Major Adverse Cardiovascular Events Related to JAK Inhibitors: A Disproportionality Analysis Using the WHO Global Individual Case Safety Database

Raffaella Napoli (), Christophe Richez, Cristina Scavone, Allison Singier, Maxime Demourgues, Annamaria Mascolo, Annalisa Capuano and Francesco Salvo
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Raffaella Napoli: University of Campania “Luigi Vanvitelli”
Christophe Richez: Centre Hospitalier Universitaire
Cristina Scavone: University of Campania “Luigi Vanvitelli”
Allison Singier: Université de Bordeaux, INSERM, Bordeaux Population Health, U1219, AHeaD Team
Maxime Demourgues: CHU de Bordeaux, Service de Pharmacologie Médicale, Centre Régional de Pharmacovigilance Bordeaux-DROM
Annamaria Mascolo: University of Campania “Luigi Vanvitelli”
Annalisa Capuano: University of Campania “Luigi Vanvitelli”
Francesco Salvo: Université de Bordeaux, INSERM, Bordeaux Population Health, U1219, AHeaD Team

Drug Safety, 2025, vol. 48, issue 8, No 8, 943-952

Abstract: Abstract Background Rheumatoid arthritis (RA) is commonly treated with Janus kinase inhibitors (JAKis) and anti-tumor necrosis factor-α (anti-TNFα), but the cardiovascular safety profiles of these drugs remain unclear. Objective The aim of this study was to describe the individual case safety reports of major adverse cardiac events (MACE) or stroke and to determine whether there was a difference in the frequency of reporting of cardiovascular events between JAKis and anti-TNFα used in RA. Methods A case/non-case study was conducted using the WHO VigiBase® database. Descriptive analysis was performed, the time to onset (TTO) of MACE was calculated, and the reporting odds ratio (ROR) was used to estimate the frequency of MACE reports associated with JAKis versus anti-TNFα in RA. Results A total of 18,099 cases of MACE were identified, of which 2543 (14%) were associated with JAKis, predominantly in women (65.4%) and in patients aged ≥65 years (49.9%). The median time to onset was 210 days (IQR 60–510) for JAKis and 690 days (210–1460) for anti-TNFα. JAKis were associated with higher odds of reporting MACE (ROR 1.38 [95% CI 1.32–1.44]), mainly due to non-fatal stroke (1.65 [1.55–1.75]). Stroke as a whole showed similar results (1.62 [1.53–1.72]). The ROR of MACE was also slightly increased in patients aged

Date: 2025
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DOI: 10.1007/s40264-025-01535-8

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