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生物制剂和靶向合成改善病情抗风湿药物在美国银屑病关节炎患者中的实际应用:持续性、与停药相关的患者特征及给药模式。

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.

作者信息

Merola Joseph F, Welby Sarah, Roque Helena, Song Jie, Pilipczuk Olga, Lu Chao, Walsh Jessica A

机构信息

Department of Dermatology, University of Texas Southwestern Medical Center, Dallas.

UCB Pharma, Brussels, Belgium.

出版信息

J Manag Care Spec Pharm. 2025 Aug;31(8):808-821. doi: 10.18553/jmcp.2025.31.8.808.

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.

摘要

背景

银屑病关节炎(PsA)是一种慢性、免疫介导的炎症性关节病,有多种表现形式,包括外周关节炎、附着点炎和皮肤银屑病(PSO)。免疫抑制/免疫调节疗法,包括生物制剂/靶向合成改善病情抗风湿药(b/tsDMARD),是PsA常见的有效治疗方法;然而,有报告称存在停药情况,且相关因素仍不清楚。

目的

描述初治和曾使用过b/tsDMARD的PsA患者在开始使用新的b/tsDMARD后12个月内持续使用b/tsDMARD治疗的概率以及停药(包括换药)时间。次要目标包括:(1)描述与b/tsDMARD持续使用或未持续使用相关的因素;(2)评估开始使用抗IL-17A药物司库奇尤单抗(SEC)或依奇珠单抗(IXE)的PsA患者的维持剂量变化。由于在本研究开展时,SEC和IXE的剂量推荐指南存在差异,因此将二者作为特别关注点。

方法

这项观察性队列研究使用了默克多市场扫描数据,纳入了2017年1月1日至2021年6月30日期间开始新处方b/tsDMARD治疗PsA且被诊断为PsA的患者。主要结局是持续使用情况,定义为从索引日期到连续索引治疗12个月期间b/tsDMARD治疗的天数,或首次出现b/tsDMARD停药/换药情况。使用Cox回归探索患者特征与结局之间的关联,通过描述性剂量分析探究特定起始/维持b/tsDMARD剂量患者的比例。

结果

共纳入7037例成年PsA患者:基线时仅患PsA的患者占26.7%,患PsA+PSO的患者占73.3%。b/tsDMARD治疗持续12个月的概率为51.2%(95%可信区间[CI],49.5%-52.9%),平均持续时间为8.3个月。PsA+PSO患者12个月时的治疗持续概率为52.7%(50.8%-57.7%),仅患PsA的患者为47.0%(43.7%-50.3%)。初治b/tsDMARD亚组12个月时的治疗持续概率为51.4%(49.6%-53.2%),曾使用过b/tsDMARD的组为49.8%(45.5%-54.1%)。女性以及基线时合并疲劳诊断与未持续治疗的概率增加相关,而合并PSO诊断与未持续治疗的概率降低相关。在剂量分析中,分析中开始使用SEC治疗的患者,60.4%被处方起始维持剂量为每4周300mg,34.1%被处方起始维持剂量为每4周150mg。分析中开始使用IXE治疗的患者,84.4%被处方起始维持剂量为每4周80mg,10.4%被处方起始维持剂量为每4周160mg。

结论

本研究结果为调整b/tsDMARD治疗以最大化临床获益提供了相关见解,并可能识别出未满足需求最大的患者。

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