背 景

        依那西普是可溶性肿瘤坏死因子(TNF)受体(人工蛋白)，用以治疗免疫介导性炎症疾病，如类风湿性关节炎(RA)、银屑病关节炎(PsA)、强直性脊柱炎(AS)和银屑病(PsO)。在加拿大现实情况中，影响是否使用依那西普以及长期保持使用该药物的因素的信息十分有限。

目 的

        测定加拿大的患者在六年时间内依那西普的保持使用率，并确定与停药相关的影响因素。

方 法

        本研究为回顾性队列研究，采用了昆泰药业自费医疗药物数据库(PDP)、安大略公费医疗药物数据库(OPDP)以及魁北克公费医疗药物数据库(RAMQ)的纵向处方药报销数据，对在2008年7月至2010年6月间初次开始使用依那西普的患者进行身份认证并进行为期72个月的跟踪研究。分别在第一年、第二年、第三年、第四年和第五年评估保持治疗的患者的12个月保持使用率，并与第一年的保持使用率进行对比。研究利用Cox比例风险模式确定在这72个月期间，与停止用药的时间点相关的协变量。

结 果

        本研究确认在选定期间内，加拿大共有4528名使用依那西普的患者(61%为女性，85%患有风湿性疾病，15%患有牛皮癣)开始接受治疗。总体而言，在沿用第一年治疗方案的患者中依那西普12个月保持使用率显著升高(p<.0001)，第一年的12个月保持使用率为66%，第二年为79%，第三年为82%，第四年为84%，第五年为83%，而第六年为79%。共有17.1%(n=771)的患者在72个月的研究期间内都保持使用依那西普。回归分析显示，相比于其他患者，牛皮癣患者的保持使用率较低(HR1.199;p<.0001)，老年患者(65岁以上)的保持使用率比年轻患者高(HR 0.802;p<.0001)，而公费医疗患者的保持使用率比比自费医疗患者高(ODB HR 0.735，RAMQ HR 0.55;p<.0001)。

结 论

        患者保持使用依那西普的可能性随着患者维持治疗年限的增加而增加。这一模式适用于各治疗领域、性别、年龄及医疗付费模式。研究发现，年龄、病症及医疗付费模式对患者决定停止治疗的时间点有显著影响。在对与保持使用率相关因素作进一步研究后，可以在支持高风险患者群体接受稳定的治疗的同时，根据他们的具体需求有针对性地设计资助方案。

原 文

Etanercept retention patterns and factors associated with treatment discontinuation: a retrospective cohort study using canadian claims-level data

        M Khraishi1, Y Zhang2, J Ivanovic2, B Millson2, M-J Brabant2, K Charland2, E Singh3, J Woolcott4, H Jones3

        Citation

        VomeroM,CapozziA,BarbatiC, et al

        FRI0028 In vitro inhibitory effect of etanercept on autophagy: a new mechanism of action of tnf inhibitors in rheumatoid arthritis

        Annals of the Rheumatic Diseases2017;76:490.

        Publication history

        Published in print1 June 2017.

        Published online15 June 2017.

ABSTRACT

Background

        Etanercept is a soluble TNF receptor (humanized protein) indicated for the treatment of immune-mediated inflammatory diseases such as rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), and psoriasis (PsO). Limited information exists on the factors associated with long-term retention and use of etanercept in Canada in a real-world setting.

Objectives

        To evaluate the 6-year retention rates of etanercept patients in Canada, and to identify factors associated with discontinuation.

Methods

        A retrospective cohort study was conducted using longitudinal prescription drug claims data from QuintilesIMS Private Drug Plan database (PDP), Ontario Public Drug Plan database (OPDP), and Quebec Public Drug Plan database (RAMQ). Between 07/2008 and 06/2010, bio-naïve patients who initiated etanercept were identified and followed for 72 months. 12-month retention rates were evaluated in 1-year increments for all patients retained on therapy at years 1, 2, 3, 4 and 5 and compared to retention rates in the first year. The covariates associated with time to discontinuation over the entire 72 month period were identified using a Cox proportional hazards regression model.

Results

        The study identified 4,528 etanercept patients (61% female, 85% rheumatic diseases, and 15% PsO) across Canada who started their therapy during the selection period. Overall, 12-month retention rates on etanercept increased significantly for patients following their first year on therapy (p<.0001), with 66% of patients retained at year 1 vs. 12- month retention rates of 79%, 82%, 84%, 83% and 79% at year 2, 3, 4, 5 and 6, respectively. A total of 17.1% (n=771) of patients were retained for the entire 72 month study. Regression analysis showed PsO patients were less likely to be retained on therapy than other indications (HR 1.199; p<.0001), older patients (65+) were more likely to be retained than younger patients (HR 0.802; p<.0001), and public plan patients (ODB HR 0.735, RAMQ HR 0.55; p<.0001) were more likely to be retained than private plan patients.

Conclusions

        Etanercept patient retention likelihood increased the more years a patient was retained on therapy. This pattern was consistent across therapeutic areas, sex, age, and payers. Age, indication, and payer were found to have a significant impact in determining etanercept patients' time to therapy discontinuation. With better understanding of factors associated with retention, patient support programs can be designed to address the specific needs of at-risk groups while supporting patients stable on therapy.