Efficacy of Ustekinumab for the treatment of perianal fistulizing Crohn’s disease: a multicentre retrospective study - Report - MDSpire

Efficacy of Ustekinumab for the treatment of perianal fistulizing Crohn’s disease: a multicentre retrospective study

  • By

  • Youran Li

  • Xiaomei Sun

  • Ke Wen

  • Lu Lu

  • Wei Wang

  • Minna Wu

  • Jiaze Ma

  • Zailong Zhou

  • Yunfei Gu

  • July 10, 2026

  • 0 min

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Clinical Report: Effectiveness of Ustekinumab in Managing Perianal Fistulizing Crohn's Disease

Overview

This multicenter retrospective analysis evaluated the effectiveness of Ustekinumab (UST) in patients with perianal fistulizing Crohn's disease (pfCD). The study enrolled 163 patients and assessed fistula response and clinical remission rates over a median follow-up of 15 months.

Background

Perianal fistulizing Crohn’s disease is a challenging complication of Crohn’s disease, affecting a significant proportion of patients and often leading to pain and reduced quality of life. Traditional treatments, particularly anti-TNF agents, may fail in a subset of patients, necessitating alternative therapies. Ustekinumab, a monoclonal antibody targeting interleukin-12 and interleukin-23, has been studied for its efficacy in this context.

Data Highlights

OutcomeRate
Fistula Response88.3%
Clinical Remission70.1%
CRP Improvement21.2 ± 28.3 → 5.2 ± 8.9 mg/L
ESR Improvement36.6 ± 24.5 → 14.5 ± 18.3 mm/h
Hemoglobin Improvement126.8 ± 18.5 → 148.2 ± 25.6 g/L
Adverse Event Rate7.4%

Key Findings

  • Fistula response rate was 88.3% and clinical remission rate was 70.1% at final follow-up.
  • Significant improvements in inflammatory biomarkers were observed (CRP, ESR, hemoglobin).
  • Definitive surgery and fewer prior biologic treatments were identified as independent predictors of healing.
  • The developed nomogram showed good discriminative ability for predicting 24-week remission (AUC = 0.852).
  • UST was well-tolerated with an adverse event rate of 7.4% and no severe safety issues reported.

Clinical Implications

The study provides data on the effectiveness of Ustekinumab in managing perianal fistulizing Crohn's disease, particularly in patients with fewer prior biologic exposures.

Conclusion

Ustekinumab demonstrates efficacy in managing perianal fistulizing Crohn's disease, with reported response rates and a manageable safety profile.

Related Resources & Content

  1. Drugs - Real World Outcomes, 2021 -- Persistence and Maintenance Dosing of Ustekinumab in Crohn's Disease Patients
  2. The New Gastroenterologist, 2025 -- Choosing Treatment Options for Moderate to Severe Inflammatory Bowel Disease
  3. Journal of Crohn's and Colitis -- A new protocolized treatment strategy optimizing medical and surgical care leads to improved healing of Crohn’s perianal fistulas
  4. Drug Safety -- Safety Profile of Ustekinumab in Patients with Psoriasis, Psoriatic Arthritis, and Crohn’s Disease
  5. ACG Clinical Guideline: Management of Crohn's Disease in Adults - PubMed
  6. Infliximab for the Treatment of Fistulas in Patients with Crohn's Disease | New England Journal of Medicine
  7. American Gastroenterological Association Clinical Practice Guideline on the Medical Management of Moderate to Severe Luminal and Fistulizing Crohn’s Disease - PMC
  8. ACG Clinical Guideline: Management of Crohn's Disease in Adults - PubMed
  9. Infliximab for the Treatment of Fistulas in Patients with Crohn's Disease | New England Journal of Medicine
  10. American Gastroenterological Association Clinical Practice Guideline on the Medical Management of Moderate to Severe Luminal and Fistulizing Crohn’s Disease - PMC

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