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CC BY-NC-ND 4.0 · Journal of Coloproctology 2022; 42(02): 178-186
DOI: 10.1055/s-0041-1730264
Review Article

Safety and Efficacy of Ustekinumab in the Treatment of Crohn Disease: A Systematic Review and Meta-analysis

Mohammed Assem Khorshid 
1   Department of Gastroenterology, Crohn's & Colitis Egypt Center, Cairo, Egypt
,
Ahmed Cordie 
2   Gastrointestinal Endoscopy and Liver Unit, Kasr Alainy, Faculty of Medicine, Cairo University, Cairo, Egypt
,
Sherief Abd-Elsalam 
3   Department of Tropical Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt
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Abstract

Background and Aims The present systematic review and meta-analysis was designed to estimate the safety and effectiveness of ustekinumab in the treatment of Crohn disease (CD) in clinical trials and observational studies.

Methods We retrieved all the related publications from the PubMed, Cochrane, EBSCO, Google Scholar and EMBASE databases using a systematic search strategy. We only included clinical trials and observational studies that were published in English.

Results Only 31 studies that met the eligibility criteria out of the 733 identified studies were included. The overall clinical response rate in the cohort studies was of 0.539 (95% confidence interval [95%CI]: 0.419–0.659), and in the clinical trials it was of 0.428 (95%CI: 0.356–0.501). The pooled clinical remission rate was of 0.399 (95%CI: 0.295–0.503) in randomized control trials (RCTs,) and of 0.440 (95%CI: 0.339–0.542) in cohort studies. The rate of adverse effects was of 0.158 (95%CI: 0.109–0.207) in cohort studies and of 0.690 (95%CI: 0.633–0.748) in RCTs.

Conclusion Ustekinumab is effective in the treatment of CD. However, more research is required on the safety profiles because there was considerable variation among the included studies.

Keywords

Crohn Disease - inflammatory bowel disease - interleukin - cytokine - biologics

Authorship Statement

All authors participated sufficiently in the work and approved the final version of the manuscript. Khorshid M. A. designed the study and developed the methodology. Khorshid M. A., Cordie A., and Abd-Elsalam S. wrote the manuscript. The three authors screened each study independently following two steps: the first step was abstract screening for eligibility criteria, and the second step was full-text article screening for the eligibility criteria of the present systematic review and meta-analysis. Disagreements were resolved by the corresponding author (Abd-Elsalam S.).




Publication History

Received: 01 October 2020

Accepted: 18 January 2021

Article published online:
15 June 2022

© 2022. Sociedade Brasileira de Coloproctologia. This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commecial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/)

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