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抗 TNF 疗法在银屑病关节炎中的疗效和安全性:来自英国风湿病学会生物制剂登记处的观察性研究。

Efficacy and safety of anti-TNF therapies in psoriatic arthritis: an observational study from the British Society for Rheumatology Biologics Register.

机构信息

School of Pharmacy and Pharmaceutical Sciences, University of Manchester, Manchester, UK.

出版信息

Rheumatology (Oxford). 2010 Apr;49(4):697-705. doi: 10.1093/rheumatology/kep423. Epub 2010 Jan 7.

Abstract

OBJECTIVES

To evaluate the risk-benefit profile of anti-TNF therapies in PsA and to study the predictors of treatment response and disease remission [disease activity score (DAS)-28 < 2.6].

METHODS

The study included PsA patients (n = 596) registered with the British Society for Rheumatology Biologics Register (BSRBR). Response was assessed using the European League against Rheumatism (EULAR) improvement criteria. Univariate and multivariate logistic regression models were developed to examine factors associated with EULAR response and disease remission using a range of covariates. Poisson regression was used to calculate incidence rate ratios (IRRs) for serious adverse events (SAEs) vs seronegative RA controls receiving DMARDs, adjusting for age, sex and baseline co-morbidity.

RESULTS

At baseline, the mean (s.d.) DAS-28 was 6.4 (5.6). Of the patients, 70.3% were EULAR responders at 12 months. At 6 months, older patients [adjusted odds ratio (OR) 0.97 per year; 95% CI 0.95, 0.99], females (adjusted OR 0.51; 95% CI 0.34, 0.78) and patients on corticosteroids (adjusted OR 0.45; 95% CI 0.28, 0.72) were less likely to achieve a EULAR response. Over 1776.2 person-years of follow-up (median 3.07 per person), the IRR of SAEs compared with controls was not increased (1.0; 0.8, 1.3) [corrected].

CONCLUSIONS

Anti-TNF therapies have a good response rate in PsA, and have an adverse event profile similar to that seen in a control cohort of patients with seronegative arthritis receiving DMARD therapy.

摘要

目的

评估抗 TNF 治疗在银屑病关节炎中的风险效益比,并研究治疗反应和疾病缓解(DAS-28<2.6)的预测因素。

方法

本研究纳入了英国风湿病学会生物制剂登记处(BSRBR)登记的银屑病关节炎患者(n=596)。使用欧洲抗风湿病联盟(EULAR)改善标准评估反应。使用单变量和多变量逻辑回归模型,使用一系列协变量研究与 EULAR 反应和疾病缓解相关的因素。使用泊松回归计算接受 DMARD 治疗的血清阴性类风湿关节炎对照患者中严重不良事件(SAE)与 SAE 的发生率比值(IRR),并调整年龄、性别和基线合并症。

结果

基线时,DAS-28 的平均值(标准差)为 6.4(5.6)。在 12 个月时,70.3%的患者为 EULAR 应答者。6 个月时,年龄较大的患者(校正优势比[OR] 每年 0.97;95%CI 0.95,0.99)、女性(校正 OR 0.51;95%CI 0.34,0.78)和使用皮质类固醇的患者(校正 OR 0.45;95%CI 0.28,0.72)更不可能达到 EULAR 反应。在超过 1776.2 人年的随访(中位数为每人 3.07 年)中,与对照组相比,SAE 的 IRR 没有增加(1.0;0.8,1.3)[校正]。

结论

抗 TNF 治疗在银屑病关节炎中有很好的反应率,且其不良事件谱与接受 DMARD 治疗的血清阴性关节炎患者的对照队列相似。

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