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肿瘤坏死因子抑制剂单药治疗与联合治疗银屑病关节炎的疗效对比:欧洲生物制剂数据库的综合分析

Tumor Necrosis Factor Inhibitor Monotherapy Versus Combination Therapy for the Treatment of Psoriatic Arthritis: Combined Analysis of European Biologics Databases.

作者信息

Thomas Matthew L, Shaddick Gavin, Charlton Rachel, Cavill Charlotte, Holland Richard, Iannone Florenzo, Lapadula Giovanni, Lopriore Simona, Závada Jakub, Uher Michal, Pavelka Karel, Szczuková Lenka, Sidiropoulos Prodromos, Flouri Irini, Drosos Alexandros, Möller Burkhard, Nissen Michael J, Müller Rüdiger B, Scherer Almut, McHugh Neil, Nightingale Alison

机构信息

M.L. Thomas, PhD, Department of Mathematical Science, University of Bath, Bath, UK.

G. Shaddick, PhD, Department of Mathematics, University of Exeter, Exeter, UK.

出版信息

J Rheumatol. 2021 Jan 1;48(1):48-57. doi: 10.3899/jrheum.190815. Epub 2020 Apr 1.

Abstract

OBJECTIVE

To investigate whether tumor necrosis factor inhibitor (TNFi) combination therapy with conventional synthetic disease-modifying antirheumatic drugs (csDMARD) is more effective for psoriatic arthritis (PsA) and/or improves TNFi drug survival compared to TNFi monotherapy.

METHODS

Five PsA biologics cohorts were investigated between 2000 and 2015: the ATTRA registry (Czech Republic); the Swiss Clinical Quality Management PsA registry; the Hellenic Registry of Biologics Therapies (Greece); the University of Bari PsA biologics database (Italy); and the Bath PsA cohort (UK). Drug persistence was analyzed using Kaplan-Meier and equality of survival using log-rank tests. Comparative effectiveness was investigated using logistic regression with propensity scores. Separate analyses were performed on (1) the combined Italian/Swiss cohorts for change in rate of Disease Activity Score in 28 joints (DAS28); and (2) the combined Italian, Swiss, and Bath cohorts for change in rate of Health Assessment Questionnaire (HAQ).

RESULTS

In total, 2294 patients were eligible for the drug survival analysis. In the Swiss ( = 0.002), Greek ( = 0.021), and Bath ( = 0.014) databases, patients starting TNFi in combination with methotrexate had longer drug survival compared to monotherapy, while in Italy the monotherapy group persisted longer ( = 0.030). In eligible patients from the combined Italian/Swiss dataset (n = 1056), there was no significant difference between treatment arms in rate of change of DAS28. Similarly, when also including the Bath cohort (n = 1205), there was no significant difference in rate of change of HAQ.

CONCLUSION

Combination therapy of a TNFi with a csDMARD does not appear to affect improvement of disease activity or HAQ versus TNFi monotherapy, but it may improve TNFi drug survival.

摘要

目的

探讨肿瘤坏死因子抑制剂(TNFi)与传统合成改善病情抗风湿药(csDMARD)联合治疗与TNFi单药治疗相比,对银屑病关节炎(PsA)是否更有效和/或能否提高TNFi药物生存率。

方法

2000年至2015年期间对五个PsA生物制剂队列进行了研究:ATTRA注册中心(捷克共和国);瑞士临床质量管理PsA注册中心;希腊生物制剂治疗注册中心(希腊);巴里大学PsA生物制剂数据库(意大利);以及巴斯PsA队列(英国)。使用Kaplan-Meier分析药物持久性,并使用对数秩检验分析生存平等性。使用倾向评分的逻辑回归研究比较有效性。对以下方面进行了单独分析:(1)意大利/瑞士联合队列中28个关节疾病活动评分(DAS28)的变化率;(2)意大利、瑞士和巴斯联合队列中健康评估问卷(HAQ)的变化率。

结果

共有2294例患者符合药物生存分析条件。在瑞士(P = 0.002)、希腊(P = 0.021)和巴斯(P = 0.014)数据库中,开始使用TNFi联合甲氨蝶呤治疗的患者与单药治疗相比药物生存期更长,而在意大利单药治疗组持续时间更长(P = 0.030)。在意大利/瑞士联合数据集的符合条件患者中(n = 1056),各治疗组之间DAS28变化率无显著差异。同样,当纳入巴斯队列(n = 1205)时,HAQ变化率也无显著差异。

结论

与TNFi单药治疗相比,TNFi与csDMARD联合治疗似乎不影响疾病活动度或HAQ的改善,但可能提高TNFi药物生存率。

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