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10 年来类风湿关节炎中肿瘤坏死因子拮抗剂停药模式的变化:来自西班牙登记处 BIOBADASER 2.0 的数据。

Change in the discontinuation pattern of tumour necrosis factor antagonists in rheumatoid arthritis over 10 years: data from the Spanish registry BIOBADASER 2.0.

机构信息

Rheumatology Department, Hospital Clínico Universitario, Santiago de Compostela, Spain.

出版信息

Ann Rheum Dis. 2012 Mar;71(3):382-5. doi: 10.1136/annrheumdis-2011-200302. Epub 2011 Oct 13.

Abstract

OBJECTIVE

To investigate in rheumatoid arthritis (RA) the rate and reason of discontinuation of tumour necrosis factor (TNF) antagonists over the past decade.

METHODS

RA patients in BIOBADASER 2.0 were stratified according to the start date of their first TNF antagonist into 2000-3, 2004-6 and 2007-9 interval years. Cumulative incidence function of discontinuation for inefficacy or toxicity was estimated with the alternative reason as competing risk. Competing risks regression models were used to measure the association of study groups with covariates and reasons for discontinuation. Association is expressed as subhazard ratios (SHR).

RESULTS

2907 RA patients were included in the study. Competing risk regression for inefficacy shows larger SHR for patients starting treatment in 2004-6 (SHR 2.57; 95% CI 1.55 to 4.25) and 2007-9 (SHR 3.4; 95% CI 2.08 to 5.55) than for those starting in 2000-3, after adjusting for TNF antagonists, clinical activity and concomitant treatment. Competing risk regression analysis for adverse events revealed no differences across the three time intervals.

CONCLUSIONS

In RA, the discontinuation rate of TNF antagonists in the first year of treatment is higher more recently than a decade ago, inefficacy being the main reason for the increased rate. The rate of discontinuation for adverse events has remained stable.

摘要

目的

在类风湿关节炎(RA)中,调查过去十年肿瘤坏死因子(TNF)拮抗剂停药的比率和原因。

方法

根据首次 TNF 拮抗剂开始日期,将 BIOBADASER 2.0 中的 RA 患者分为 2000-3、2004-6 和 2007-9 年间隔。使用替代原因作为竞争风险,估计因无效或毒性而停药的累积发生率函数。使用竞争风险回归模型来衡量研究组与协变量和停药原因的相关性。关联表示为亚危险比(SHR)。

结果

本研究纳入了 2907 例 RA 患者。无效的竞争风险回归显示,2004-6 年(SHR 2.57;95%CI 1.55 至 4.25)和 2007-9 年(SHR 3.4;95%CI 2.08 至 5.55)开始治疗的患者的 SHR 大于 2000-3 年开始治疗的患者,调整 TNF 拮抗剂、临床活动和伴随治疗后。对不良事件的竞争风险回归分析显示,三个时间间隔之间没有差异。

结论

在 RA 中,治疗第一年 TNF 拮抗剂的停药率比十年前更高,无效是导致这一比率增加的主要原因。不良事件的停药率保持稳定。

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