Leflunomide-induced interstitial lung disease: prevalence and risk factors in Japanese patients with rheumatoid arthritis
Leflunomide-induced interstitial lung disease: prevalence and risk factors in Japanese patients with rheumatoid arthritis
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DOI：
10.1093/rheumatology/kep052
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发表时间：
2009-09-01
期刊：
影响因子：
5.5
通讯作者：
Sagawa, Akira
中科院分区：
文献类型：
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作者：
Sawada, Tetsuji;Inokuma, Shigeko;Sagawa, Akira
目标. LEF和间质性肺病（ILD）之间的可能联系引起了越来越多的关注。本研究的目的是根据上市后监测数据阐明新发和/或加重ILD的患病率和风险因素，其中所有接受LEF的RA患者在日本进行了24周的预先登记和监测。我们分析了自2003年9月在日本上市以来接受LEF治疗的5054例RA患者的队列数据。多因素Logistic回归分析确定新发和/或加重ILD的危险因素。在接受LEF治疗的5054例RA患者中，61例（1.2%）报告发生ILD和/或加重，由主治医生判断为LEF的药物不良反应。多变量logistic回归分析确定了既存ILD [比值比（OR）8.17; 95% CI 4.63，14.4]、吸烟（3.12; 95% CI 1.73，5.60），低体重（50 kg）（2.91; 95%CI 1.15，7.37）和使用负荷剂量（3.97; 95%CI 1.22，12.9）作为LEF诱导ILD的独立危险因素。预先存在的ILD是LEF诱导的ILD的最重要的危险因素。我们建议，LEF不应处方类风湿关节炎患者并发间质性肺病。
Objectives. The possible link between LEF and interstitial lung disease (ILD) has evoked increasing concern. The aim of the present study was to elucidate the prevalence and risk factors for newly developed and/or exacerbated ILD, based on post-marketing surveillance data, in which all RA patients receiving LEF were pre-registered and monitored for 24 weeks in Japan.Methods. We analysed data from a cohort of 5054 RA patients who were prescribed LEF since its launch in September 2003 in Japan. Multivariable logistic analysis was performed to identify the risk factors for newly developed and/or exacerbation of ILD.Results. Sixty-one (1.2%) of 5054 RA patients who received LEF were reported to have development and/or exacerbation of ILD as an adverse drug reaction to LEF, judged by the attending physicians. Multivariable logistic regression analysis identified pre-existing ILD [odds ratio (OR) 8.17; 95% CI 4.63, 14.4], cigarette smoking (3.12; 95% CI 1.73, 5.60), a low body weight (50 kg) (2.91; 95% CI 1.15, 7.37) and the use of a loading dose (3.97; 95% CI 1.22, 12.9) as independent risk factors for LEF-induced ILD.Conclusions. Pre-existing ILD was the most important risk factor for LEF-induced ILD. We suggest that LEF should not be prescribed for RA patients complicated with ILD.