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口服糖皮质激素治疗起始后第一年系统性红斑狼疮患者的临床和经济负担:一项美国回顾性数据库研究

Clinical and Economic Burden in Patients With Systemic Lupus Erythematosus During the First Year After Initiating Oral Corticosteroids: A Retrospective US Database Study.

作者信息

DerSarkissian Maral, Gu Yuqian M, Duh Mei Sheng, Benson John, Huang Shirley P, Averell Carlyne, Vu Jensen, Wang Min-Jung, Bell Christopher F

机构信息

Maral DerSarkissian, PhD, Yuqian M. Gu, MS (current address: Kaiser Permanente, Pasadena, CA, United States), Mei Sheng Duh, MPH, ScD, John Benson, MS, Jensen Vu, BA (current address: Republic, New York, NY, United States, and VietChallenge, Boston, MA, United States), Min-Jung Wang, ScD,MS (current address: Amgen Inc., Thousand Oaks, CA, United States): Analysis Group, Inc., Boston, Massachusetts, United States.

Shirley P. Huang, PharmD, MS (current address: Seagen Inc., Bothwell, WA, United States), Carlyne Averell, MS, SM (no current affiliation), Christopher F. Bell, PharmD, Research Triangle Park, North Carolina, United States.

出版信息

ACR Open Rheumatol. 2023 Jun;5(6):318-328. doi: 10.1002/acr2.11550. Epub 2023 May 24.

Abstract

OBJECTIVE

To characterize health care resource utilization (HCRU), health care costs, and adverse events (AEs) among patients with systemic lupus erythematosus (SLE) initiating oral corticosteroids (OCS) versus patients without OCS use.

METHODS

In this retrospective cohort study (GSK Study 213061), eligible patients (aged ≥5 years at first OCS claim) with SLE from the IQVIA Real-World Data Adjudicated Claims-US database (January 2006 to July 2019) had continuous enrollment during the 6-month preindex (baseline) and 12-month postindex (observation) periods and one or more inpatient or emergency department SLE diagnosis codes or two or more outpatient SLE diagnosis codes during baseline. The "OCS-initiator cohort" comprised patients with one or more OCS pharmacy claims during the study period and no evidence of preindex OCS use and was classified into three exposure categories based on the number of 6-month periods of more than 5 mg/day of OCS use (0, 1, 2). The "no-OCS-use cohort" comprised patients without OCS claims, although patients may have received OCS prior to the study period. Clinical and economic outcomes were reported over the observation period.

RESULTS

Adjusted health care costs differed significantly ($6542 [95% confidence interval (CI): $5761-$7368], $19,149 [95% CI: $16,954-$21,471], $28,985 [95% CI: $25,546-$32,885]). HCRU incidence rates were significantly greater for all OCS-initiator exposure categories (n = 16,216) versus the no-OCS-use cohort (n = 11,137; adjusted incidence rate ratios [95% CI]: 1.22 [1.19-1.24], 1.39 [1.34-1.43], 1.66 [1.60-1.73]). OCS-related AEs were experienced by 67.1% to 74.1% of patients with OCS initiation, most commonly affecting the immune system.

CONCLUSION

Within 12 months of OCS initiation, patients with SLE experienced substantial clinical and economic burden, which may imply a need to minimize OCS use.

摘要

目的

比较开始使用口服糖皮质激素(OCS)的系统性红斑狼疮(SLE)患者与未使用OCS的患者的医疗资源利用(HCRU)、医疗费用及不良事件(AE)情况。

方法

在这项回顾性队列研究(葛兰素史克研究213061)中,来自IQVIA真实世界数据判定索赔 - 美国数据库(2006年1月至2019年7月)的符合条件的SLE患者(首次OCS索赔时年龄≥5岁)在索引前6个月(基线)和索引后12个月(观察)期间持续入组,且在基线时有一个或多个住院或急诊科SLE诊断代码或两个或更多门诊SLE诊断代码。“OCS启动者队列”包括在研究期间有一个或多个OCS药房索赔且无索引前OCS使用证据的患者,并根据6个月期间每天使用超过5 mg OCS的次数分为三个暴露类别(0、1、2)。“未使用OCS队列”包括无OCS索赔的患者,尽管患者在研究期间之前可能已接受过OCS治疗。在观察期内报告临床和经济结果。

结果

调整后的医疗费用差异显著(分别为6542美元[95%置信区间(CI):5761 - 7368美元]、19149美元[95%CI:16954 - 21471美元]、28985美元[95%CI:25546 - 32885美元])。所有OCS启动者暴露类别(n = 16216)的HCRU发生率显著高于未使用OCS队列(n = 11137;调整后的发生率比值[95%CI]:1.22[1.19 - 1.24]、1.39[1.34 - 1.43]、1.66[1.60 - 1.73])。67.1%至74.1%开始使用OCS的患者经历了与OCS相关的AE,最常见的是影响免疫系统。

结论

在开始使用OCS的12个月内,SLE患者经历了巨大的临床和经济负担,这可能意味着需要尽量减少OCS的使用。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3750/10267805/93422387bde8/ACR2-5-318-g002.jpg

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