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生物制剂起始治疗前溃疡性结肠炎患者病程的理解:一项为期5年的探索

Understanding patient journey in ulcerative colitis prior to biologic initiation: a 5-year exploration.

作者信息

Wang Yiting, Makadia Rupa, Knoll Christopher, Hardin Jill, Voss Erica A, Fife Daniel, Davis Kourtney, Sloan Sheldon

机构信息

Janssen Research & Development, LLC, 1125 Trenton-Harbourton Road, Titusville, NJ, 08560, USA.

Janssen Global Services, LLC, Raritan, 08869, NJ, USA.

出版信息

BMC Gastroenterol. 2021 Mar 17;21(1):121. doi: 10.1186/s12876-021-01708-6.

Abstract

BACKGROUND

There has been a more pronounced shift toward earlier, more aggressive therapies in Crohn's disease than in ulcerative colitis (UC). The aim of this study was to describe the pre-biologic treatment and health care experience, including co-morbidities and overall health care utilization, for UC patients who initiated biologic therapies, in the 5 years prior to the initiation of the first biologic agent.

METHODS

UC patients who initiated a biologic agent approved for UC between 9/15/2005 and 1/30/2018 were identified from the IBM® MarketScan® Commercial Database, a large US database. The date of the first recorded UC biologic exposure was defined as the index date, and ≥ 5 years of pre-index records were required to evaluate patients' treatment, disease progression and overall health care utilization prior to initiating biologic agents.

RESULTS

Among the 1891 eligible patients, treatment with oral corticosteroids, 5-aminosalicylates, and other non-biologic immunomodulators, all increased progressively across the 5 years prior to the index. From within year-five to within year-one prior to the index, the median duration of oral corticosteroid treatment increased from 34 to 88 days per year and the proportion of patients who experienced more extensive/pancolitis disease increased from 16 to 59%. Overall, the frequency of all-cause health care visits also increased.

CONCLUSIONS

Patients with UC experienced increasing morbidity and treatment burden in the 5 years prior to initiating biologic therapy. To achieve reduced corticosteroids in UC management, better risk stratification is needed to help identify patients for more timely biologic treatment.

摘要

背景

与溃疡性结肠炎(UC)相比,克罗恩病的治疗已更明显地转向更早期、更积极的治疗方法。本研究的目的是描述在首次使用生物制剂前5年中开始使用生物疗法的UC患者的生物制剂治疗前和医疗保健经历,包括合并症和整体医疗保健利用情况。

方法

从美国大型数据库IBM® MarketScan®商业数据库中识别出在2005年9月15日至2018年1月30日期间开始使用已获批用于UC的生物制剂的UC患者。首次记录的UC生物制剂暴露日期定义为索引日期,需要≥5年的索引前记录来评估患者在开始使用生物制剂之前的治疗、疾病进展和整体医疗保健利用情况。

结果

在1891名符合条件的患者中,口服糖皮质激素、5-氨基水杨酸酯和其他非生物免疫调节剂的治疗在索引前的5年中均逐渐增加。从索引前第5年到第1年,口服糖皮质激素治疗的中位持续时间从每年34天增加到88天,经历更广泛/全结肠炎疾病的患者比例从16%增加到59%。总体而言,全因医疗就诊频率也有所增加。

结论

UC患者在开始生物治疗前的5年中发病率和治疗负担不断增加。为了在UC管理中减少糖皮质激素的使用,需要更好的风险分层来帮助识别患者以便更及时地进行生物治疗。

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