A epidemiological study of long-term safety of biological disease-modifying antirheumatic drugs for patients with rheumatoid arthritis and risk factors for adverse drug reactions.

我们实施了本项目，以阐明生物疾病缓解抗风湿药物（生物制剂）在日本RA患者中的中长期安全性，并评价这些药物的获益-风险平衡。在真实的研究中，我们确定使用肿瘤坏死因子（TNF）抑制剂是日本RA患者严重感染的一个重要风险因素。SECURE研究显示，在接受TNF抑制剂治疗的日本RA患者中，所有恶性肿瘤、非造血系统恶性肿瘤和造血系统恶性肿瘤的风险均未增加。我们还进行了药物经济学研究，以计算真实的研究中观察到的严重不良事件的医疗费用。这些数据为日本RA患者使用生物制剂的中长期安全性提供了坚实而有用的证据。

We implemented this project to clarify mid- to long-term safety of biological disease modifying antirheumatic drugs (biologics) in Japanese RA patients and to evaluate benefit-risk balance of these drugs. In the REAL study, we identified the use of tumor necrosis factor (TNF) inhibitors as a significant risk factor for serious infection in Japanese RA patients. SECURE study revealed that risks for all malignancies, non-hematopoietic malignancies, and hematopoietic malignancies were not increased in Japanese RA patients given TNF inhibitors. We also performed pharmacoeconomical study to calculate the medical cost for serious adverse events which were observed in the REAL study. These data provided solid and useful evidences for mid- to long-term safety of biologics in Japanese RA patients.