Investigation into the Impact of Aging on Serious Adverse Events Associated with Antirheumatic Agents Using the Japanese
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ORIGINAL RESEARCH ARTICLE
Investigation into the Impact of Aging on Serious Adverse Events Associated with Antirheumatic Agents Using the Japanese Adverse Drug Event Report Database Yomei Matsuoka1
•
Masayuki Kaneko1 • Mamoru Narukawa1
Ó Springer International Publishing AG, part of Springer Nature 2018
Abstract Background With the aging of the population, it is expected that the number of elderly people with inflammatory rheumatic diseases will continue to increase. Objective The purpose of this study was to provide useful information for risk minimization of antirheumatic agents using the Japanese Adverse Drug Event Report database through investigation of the influence of aging on adverse events (AEs) in patients treated with tumor necrosis factora inhibitors (TNF-Is) or methotrexate (MTX). Methods Infections and malignant tumors were selected as typical serious AEs for antirheumatic agents, which are indicated in the treatment guidelines for rheumatoid arthritis. The relationship between age and AEs in patients treated with TNF-Is or MTX was evaluated by using an adjusted reporting odds ratio, using the 50–59 years age group as the reference group. Results The relative reporting ratio of infections associated with patients treated with TNF-Is was higher in the group of patients [ 70 years of age, and lower in the group of patients \ 50 years of age, compared with the reference group. The relative reporting ratio of malignant lymphoma associated with patients treated with MTX was higher in the group of patients 70–79 years of age compared with the reference group. Conclusion For infections associated with patients treated with TNF-Is, physicians should take a patient’s age into
& Yomei Matsuoka [email protected] 1
Department of Clinical Medicine (Pharmaceutical Medicine), Graduate School of Pharmaceutical Sciences, Kitasato University, 5-9-1, Shirokane, Minato-ku, Tokyo 108-8641, Japan
consideration when making their observations, with more careful observation in elderly patients.
Key Points The incidence of infections increased with age in patients treated with antirheumatic agents. The Japanese Adverse Drug Event Report (JADER) database is considered to reflect actual clinical practice in the postmarketing stage. The information from JADER is expected to contribute to the risk minimization of drugs, and to be useful for physicians when prescribing a drug long-term.
1 Introduction Rheumatoid arthritis (RA) is a chronic inflammatory disease of the joints that causes joint destruction and disability. In recent years, the treatment of RA has shifted to a proactive approach using a combination of a biological product, such as tumor necrosis factor-a inhibitors (TNFIs), and conventional synthetic disease-modifying antirheumatic drugs, and it is now possible to control disease activity and improve function. As of October 2016, the total population of Japan was 126.7 million, including 34.5 million people over the age of 65 years. In the total population, the proportion of elderly was 27.
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