Background Upadacitinib (UPA) is a novel selective Janus kinase 1 inhibitor that has shown efficacy and received approval for the treatment of moderate-to-severe ulcerative colitis (UC) and Crohn's disease (CD). We previously reported a large real-world experience of UPA induction in UC and CD (Friedberg, CGH. 2023). Here we report our 1-year real-world experience. Methods This is a prospectively collected study of clinical outcomes of UPA treatment in patients with UC and CD using predetermined intervals at weeks 0, 2, 4, 8, then every 3 months until week 52 as part of a formalized treatment protocol at our institution. We used the Simple Clinical Colitis Activity Index and the Harvey-Bradshaw index, as well as C-reactive protein and faecal calprotectin to assess efficacy, and also recorded treatment-related adverse events and serious adverse events. Results 110 patients were initiated on UPA and followed for a one-year period (CD=57, UC=44, IBDU=5, pouchitis=4). 109/110 (99%) were biologic exposed and 31/110 (28.2 %) were tofacitinib exposed. 99/110 (90%) were initiated on UPA for luminal disease (Table 1). 54 patients remained on UPA therapy at 1 year. In UC: week 8 clinical response and remission was 24/47 (51.1%), 39/47 (83%), respectively; week 26 clinical response and remission was 20/34 (58.8%), 24/34 (70.6%), respectively; 52 week clinical response and remission was 17/30 (56.7%), 29/30 (96.7%), respectively. In CD: week 8 clinical response and remission was 14/32 (43.8%), 25/32 (78.1%%), respectively; week 26 clinical response and remission was 9/22 (40.9%), 15/22 (68.2%), respectively; 52 week clinical response and remission was 10/17 (58.8%), 13/17 (76.5%), respectively. 56 patients discontinued UPA prior to the 1 year follow-up, 13 were due to adverse events[DR1] . The most commonly experienced AEs leading to discontinuation was dermatological side effects (CD=2, UC=2). One instance of shingles occurred leading to discontinuation. No other serious infections or serious adverse events including VTE, MACE, or malignancies occurred. Conclusion In this large 1-year real-world experience in medically resistant patients with UC or CD, we report that UPA is both effective and safe, including in those who had prior exposure to tofacitinib.

中文翻译：

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P465 乌帕替尼治疗溃疡性结肠炎和克罗恩病有效且安全：1 年前瞻性现实经验

背景 Upadacitinib (UPA) 是一种新型选择性 Janus 激酶 1 抑制剂，已显示出疗效并已获得批准用于治疗中重度溃疡性结肠炎 (UC) 和克罗恩病 (CD)。我们之前报道了 UC 和 CD 中 UPA 诱导的大量真实经验 (Friedberg, CGH. 2023)。在这里，我们报告我们一年的实际经验。方法 这是一项前瞻性收集的研究，研究 UPA 治疗 UC 和 CD 患者的临床结果，作为我们机构正式治疗方案的一部分，在第 0、2、4、8 周预定间隔，然后每 3 个月一次，直至第 52 周。我们使用简单临床结肠炎活动指数和Harvey-Bradshaw指数，以及C反应蛋白和粪便钙卫蛋白来评估疗效，并记录治疗相关的不良事件和严重不良事件。结果 110 名患者开始接受 UPA 治疗并随访一年（CD = 57，UC = 44，IBDU = 5，储袋炎 = 4）。109/110 (99%) 的患者暴露于生物制剂，31/110 (28.2%) 的患者暴露于托法替布。99/110 (90%) 因管腔疾病开始接受 UPA（表 1）。54 名患者在 1 年时仍接受 UPA 治疗。UC：第 8 周临床缓解率和缓解率分别为 24/47 (51.1%)、39/47 (83%)；第26周临床缓解率和缓解率分别为20/34 (58.8%)、24/34 (70.6%)；52 周临床缓解率和缓解率分别为 17/30 (56.7%)、29/30 (96.7%)。CD 中：第 8 周临床缓解率和缓解率分别为 14/32 (43.8%)、25/32 (78.1%%)；第26周临床缓解率和缓解率分别为9/22 (40.9%)、15/22 (68.2%)；52 周临床缓解率和缓解率分别为 10/17 (58.8%)、13/17 (76.5%)。56 名患者在 1 年随访前终止 UPA，其中 13 名患者因不良事件而终止[DR1]。导致停药的最常见的 AE 是皮肤副作用（CD=2，UC=2）。发生一例带状疱疹导致停药。没有发生其他严重感染或严重不良事件，包括 VTE、MACE 或恶性肿瘤。结论 在这项针对 UC 或 CD 耐药患者的 1 年大量真实世界经验中，我们报告 UPA 既有效又安全，包括对于既往曾接触过托法替布的患者。