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

Expert Opinion on Drug Safety
Ling PengYing-Jie Wang

Abstract

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. 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). 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. The incidence of these AEs does not appear above the background expe...Continue Reading

References

Jan 6, 2001·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·M LindquistR H Meyboom
Aug 19, 2004·Pharmacoepidemiology and Drug Safety·Kenneth J RothmanSusan T Sacks
May 13, 2006·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Lorna Hazell, Saad A W Shakir
Jul 27, 2012·Arthritis Care & Research·Jessica WiddifieldClaire Bombardier
Jun 26, 2013·International Journal of Medical Sciences·Toshiyuki SakaedaYasushi Okuno
Feb 16, 2017·The New England Journal of Medicine·Peter C TaylorYoshiya Tanaka
Mar 16, 2017·Drugs·Anthony Markham
Nov 7, 2017·Nature Reviews. Drug Discovery·Daniella M SchwartzJohn J O'Shea
Dec 3, 2017·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Abril VerdenKeith B Hoffman
Mar 4, 2018·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Ian C ScottDavid L Scott
Feb 1, 2019·BioDrugs : Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy·Anniina T VirtanenOlli Silvennoinen
Jul 11, 2019·Mini Reviews in Medicinal Chemistry·Jun DaiGlynn Addison
Sep 15, 2019·Autoimmunity Reviews·Yvan JamillouxPascal Sève
Feb 8, 2020·Lancet·Peter RichardsonJustin Stebbing
Feb 25, 2020·Gastroenterology·William J SandbornPeter D R Higgins
Mar 3, 2020·The Lancet Infectious Diseases·Justin StebbingPeter Richardson
Mar 3, 2020·Clinical Chemistry and Laboratory Medicine : CCLM·Giuseppe Lippi, Mario Plebani
Mar 17, 2020·Expert Opinion on Drug Safety·Suguru Honda, Masayoshi Harigai
Apr 1, 2020·Signal Transduction and Targeted Therapy·Li TanHongming Miao
Apr 17, 2020·Signal Transduction and Targeted Therapy·Li TanHongming Miao
May 31, 2020·EMBO Molecular Medicine·Justin StebbingUNKNOWN Sacco Baricitinib Study Group
Jun 14, 2020·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Enriqueta Vallejo-YagüeAndrea M Burden

❮ Previous
Next ❯

Citations

Aug 26, 2020·Expert Opinion on Drug Safety·Emanuel RaschiFabrizio De Ponti
Aug 18, 2020·Expert Opinion on Drug Safety·Ling PengYing-Jie Wang
Jun 9, 2021·Annals of the Rheumatic Diseases·Oleg MelikhovJustin Stebbing

❮ Previous
Next ❯

Related Concepts

Trending Feeds

COVID-19

Coronaviruses encompass a large family of viruses that cause the common cold as well as more serious diseases, such as the ongoing outbreak of coronavirus disease 2019 (COVID-19; formally known as 2019-nCoV). Coronaviruses can spread from animals to humans; symptoms include fever, cough, shortness of breath, and breathing difficulties; in more severe cases, infection can lead to death. This feed covers recent research on COVID-19.

Blastomycosis

Blastomycosis fungal infections spread through inhaling Blastomyces dermatitidis spores. Discover the latest research on blastomycosis fungal infections here.

Nuclear Pore Complex in ALS/FTD

Alterations in nucleocytoplasmic transport, controlled by the nuclear pore complex, may be involved in the pathomechanism underlying multiple neurodegenerative diseases including Amyotrophic Lateral Sclerosis and Frontotemporal Dementia. Here is the latest research on the nuclear pore complex in ALS and FTD.

Applications of Molecular Barcoding

The concept of molecular barcoding is that each original DNA or RNA molecule is attached to a unique sequence barcode. Sequence reads having different barcodes represent different original molecules, while sequence reads having the same barcode are results of PCR duplication from one original molecule. Discover the latest research on molecular barcoding here.

Chronic Fatigue Syndrome

Chronic fatigue syndrome is a disease characterized by unexplained disabling fatigue; the pathology of which is incompletely understood. Discover the latest research on chronic fatigue syndrome here.

Evolution of Pluripotency

Pluripotency refers to the ability of a cell to develop into three primary germ cell layers of the embryo. This feed focuses on the mechanisms that underlie the evolution of pluripotency. Here is the latest research.

Position Effect Variegation

Position Effect Variagation occurs when a gene is inactivated due to its positioning near heterochromatic regions within a chromosome. Discover the latest research on Position Effect Variagation here.

STING Receptor Agonists

Stimulator of IFN genes (STING) are a group of transmembrane proteins that are involved in the induction of type I interferon that is important in the innate immune response. The stimulation of STING has been an active area of research in the treatment of cancer and infectious diseases. Here is the latest research on STING receptor agonists.

Microbicide

Microbicides are products that can be applied to vaginal or rectal mucosal surfaces with the goal of preventing, or at least significantly reducing, the transmission of sexually transmitted infections. Here is the latest research on microbicides.