What question did this study set out to answer?

This study aimed to assess the effectiveness and safety of upadacitinib in patients with difficult-to-treat inflammatory bowel disease.

January 23, 2026

P0683Efficacy and Safety of Upadacitinib in Difficult-to-Treat Inflammatory Bowel Disease: A Prospective, Multicenter, Real-World Study (EaseUpIBD Study)

Key Points

This study aimed to assess the effectiveness and safety of upadacitinib in patients with difficult-to-treat inflammatory bowel disease.
Conducted a prospective, multicenter, real-world study with patients diagnosed with difficult-to-treat inflammatory bowel disease.
Patients were followed for 52 weeks after initiating upadacitinib treatment.
Outcomes evaluated included clinical remission, endoscopic remission, mucosal healing, and adverse events at set intervals.
At week 12, 61.4% of Crohn's disease patients achieved clinical remission.
After maintenance therapy, clinical remission rates for Crohn's disease reached 85.3% by week 52.
For ulcerative colitis patients, clinical remission at week 8 was observed in 63.6%, improving to 86.3% at week 52 after maintenance.

Abstract

Abstract Background Treatment of difficult-to-treat inflammatory bowel disease (DTT-IBD) is challenging. Upadacitinib has demonstrated efficacy in IBD patients. This study aimed to evaluate the efficacy and safety of upadacitinib for DTT-IBD in real-world practice. Methods This was a prospective, multicenter, real-world study. Patients with DTT-IBD diagnosed according to the IOIBD consensus and planning to initiate upadacitinib treatment were enrolled and followed for 52 weeks. The rates of clinical remission, endoscopic remission, mucosal healing, transmural healing, and incidence of adverse events were evaluated at weeks 8-12 and weeks 52. Results A total of 224 patients were enrolled, including 158 with Crohn’s disease (CD) and 66 with ulcerative colitis (UC). 89.7% of patients had failed multi-mechanism advanced therapies; 43.8% had complex perianal disease. At week 12, CD patients demonstrated clinical remission in 61.4%, endoscopic remission in 50.0%, and transmural healing in 28.5%. Among the 129 responders who continued upadacitinib maintenance therapy, clinical remission, endoscopic remission, and transmural healing rates at week 52 were 85.3%, 63.6%, and 36.4%, respectively. For UC patients, week 8 outcomes included clinical remission (63.6%), endoscopic remission (47.0%), mucosal healing (13.6%) and clinical response (77.3%). Of the 51 responders who received upadacitinib maintenance therapy, the rates of clinical remission, endoscopic remission and mucosal healing were 86.3%, 56.9% and 13.7% by week 52, respectively. The low-dose maintenance group required a higher proportion of dose optimization (31.0% vs. 11.0%); dose optimization improved clinical response. Prior failure of biologics and pan-JAK inhibitors did not affect clinical remission. Seventy-two patients (32.1%) reported 139 adverse events. Upper respiratory tract infections, acne, and herpes were the most common events. No reactivation of latent tuberculosis or hepatitis B virus was observed. Conclusion Upadacitinib effectively induced and sustaind clinical and endoscopic remission in DTT-IBD patients in the real world, with an acceptable safety profile. Conflict of interest: Dr. Lin, Lang: No conflict of interest Tang, Jian: No conflict of interest Gao, Xiang: No conflict of interest Chao, Kang: No conflict of interest

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P0683Efficacy and Safety of Upadacitinib in Difficult-to-Treat Inflammatory Bowel Disease: A Prospective, Multicenter, Real-World Study (EaseUpIBD Study)

Key Points

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