| アブストラクト | Vaccine-associated rheumatic diseases are rare but one of the most feared adverse drug reactions (ADRs). However, this topic has been investigated less with large-scale data in the literature. With the rapid progress in the development and approval of vaccines during the pandemic, public concerns regarding their safety have been raised. To assess the global and regional burden, long-term trends, and potential risk factors of vaccines-associated six types of rheumatic diseases (ankylosing spondylitis [AS], polymyalgia rheumatica [PMR], rheumatoid arthritis [RA], Sjogren's syndrome, Systemic lupus erythematosus [SLE], Systemic scleroderma), this study conducted disproportionality analysis based on the reports from the World Health Organization International Pharmacovigilance Database documented between 1967 and 2023 (n for total reports = 131 255 418) across 156 countries and territories. We estimated the reporting odds ratio (ROR) and information component (IC) to determine the disproportionality signal for rheumatic diseases. Of 198 046 reports of all-cause rheumatic diseases, 14 703 reports of vaccine-associated rheumatic diseases were identified. While the reporting counts have gradually increased over time globally, we observed a dramatic increase in reporting counts after 2020, potentially due to a large portion of reports of COVID-19 mRNA vaccine-associated rheumatic diseases. The disproportionality signal for rheumatic diseases was most pronounced in HBV vaccines (ROR, 4.11; IC(025), 1.90), followed by COVID-19 mRNA (ROR, 2.79; IC(025), 1.25), anthrax (ROR, 2.52; IC(025), 0.76), papillomavirus (ROR, 2.16; IC(025), 0.95), encephalitis (ROR, 2.01; IC(025), 0.58), typhoid (ROR, 1.91; IC(025), 0.44), influenza (ROR, 1.49; IC(025), 0.46), and HAV vaccines (ROR, 1.41; IC(025), 0.20). From age- and sex-specific perspective, young females and old males are likely to have vaccine-associated rheumatic disease reports. Furthermore, overall vaccines showed a disproportionality signal for PMR (IC(025), 3.13) and Sjogren's syndrome (IC(025), 0.70), systemic scleroderma (IC(025), 0.64), specifically while the COVID-19 mRNA vaccines are associated with all six types of diseases. Although multiple vaccines are associated with rheumatic disease reports, healthcare providers should be aware of the potential of autoimmune manifestations following vaccination, particularly the COVID-19 mRNA and HBV vaccines, and take into account for risk factors associated with these ADRs. Most ADRs exhibited an average time to onset of 11 days, underscoring the significance of monitoring and timely management by clinicians. |
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| 投稿者 | Oh, Jiyeon; Jo, Hyesu; Park, Jaeyu; Lee, Hayeon; Kim, Hyeon Jin; Lee, Hyeri; Kang, Jiseung; Hwang, Jiyoung; Woo, Selin; Son, Yejun; Kim, Soeun; Smith, Lee; Rahmati, Masoud; Jacob, Louis; Lee, Jinseok; Lee, Jun Hyuk; Lopez Sanchez, Guillermo F; Dragioti, Elena; Udeh, Raphael; Veronese, Nicola; Soysal, Pinar; Woo, Ho Geol; Yon, Dong Keon |
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| 組織名 | Department of Medicine, Kyung Hee University College of Medicine, Seoul, South;Korea.;Center for Digital Health, Medical Science Research Institute, Kyung Hee;University College of Medicine, Seoul, South Korea.;Department of Regulatory Science, Kyung Hee University, Seoul, South Korea.;Department of Biomedical Engineering, Kyung Hee University, Yongin, South Korea.;Division of Sleep Medicine, Harvard Medical School, Boston, Massachusetts, USA.;Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General;Hospital, Boston, Massachusetts, USA.;Department of Precision Medicine, Kyung Hee University College of Medicine,;Seoul, South Korea.;Centre for Health, Performance and Wellbeing, Anglia Ruskin University,;Cambridge, UK.;Health Service Research and Quality of Life Center (CEReSS), Assistance;Publique-Hopitaux de Marseille, Aix-Marseille Universite, Marseille, France.;Department of Physical Education and Sport Sciences, Faculty of Literature and;Human Sciences, Lorestan University, Khoramabad, Iran.;Research and Development Unit, Parc Sanitari Sant Joan de Deu, CIBERSAM, ISCIII,;Barcelona, Spain.;Department of Physical Medicine and Rehabilitation, Lariboisiere-Fernand Widal;Hospital, AP-HP, Universite Paris Cite, Paris, France.;Epidemiology of Ageing and Neurodegenerative Diseases (EpiAgeing), Inserm U1153,;Universite Paris Cite, Paris, France.;Health and Human Science, University of Southern California, Los Angeles,;California, USA.;Division of Preventive Medicine and Public Health, Department of Public Health;Sciences, School of Medicine, University of Murcia, Murcia, Spain.;Pain and Rehabilitation Centre, and Department of Medical and Health Sciences,;Linkoping University, Linkoping, Sweden.;School of Life Sciences, Faculty of Science, University of Technology Sydney,;Ultimo, Australia.;Geriatric Unit, Department of Medicine, University of Palermo, Palermo, Italy.;Department of Geriatric Medicine, Faculty of Medicine, Bezmialem Vakif;University, Istanbul, Turkey.;Department of Neurology, Kyung Hee University Medical Center, Kyung Hee;Department of Pediatrics, Kyung Hee University College of Medicine, Seoul, South |
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