European journal of gastroenterology & hepatology · 2026
Dual-targeted therapy with ustekinumab and vedolizumab as a novel rescue strategy: achieving high clinical response rates in Crohn's disease refractory to both monotherapies.
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Lu Chong, Ling Tao, Li Yafang, Wei Jiaojiao, Chen Yuan, Ding Jin, Wang Qunying
Аннотация
BACKGROUND: Managing Crohn's disease is challenging as a substantial proportion of patients lose response to biologics. This study evaluated dual targeted therapy (DTT) with ustekinumab (UST) and vedolizumab (VDZ) in patients refractory to both agents as monotherapies.
METHODS: This retrospective study enrolled 23 patients with active Crohn's disease and prior inadequate response to both UST and VDZ monotherapy. All patients initiated DTT following standard induction and maintenance protocols. The primary endpoint was clinical response at week 24. Secondary endpoints included clinical remission, biomarker normalization, endoscopic improvement, and safety.
RESULTS: At week 24, DTT induced clinical response in 82.6% (19/23) and clinical remission in 34.8% (8/23) of patients, with all responders achieving corticosteroid-free remission. Inflammatory biomarkers significantly decreased: median C-reactive protein (CRP) from 11.6 to 3.5 mg/L (P = 0.011) and median fecal calprotectin from 337.4 to 146.6 μg/g (P = 0.035). Normalization rates were 60.9% for CRP and 73.9% for calprotectin. At week 48, 86.9% of patients remained on DTT, with 45.0% in sustained remission. Endoscopic assessment showed remission in 33.3% and response in 61.1% of evaluated patients. Safety was favorable, with only mild adverse events (8.7%).
CONCLUSION: UST and VDZ dual therapy effectively recaptured response and induced remission in Crohn's disease patients failing both monotherapies, representing a promising rescue strategy for refractory Crohn's disease that merits prospective validation.
METHODS: This retrospective study enrolled 23 patients with active Crohn's disease and prior inadequate response to both UST and VDZ monotherapy. All patients initiated DTT following standard induction and maintenance protocols. The primary endpoint was clinical response at week 24. Secondary endpoints included clinical remission, biomarker normalization, endoscopic improvement, and safety.
RESULTS: At week 24, DTT induced clinical response in 82.6% (19/23) and clinical remission in 34.8% (8/23) of patients, with all responders achieving corticosteroid-free remission. Inflammatory biomarkers significantly decreased: median C-reactive protein (CRP) from 11.6 to 3.5 mg/L (P = 0.011) and median fecal calprotectin from 337.4 to 146.6 μg/g (P = 0.035). Normalization rates were 60.9% for CRP and 73.9% for calprotectin. At week 48, 86.9% of patients remained on DTT, with 45.0% in sustained remission. Endoscopic assessment showed remission in 33.3% and response in 61.1% of evaluated patients. Safety was favorable, with only mild adverse events (8.7%).
CONCLUSION: UST and VDZ dual therapy effectively recaptured response and induced remission in Crohn's disease patients failing both monotherapies, representing a promising rescue strategy for refractory Crohn's disease that merits prospective validation.