysed data; Belling N and Wehling C performed research.
Institutional review board statement: This study was reviewed and approved by the Ethics Committee of Heidelberg.
Informed consent statement: For NOD2 genotyping, written informed consent was necessary. For the retrospective analysis there was no informed consent required according to the Ethics Committee of Heidelberg.
Data sharing statement: No additional data are available.
Open-Access: 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. See: http://creativecommons.org/licenses/by-nc/4.0/
Corresponding author: Peter Hoffmann, MD, Doctor, Department of Gastroenterology and Hepatology, University Hospital Heidelberg, Im Neuenheimer Feld 410, Heidelberg 69120, Germany. peter.hoffmann@med.uni-heidelberg.de
Telephone: +49-6221-5636422 Fax: +49-6221-565255
Received: May 9, 2019 Peer-review started: May 10, 2019 First decision: June 16, 2019 Revised: July 9, 2019 Accepted: July 19, 2019 Article in press: July 19, 2019 Published online: August 21, 2019 Processing time: 104 Days and 16 Hours
ARTICLE HIGHLIGHTS
Research background
Ustekinumab is a relatively new therapy for Crohn’s disease (CD) which blocks the activity of interleukin-12 and interleukin-23.
Research motivation
“Real world” data on ustekinumab in CD are scarce.
Research objectives
This study investigated the response and remission rates in a German cohort of patients with CD receiving treatment with ustekinumab.
Research methods
This is a retrospective analysis of response and remission rates at 24 ± 6 wk of ustekinumab therapy in patients with CD who began therapy between December 2016 and March 2018.
Research results
Fifty-seven patients were included in the study. Twenty patients (35.1%) achieved remission and 6 (10.5%) achieved clinical response. Male sex, extraintestinal manifestations, and the use of steroids at baseline were predictors of nonresponse to ustekinumab therapy.
Research conclusions
In a “real-world” treatment-refractory cohort of patients with CD, ustekinumab appeared efficacious and safe.
Research perspectives
The identified predictors of nonresponse to ustekinumab therapy, comprising male sex, extraintestinal manifestations, and the use of steroids at baseline, should be verified in a prospective study.
