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A real-world disproportionality analysis of FDA Adverse Event Reporting System (FAERS) events for baricitinib.

Title: A real-world disproportionality analysis of FDA Adverse Event Reporting System (FAERS) events for baricitinib.
Authors: Peng, L
Xiao, K
Ottaviani, S
Stebbing, J
Wang, Y-J
Item Type: Journal Article
Abstract: BACKGROUND: Baricitinib is approved for the treatment of rheumatoid arthritis (RA). The authors retrospectively investigated adverse events (AEs) by data-mining a self-reporting database to better understand toxicities, especially since it has been used during the coronavirus disease 2019 (COVID-19) pandemic. METHODS: A reporting odds ratio (ROR) was used to detect the risk signals from the data in the US Food and Drug Administration (FDA) adverse event reporting system database (FAERS). The definition relied on system organ class (SOCs) and preferred terms (PTs) by the Medical Dictionary for Regulatory Activities (MedDRA). RESULTS: The search retrieved 1,598 baricitinib-associated cases within the reporting period: 86 PTs with significant disproportionality were retained. Infections including 'herpes zoster,' 'oral herpes,' and 'herpes virus infection' were found at a similar rate to those reported in trials, and such events were rare. Reports emerged for several thrombotic adverse events, while these events were also rare. Unexpected safety signals as opportunistic infections were detected. Serious outcomes as death and life-threatening outcomes accounted for 9.76% of the reported cases. CONCLUSIONS: The incidence of these AEs does not appear above the background expected. These data are consistent with routine clinical observations and suggest the importance of pharmacovigilance.
Issue Date: 31-Jul-2020
Date of Acceptance: 20-Jul-2020
URI: http://hdl.handle.net/10044/1/81908
DOI: 10.1080/14740338.2020.1799975
ISSN: 1474-0338
Publisher: Taylor and Francis
Start Page: 1505
End Page: 1511
Journal / Book Title: Expert Opinion on Drug Safety
Volume: 19
Issue: 11
Copyright Statement: © 2020 Informa UK Limited, trading as Taylor & Francis Group. This is an Accepted Manuscript of an article published by Taylor & Francis in Expert Opinion on Drug Safety on 21 July 2020, available online: https://doi.org/10.1080/14740338.2020.1799975
Sponsor/Funder: National Institute for Health Research
Imperial College Healthcare NHS Trust- BRC Funding
Funder's Grant Number: NIHR-RP-011-053
RDB01 79560
Keywords: Science & Technology
Life Sciences & Biomedicine
Pharmacology & Pharmacy
Science & Technology
Life Sciences & Biomedicine
Pharmacology & Pharmacy
Baricitinib
JAK inhibitor
pharmacovigilance
FAERS
adverse event
Baricitinib
FAERS
JAK inhibitor
adverse event
pharmacovigilance
Baricitinib
FAERS
JAK inhibitor
adverse event
pharmacovigilance
1007 Nanotechnology
1115 Pharmacology and Pharmaceutical Sciences
Pharmacology & Pharmacy
Publication Status: Published
Conference Place: England
Online Publication Date: 2020-07-21
Appears in Collections:Department of Surgery and Cancer
Faculty of Medicine