Major adverse cardiovascular events related to JAK inhibitors: A disproportionality analysis using the WHO Global Individual Case Safety Database
Drug Safety. 2025. Epub ahead of print. doi: 10.1007/s40264-025-01535-
Di Napoli et al. conducted a global pharmacovigilance analysis comparing MACE between JAKis and anti-TNFα therapies in patients with RA. JAKis were more frequently associated with reported MACE, particularly stroke, and had a shorter median time to onset than
anti-TNFα therapy.
This disproportionality analysis included over 18,000 MACE reports sourced from VigiBase®, identifying increased reporting odds for JAKis vs anti-TNFα for non-fatal stroke, myocardial infarction, and fatal cardiovascular events. This study evaluated whether differences in frequency and timing of MACE reporting existed between JAKis and anti-TNFα in RA, with implications for therapeutic decision-making in patients with cardiovascular risk.
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