评估托法替布与阿达木单抗、依那西普和阿巴西普在既往接受过 1 种生物 DMARDs 治疗的 RA 患者中的真实世界疗效:来自美国行政索赔数据库的数据。

Evaluation of Real-World Experience with Tofacitinib Compared with Adalimumab, Etanercept, and Abatacept in RA Patients with 1 Previous Biologic DMARD: Data from a U.S. Administrative Claims Database.

机构信息

1 Pfizer, New York, New York.

2 Pfizer, Groton, Connecticut.

出版信息

J Manag Care Spec Pharm. 2016 Dec;22(12):1457-1471. doi: 10.18553/jmcp.2016.22.12.1457.

Abstract

BACKGROUND

Real-world data comparing tofacitinib with biologic disease-modifying antirheumatic drugs (bDMARDs) are limited.

OBJECTIVE

To compare characteristics, treatment patterns, and costs of patients with rheumatoid arthritis (RA) receiving tofacitinib versus the most common bDMARDs (adalimumab [ADA], etanercept [ETN], and abatacept [ABA]) following a single bDMARD in a U.S. administrative claims database.

METHODS

This study was a retrospective cohort analysis of patients aged ≥ 18 years with an RA diagnosis (ICD-9-CM codes 714.0x-714.4x; 714.81) and 1 previous bDMARD filling ≥ 1 tofacitinib or bDMARD claim in the Truven MarketScan Commercial and Medicare Supplemental claims databases (November 1, 2012-October 31, 2014). Monotherapy was defined as absence of conventional synthetic DMARDs within 90 days post-index. Persistence was evaluated using a 60-day gap. Adherence was assessed using proportion of days covered (PDC). RA-related total, pharmacy, and medical costs were evaluated in the 12-month pre- and post-index periods. Treatment patterns and costs were adjusted using linear models including a common set of clinically relevant variables of interest (e.g., previous RA treatments), which were assessed separately using t-tests and chi-squared tests.

RESULTS

Overall, 392 patients initiated tofacitinib; 178 patients initiated ADA; 118 patients initiated ETN; and 191 patients initiated ABA. Tofacitinib patients were older versus ADA patients (P = 0.0153) and had a lower proportion of Medicare supplemental patients versus ABA patients (P = 0.0095). Twelve-month pre-index bDMARD use was greater in tofacitinib patients (77.6%) versus bDMARD cohorts (47.6%-59.6%). Tofacitinib patients had greater 12-month pre-index RA-related total costs versus bDMARD cohorts (all P < 0.0001) and greatest index use of monotherapy (P = 0.0080 vs. ABA). A similar (all P > 0.10) proportion of patients were persistent with tofacitinib (42.6%) versus ADA (37.6%), ETN (42.4%), and ABA (43.5%). Mean PDC was 0.55 for tofacitinib versus 0.57 (ADA), 0.59 (ETN), and 0.44 (ABA; P = 0.0003). Adjusted analyses generated similar findings to the unadjusted treatment patterns. Tofacitinib had lower adjusted 12-month post-index mean RA-related total costs ($23,568) versus ADA ($29,278; P < 0.0001), ETN ($26,885; P = 0.0248), and ABA ($30,477; P < 0.0001).

CONCLUSIONS

In this study, tofacitinib was more commonly used as monotherapy and yielded at least comparable persistence and adherence with lower adjusted mean RA-related total costs versus ADA, ETN, and ABA. Further analysis is warranted given the greater 12-month pre-index bDMARD use and RA-related costs for tofacitinib versus bDMARDs.

DISCLOSURES

This study was sponsored by Pfizer. Harnett, Gerber, Gruben, Koenig, and Chen are employees and shareholders of Pfizer. Some data reported in this manuscript have been previously presented at the Academy of Managed Care Nexus 2015; Orlando, Florida; October 26-29, 2015, and was submitted in abstract form to the European League Against Rheumatism Congress; London, United Kingdom; June 8-11, 2016. All authors were involved in the conception and design of this study. Harnett and Gruben were involved in data collection and analysis. All authors interpreted the data, critically reviewed and revised the manuscript, and read and approved the final manuscript.

摘要

背景

与生物疾病修正抗风湿药物(bDMARDs)相比,比较托法替布的真实世界数据有限。

目的

在一个美国行政索赔数据库中,比较接受托法替布与最常见的 bDMARD(阿达木单抗[ADA]、依那西普[ETN]和阿巴西普[ABA])的类风湿关节炎(RA)患者的特征、治疗模式和成本,这些患者在接受单一 bDMARD 后。

方法

本研究是对 Truven MarketScan 商业和医疗保险补充索赔数据库中年龄≥18 岁、有 RA 诊断(ICD-9-CM 代码 714.0x-714.4x;714.81)和 1 次以上 bDMARD 填充≥1 次托法替布或 bDMARD 索赔的患者(2012 年 11 月 1 日至 2014 年 10 月 31 日)的回顾性队列分析。单药治疗定义为指数后 90 天内无常规合成 DMARD。通过 60 天的间隔来评估持久性。使用比例的方法评估了 RA 相关的总费用、药房费用和医疗费用在指数前和后 12 个月的情况。使用包括一系列感兴趣的临床相关变量(例如,以前的 RA 治疗)的线性模型来调整治疗模式和成本,这些变量分别使用 t 检验和卡方检验进行评估。

结果

共有 392 例患者开始使用托法替布;178 例患者开始使用 ADA;118 例患者开始使用 ETN;191 例患者开始使用 ABA。与 ADA 患者相比,托法替布患者年龄更大(P=0.0153),与 ABA 患者相比,托法替布患者中补充医疗保险患者的比例较低(P=0.0095)。与 bDMARD 队列(47.6%-59.6%)相比,托法替布患者在指数前 12 个月的 bDMARD 使用率更高(P<0.0001)。与 bDMARD 队列相比(所有 P<0.0001),托法替布患者的 RA 相关总费用在前 12 个月的指数中更高,并且指数使用单药治疗的比例最高(P=0.0080 与 ABA)。与 ADA(37.6%)、ETN(42.4%)和 ABA(43.5%)相比,有相似比例的患者(所有 P>0.10)对托法替布有持久性。托法替布的平均 PDC 为 0.55,ADA 为 0.57,ETN 为 0.59,ABA 为 0.44(P=0.0003)。调整后的分析产生了与未调整的治疗模式相似的结果。与 ADA(P<0.0001)、ETN(P=0.0248)和 ABA(P<0.0001)相比,托法替布在指数后 12 个月的调整后 RA 相关总费用($23568)更低。

结论

在这项研究中,与 ADA、ETN 和 ABA 相比,托法替布作为单药治疗的应用更为常见,并且至少具有相似的持久性和一致性,同时 RA 相关总成本也较低。鉴于托法替布与 bDMARD 相比,12 个月前 bDMARD 的使用率和 RA 相关费用更高,因此需要进一步分析。

披露

这项研究由辉瑞公司赞助。Harnett、Gerber、Gruben、Koenig 和 Chen 是辉瑞公司的员工和股东。本研究中报告的一些数据先前已在管理保健联盟 Nexus 2015 年会上提出,并于 2016 年 6 月 8 日至 11 日在伦敦举行的欧洲抗风湿病联盟大会上以摘要形式提交。所有作者都参与了这项研究的构思和设计。Harnett 和 Gruben 参与了数据收集和分析。所有作者解释了数据,批判性地审查和修改了手稿,并阅读和批准了最终手稿。

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