What question did this study set out to answer?

This research compares the risk of cardiovascular events in patients treated with JAK inhibitors versus TNF inhibitors.

February 2, 2026Open Access

Cardiovascular Adverse Events of JAK vs. TNF Inhibitors using the Korean Pharmacovigilance Database

JYJinkyoung YoonChungnam National University SKSeonghae KimChungnam National University BYBo Ram YangChungnam National University

Key Points

This research compares the risk of cardiovascular events in patients treated with JAK inhibitors versus TNF inhibitors.
Analyzed adverse event reports from the Korea Adverse Event Reporting System (KAERS) database from 2015-2020.
Included patients receiving either JAK inhibitors (tofacitinib or baricitinib) or TNF inhibitors (adalimumab, etanercept, or golimumab).
Categorized cardiovascular events into major cardiovascular events (MACEs), thrombosis, and other events.
Calculated reporting odds ratios (RORs) with 95% confidence intervals using 2x2 contingency tables.
Identified 625 adverse event reports for JAK inhibitors and 4,777 for TNF inhibitors.
Found a significant association between JAK inhibitors and cardiovascular events (ROR: 4.90, 95% CI: 2.80–8.59), especially for thrombosis (ROR: 12.70, 95% CI: 5.10–31.66).
Notable trends observed in women (ROR: 7.52, 95% CI: 3.06-18.47) and patients over 50 years old (ROR: 5.01, 95% CI: 2.02-12.43).

Abstract

Introduction Janus kinase inhibitors (JAK-Is), as novel medications, are utilized in treating immune-mediated inflammatory diseases such as rheumatoid arthritis. However, concerns about their cardiovascular safety associated with the use of JAK inhibitors have been increasing in recent years. This study aimed to compare the risk of cardiovascular events (CVEs) in patients taking JAK-Is and tumor necrosis factor alpha inhibitors (TNF-Is) using the Korea Adverse Event Reporting System (KAERS) database. Methods Adverse event (AE) reports between January 1, 2015 and December 31, 2020 of JAK-Is (tofacitinib or baricitinib) or TNF-Is (adalimumab, etanercept, or golimumab) were included. CVEs were categorized into major cardiovascular events (MACEs), thrombosis, and other CVEs. The reporting odds ratios (RORs) for outcomes with 95% confidence interval (CIs) were calculated using 2x2 contingency tables. Results A total of 625 AE reports were identified for JAK-I and 4,777 for TNF-Is, resulting in 876 and 7,999 drug-AE pairs, respectively. Disproportionality analysis showed reporting signals suggesting possible associations between JAK-Is and CVEs compared with TNF-Is (ROR: 4.90, 95% CI: 2.80–8.59), with particularly pronounced for thrombosis (ROR: 12.70, 95% CI: 5.10–31.66). These trends were particularly notable in women (CVEs: ROR: 7.52, 95% CI: 3.06-18.47) and in patients over 50 years old (CVEs: ROR: 5.01, 95% CI: 2.02-12.43). Conclusion This disproportionality analysis using a national pharmacovigilance database identified reporting signals for total CVEs with JAK-Is compared to TNF-Is; in particular, a significant signal for thrombosis was observed.

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