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口服和注射用甲氨蝶呤的不依从率和停药率:一项对8952例银屑病关节炎患者的回顾性队列研究。

Non-adherence and discontinuation rate for oral and parenteral methotrexate: A retrospective-cohort study in 8,952 patients with psoriatic arthritis.

作者信息

Generali Elena, Carrara Greta, Bortoluzzi Alessandra, De Santis Maria, Ceribelli Angela, Scirè Carlo A, Selmi Carlo

机构信息

Division of Rheumatology and Clinical Immunology, Humanitas Research Hospital - IRCCS, Rozzano, Milan, Italy.

Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy.

出版信息

J Transl Autoimmun. 2021 Aug 16;4:100113. doi: 10.1016/j.jtauto.2021.100113. eCollection 2021.

Abstract

BACKGROUND AND AIMS

Treatment options for PsA, following non-steroidal anti-inflammatory drugs (NSAIDs), include conventional synthetic disease modifying anti-rheumatic drugs (csDMARDS), particularly methotrexate (MTX). The present study was performed to determine the non-adherence and discontinuation rates of different methotrexate (MTX) formulations in psoriatic arthritis (PsA).

APPROACH AND RESULTS

We performed a retrospective-cohort study on patients with PsA identified by disease-specific code in the administrative-health-databases of a Northern Italian region (Lombardy) between 2004 and 2015. Subjects were defined as non-adherent if less than 80% of the prescribed MTX dose was taken based on the time between each prescription. Discontinuation rates were calculated using the time between the first and the last MTX prescription over an observation period of 120 months. Among 8952 patients with PsA, 33% were treated with MTX (mean dosage 10 mg/week ± 2.5 mg standard deviation), more frequently (59%) in its parenteral formulation at a 10 mg weekly dosage (35%). Oral glucocorticoids were prescribed to 21% of patients, while non-steroidal anti-inflammatory drugs to 45%. Approximately 37% of patients with PsA were defined as non-adherent to MTX, with the oral formulation associated with an increased risk of non-adherence (hazard ratio 2.08, 95% confidence interval 1.84-2.35, p < 0.001) compared with parenteral 10-15 mg weekly doses. Oral MTX was discontinued in 52% of cases without a significantly increased risk of discontinuation compared to parenteral formulations which, at higher dosages, had a more favorable retention rate.

CONCLUSION

Oral MTX formulation is associated with a 2-fold risk of non-adherence compared to MTX parenteral route in PsA.

摘要

背景与目的

银屑病关节炎(PsA)在使用非甾体抗炎药(NSAIDs)之后的治疗选择包括传统合成改善病情抗风湿药(csDMARDs),尤其是甲氨蝶呤(MTX)。本研究旨在确定不同甲氨蝶呤(MTX)制剂在银屑病关节炎(PsA)中的不依从率和停药率。

方法与结果

我们对2004年至2015年间在意大利北部地区(伦巴第)行政健康数据库中通过疾病特定编码识别出的PsA患者进行了一项回顾性队列研究。如果根据每次处方之间的时间计算,服用的MTX剂量少于规定剂量的80%,则受试者被定义为不依从。停药率是根据120个月观察期内第一次和最后一次MTX处方之间的时间计算的。在8952例PsA患者中,33%接受MTX治疗(平均剂量10mg/周±2.5mg标准差),更常见的是(59%)采用每周10mg剂量的肠胃外制剂(35%)。21%的患者使用了口服糖皮质激素,而45%的患者使用了非甾体抗炎药。大约37%的PsA患者被定义为对MTX不依从,与每周10 - 15mg的肠胃外剂量相比,口服制剂的不依从风险增加(风险比2.08,95%置信区间1.84 - 2.35,p < 0.001)。52%的口服MTX病例停药,与肠胃外制剂相比,停药风险没有显著增加,肠胃外制剂在较高剂量时保留率更有利。

结论

在PsA中,与MTX肠胃外给药途径相比,口服MTX制剂的不依从风险增加两倍。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f27b/8716656/683bb26de052/gr1.jpg

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