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Risk of cancer, cardiovascular disease, thromboembolism, and mortality in patients with rheumatoid arthritis receiving Janus kinase inhibitors: a real-world retrospective observational study using Korean health insurance data
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Hong Ki Min, Hyeongsu Kim, Ho Jin Jeong, Se Hee Kim, Hae-Rim Kim, Sang-Heon Lee, KunSei Lee, Soon-Ae Shin, Jong Heon Park
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Epidemiol Health. 2023;45:e2023045. Published online April 15, 2023
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DOI: https://doi.org/10.4178/epih.e2023045
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Abstract
OBJECTIVES
This study investigated whether Janus kinase inhibitors (JAKis) raise the risk of cardiovascular disease (CVD), venous thromboembolism (VTE), and cancer in patients with rheumatoid arthritis (RA).
METHODS We conducted a real-world retrospective observational study using data obtained from the Korean National Health Insurance Service database. Two data sets were analyzed: tumor necrosis factor inhibitor (TNFi)/JAKi-naive RA patients (set 1) and all RA patients who used TNFis or JAKis (set 2). The incidence rate ratios (IRRs) and hazard ratios (HRs) for acute myocardial infarction (AMI), stroke, cardiovascular (CV)-related mortality, major adverse cardiovascular events (MACE), VTE, arterial thromboembolism (ATE), cancer, and all-cause mortality were compared between the JAKi and TNFi groups.
RESULTS Set 1 included 1,596 RA patients (JAKi group: 645; TNFi group: 951), and set 2 included 11,765 RA patients (JAKi group: 2,498; TNFi group: 9,267). No adverse events (AEs) showed significantly higher IRRs in the JAKi groups than in the TNFi groups of sets 1 and 2. The HRs for MACE in the JAKi groups of sets 1 and 2 were 0.59 (95% confidence [CI], 0.35 to 0.99) and 0.80 (95% CI, 0.67 to 0.97), respectively. The JAKi group of set 2 showed a significantly higher risk of all-cause mortality (HR, 1.71; 95% CI, 1.32 to 2.20), but the other AEs did not demonstrate increased risks in the JAKi groups.
CONCLUSIONS In this study, JAKis did not increase the risk of AMI, stroke, CV-related mortality, MACE, VTE, ATE, or cancer in Korean RA patients relative to TNFis.
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Summary
Korean summary
1. 한국인 류마티스관절염 환자를 대상으로 한 실제임상자료 결과, JAK 억제제가 종양괴사인자 억제제에 비해 심혈관질환, 혈전증, 암 등의 심각한 부작용을 증가시키지는 않았다.
2. 본 연구를 토대로 한국인 대상자에서 JAK 억제제가 심혈관질환 등의 심각한 부작용을 증가시키는지에 대한 재평가가 필요하다.
Key Message
1. The real word-data based results showed that risks of MACE, thromboembolism, and cancers were not increased in Korean RA patients with JAK inhibitor when compared to Korean RA patients with TNF inhibitors.
2. Therefore, the risk of serious adverse events of JAK inhibitors in Korean population should be reconsidered and reassessed before adding black box warning of JAK inhibitors.
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Citations
Citations to this article as recorded by  - Multicenter evaluation of tofacitinib retention and safety in rheumatoid arthritis – why cardiovascular risk factors do not equate to overt risk
Anna Felis-Giemza, Mateusz Moskal, Krzysztof Proc, Zbigniew Guzera, Marcin Stajszczyk, Karolina Palej, Kornelia Chmurzyńska, Piotr Wiland, Krzysztof Batko, Bogdan Batko
Rheumatology.2024; 61(6): 414. CrossRef - Safety and Effectiveness of Baricitinib in Chinese Patients with Moderate-to-Severe Rheumatoid Arthritis: 24-Week Results from a Post-Marketing Safety Study
Chan-yuan Wu, Qian Wang, Jian Shi, Xiu-ying Zhang, Rong Du, Jie-ruo Gu, Qi-huan Liu, Jiao Yu, Jia-wei Xu, Yan-jie Zhang, Hao Zhu, Meng-tao Li, Xiao-feng Zeng
Rheumatology and Therapy.2023; 10(6): 1609. CrossRef - Comparative cardiovascular safety with janus kinase inhibitors and biological disease-modifying antirheumatic drugs as used in clinical practice: an observational cohort study from Sweden in patients with rheumatoid arthritis
Hannah Bower, Thomas Frisell, Daniela di Giuseppe, Benedicte Delcoigne, Johan Askling
RMD Open.2023; 9(4): e003630. CrossRef - Are JAKis more effective among elderly patients with RA, smokers and those with higher cardiovascular risk? A comparative effectiveness study of b/tsDMARDs in Sweden
Hannah Bower, Thomas Frisell, Daniela di Giuseppe, Benedicte Delcoigne, Ulf Lindström, Carl Turesson, Katerina Chatzidionysiou, Elisabet Lindqvist, Ann Knight, Helena Forsblad-d'Elia, Johan Askling
RMD Open.2023; 9(4): e003648. CrossRef
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