Efficacy and safety of upadacitinib in anti-TNF-refractory intestinal Behçet’s disease: a single-center retrospective study

Abstract Objectives To evaluate the efficacy and safety of upadacitinib in patients with anti-TNF -refractory intestinal Behçet’s disease (BD). Methods We conducted a single-center retrospective study using data from a maintained BD registry at Peking Union Medical College Hospital between July 2024 and April 2026. Seventeen consecutive patients were included. Upadacitinib was initiated at a daily dose of 15 mg for all patients, with dose escalation to 30 mg in nine cases due to an inadequate response. The primary endpoint was a complete remission (CR) at Month 6, defined by a composite disease activity index incorporating global gastrointestinal (GI) symptom score and endoscopic evaluation. Secondary endpoints included changes in Disease Activity Index for Intestinal Behçet’s Disease (DAIBD), inflammatory markers, glucocorticoid dosage, and safety. Results At Month 6, 50.0% (8/16) of patients who underwent endoscopy evaluation achieved CR based on the composite disease activity index. CR of global GI symptom score was observed in 76.5% (13/17) of patients and mucosal healing in 50% (8/16). Median DAIBD score decreased markedly from 55.0 (IQR 45.0-80.0) at baseline to 0.0 (IQR 0.0-10.0), accompanied by significant reductions in C-reactive protein and erythrocyte sedimentation rate. Upadacitinib demonstrated a glucocorticoid-sparing effect and was generally well tolerated. Conclusions Upadacitinib represents a potential therapeutic option for patients with anti-TNF-refractory intestinal BD.