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日本新诊断克罗恩病治疗第一年生物制剂的真实世界使用情况:2010年至2021年的索赔分析

Real-world use of biologics during the first year of treatment for newly diagnosed Crohn's disease in Japan: a claims analysis from 2010 to 2021.

作者信息

Miyoshi Jun, Yoon Annabelle, Matsuura Minoru, Hisamatsu Tadakazu

机构信息

Department of Gastroenterology and Hepatology, Kyorin University School of Medicine, Mitaka, Japan.

Japan Medical Office, Takeda Pharmaceutical Company Limited, Tokyo, Japan.

出版信息

Intest Res. 2025 Jan 23. doi: 10.5217/ir.2024.00082.

Abstract

BACKGROUND/AIMS: Crohn's disease (CD) leads to bowel damage and disability if suboptimally treated. We investigated firstyear treatment decisions and real-world use of biologics in patients with CD in Japan.

METHODS

In this retrospective observational study (2010-2021) from the JMDC claims database, patients with a new diagnosis of CD (no CD claims record within 12 months before index) who received ≥ 1 pre-defined treatment were grouped by use of biologics and systemic corticosteroids (SCS) within the first year of diagnosis.

RESULTS

Of 823 patients included, 470 (57.1%) were prescribed biologics and 353 (42.9%) were not; 77.6% were male, 75.7% had adult-onset CD, and median age was 24 years. Patients prescribed biologics were younger (median: 23 years vs. 28 years) and more had perianal lesions (43.0% vs. 22.9%) than those not prescribed biologics; 64.9% (95% confidence interval, 60.4%-69.2%) received a top-down treatment approach (no SCS before biologics). Factors significantly associated with a top-down treatment approach were male sex, perianal lesions, no use of immunomodulators, and use of anti-tumor necrosis factor therapies. The proportion of patients receiving SCS before biologics (step-up approach) increased after 2018, with a shift from prednisolone to budesonide from 2016. Persistence with first biologics decreased over time, with no differences between biologic types.

CONCLUSIONS

Use of biologics for treatment of CD within the first year of diagnosis in Japan has remained stable over the past decade. However, there was a shift to a step-up treatment approach, with an increase in use of SCS before biologics over time.

摘要

背景/目的:如果克罗恩病(CD)治疗不充分,会导致肠道损伤和残疾。我们调查了日本CD患者的第一年治疗决策及生物制剂的实际使用情况。

方法

在这项来自JMDC索赔数据库的回顾性观察研究(2010 - 2021年)中,新诊断为CD(索引前12个月内无CD索赔记录)且接受≥1种预定义治疗的患者,在诊断后的第一年内按生物制剂和全身用糖皮质激素(SCS)的使用情况进行分组。

结果

纳入的823例患者中,470例(57.1%)被处方使用生物制剂,353例(42.9%)未使用;77.6%为男性,75.7%为成年起病的CD,中位年龄为24岁。与未使用生物制剂的患者相比,使用生物制剂的患者更年轻(中位年龄:23岁对28岁),肛周病变更多(43.0%对22.9%);64.9%(95%置信区间,60.4% - 69.2%)采用自上而下的治疗方法(在使用生物制剂前未使用SCS)。与自上而下治疗方法显著相关的因素包括男性、肛周病变、未使用免疫调节剂以及使用抗肿瘤坏死因子疗法。2018年后,在使用生物制剂前使用SCS(逐步升级方法)的患者比例增加,自2016年起从泼尼松龙转向布地奈德。随着时间推移,首次使用生物制剂的持续率下降,不同生物制剂类型之间无差异。

结论

在过去十年中,日本CD患者诊断后第一年内使用生物制剂进行治疗的情况保持稳定。然而,治疗方法已转向逐步升级,随着时间推移,在使用生物制剂前使用SCS的情况有所增加。

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