1 University of Utah School of Medicine and Salt Lake City Veterans Affairs Medical Center, Salt Lake City, Utah.
2 Optum, Eden Prairie, Minnesota.
J Manag Care Spec Pharm. 2018 Jul;24(7):623-631. doi: 10.18553/jmcp.2018.24.7.623.
In patients with psoriatic arthritis (PsA), limited data exist regarding patterns of biologic therapy use.
To examine treatment patterns and therapy modifications in U.S. patients with PsA receiving a tumor necrosis factor inhibitor (TNFi) or an anti-interleukin (IL)-12/23 inhibitor.
Adults with PsA who newly initiated a biologic therapy (index biologic) between January 1, 2013, and January 31, 2015, were included from the Optum Research Database. Biologic therapies comprised those that were approved by the FDA for the treatment of PsA at the time of the study initiation (adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, or ustekinumab). Outcomes included adherence, persistence, and discontinuation of the index biologic; initiation of adjunctive medications (nonbiologics, including those commonly used for pain and/or inflammation); and dose escalation of the index biologic during the 12-month follow-up period.
Of the 1,235 patients included, 52.5% were female, and mean (SD) age was 50.3 (12.1) years. The mean (SD) duration of persistence with a newly initiated index biologic (etanercept [48.1%], adalimumab [24.0%], infliximab [10.4%], golimumab [8.3%], ustekinumab [7.2%], or certolizumab pegol [2.0%]) was 246 (128) days; 44.5% of patients persisted with the index biologic for ≥ 12 months. During the 12-month follow-up period, 22.9% of patients switched to a different biologic, 26.8% discontinued without switching or restarting, and 5.8% discontinued and restarted the index biologic. Of the 1,010 patients who persisted with the index biologic for > 90 days, 45.6% received ≥ 1 adjunctive medication during the period from 90 days after the index date to the end of persistence or 12 months. The most commonly initiated adjunctive medications were corticosteroids (22.0%), opioids (17.1%), and nonsteroidal anti-inflammatory drugs (12.9%). Overall, 9.6% of patients had a dose escalation of the index biologic in the immediate 12-month post-index period.
This real-world study of treatment patterns for PsA, which used a large U.S. claims database, demonstrated that the majority of patients with PsA discontinued their index biologic (TNFi or anti-IL-12/23 inhibitor) before 12 months. Nearly half of patients initiated an adjunctive medication, many of which were pain and conventional anti-inflammatory medications.
This study was sponsored by Novartis Pharmaceuticals. Optum was commissioned by Novartis to conduct this study, but employment was not contingent on results of the study. Walsh is a paid consultant for Novartis. Adejoro was an employee of Optum at the time of the study and writing of the manuscript. Chastek is an employee of Optum. Palmer and Hur are employees of Novartis. Results of this study were presented as an abstract and poster at the Academy of Managed Care Pharmacy Nexus 2017; October 16-19, 2017; Dallas, TX; and the EULAR 2017 Annual European Congress of Rheumatology; June 14-17, 2017; Madrid, Spain.
在患有银屑病关节炎(PsA)的患者中,关于生物疗法使用模式的有限数据。
研究美国接受肿瘤坏死因子抑制剂(TNFi)或抗白细胞介素(IL)-12/23 抑制剂治疗的 PsA 患者的治疗模式和治疗调整。
从 Optum Research Database 中纳入 2013 年 1 月 1 日至 2015 年 1 月 31 日期间新开始生物治疗(索引生物治疗)的成人 PsA 患者。生物疗法包括在研究启动时获得 FDA 批准用于治疗 PsA 的那些(阿达木单抗、依那西普、依那西普、戈利木单抗、英夫利昔单抗或乌司奴单抗)。结局包括索引生物治疗的依从性、持久性和停药;辅助药物(非生物制剂,包括常用于疼痛和/或炎症的药物)的起始;以及在 12 个月随访期间索引生物治疗的剂量升级。
在纳入的 1235 例患者中,52.5%为女性,平均(标准差)年龄为 50.3(12.1)岁。新开始的索引生物治疗(依那西普[48.1%]、阿达木单抗[24.0%]、英夫利昔单抗[10.4%]、戈利木单抗[8.3%]、乌司奴单抗[7.2%]或依那西普[2.0%])的持久性平均(标准差)为 246(128)天;44.5%的患者索引生物治疗的持久性≥12 个月。在 12 个月的随访期间,22.9%的患者转换为另一种生物治疗,26.8%的患者停药但未转换或重新开始,5.8%的患者停药并重新开始索引生物治疗。在持久性超过 90 天的 1010 例患者中,45.6%的患者在索引日期后 90 天至持久性结束或 12 个月期间至少使用了 1 种辅助药物。最常起始的辅助药物为皮质类固醇(22.0%)、阿片类药物(17.1%)和非甾体抗炎药(12.9%)。总体而言,9.6%的患者在索引后 12 个月内索引生物治疗的剂量升级。
这项针对银屑病关节炎治疗模式的真实世界研究使用了美国大型索赔数据库,表明大多数银屑病关节炎患者在 12 个月前停止使用其索引生物治疗(TNFi 或抗 IL-12/23 抑制剂)。近一半的患者开始使用辅助药物,其中许多是疼痛和传统抗炎药物。
这项研究由诺华制药公司赞助。Optum 受诺华委托进行这项研究,但研究结果并不是雇佣的条件。Walsh 是诺华的付费顾问。Adejoro 在研究期间是 Optum 的员工,并参与了手稿的撰写。Chastek 是 Optum 的员工。Palmer 和 Hur 是诺华的员工。这项研究的结果以摘要和海报的形式在 2017 年 Academy of Managed Care Pharmacy Nexus 会议上公布;2017 年 10 月 16 日至 19 日;达拉斯,TX;以及 2017 年 6 月 14 日至 17 日举行的欧洲风湿病学会 2017 年年会。