| アブストラクト | BACKGROUND: Rheumatoid arthritis (RA) is commonly treated with Janus kinase inhibitors (JAKis) and anti-tumor necrosis factor-alpha (anti-TNFalpha), 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-TNFalpha used in RA. METHODS: A case/non-case study was conducted using the WHO VigiBase((R)) 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-TNFalpha 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-TNFalpha. 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 <65 years treated with JAKis (1.29 [1.21-1.39]). CONCLUSIONS: Compared with anti-TNFalpha, JAKis were more associated with MACE, especially stroke, and with a shorter time to onset. These data support the hypothesis of a different cardiovascular reporting frequency between JAKis and anti-TNFalpha. In patients with identified cardiovascular risk, anti-TNFalpha should be preferred to JAKis until more definitive results are available. |
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| 投稿者 | Di Napoli, Raffaella; Richez, Christophe; Scavone, Cristina; Singier, Allison; Demorgues, Maxime; Mascolo, Annamaria; Capuano, Annalisa; Salvo, Francesco |
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| 組織名 | Campania Regional Centre for Pharmacovigilance and Pharmacoepidemiology,;Department of Experimental Medicine, Section of Pharmacology "L. Donatelli",;University of Campania "Luigi Vanvitelli", Via Costantinopoli 16, 80138, Naples,;Italy. raffaella.dinapoli@unicampania.it.;Department of Experimental Medicine-Section of Pharmacology "L. Donatelli",;University of Campania "Luigi Vanvitelli", Naples, Italy.;raffaella.dinapoli@unicampania.it.;Universite de Bordeaux, INSERM, Bordeaux Population Health, U1219, AHeaD Team,;33000, Bordeaux, France. raffaella.dinapoli@unicampania.it.;Service de Rhumatologie, Centre de reference des maladies auto-immunes;systemiques rares RESO, Hopital Pellegrin, Centre Hospitalier Universitaire,;Bordeaux, France.;CNRS-UMR 5164, ImmunoConcept, Universite de Bordeaux, Bordeaux, France.;Italy.;Department of Life Science, Health, and Health Professions, Link Campus;University, Rome, Italy.;33000, Bordeaux, France.;CHU de Bordeaux, Service de Pharmacologie Medicale, Centre Regional de;Pharmacovigilance Bordeaux-DROM, 33000, Bordeaux, France. |
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