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.

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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.