| アブストラクト | This study aimed to detect signals of adverse drug reactions (ADRs) associated with biological disease-modifying antirheumatic drugs (DMARDs) and targeted therapies in rheumatoid arthritis (RA) and ankylosing spondylitis (AS) patients. Utilizing the KOrean College of Rheumatology BIOlogics & Targeted Therapy Registry (KOBIO) data, we calculated relative risks, excluded previously reported drug-ADR pairs, and externally validated remaining pairs using US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) and single centre's electronic health records (EHR) data. Analyzing data from 2279 RA and 1940 AS patients, we identified 35 significant drug-ADR pairs in RA and 26 in AS, previously unreported in drug labels. Among the novel drug-ADR pairs from KOBIO, 15 were also significant in the FAERS data. Additionally, 2 significant drug-laboratory abnormality pairs were found in RA using CDM MetaLAB analysis. Our findings contribute to the identification of 14 novel drug-ADR signals, expanding our understanding of potential adverse effects related to biological DMARDs and targeted therapies in RA and AS. These results emphasize the importance of ongoing pharmacovigilance for patient safety and optimal therapeutic interventions. |
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| 投稿者 | Kwon, M; Joung, C I; Shin, H; Lee, C C; Song, Y S; Lee, Y J; Kang, S; Kim, J Y; Lee, S |
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| 組織名 | Department of Internal Medicine, School of Medicine, Konyang University, Daejeon,;South Korea.;Konyang University Myunggok Medical Research Institute, Daejeon, South Korea.;Department of Biomedical Informatics, School of Medicine, Konyang University,;Daejeon, South Korea.;Healthcare Data Science Centre, Konyang University Hospital, Daejeon, South;Korea.;Department of Pathology, School of Medicine, Konyang University, Daejeon, South;Department of Rehabilitation Medicine, School of Medicine, Konyang University,;Department of Otorhinolaryngology-Head and Neck Surgery, School of Medicine,;Konyang University, Daejeon, South Korea.;Department of Computer Engineering, Gachon University, (13120) 1342;Seongnamdaero, Sujeong-gu, Seongnam-si, Gyeonggi-do, South Korea.;leesh@gachon.ac.kr. |
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