Frontiers in medicine · 2026
Efficacy of Ustekinumab for the treatment of perianal fistulizing Crohn's disease: a multicentre retrospective study.
СтатьяНазвание и аннотация: Перевод в очереди
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Li Youran, Sun Xiaomei, Wen Ke, Lu Lu, Wang Wei, Wu Minna, Ma Jiaze, Zhou Zailong, Gu Yunfei
Аннотация
BACKGROUND: Perianal fistulizing Crohn's disease (pfCD) is a refractory complication of Crohn's disease (CD) with limited therapeutic options, particularly for patients failing anti-tumor necrosis factor agents. Ustekinumab (UST) shows promise in pfCD, but long-term outcomes and predictive factors remain unclear.
METHODS: This multicenter retrospective study enrolled 163 pfCD patients treated with UST (2020-2023) with a median 15-month follow-up. Primary endpoints were fistula response and clinical remission rates. Univariate/multivariate logistic regression identified healing predictors, and a nomogram was developed for outcome prediction.
RESULTS: At final follow-up, the fistula response rate was 88.3% and clinical remission rate 70.1%. Significant improvements were observed in inflammatory biomarkers (CRP: 21.2 ± 28.3 → 5.2 ± 8.9 mg/L; ESR: 36.6 ± 24.5 → 14.5 ± 18.3 mm/h) and hemoglobin (126.8 ± 18.5 → 148.2 ± 25.6 g/L; all p < 0.001). Definitive surgery (adjusted OR = 9.613, p < 0.001) and fewer prior biologics (adjusted OR = 0.541, p = 0.006) were independent healing predictors. The nomogram exhibited good discriminative ability (AUC = 0.852 for 24-week remission). UST was well-tolerated (adverse event rate = 7.4%) with no severe safety issues.
CONCLUSION: UST demonstrated clinically meaningful efficacy within a combined multidisciplinary strategy for pfCD, with fistula response and clinical remission rates of 88.3 and 70.1%, respectively, though MRI-confirmed healing was modest (14.2%). Definitive surgery and fewer prior biologic exposures predicted better fistula healing. The developed nomogram facilitates individualized treatment decision-making.
METHODS: This multicenter retrospective study enrolled 163 pfCD patients treated with UST (2020-2023) with a median 15-month follow-up. Primary endpoints were fistula response and clinical remission rates. Univariate/multivariate logistic regression identified healing predictors, and a nomogram was developed for outcome prediction.
RESULTS: At final follow-up, the fistula response rate was 88.3% and clinical remission rate 70.1%. Significant improvements were observed in inflammatory biomarkers (CRP: 21.2 ± 28.3 → 5.2 ± 8.9 mg/L; ESR: 36.6 ± 24.5 → 14.5 ± 18.3 mm/h) and hemoglobin (126.8 ± 18.5 → 148.2 ± 25.6 g/L; all p < 0.001). Definitive surgery (adjusted OR = 9.613, p < 0.001) and fewer prior biologics (adjusted OR = 0.541, p = 0.006) were independent healing predictors. The nomogram exhibited good discriminative ability (AUC = 0.852 for 24-week remission). UST was well-tolerated (adverse event rate = 7.4%) with no severe safety issues.
CONCLUSION: UST demonstrated clinically meaningful efficacy within a combined multidisciplinary strategy for pfCD, with fistula response and clinical remission rates of 88.3 and 70.1%, respectively, though MRI-confirmed healing was modest (14.2%). Definitive surgery and fewer prior biologic exposures predicted better fistula healing. The developed nomogram facilitates individualized treatment decision-making.