(016) Cardiovascular Adverse Events associated with JAK Inhibitor versus TNF Inhibitor: A Disproportionality Analysis in National Pharmacovigilance Database of Korea
Researcher College of Pharmacy, Chungnam National University, Daejeon, Republic of Korea, Republic of Korea
Background: FDA recently updated a warning about the increased cardiovascular risk for JAK inhibitor indicated for inflammatory diseases. However, the real-world evidence for cardiovascular safety still needs to be cleared.
Objectives: This study aimed to compare the risk of cardiovascular events (CVEs) in patients taking Janus kinase inhibitors (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 logistic regression. Subgroup analyses were performed, stratifying by age category ( <50 years or ≥ 50 years) and sex.
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. The use of JAK-Is was associated with significantly more frequent reports of total CVEs (ROR: 4.90, 95% CI: 2.80-8.59) and a markedly elevated risk for thrombosis compared with TNF-Is (ROR: 12.70, 95% CI: 5.10-31.66). The ROR for MACEs of JAK-Is was higher compared to TNF-Is, but without a statistically significant difference (ROR: 2.03, 95% CI: 0.69–6.02). Similar trends were observed when comparing tofacitinib and baricitinib separately to TNF-Is, as well as in women and patients over 50 years old.
Conclusions: This disproportionality analysis using a national pharmacovigilance database identified a potential association of total CVEs with JAK-Is compared to TNF-Is; in particular, a significant signal for thrombosis was observed.
