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生物制剂和靶向合成疾病修正抗风湿药物在银屑病关节炎患者中的真实世界药物生存情况。

Real-World Drug Survival of Biologics and Targeted Synthetic Disease-Modifying Anti-rheumatic Drugs Among Patients with Psoriatic Arthritis.

机构信息

Maccabi Institute for Research and Innovation, Maccabi Healthcare Services, Tel Aviv, Israel.

Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.

出版信息

Drugs Aging. 2024 Aug;41(8):685-697. doi: 10.1007/s40266-024-01136-7. Epub 2024 Aug 6.

DOI:10.1007/s40266-024-01136-7
PMID:39106030
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11322234/
Abstract

BACKGROUND

While the variety of biologics (b) and targeted synthetic (ts) disease-modifying anti-rheumatic drugs (DMARDs) available for patients with psoriatic arthritis (PsA) has proved to be efficacious in randomized clinical trials, there is a growing importance to understand the benefits and potential drawbacks of these different therapies in real-world settings, which includes bio-experienced and older patients as well.

OBJECTIVE

To evaluate the real-world adherence, drug survival, and discontinuation risk of bDMARDs and tsDMARDs among patients with PsA, comprising both younger and older patients.

METHODS

A retrospective study using a computerized database. Treatment-naïve and treatment-experiencedpatients with PsA, younger and older than 60 years, who initiated treatment with bDMARDs [TNF-α inhibitors (TNF-αis), IL-17 inhibitors (IL-17is), IL-12/23 inhibitors (IL-12/23i)] or tsDMARDs (the PDE-4 inhibitor apremilast) during 2015-2018 were included. Adherence was assessed using the proportion of days covered (PDC) method. Time to discontinuation was analyzed using Kaplan-Meier estimates. Risk of discontinuation was estimated by Cox proportional hazard model.

RESULTS

We identified 427 eligible patients (22.2 % were older than 60 years), utilizing 673 treatment lines. The proportion of adherent patients (PDC ≥ 0.8) was similar (62.1-66.5%) across all lines of therapy and across different biologics (70.0-72.0%), while apremilast showed the lowest, in both treatment-naïve and experienced settings (43.6% and 25.5%, respectively). The Kaplan-Meier analysis showed that in the treatment-naïve TNF-αis had higher drug survival compared with apremilast (P = 0.032). Apremilast also had the lowest drug survival in the treatment-experienced group (P < 0.0001). Kaplan-Meier analysis by age groups showed similar drug survival rates in older (≥ 60 years) and younger (age < 60 years) patients, regardless of treatment-experience status. The multivariable model showed that apremilast had increased risk for discontinuation compared with TNF-αis.

CONCLUSION

Adherence, drug survival and risk for discontinuation were similar for all included bDMARDs, regardless of treatment experience status, while apremilast showed lower rates and increased risk. Adherence and discontinuation rate were similar in older and younger patients. With the variety of drug modes of action available for patients with PsA, these findings may assist caregivers in selecting the appropriate treatment.

摘要

背景

虽然生物制剂(b)和靶向合成(ts)疾病修饰抗风湿药物(DMARDs)的种类繁多,可用于治疗银屑病关节炎(PsA)患者,但在随机临床试验中已证明其具有疗效,但越来越需要了解这些不同疗法在真实世界环境中的益处和潜在缺点,其中包括生物经验丰富和老年患者。

目的

评估生物制剂和靶向合成 DMARDs 在包括年轻和老年患者在内的 PsA 患者中的真实世界依从性、药物生存率和停药风险。

方法

这是一项使用计算机化数据库的回顾性研究。2015 年至 2018 年期间,纳入了开始接受生物制剂(TNF-α 抑制剂(TNF-αi)、IL-17 抑制剂(IL-17i)、IL-12/23 抑制剂(IL-12/23i))或靶向合成 DMARDs(磷酸二酯酶-4 抑制剂阿普米司特)治疗的治疗初治和治疗经验丰富的年轻(<60 岁)和老年(>60 岁)PsA 患者。采用比例天数覆盖(PDC)法评估依从性。使用 Kaplan-Meier 估计分析停药时间。采用 Cox 比例风险模型估计停药风险。

结果

我们确定了 427 名符合条件的患者(22.2%的患者年龄>60 岁),使用了 673 条治疗线。在所有治疗线和不同生物制剂中,依从性良好的患者(PDC≥0.8)的比例相似(62.1%-66.5%),而阿普米司特在治疗初治和治疗经验丰富的患者中均显示出最低的比例(分别为 43.6%和 25.5%)。Kaplan-Meier 分析显示,在治疗初治患者中,TNF-αi 的药物生存率高于阿普米司特(P=0.032)。阿普米司特在治疗经验丰富的患者中也具有最低的药物生存率(P<0.0001)。Kaplan-Meier 分析按年龄组显示,无论治疗经验状态如何,老年(≥60 岁)和年轻(年龄<60 岁)患者的药物生存率相似。多变量模型显示,与 TNF-αi 相比,阿普米司特的停药风险增加。

结论

无论治疗经验状态如何,所有纳入的生物制剂的依从性、药物生存率和停药风险相似,而阿普米司特的比例较低且风险增加。在老年和年轻患者中,依从性和停药率相似。对于患有 PsA 的患者,有多种药物作用模式可供选择,这些发现可能有助于护理人员选择适当的治疗方法。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a03c/11322234/8915cc348c17/40266_2024_1136_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a03c/11322234/2d4834984bdf/40266_2024_1136_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a03c/11322234/ee1541a8da3b/40266_2024_1136_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a03c/11322234/8915cc348c17/40266_2024_1136_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a03c/11322234/2d4834984bdf/40266_2024_1136_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a03c/11322234/ee1541a8da3b/40266_2024_1136_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a03c/11322234/8915cc348c17/40266_2024_1136_Fig3_HTML.jpg

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Uptake and effectiveness of newer biologic and targeted synthetic disease-modifying antirheumatic drugs in psoriatic arthritis: results from five Nordic biologics registries.新型生物制剂和靶向合成疾病修饰抗风湿药物在银屑病关节炎中的摄取和疗效:来自五个北欧生物制剂登记处的结果。
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Long-term persistence of second-line biologics in psoriatic arthritis patients with prior TNF inhibitor exposure: a nationwide cohort study from the French health insurance database (SNDS).
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RMD Open. 2022 Dec;8(2). doi: 10.1136/rmdopen-2022-002681.
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Targeted systemic therapies for psoriatic arthritis: a systematic review and comparative synthesis of short-term articular, dermatological, enthesitis and dactylitis outcomes.靶向治疗银屑病关节炎的系统评价:短期关节、皮肤、附着点炎和指(趾)炎结局的比较综合分析。
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