Department of Gastroenterology, Graduate School of Medicine, Chiba University, 1-8-1 Inohana, Chuo-ku, Chiba, 260-8670, Japan.
Endoscopy Center, Chiba University Hospital, Chiba, Japan.
Sci Rep. 2023 Aug 21;13(1):13555. doi: 10.1038/s41598-023-40624-5.
Many molecular targeted agents, including biologics, have emerged for inflammatory bowel diseases (IBD), but their high prices have prevented their widespread use. This study aimed to reveal the changes in patient characteristics and the therapeutic strategies of IBD before and after the implementation of biologics in Japan, where the unique health insurance system allows patients with IBD and physicians to select drugs with minimum patient expenses. The analysis was performed using a prospective cohort, including IBD expert and nonexpert hospitals in Japan. In this study, patients were classified into two groups according to the year of diagnosis based on infliximab implementation as the prebiologic and biologic era groups. The characteristics of therapeutic strategies in both groups were evaluated using association analysis. This study analyzed 542 ulcerative colitis (UC) and 186 Crohn's disease (CD). The biologic era included 53.3% of patients with UC and 76.2% with CD, respectively. The age of UC (33.9 years vs. 38.8 years, P < 0.001) or CD diagnosis (24.3 years vs. 31.9 years, P < 0.001) was significantly higher in the biologic era group. The association analysis of patients with multiple drug usage histories revealed that patients in the prebiologic era group selected anti-tumor necrosis factor (TNF)-α agents, whereas those in the biologic era group preferred biologic agents with different mechanisms other than anti-TNF-α. In conclusion, this study demonstrated that both patient characteristics and treatment preferences in IBD have changed before and after biologic implementation.
许多分子靶向药物,包括生物制剂,已经被用于治疗炎症性肠病(IBD),但由于其价格高昂,限制了它们的广泛应用。本研究旨在揭示日本在引入生物制剂前后,IBD 患者特征和治疗策略的变化。日本独特的医疗保险制度允许 IBD 患者和医生选择对患者花费最小的药物。该分析使用了一个前瞻性队列,包括日本的 IBD 专家和非专家医院。在这项研究中,根据英夫利昔单抗实施前后的诊断年份,将患者分为生物制剂前和生物制剂两个组。使用关联分析评估了两组治疗策略的特征。本研究分析了 542 例溃疡性结肠炎(UC)和 186 例克罗恩病(CD)患者。生物制剂时代分别包括 53.3%的 UC 患者和 76.2%的 CD 患者。UC 患者(33.9 岁 vs. 38.8 岁,P < 0.001)或 CD 诊断(24.3 岁 vs. 31.9 岁,P < 0.001)的年龄在生物制剂时代组显著更高。具有多种药物使用史的患者的关联分析显示,生物制剂前组的患者选择了抗肿瘤坏死因子(TNF)-α 制剂,而生物制剂组则倾向于选择不同作用机制的生物制剂,而不是 TNF-α 制剂。总之,本研究表明,在引入生物制剂前后,IBD 患者的特征和治疗偏好都发生了变化。