P556 Safety and efficacy of ustekinumab in the treatment of Crohn's Disease: A systematic review and meta-analysis

KhorshidFASGE, M.(1);Cordie, A.(2);Abd-Elsalam, S.(3);

(1)EDGE Foundation, Department of Clinical Research, Cairo, Egypt;(2)Cairo University, GI & Liver Endoscopy Unit, Cairo, Egypt;(3)Tanta University, Department of Tropical Medicine & Infectious Diseases, Tanta, Egypt


This systematic review and meta-analysis was designed to estimate the safety and effectiveness of ustekinumab in the treatment for Crohn’s disease (CD) in clinical trials and observational studies.


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


Only 31 studies that met the eligibility criteria out of the 733 identified studies were included. Twenty-one studies reported the clinical response rate; three of these were clinical trials, and the other 18 were cohort studies. The overall clinical response rate in the cohort studies was 0.539, 95% CI (0.419–0.659) with significant heterogeneity (I2 = 96.22%, P < 0.001) and that in the clinical trials was 0.428, 95% CI (0.356–0.501). The pooled clinical remission rate was 0.399, 95% CI (0.295–0.503) in randomised control trials (RCTs) and 0.440, 95% CI (0.339–0.542) in cohort studies. Twenty-one studies reported the incidence of adverse effects. The rate of adverse effects was 0.158, 95% CI (0.109–0.207) in cohort studies and 0.690, 95% CI (0.633–0.748) in RCTs. Three RCTs had an infection rate of 0.275, 95% CI (0.245–0.295), while the 18 cohort studies had a rate of 0.076, 95% CI (0.047–0.105). Only ten studies reported the incidence of injection or infusion reaction; it was 0.035, 95% CI (0.027–0.043) for RCTs and 0.012, 95% CI (0.002–0.022) for cohort studies.


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.