ArticleBMC gastroenterology2025
Ustekinumab trough concentrations predict clinical remission in perianal fistulizing crohn's disease: a real-world retrospective cohort study.
Article in BMC gastroenterology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
3 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Pharmacokinetics of IL-23p19 Inhibitors: A Systematic Review Across Immune-Mediated Inflammatory Diseases.Clinical pharmacokinetics · 2026Pooled it
- Medical Therapies Beyond Infliximab for Perianal Fistulizing Crohn's Disease: Current Evidence and Future Perspectives.Journal of clinical medicine · 2026Review
- Perianal Crohn's Disease in Inflammatory Bowel Disease: Diagnosis, Assessment and Treatment.Life (Basel, Switzerland) · 2026Review
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Authors and funding
11 authors.
Funding
Abstract
backgroundLimited evidence exists on the long-term efficacy of ustekinumab (UST) in perianal fistulizing Crohn's disease (PFCD), and the optimal UST trough level for predicting fistula remission remains uncertain. This study aimed to assess both short- and long-term effectiveness of UST in PFCD and to identify thresholds predicting fistula clinical remission.
methodsThis retrospective cohort included 89 PFCD patients treated with UST. Evaluations utilized the Harvey-Bradshaw Index (HBI), Perianal Crohn's Disease Activity Index (PDAI), and Fistula Drainage Assessment (FDA). Magnetic resonance imaging (MRI) with the Van Assche Index (VAI) was performed at 52 weeks. Receiver operating characteristic (ROC) curves identified UST trough levels predictive of clinical remission.
resultsThe fistula clinical remission rates were 66.3% (59/89) at 16/20 weeks and 74.2% (66/89) at 52 weeks. Biochemical markers, including CRP, ESR, and PLT, significantly decreased, while RBC and HB levels increased after treatment (p < 0.05). MRI showed fistula improvement in 54.7% (35/64) of patients and complete healing in 21.8% (14/64). Comparative analysis revealed that anti-TNF-naïve patients had significantly higher rates of fistula remission, whereas seton insertion did not affect long-term fistula healing. ROC analysis identified UST trough concentrations ≥3.95 µg/mL at 16/20 weeks as predictive of clinical fistula remission (AUC: 0.791; sensitivity: 73.8%; specificity: 78.6%).
conclusionUST achieves 74.2% fistula clinical remission at 52 weeks in PFCD, with trough concentrations at 16/20 weeks predictive of clinical remission. These findings support the use of therapeutic drug monitoring(TDM) to optimize clinical outcomes.
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