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德国接受皮下生物制剂治疗的类风湿病(类风湿关节炎、强直性脊柱炎、银屑病关节炎)患者的治疗持续性。

Treatment persistence among patients with rheumatoid disease (RA, AS, PsA) treated with subcutaneous biologics in Germany.

作者信息

Lyu Ramon, Govoni Marinella, Ding Qian, Black Christopher M, Kachroo Sumesh, Fan Tao, Ogbonnaya Augstina, Donga Prina, Hill Jerrold, Makin Charles

机构信息

Merck Co., Inc, Whitehouse Station, NJ, USA.

MSD Italy, Rome, Italy.

出版信息

Rheumatol Int. 2016 Jan;36(1):143-53. doi: 10.1007/s00296-015-3348-4. Epub 2015 Aug 28.

Abstract

Patients with rheumatoid arthritis (RA), ankylosing spondylitis (AS), and psoriatic arthritis (PsA) are frequently treated with subcutaneous biologic therapies when disease progresses or when response to synthetic disease-modifying antirheumatic drugs (DMARDs) is inadequate. This study analyzed treatment persistence and treatment patterns for RA, AS, and PsA patients in Germany initiating subcutaneous biologic therapies with and without prior DMARDs use. A retrospective cohort study was conducted using the Electronic Medical Record database of IMS Disease Analyzer, Germany. Patients who were ≥18 years old; had at least one ICD-10 diagnosis code of RA, AS, or PsA during the study period; and had exposure to a subcutaneous biologic agent between January 1, 2009 and June 30, 2012 were selected. Patients were required to have continuous observation ≥12 months prior to and after index medication date. Persistence was defined as consecutive days from treatment initiation until treatment discontinuation (≥60-day lapse in medication coverage). Patients were stratified by pre-index use of DMARDs. Kaplan-Meier analysis was conducted to assess time to discontinuation, and logistic regression was conducted to identify characteristics associated with persistence. A total of 576 RA, 108 AS, and 197 PsA patients without biologic experience during the pre-index period were selected. The percentages of RA, AS, and PsA patients persistent ≥12 months were 51.9, 48.1, and 57.9 %, respectively. Median persistent time over 12 months was 365.0 days for RA (mean 245.9 days), 281.0 for AS (mean 228.5), and 365.0 for PsA (mean 264.1). In the RA cohort, a significantly higher proportion of those with pre-index DMARD use were persistent compared to those without pre-index DMARD (56.1 vs. 33.3 %, p = 0.0001). No significant differences were observed for the AS and PsA cohorts. Multivariate analyses confirmed that DMARD-experienced patients were 2.45 times more likely to be persistent with subcutaneous biologic therapy in the RA cohort. Switching between subcutaneous biologics occurred in <10 % of patients in all three cohorts. In the subpopulations with at least two prescriptions for the index subcutaneous biologic and who remained persistent on the index subcutaneous biologic, dose escalation of ≥50 % occurred in 50, 60, and 49 % in the RA, AS, and PsA cohorts, respectively. Among RA, AS, and PsA patients newly initiating subcutaneous biologic agents in Germany, persistence at 12 months is relatively low (48-58 %). For the RA cohort, patients with pre-index DMARD use are more persistent than patients without. The majority of patients do not switch between subcutaneous biologics. A notable proportion of patients who remained persistent on their index subcutaneous biologic had a dose escalation. There are opportunities to improve outcomes of patient with rheumatoid disease through improved medication persistence.

摘要

类风湿关节炎(RA)、强直性脊柱炎(AS)和银屑病关节炎(PsA)患者在疾病进展或对合成抗风湿药物(DMARDs)反应不足时,常接受皮下生物制剂治疗。本研究分析了德国开始皮下生物制剂治疗的RA、AS和PsA患者在使用和未使用过DMARDs情况下的治疗持续性和治疗模式。利用德国IMS疾病分析器的电子病历数据库进行了一项回顾性队列研究。入选患者年龄≥18岁;在研究期间至少有一个RA、AS或PsA的ICD - 10诊断代码;并且在2009年1月1日至2012年6月30日期间接触过皮下生物制剂。要求患者在索引用药日期前后连续观察≥12个月。持续性定义为从治疗开始到治疗中断的连续天数(药物覆盖中断≥60天)。患者按索引前DMARDs的使用情况分层。进行Kaplan - Meier分析以评估停药时间,并进行逻辑回归以确定与持续性相关的特征。共选择了576例索引前无生物制剂使用经验的RA患者、108例AS患者和197例PsA患者。RA、AS和PsA患者持续≥12个月的百分比分别为51.9%、48.1%和57.9%。超过12个月的RA患者中位持续时间为365.0天(平均245.9天),AS患者为281.0天(平均228.5天),PsA患者为365.0天(平均264.1天)。在RA队列中,索引前使用DMARDs的患者持续治疗的比例显著高于未使用索引前DMARDs的患者(56.1%对33.3%,p = 0.0001)。AS和PsA队列未观察到显著差异。多变量分析证实,在RA队列中,有DMARDs使用经验的患者皮下生物制剂治疗持续的可能性是无经验患者的2.45倍。所有三个队列中<10%的患者在皮下生物制剂之间进行了转换。在至少有两次索引皮下生物制剂处方且在索引皮下生物制剂上持续治疗的亚组中,RA、AS和PsA队列中剂量增加≥50%的患者分别为50%、60%和49%。在德国新开始皮下生物制剂治疗的RA、AS和PsA患者中,12个月时的持续性相对较低(48 - 58%)。对于RA队列,索引前使用DMARDs的患者比未使用者更具持续性。大多数患者未在皮下生物制剂之间转换。在索引皮下生物制剂上持续治疗的患者中有相当比例的患者剂量增加。通过改善药物持续性,有机会改善类风湿疾病患者的治疗结果。

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