Upadacitinib Treatment Outcomes in Crohn’s Disease: A Retrospective Analysis of Clinical Response and Perianal Fistula Resolution

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Introduction: Upadacitinib (UPA), a Janus kinase inhibitor approved for the treatment of Crohn's disease (CD), has demonstrated high efficacy in clinical trials; however, real-world data on its outcomes remain limited. This study evaluated UPA outcomes in patients with CD in a real-world setting. Methods: We retrospectively analyzed patients who initiated UPA treatment between June 2023 and June 2024. The primary endpoints were clinical response and remission at 12 and 54 weeks. The secondary endpoints included changes in the C-reactive protein (CRP) levels, serum albumin levels, and perianal fistula response. Results: Thirteen patients (mean age, 32.0 years; 92.3% male; mean disease duration, 114.1 months) were included. At baseline, three (23.1%) patients used oral corticosteroids, and 11 (84.6%) had undergone prior biologic therapy, with nine (81.8%) exposed to anti-tumor necrosis factor-alpha antibodies. The mean follow-up period was 53.1 weeks, and the 54-week continuation rate was 83.3%. The clinical response rates were 46.2% and 53.8%, and the remission rates were 69.2% and 84.6% at 12 and 54 weeks, respectively. The mean Crohn's Disease Activity Index scores decreased from 226.8 at baseline to 73.7 at 54 weeks, and the average CRP and albumin levels improved correspondingly. Among the 7 patients (53.8%) with draining perianal fistulas, six (85.7%) achieved cessation of pus discharge by week 8 (mean, 4.4 weeks). No significant adverse events were observed. Conclusion: UPA appears to be an effective treatment for CD and may facilitate the early resolution of perianal fistulas, supporting its role in managing perianal disease.

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