Lee Chang Kyun, Moon Won, Chun Jaeyoung, Kim Eun Soo, Kim Hyung Wook, Yoon Hyuk, Kim Hyun Soo, Lee Yoo Jin, Choi Chang Hwan, Jung Yunho, Park Sung Chul, Song Geun Am, Lee Jong Hun, Jung Eun Suk, Kim Youngdoe, Jung Su Young, Choi Jong Min, Ye Byong Duk
Department of Gastroenterology, Center for Crohn's and Colitis, Kyung Hee University Hospital, Kyung Hee University College of Medicine, Seoul, Korea.
Department of Internal Medicine, Kosin University College of Medicine, Busan, Korea.
Inflamm Bowel Dis. 2025 May 12;31(5):1306-1316. doi: 10.1093/ibd/izae171.
This study investigated the safety and effectiveness of ustekinumab (UST) in Korean patients with Crohn's disease (CD).
Adult patients with CD treated with UST were prospectively enrolled in the K-STAR (Post-MarKeting Surveillance for Crohn's Disease patients treated with STelARa) study between April 2018 and April 2022. Both the clinical effectiveness and adverse effects of UST therapy were analyzed. Missing data were handled using nonresponder imputation (ClinicalTrials.gov Identifier: NCT03942120).
Of the 464 patients enrolled from 44 hospitals across Korea, 457 and 428 patients (Crohn's disease activity index ≥150) were included in the safety analysis and effectiveness analysis sets, respectively. At weeks 16 to 20 after initiating UST, clinical response, clinical remission, and corticosteroid-free remission rates were 75.0% (321 of 428), 64.0% (274 of 428), and 61.9% (265 of 428), respectively. At week 52 to 66, clinical response, clinical remission, and corticosteroid-free remission rates were 62.4% (267 of 428), 52.6% (225 of 428), and 50.0% (214 of 428), respectively. Combined effectiveness (clinical response + biochemical response) was achieved in 40.0% (171 of 428) and 41.6% (178 of 428) at week 16 to 20 and week 52 to 66, respectively. Biologic-naïve patients exhibited significantly higher rates of combined effectiveness than biologic-experienced patients (50.3% vs 30.7% at week 16-20, P < .001; 47.7% vs 36.0% at week 52-66, P = .014). No additional benefits were observed with the concomitant use of immunomodulators. Ileal location was independently associated with a higher probability of clinical remission compared with colonic or ileocolonic location at week 52 to 66. Adverse and serious adverse events were observed in 28.2% (129 of 457) and 12.7% (58 of 457), respectively, with no new safety signal associated with UST treatment.
Ustekinumab was well-tolerated, effective, and safe as induction and maintenance therapy for CD in Korea.
本研究调查了乌司奴单抗（UST）在韩国克罗恩病（CD）患者中的安全性和有效性。
2018年4月至2022年4月期间，将接受UST治疗的成年CD患者前瞻性纳入K-STAR（接受STelARa治疗的克罗恩病患者上市后监测）研究。分析了UST治疗的临床有效性和不良反应。采用无反应者插补法处理缺失数据（ClinicalTrials.gov标识符：NCT03942120）。
在韩国44家医院招募的464例患者中，457例和428例（克罗恩病活动指数≥150）分别纳入安全性分析集和有效性分析集。在开始UST治疗后的第16至20周，临床缓解率、临床缓解率和无皮质类固醇缓解率分别为75.0%（428例中的321例）、64.0%（428例中的274例）和61.9%（428例中的265例）。在第52至66周，临床缓解率、临床缓解率和无皮质类固醇缓解率分别为62.4%（428例中的267例）、52.6%（428例中的225例）和50.0%（428例中的214例）。在第16至20周和第52至66周，联合有效性（临床缓解+生化缓解）分别为40.0%（428例中的171例）和41.6%（428例中的178例）。初治生物制剂患者的联合有效性率显著高于有生物制剂使用经验的患者（第16 - 20周时为50.3%对30.7%，P <.001；第52 - 66周时为47.7%对36.0%，P = 0.014）。同时使用免疫调节剂未观察到额外益处。在第52至66周，与结肠或回结肠部位相比，回肠部位临床缓解的可能性更高。分别有28.2%（457例中的129例）和12.7%（457例中的58例）观察到不良事件和严重不良事件，未发现与UST治疗相关的新安全信号。
在韩国，乌司奴单抗作为CD的诱导和维持治疗耐受性良好且有效、安全。
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