Patients with refractory inflammatory bowel disease (IBD) show inadequate response to conventional biologics and small molecule drugs, with persistently active disease that severely impacts quality of life and long-term prognosis. Current treatment options are limited, and the substantial disease heterogeneity makes traditional randomized controlled trials difficult to implement in this population. This study aims to explore the efficacy and safety of guselkumab (GUS) with JAK inhibitors (such as upadacitinib/tofacitinib) in this patient population, providing novel therapeutic strategies for clinical practice.
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12-week clinical response and 52-week endoscopic response
Timeframe: The composite endpoint achievement rate of 12-week clinical response (CDAI decrease ≥100) and 52-week endoscopic response (SES-CD improvement ≥50%).