Ustekinumab in the Management of Perianal Fistulizing Crohn’s Disease: Current Evidence and Practical Strategies

Perianal fistulizing Crohn's disease (PFCD) is a severe and complex manifestation associated with high morbidity and limited treatment durability. Ustekinumab is a monoclonal antibody targeting the interleukin-12/23 pathway, which is involved in the pathogenesis of PFCD. Evidence from post hoc analyses and real-world studies has shown the therapeutic potential of ustekinumab in both anti-tumor necrosis factor-experienced and selected biologic-naïve patients with PFCD. Preliminary evidence has indicated that the treatment effect may be improved when used in combination with surgical interventions such as seton placement or sphincter-preserving procedures. Adjunctive antibiotics during induction and early monitoring of clinical and radiologic response may further enhance outcomes. While ustekinumab is increasingly being incorporated into multidisciplinary PFCD management, prospective fistula-specific trials are needed to clarify its optimal positioning. Future research should also focus on predictive biomarkers and treatment algorithms to support personalized and durable care.

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Publication Details

Journal
Drugs in R&D
Published
2026-05-22
DOI
https://doi.org/10.1007/s40268-026-00545-w
Primary Topic
Inflammatory Bowel Disease
Type
article
Field-Weighted Citation Impact
0.00

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article

Ustekinumab in the Management of Perianal Fistulizing Crohn’s Disease: Current Evidence and Practical Strategies

Bolin Yang
Drugs in R&D
Inflammatory Bowel Disease
article

Ustekinumab in the Management of Perianal Fistulizing Crohn’s Disease: Current Evidence and Practical Strategies

Bolin Yang
article en

Abstract

Perianal fistulizing Crohn's disease (PFCD) is a severe and complex manifestation associated with high morbidity and limited treatment durability. Ustekinumab is a monoclonal antibody targeting the interleukin-12/23 pathway, which is involved in the pathogenesis of PFCD. Evidence from post hoc analyses and real-world studies has shown the therapeutic potential of ustekinumab in both anti-tumor necrosis factor-experienced and selected biologic-naïve patients with PFCD. Preliminary evidence has indicated that the treatment effect may be improved when used in combination with surgical interventions such as seton placement or sphincter-preserving procedures. Adjunctive antibiotics during induction and early monitoring of clinical and radiologic response may further enhance outcomes. While ustekinumab is increasingly being incorporated into multidisciplinary PFCD management, prospective fistula-specific trials are needed to clarify its optimal positioning. Future research should also focus on predictive biomarkers and treatment algorithms to support personalized and durable care.

Drugs in R&D
Nanjing University of Chinese Medicine (CN)
Janssen Biotech
Openalex Percentile: Top 5%
Inflammatory Bowel Disease
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