Real-world use of biologic and targeted synthetic disease-modifying antirheumatic drugs in US patients with psoriatic arthritis: Persistence, patient characteristics associated with discontinuation, and dosing patterns.

IF 2.9 4区 医学 Q2 HEALTH CARE SCIENCES & SERVICES
Joseph F Merola, Sarah Welby, Helena Roque, Jie Song, Olga Pilipczuk, Chao Lu, Jessica A Walsh
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引用次数: 0

Abstract

Background: Psoriatic arthritis (PsA) is a chronic, immune-mediated inflammatory arthropathy presenting with multiple manifestations, including peripheral arthritis, enthesitis, and skin psoriasis (PSO). Immunosuppressive/immunomodulatory therapies, including biologic/targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARD), are common effective treatments for PsA; however, discontinuation is reported and contributing factors remain unclear.

Objective: To describe the probability of persistence and time to discontinuation (including switch) of b/tsDMARD therapy in both b/tsDMARD-naive and -experienced patients with PsA within 12 months following initiation of a new b/tsDMARD. Secondary objectives included (1) describing the factors associated with b/tsDMARD persistence or nonpersistence and (2) assessing maintenance dose changes among patients with PsA initiating the anti-IL17A agents secukinumab (SEC) or ixekizumab (IXE). SEC and IXE were of particular focus owing to the variability in their dosage recommendation guidelines at the time of this study.

Methods: This observational cohort study used Merative MarketScan data and included patients initiating a new prescription of b/tsDMARD treatment for PsA, with a diagnosis of PsA between January 1, 2017, and June 30, 2021. The primary outcome was persistence, defined as days of b/tsDMARD therapy use from index date to 12 months of continuous index treatment, or first occurrence of b/tsDMARD discontinuation/switch. Associations between patient characteristics and outcomes were explored using Cox regressions, with descriptive dose analyses exploring proportions of patients with specific starting/maintenance b/tsDMARD doses.

Results: 7,037 adult patients with PsA were included: 26.7% with PsA only and 73.3% with PsA+PSO at baseline. The 12-month probability for persistence of b/tsDMARD treatment was 51.2% (95% CI, 49.5%-52.9%), with an 8.3-month mean length of persistence. Treatment persistence probability at 12 months was 52.7% (50.8%-57.7%) for patients with PsA+PSO and 47.0% (43.7%-50.3%) for patients with PsA only. Treatment persistence probability at 12 months was 51.4% (49.6%-53.2%) for the b/tsDMARD-naive subgroup and 49.8% (45.5%-54.1%) for the b/tsDMARD-experienced group. Female sex and a baseline codiagnosis of fatigue were associated with an increased probability of nonpersistence, whereas codiagnosis of PSO was associated with decreased probability of nonpersistence. In the dosing analysis, of the patients initiating SEC therapy included in the analysis, 60.4% were prescribed a starting maintenance dose of 300 mg every 4 weeks (Q4W) and 34.1% were prescribed a starting maintenance dose of 150 mg Q4W. Of patients initiating IXE therapy included in the analysis, 84.4% were prescribed an 80-mg Q4W starting maintenance dose and 10.4% were prescribed a 160-mg Q4W starting maintenance dose.

Conclusions: The findings of this study provide relevant insights into tailoring b/tsDMARD therapy to maximize clinical benefit and potentially identify patients with the greatest unmet need.

美国银屑病关节炎患者实际使用生物和靶向合成疾病改善抗风湿药物:持久性、与停药相关的患者特征和给药模式
背景:银屑病关节炎(Psoriatic arthritis, PsA)是一种慢性、免疫介导的炎症性关节病,表现为多种表现,包括外周关节炎、全身炎和皮肤银屑病(skin psoriasis, PSO)。免疫抑制/免疫调节疗法,包括生物/靶向合成疾病缓解抗风湿药物(b/tsDMARD),是PsA的常见有效治疗方法;然而,有停止使用的报道,造成这种情况的原因尚不清楚。目的:描述b/tsDMARD初始和有经验的PsA患者在开始新的b/tsDMARD治疗后12个月内b/tsDMARD治疗持续的概率和停药时间(包括切换)。次要目标包括(1)描述与b/tsDMARD持续性或非持续性相关的因素;(2)评估PsA患者启动抗il17a药物secukinumab (SEC)或ixekizumab (ixxe)的维持剂量变化。由于在本研究期间其剂量推荐指南的可变性,SEC和IXE受到特别关注。方法:这项观察性队列研究使用了Merative MarketScan的数据,纳入了2017年1月1日至2021年6月30日期间诊断为PsA的患者,这些患者开始使用b/tsDMARD治疗PsA的新处方。主要结局是持续性,定义为b/tsDMARD治疗使用的天数,从指标日期到连续指标治疗的12个月,或首次出现b/tsDMARD停药/切换。使用Cox回归分析了患者特征与结局之间的关系,描述性剂量分析探讨了特定起始/维持b/tsDMARD剂量的患者比例。结果:7037例成年PsA患者纳入:基线时仅PsA为26.7%,PsA+PSO为73.3%。b/tsDMARD治疗持续12个月的概率为51.2% (95% CI, 49.5%-52.9%),平均持续时间为8.3个月。PsA+PSO患者12个月的治疗持续概率为52.7%(50.8%-57.7%),单纯PsA患者为47.0%(43.7%-50.3%)。b/ tsdmard初发亚组12个月的治疗持续概率为51.4% (49.6%-53.2%),b/ tsdmard经验亚组为49.8%(45.5%-54.1%)。女性和基线共同诊断的疲劳与不持续性的可能性增加有关,而共同诊断的PSO与不持续性的可能性降低有关。在剂量分析中,纳入分析的开始进行SEC治疗的患者中,60.4%的患者给予每4周300 mg (Q4W)的起始维持剂量,34.1%的患者给予150 mg Q4W的起始维持剂量。在纳入分析的开始IXE治疗的患者中,84.4%的患者处方80 mg Q4W起始维持剂量,10.4%的患者处方160 mg Q4W起始维持剂量。结论:本研究的发现为定制b/tsDMARD治疗提供了相关的见解,以最大限度地提高临床效益,并有可能识别最大未满足需求的患者。
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来源期刊
Journal of managed care & specialty pharmacy
Journal of managed care & specialty pharmacy Health Professions-Pharmacy
CiteScore
3.50
自引率
4.80%
发文量
131
期刊介绍: JMCP welcomes research studies conducted outside of the United States that are relevant to our readership. Our audience is primarily concerned with designing policies of formulary coverage, health benefit design, and pharmaceutical programs that are based on evidence from large populations of people. Studies of pharmacist interventions conducted outside the United States that have already been extensively studied within the United States and studies of small sample sizes in non-managed care environments outside of the United States (e.g., hospitals or community pharmacies) are generally of low interest to our readership. However, studies of health outcomes and costs assessed in large populations that provide evidence for formulary coverage, health benefit design, and pharmaceutical programs are of high interest to JMCP’s readership.
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