Efficacy of ustekinumab for active perianal fistulizing Crohn’s disease: a systematic review and meta-analysis of the current literature

Abstract

Background

Although the number of biological therapies for the treatment of Crohn’s disease (CD) is rapidly increasing, their efficacy in inducing healing of fistulas in perianal Crohn’s disease (pCD) is practically unknown, although they occur in up to 50% of patients with CD.

Objective

We aimed to investigate the clinical effectiveness of ustekinumab for pCD in a systemic review and meta-analysis.

Methods

Studies describing the efficacy of ustekinumab on fistulas in pCD in PubMed and EMBASE database from inception until 22 September 2020, were assessed in a systemic review and meta-analysis. The random-effect model was applied for the meta-analysis.

Results

The systematic review of the current literature yielded 2,243 studies of which nine studies with a total of 396 patients were found eligible for inclusion. The pooled proportions of patients experiencing fistula response were 41.0% (95% CI 23.9–60.6%9), I² = 85%, 39.7% (95% CI 24.3–57.4%), I² = 69% and 55.9% (95% CI 40.8–69.9%, I² = 67% at weeks 8, 24, and 52, respectively. Regarding fistula remission, the pooled proportions were 17.1% (95% CI 8.1–32.7%), I² = 45%, 17.7% (95% CI 1.8–71.9%), I² = 68%, and 16.7% (95% CI 3.0–56.5%, I² = 51% at week 8, 24, and 52, respectively.

Conclusion

In this systematic review with meta-analysis, we found a signal of efficacy of ustekinumab on fistulizing pCD, emphasizing that these patients might benefit from this therapy.

Keywords:

• Ustekinumab
• perianal fistulizing Crohn’s disease
• systematic review
• meta-analysis

Acknowledgments

None.

Author contributions

JS: Guarantor of the article; MA: study concept design, search strategy design and execution, data extraction, analysis and interpretation of data, drafting of the manuscript; JB and JS: study concept design, search strategy design, critical revision of manuscript, supervision. All authors approved the final version of the article, including the authorship list.

Disclosure statement

MA: None; JB: personal fees from AbbVie, Janssen-Cilag, Celgene, MSD, Samsung Bioepis, and Pfizer; grants and personal fees from Takeda and Tillots Pharma. None of these pertain to the research submitted here; JS: Research grants from Takeda and the Capital Region Denmark, national coordinator of studies from AbbVie, Arena Pharmaceuticals, Ely Lilly, and Boehringer Ingelheim. None of these pertain to the research submitted here.