Thromboembolic Safety Reporting of Tofacitinib and Baricitinib: An Analysis of the WHO VigiBase.

Drug Safety : an International Journal of Medical Toxicology and Drug Experience
Enriqueta Vallejo-YagüeAndrea M Burden

Abstract

The Janus kinase (JAK) inhibitors tofacitinib and baricitinib are new treatments for rheumatic diseases. Recent concerns regarding the risk of thrombosis have led to warnings by competent authorities. We therefore aimed to examine the thromboembolic safety signal for tofacitinib and baricitinib. Individual case safety reports (ICSRs) for tofacitinib and baricitinib were retrieved from the World Health Organization global database VigiBase in April 2019. Primary outcomes were deep vein thrombosis (DVT) and pulmonary thrombosis (PT) or pulmonary embolism (PE). Patient demographics were summarized and then stratified by outcome. Disproportionality analyses were conducted by estimating the reporting odds ratios (RORs) and 95% confidence intervals (CIs) worldwide, and stratified by either Europe or the US. In both the tofacitinib (n = 40,017) and baricitinib (n = 2138) ICSRs, patients with reported DVT or PT/PE were older and had higher reporting of prothrombotic medications or antithrombotic treatments, suggesting a pre-existing thromboembolic risk/event. In Europe, tofacitinib was associated with increased reporting for DVT (ROR 2.37, 95% CI 1.23-4.56) and PT/PE (ROR 2.38. 95% CI 1.45-3.89). For baricitinib, a threefold increased ...Continue Reading

References

Apr 10, 2009·Pharmacoepidemiology and Drug Safety·A Bate, S J W Evans
Jan 15, 2014·Journal of Medicinal Chemistry·James D ClarkJean-Baptiste Telliez
Dec 3, 2017·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Abril VerdenKeith B Hoffman
Mar 26, 2019·The Annals of Pharmacotherapy·Amanda MogulLaura McAuliffe

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Citations

Aug 26, 2020·Expert Opinion on Drug Safety·Emanuel RaschiFabrizio De Ponti
Jul 18, 2020·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Fowzia Ibrahim, David L Scott
Aug 17, 2020·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Sarah C J JorgensenLinda D Dresser
Mar 7, 2021·International Journal of Molecular Sciences·Przemysław J KotylaMd Asiful Islam

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