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类风湿关节炎患者皮下注射托珠单抗的真实世界剂量调整模式

Real-World Dose Modification Patterns of Subcutaneous Tocilizumab Among Patients with Rheumatoid Arthritis.

作者信息

Punekar Rajeshwari, Choi Jeannie, Boklage Susan, Iglesias-Rodriguez Melitza, Nola Kamala

机构信息

Director, Real World Evidence, Sanofi, Cambridge, MA.

Director, Health Economics and Value Assessment, Sanofi, Bridgewater NJ.

出版信息

Am Health Drug Benefits. 2019 Dec;12(8):400-409.

Abstract

BACKGROUND

The treatment of rheumatoid arthritis is based on the use of disease-modifying antirheumatic drugs (DMARDs). Tocilizumab can be used as monotherapy or in combination with conventional synthetic DMARDs for the treatment of moderate-to-severe active rheumatoid arthritis. Subcutaneous (SC) and intravenous forms of the drug are available, but the SC form is more widely used.

OBJECTIVE

To understand the real-world dose modification patterns of SC tocilizumab in the treatment of patients with rheumatoid arthritis in the United States.

METHODS

Data were obtained from the Truven (now IBM) MarketScan and Optum Clinformatics databases. Patients were included if they had ≥1 pharmacy claims for SC tocilizumab and met other inclusion criteria. The mean, standard deviation, and median values were reported for the continuous variables, and frequency was reported for the categorical variables. Kaplan-Meier analysis was used to analyze the time to first dose modification. Logistic regression modeling was used to identify predictors of the likelihood of dose modification.

RESULTS

The study included 1266 patients in the Truven database and 512 patients in the Optum database who had commercial or Medicare Advantage or supplemental insurance. Of the patients who started treatment with biweekly SC tocilizumab (48% each in the Truven and Optum databases), 37% in Truven and 40% in Optum had dose escalation to a weekly dose. Of those who started weekly SC tocilizumab (43% in the Truven and 49% in the Optum databases), 3% (Truven) and 4% (Optum) had dose reduction. The remaining patients started alternative SC tocilizumab doses. Overall, 60% and 68% of patients in the Truven and Optum cohorts, respectively, initiated or escalated to the higher weekly dose of tocilizumab; the mean time to dose escalation was 126 days and 112 days, respectively. In the Truven cohort, corticosteroid use, age, and anemia were the main predictors for dose escalation. In the Optum cohort, female patients had increased odds of dose escalation compared with male patients.

CONCLUSION

The dosing trends observed in this study show that physicians have taken advantage of the option to increase SC tocilizumab dosing, but only a few providers chose to reduce the dose. This trend in dose modification may increase the costs related to SC tocilizumab therapy.

摘要

背景

类风湿关节炎的治疗基于使用改善病情抗风湿药(DMARDs)。托珠单抗可作为单一疗法或与传统合成DMARDs联合使用,用于治疗中重度活动性类风湿关节炎。该药物有皮下注射(SC)和静脉注射两种剂型,但SC剂型应用更为广泛。

目的

了解美国皮下注射托珠单抗治疗类风湿关节炎患者时的实际剂量调整模式。

方法

数据来自Truven(现IBM)MarketScan和Optum Clinformatics数据库。纳入有≥1次皮下注射托珠单抗药房报销记录且符合其他纳入标准的患者。连续变量报告均值、标准差和中位数,分类变量报告频率。采用Kaplan-Meier分析来分析首次剂量调整时间。采用逻辑回归模型来确定剂量调整可能性的预测因素。

结果

该研究纳入了Truven数据库中的1266例患者和Optum数据库中的512例有商业保险、医疗保险优势计划或补充保险的患者。在开始每两周皮下注射托珠单抗治疗的患者中(Truven和Optum数据库各占48%),Truven数据库中有37%的患者和Optum数据库中有40%的患者剂量增加至每周一次。在开始每周皮下注射托珠单抗的患者中(Truven数据库占43%,Optum数据库占49%),3%(Truven)和4%(Optum)的患者剂量减少。其余患者开始使用其他皮下注射托珠单抗剂量。总体而言,Truven队列和Optum队列中分别有60%和68%的患者开始或增加至更高的每周托珠单抗剂量;剂量增加的平均时间分别为126天和112天。在Truven队列中,使用皮质类固醇、年龄和贫血是剂量增加的主要预测因素。在Optum队列中,女性患者相比男性患者剂量增加的几率更高。

结论

本研究中观察到的给药趋势表明,医生利用了增加皮下注射托珠单抗剂量的选择,但只有少数医疗服务提供者选择降低剂量。这种剂量调整趋势可能会增加皮下注射托珠单抗治疗的相关费用。

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