Matsuoka Katsuyoshi, Nakajo Ko, Kawamura Shiho, Zhang Yongjing, Chung Hsingwen, Wahking Bryan, Tan Jin Yu, Qiu Hong
Division of Gastroenterology and Hepatology, Department of Internal Medicine, Sakura Medical Center, Toho University, Sakura, Japan.
Office of the Chief Medical Officer, Johnson & Johnson, Tokyo, Japan.
Intest Res. 2025 Jul;23(3):358-371. doi: 10.5217/ir.2024.00118. Epub 2025 Jan 2.
BACKGROUND/AIMS: There are few studies that comprehensively report real-world persistence for first-line advanced therapies used to treat inflammatory bowel disease. We aimed to describe persistence of first-line advanced therapies among incident biologic or Janus kinase inhibitor users with inflammatory bowel disease.
Retrospective cohort study using the Japan Medical Data Center database from January 1, 2010, until September 30, 2022. Patients aged ≥15 years with relevant diagnostic and treatment codes were included. All eligible patients were observed until study end (September 30, 2022), death, or disenrollment, whichever occurred first.
Among 1,115 patients with Crohn's disease included in the analysis, 41.4% initiated adalimumab, 37.4% infliximab, 18.1% ustekinumab, and 3.0% vedolizumab. Median age was 31.2-34.8 years, 72.8% to 85.9% were male. Persistence at 12 months was 84.7% for adalimumab, 87.7% for infliximab, 91.3% for ustekinumab, and 53.1% for vedolizumab. Persistence at 24 months was 76.3%, 76.8%, 80.4%, and 28.6%, respectively. Among 1,942 patients with ulcerative colitis, 24.8% initiated adalimumab, 33.6% infliximab, 11.2% golimumab, 17.5% vedolizumab, 5.6% ustekinumab, and 7.3% tofacitinib. Mean age was 38.2-40.4 years, 57.4% to 65.8% were male. Persistence at 12 months was 57.6% for adalimumab, 87.7% for infliximab, 54.9% for golimumab, 69.7% for vedolizumab, and 84.0% for ustekinumab. At month 24, persistence for ustekinumab was 75.0%, versus 42.9%-59.4% for other treatments.
Index treatment with ustekinumab resulted in high persistence through 24 months after initiation in patients with Crohn's disease or ulcerative colitis. Our study provides insights into the real-world usage of advanced treatments for patients with IBD in Japan.
背景/目的:很少有研究全面报告用于治疗炎症性肠病的一线先进疗法的实际持久性。我们旨在描述炎症性肠病患者中首次使用生物制剂或Janus激酶抑制剂的一线先进疗法的持久性。
采用日本医疗数据中心数据库进行回顾性队列研究,时间从2010年1月1日至2022年9月30日。纳入年龄≥15岁且有相关诊断和治疗代码的患者。所有符合条件的患者均被观察至研究结束(2022年9月30日)、死亡或退出研究,以先发生者为准。
在纳入分析的1115例克罗恩病患者中,41.4%开始使用阿达木单抗,37.4%使用英夫利昔单抗,18.1%使用乌司奴单抗,3.0%使用维多珠单抗。中位年龄为31.2 - 34.8岁,72.8%至85.9%为男性。阿达木单抗12个月时的持久性为84.7%,英夫利昔单抗为87.7%,乌司奴单抗为91.3%,维多珠单抗为53.1%。24个月时的持久性分别为76.3%、76.8%、80.4%和28.6%。在1942例溃疡性结肠炎患者中,24.8%开始使用阿达木单抗,33.6%使用英夫利昔单抗,11.2%使用戈利木单抗,17.5%使用维多珠单抗,5.6%使用乌司奴单抗,7.3%使用托法替布。平均年龄为38.2 - 40.4岁,57.4%至65.8%为男性。阿达木单抗12个月时的持久性为57.6%,英夫利昔单抗为87.7%,戈利木单抗为54.9%,维多珠单抗为69.7%,乌司奴单抗为84.0%。在第24个月时,乌司奴单抗的持久性为75.0%,而其他治疗为42.9% - 59.4%。
对于克罗恩病或溃疡性结肠炎患者,起始使用乌司奴单抗进行初始治疗在开始后的24个月内具有较高的持久性。我们的研究为日本炎症性肠病患者先进治疗的实际使用情况提供了见解。