Effectiveness and safety of Ustekinumab for the treatment of Crohn’s disease in real-life experiences: a meta-analysis of observational studies

Background: The aim of this meta-analysis was to estimate the effectiveness and safety of Ustekinumab in Crohn’s disease (CD) reported by observational studies. Research design and methods: PubMed/Medline and Embase were systematically searched through September 2019. Only real-life observational studies were included. Results: Thirteen studies comprising 1450 patients met the inclusion criteria. Ustekinumab was administered subcutaneously at induction among 7 studies, while in 6 studies the intravenous formulation was used. At induction (8–16 weeks), the pooled estimate rates of clinical response and remission were 56% (95% CI: 43-68%; range: 16–94%; I2 = 94%) and 34% (95% CI: 25–45%; range: 15–58%; I2 = 90%), respectively. The rate of clinical response was higher among studies which employed the subcutaneous compared with the intravenous induction (68% vs. 38%, p = 0.01). At maintenance, the pooled estimate rates of clinical response, clinical remission, endoscopic response, and endoscopic remission were 62% (95% CI: 50-73%; range: 42–89%; I2 = 89%), 40% (95% CI: 28–54%; range: 26–73%; I2 = 90%), 56% (95% CI: 37-73%; range: 20–77%; I2 = 87%), and 19% (95% CI: 11-30%; range: 7–31%; I2 = 67%), respectively. Conclusions: Ustekinumab is an effective treatment in patients with CD with a reassuring safety profile. The subcutaneous induction seems to be superior to the intravenous one.