Department of Gastroenterology, Faculty of Medicine, Fukuoka University, Fukuoka, Japan.
Japan Medical Office, Takeda Pharmaceutical Company Limited, Tokyo, Japan.
Digestion. 2023;104(2):109-120. doi: 10.1159/000527045. Epub 2022 Nov 30.
Crohn's disease (CD) is a chronic inflammatory condition affecting any part of the gastrointestinal tract. Current therapies involve pharmacological efforts to dampen inflammation. Biologics are recommended for patients with steroid-dependent or steroid-refractory disease; however, little is known about current biologic use in real-world settings in Japan.
This observational, longitudinal, cohort study utilized the Japan Medical Data Center (JMDC) database to analyze claims data of patients who were prescribed ≥1 biologic (adalimumab, infliximab, or ustekinumab) following a new CD diagnosis made between January 2009 and January 2019. We primarily assessed the type of first-line treatment prescribed within 6 months of a patient's first CD diagnosis.
Of the 1,346 eligible patients, the most common prescriptions were 5-aminosalicylic acid (5-ASA) monotherapy (26.8%), 5-ASA plus biologic combination (26.3%), and biologic monotherapy (12.9%). First-line biologics were prescribed within 6 months of initial CD diagnosis in 61.1% of patients, either alone or in combination with other therapies. As an individual first-line treatment, the proportion of patients receiving prescriptions of infliximab was high (66.3%) and steroids, low (1.3%). Patients who had a procedure to inspect the small intestine, such as endoscopy (n = 508), were mostly treated with a nonbiologic therapy (74.8%), whereas those who had not (n = 838), mostly received biologics (alone or in combination, 82.8%) as a first-line treatment.
In this study, we discovered the typical treatment pattern of patients with CD who received biologics and are registered in the JMDC database in Japan. Biologics were commonly used in the early phase of CD treatment. Treatment with traditional approaches such as steroids and nutritional therapy with evaluation for small intestine lesions, before turning to the use of biologics, may be prudent for achieving optimal outcomes.
克罗恩病（CD）是一种影响胃肠道任何部位的慢性炎症性疾病。目前的治疗方法包括药物治疗以抑制炎症。生物制剂被推荐用于依赖激素或激素抵抗的疾病患者；然而，关于日本真实世界环境中生物制剂的使用情况，我们知之甚少。
本观察性、纵向、队列研究利用日本医疗数据中心（JMDC）数据库，分析了 2009 年 1 月至 2019 年 1 月期间首次诊断为 CD 后至少使用一种生物制剂（阿达木单抗、英夫利昔单抗或乌司奴单抗）的患者的理赔数据。我们主要评估了患者首次 CD 诊断后 6 个月内开具的一线治疗药物类型。
在 1346 名符合条件的患者中，最常见的处方是 5-氨基水杨酸（5-ASA）单药治疗（26.8%）、5-ASA 联合生物制剂联合治疗（26.3%）和生物制剂单药治疗（12.9%）。61.1%的患者在首次 CD 诊断后 6 个月内接受了一线生物制剂治疗，或单独使用或联合其他治疗药物。作为单一的一线治疗药物，接受英夫利昔单抗治疗的患者比例较高（66.3%），而接受激素治疗的患者比例较低（1.3%）。接受小肠检查（如内镜）的患者（n=508）大多接受非生物制剂治疗（74.8%），而未接受小肠检查的患者（n=838）大多接受生物制剂（单独或联合使用，82.8%）作为一线治疗药物。
在这项研究中，我们发现了在日本 JMDC 数据库中登记的接受生物制剂治疗的 CD 患者的典型治疗模式。生物制剂在 CD 治疗的早期阶段被广泛使用。在使用生物制剂之前，采用传统方法（如激素和营养治疗）并评估小肠病变，可能有助于实现最佳治疗效果。
