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美国商业保险覆盖的年轻慢性淋巴细胞白血病患者的真实世界治疗模式、不良事件、资源利用和成本:一项回顾性队列研究。

Real-World Treatment Patterns, Adverse Events, Resource Use, and Costs Among Commercially Insured, Younger Patients with Chronic Lymphocytic Leukemia in the USA: A Retrospective Cohort Study.

机构信息

AstraZeneca, Gaithersburg, MD, USA.

IQVIA, Falls Church, VA, USA.

出版信息

Adv Ther. 2020 Jul;37(7):3129-3148. doi: 10.1007/s12325-020-01350-w. Epub 2020 May 12.

Abstract

INTRODUCTION

Amidst a changing treatment landscape, real-world evidence on the burden of chronic lymphocytic leukemia (CLL) is limited. The purpose of this study was to describe treatment patterns, adverse events (AEs), and economic burden among treated patients with CLL.

METHODS

A retrospective cohort study was conducted with IQVIA PharMetrics Plus. Patients at least 18 years old with CLL treatment between November 1, 2013 and May 31, 2018 were identified; index date was first observed CLL treatment. Patients had at least one CLL diagnosis pre-index and a second diagnosis anytime during the study period, at least 1-year pre- and at least 30-day post-index continuous enrollment and no pre-index CLL treatment. Analyses focused on patients receiving one of the four most common regimens observed. Outcomes included treatment patterns, frequency of incident AEs, and healthcare resource use and costs. Multivariable logistic regression and generalized linear modelling were used to evaluate risk of hospitalization and all-cause costs per patient per month (PPPM).

RESULTS

A total of 1706 patients were included in the study (median [interquartile range] age 58 [55-62] years, 66% male, median Charlson Comorbidity Index 2 [2-3], median follow-up 16 [8-28] months). Common regimens, irrespective of treatment line, were bendamustine-rituximab (B-R, 27%), ibrutinib monotherapy (I, 27%), rituximab monotherapy (R, 19%), and fludarabine combined with cyclophosphamide and rituximab (FCR, 16%); 59% had at least one incident AE (B-R, 62%; I, 60%; R, 25%; FCR, 79%). Mean total all-cause healthcare cost over follow-up was $13,858 ± 14,626 PPPM. Increased number of AEs was associated with increased odds of hospitalization (odds ratio = 2.9; 95% confidence interval [CI] 2.5-3.4) and increased mean cost PPPM (cost ratio = 1.2; 95% CI 1.1-1.2).

CONCLUSION

This study highlights the treatment toxicity and associated economic burden among patients with CLL in the USA. As novel therapies are increasingly used, further research examining outcomes will inform the risks, benefits, and value of novel agents to prescribers and patients.

摘要

简介

在治疗环境不断变化的情况下,关于慢性淋巴细胞白血病(CLL)负担的真实世界证据有限。本研究的目的是描述接受治疗的 CLL 患者的治疗模式、不良事件(AE)和经济负担。

方法

采用 IQVIA PharMetrics Plus 进行回顾性队列研究。纳入 2013 年 11 月 1 日至 2018 年 5 月 31 日期间至少 18 岁接受 CLL 治疗的患者;索引日期为首次观察到 CLL 治疗。患者在指数前至少有一次 CLL 诊断,在研究期间的任何时候都有第二次诊断,在指数前至少 1 年和指数后至少 30 天连续入组,且在指数前没有 CLL 治疗。分析重点关注观察到的四种最常见方案中的一种。结果包括治疗模式、新发 AE 的频率以及医疗资源的使用和成本。多变量逻辑回归和广义线性模型用于评估住院风险和每位患者每月的全因费用(PPPM)。

结果

共有 1706 例患者纳入研究(中位[四分位间距]年龄 58[55-62]岁,66%为男性,中位 Charlson 合并症指数为 2[2-3],中位随访时间为 16[8-28]个月)。常见方案无论治疗线如何,均为苯达莫司汀联合利妥昔单抗(B-R,27%)、伊布替尼单药治疗(I,27%)、利妥昔单抗单药治疗(R,19%)和氟达拉滨联合环磷酰胺和利妥昔单抗(FCR,16%);59%的患者至少发生一次 AE(B-R,62%;I,60%;R,25%;FCR,79%)。随访期间的总全因医疗费用平均为 13858 美元±14626 美元/PPPM。AE 数量的增加与住院的可能性增加相关(比值比=2.9;95%置信区间[CI] 2.5-3.4)和平均成本 PPPM 增加(成本比=1.2;95%CI 1.1-1.2)。

结论

本研究强调了美国 CLL 患者的治疗毒性和相关经济负担。随着新型疗法的日益应用,进一步研究将评估结果,为医生和患者提供新型药物的风险、益处和价值。

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