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

ABSTRACT

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.

KEYWORDS:

• Biologics
• effectiveness
• meta-analysis
• real-life
• Ustekinumab

Author contributions

FS Macaluso and M Maida: conception and design of the study, collection and interpretation of the data, drafting of the manuscript. M Ventimiglia: statistical analysis. M Cottone and A Orlando: critical revision of the manuscript for relevant intellectual content. All authors contributed to drafting the paper/revising it critically for intellectual content and approved the final version of the manuscript to be published.

Declaration of interest

FS Macaluso served as advisory board member or received lecture grants from MSD, Takeda Pharmaceuticals, AbbVie, Biogen, Pfizer. A Orlando served as advisory board member for AbbVie, MSD, Takeda Pharmaceuticals, and received lecture grants from AbbVie, MSD, Sofar, Chiesi, Takeda Pharmaceuticals, Pfizer. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer Disclosures

Peer reviewers on this manuscript have no relevant financial relationships or otherwise to disclose.

Supplementary material

Supplemental data for this article can be accessed here.

Additional information

Funding

This study was not funded.