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Thromboembolic Events in JAK inhibitors: A Pharmacovigilance Study From 2012 to 2021 Based on FAERS.

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INTRODUCTION As a new type of drug developed rapidly in recent years, Janus kinase inhibitors (JAKinibs) have caused controversy due to possible adverse reactions of thromboembolism. The aim of this… Click to show full abstract

INTRODUCTION As a new type of drug developed rapidly in recent years, Janus kinase inhibitors (JAKinibs) have caused controversy due to possible adverse reactions of thromboembolism. The aim of this study was to analyze and evaluate the association between thromboembolic events (TEs) and the use of JAKinibs, on the base of the latest data in the FDA's Adverse Event Reporting System (FAERS). METHODS A disproportionality analysis was conducted, utilizing data from 1 January 2012 to 30 September 2021 in the FAERS. For each drug-adverse event pair, reporting odds ratio (ROR) and information components (IC) were calculated. RESULTS A total of 15 positive safety signals were detected within the FAERS: ruxolitinib was significantly associated with PVT (ROR025 =3.49, IC025 =1.50), tofacitinib IR with pulmonary embolism (ROR025 =2.09, IC025 =1.02) and thrombosis (ROR025 =1.15, IC025 =0.18), tofacitinib XR with pulmonary embolism (ROR025 =1.27, IC025 =0.26) and thrombosis (ROR025 =1.29, IC025 =0.33), baricitinib with DVT (ROR025 =8.27, IC025 =3.00), PVT (ROR025 =1.97, IC025 =0.63), pulmonary embolism (ROR025 =7.90, IC025 =2.94), thrombosis (ROR025 =2.04, IC025 =0.93) and venous thrombosis (ROR025 =2.15, IC025 =0.81), upadacitinib with pulmonary embolism (ROR025 =1.25, IC025 =0.25), pulmonary thrombosis (ROR025 =5.32, IC025 =2.33) and thrombosis (ROR025 =2.72, IC025 =1.39), and filgotinib with pulmonary embolism (ROR025 =4.83, IC025 =2.10). In the analysis of the time to onset of TEs, no obviously recognizable pattern was found. Several safety signals with embolic and thrombotic events (SMQ) were found in the study. CONCLUSIONS This pharmacovigilance study covered 8 types of JAKinibs that are already on the market, and provided new safety signals based on past safety information. Some of these signals still need more medical evidence to confirm. FUNDING National Nature Science Foundation of China, Grant/Award Number: 82073671; Military Key Discipline Construction Project (Health Service-Naval Health Service Organization and Command), Grant/Award Number: 03; Three year Action Program of Shanghai Municipality for Strengthening the Construction of Public Health System, Grant/Award Number: GWV10.1-XK05; Leading Talents of Public Health in Shanghai, Grant/Award Number: GWV-10.2-XD22.

Keywords: thrombosis ror025; ror025; study; ror025 ic025

Journal Title: British journal of clinical pharmacology
Year Published: 2022

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