One-year Safety and Effectiveness of Ustekinumab in Patients With Crohn's Disease: The K-STAR Study.

IF 4.5 3区医学 Q1 GASTROENTEROLOGY & HEPATOLOGY

Inflammatory Bowel Diseases Pub Date : 2024-08-03 DOI:10.1093/ibd/izae171

Chang Kyun Lee, Won Moon, Jaeyoung Chun, Eun Soo Kim, Hyung Wook Kim, Hyuk Yoon, Hyun Soo Kim, Yoo Jin Lee, Chang Hwan Choi, Yunho Jung, Sung Chul Park, Geun Am Song, Jong Hun Lee, Eun Suk Jung, Youngdoe Kim, Su Young Jung, Jong Min Choi, Byong Duk Ye

{"title":"One-year Safety and Effectiveness of Ustekinumab in Patients With Crohn's Disease: The K-STAR Study.","authors":"Chang Kyun Lee, Won Moon, Jaeyoung Chun, Eun Soo Kim, Hyung Wook Kim, Hyuk Yoon, Hyun Soo Kim, Yoo Jin Lee, Chang Hwan Choi, Yunho Jung, Sung Chul Park, Geun Am Song, Jong Hun Lee, Eun Suk Jung, Youngdoe Kim, Su Young Jung, Jong Min Choi, Byong Duk Ye","doi":"10.1093/ibd/izae171","DOIUrl":null,"url":null,"abstract":"Background: This study investigated the safety and effectiveness of ustekinumab (UST) in Korean patients with Crohn's disease (CD).Methods: 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).Results: 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.Conclusions: Ustekinumab was well-tolerated, effective, and safe as induction and maintenance therapy for CD in Korea.","PeriodicalId":13623,"journal":{"name":"Inflammatory Bowel Diseases","volume":null,"pages":null},"PeriodicalIF":4.5000,"publicationDate":"2024-08-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Inflammatory Bowel Diseases","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1093/ibd/izae171","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"GASTROENTEROLOGY & HEPATOLOGY","Score":null,"Total":0}

引用次数: 0

Abstract

Background: This study investigated the safety and effectiveness of ustekinumab (UST) in Korean patients with Crohn's disease (CD).

Methods: 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).

Results: 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.

Conclusions: Ustekinumab was well-tolerated, effective, and safe as induction and maintenance therapy for CD in Korea.

查看原文本刊更多论文

Ustekinumab 用于克罗恩病患者的一年安全性和有效性：K-STAR研究

背景本研究调查了乌司替单抗（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，接受UST治疗的成年克罗恩病患者前瞻性地加入了K-STAR（克罗恩病患者接受STelARa治疗后的监测）研究。研究分析了UST疗法的临床疗效和不良反应。缺失数据采用非应答者估算法处理（ClinicalTrials.gov Identifier：NCT03942120）：来自韩国44家医院的464名患者中，分别有457名和428名患者（克罗恩病活动指数≥150）被纳入安全性分析和有效性分析组。在开始使用UST后的第16至20周，临床应答率、临床缓解率和无皮质类固醇缓解率分别为75.0%（428人中有321人）、64.0%（428人中有274人）和61.9%（428人中有265人）。在第52周至第66周，临床应答率、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，分别有40.0%（428例中的171例）和41.6%（428例中的178例）的患者获得了综合疗效（临床应答+生化应答）。无生物制剂治疗经验的患者的综合有效率明显高于有生物制剂治疗经验的患者（第16-20周为50.3% vs 30.7%，P 结论：优思康单抗的治疗效果良好：在韩国，Ustekinumab作为CD诱导和维持治疗药物具有良好的耐受性、有效性和安全性。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Inflammatory Bowel Diseases 医学-胃肠肝病学

CiteScore

9.70

自引率

6.10%

发文量

462

审稿时长

1 months

期刊介绍： Inflammatory Bowel Diseases® supports the mission of the Crohn''s & Colitis Foundation by bringing the most impactful and cutting edge clinical topics and research findings related to inflammatory bowel diseases to clinicians and researchers working in IBD and related fields. The Journal is committed to publishing on innovative topics that influence the future of clinical care, treatment, and research.