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性别对生物制剂治疗结果的影响——一项基于丹麦医疗注册系统的 1750 例银屑病关节炎患者的研究

Gender differences in biologic treatment outcomes-a study of 1750 patients with psoriatic arthritis using Danish Health Care Registers.

机构信息

Rigshospitalet Gentofte, Center for Rheumatology and Spine Diseases, Aalborg University Hospital, Denmark.

Frederiksberg and Bispebjerg Hospitals, The Parker Institute, Aalborg University Hospital, Denmark.

出版信息

Rheumatology (Oxford). 2018 Sep 1;57(9):1651-1660. doi: 10.1093/rheumatology/key140.

DOI:10.1093/rheumatology/key140
PMID:29893926
Abstract

OBJECTIVE

We aimed to investigate gender differences in disease manifestations, patient-reported outcomes, comorbidities and treatment effectiveness among patients with PsA treated with their first TNFα inhibitor (TNFI).

METHODS

In this observational cohort study, the DANBIO register provided prospectively collected data on PsA patients who initiated their first TNFI in 2000-15. Comorbidity information was achieved from the Danish Nationwide Patient Register. Response to treatment was assessed according to EULAR and ACR criteria at 3 and 6 months. Cox and logistic regression models analysed the impact of gender on TNFI persistence and response, respectively, while adjusting for a priori selected confounders including clinical-, laboratory- and patient-reported factors, comorbidities and lifestyle characteristics.

RESULTS

A total of 1750 PsA patients (935 women) were included. At baseline, women were older (49 years/47 years), more often smokers (32%/26%), had worse patient-reported scores (e.g. global score 71 mm/65 mm) and higher frequencies of hospital-diagnosed anxiety or depression (7%/4%) and chronic pulmonary disease (7%/3%) than men (all P < 0.01). Median TNFI persistence was 3.8 years (95% CI: 3.0, 5.7) in men vs 1.4 (1.1, 1.8) in women (P < 0.001). Men had higher odds of achieving response after 3 and 6 months, for example, adjusted odds ratio = 3.2 (1.6, 6.1) for EULAR good/moderate response (vs women) at 6 months.

CONCLUSION

Male gender was strongly associated with greater TNFI treatment effectiveness. Adjustment for baseline risk factors including patient-reported outcomes, disease activity, comorbidities and lifestyle factors did not influence this relationship, which suggests a role of biological factors.

摘要

目的

本研究旨在探究接受首次肿瘤坏死因子-α抑制剂(TNFI)治疗的银屑病关节炎(PsA)患者中,疾病表现、患者报告结局、合并症及治疗效果的性别差异。

方法

在这项观察性队列研究中,DANBIO 登记处提供了 2000 年至 2015 年期间首次接受 TNFI 治疗的 PsA 患者的前瞻性数据。合并症信息来自丹麦全国患者登记处。根据 EULAR 和 ACR 标准,在 3 个月和 6 个月时评估治疗反应。Cox 和逻辑回归模型分别分析了性别对 TNFI 持续时间和反应的影响,同时调整了预先选择的混杂因素,包括临床、实验室和患者报告的因素、合并症和生活方式特征。

结果

共纳入 1750 例 PsA 患者(935 例女性)。基线时,女性年龄更大(49 岁/47 岁),吸烟比例更高(32%/26%),患者报告的评分更差(如整体评分 71mm/65mm),焦虑或抑郁(7%/4%)和慢性肺部疾病(7%/3%)的住院诊断频率更高(均 P < 0.01)。男性 TNFI 持续时间中位数为 3.8 年(95%CI:3.0,5.7),女性为 1.4 年(95%CI:1.1,1.8)(P < 0.001)。男性在 3 个月和 6 个月时达到缓解的可能性更高,例如,调整后的比值比=3.2(1.6,6.1),6 个月时 EULAR 良好/中度缓解(与女性相比)。

结论

男性性别与更大的 TNFI 治疗效果密切相关。调整包括患者报告的结局、疾病活动度、合并症和生活方式因素在内的基线风险因素并未影响这种关系,这表明存在生物学因素的作用。

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