Supplementary Material for: Treatment Patterns in Newly Diagnosed Patients with Crohn’s Disease Who Received Biologics Following Diagnosis: A Nationwide, Retrospective, Longitudinal, Observational Study Using a Medical Claims Database in Japan

<b><i>Introduction:</i></b> 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. <b><i>Methods:</i></b> 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. <b><i>Results:</i></b> 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 (<i>n</i> = 508), were mostly treated with a nonbiologic therapy (74.8%), whereas those who had not (<i>n</i> = 838), mostly received biologics (alone or in combination, 82.8%) as a first-line treatment. <b><i>Conclusions:</i></b> 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.

<b><i>引言：</i></b> 克罗恩病（Crohn’s disease, CD）是一种可累及胃肠道任意部位的慢性炎症性疾病。当前临床治疗以药物抑制炎症为主要手段。对于激素依赖或激素难治性克罗恩病患者，临床推荐使用生物制剂；然而目前针对日本真实世界中生物制剂的临床使用现状，相关研究仍较为匮乏。
<b><i>方法：</i></b> 本研究为观察性纵向队列研究，采用日本医疗数据中心（Japan Medical Data Center, JMDC）数据库，对2009年1月至2019年1月期间新确诊克罗恩病、且后续接受至少1种生物制剂（阿达木单抗adalimumab、英夫利昔单抗infliximab或乌司奴单抗ustekinumab）治疗的患者的医保理赔数据进行分析。本研究的主要评估指标为患者首次确诊克罗恩病后6个月内开具的一线治疗方案类型。
<b><i>结果：</i></b> 在1346名符合入组标准的患者中，最常见的治疗方案为5-氨基水杨酸（5-aminosalicylic acid, 5-ASA）单药治疗（26.8%）、5-氨基水杨酸联合生物制剂治疗（26.3%）以及生物制剂单药治疗（12.9%）。61.1%的患者在首次确诊克罗恩病后的6个月内接受了一线生物制剂治疗，可单独使用或联合其他治疗手段。作为单一一线治疗方案，英夫利昔单抗的处方占比最高（66.3%），而激素治疗的占比仅为1.3%。接受小肠内镜检查等小肠检视操作的患者（<i>n</i> = 508）中，多数采用非生物制剂治疗（74.8%）；而未接受该类操作的患者（<i>n</i> = 838）中，82.8%的患者一线治疗采用生物制剂（单独或联合其他疗法）。
<b><i>结论：</i></b> 本研究明确了日本JMDC数据库中接受生物制剂治疗的克罗恩病患者的典型诊疗模式。生物制剂在克罗恩病治疗的早期阶段应用较为普遍。在启用生物制剂治疗前，先采用激素、营养支持等传统治疗手段，并评估小肠病变情况，或可帮助患者获得更佳的治疗结局。