Samantha Hider s.hider@keele.ac.uk
Thromboembolism with Janus Kinase (JAK) Inhibitors for Rheumatoid Arthritis: How Real is the Risk?
Hider, Samantha
Authors
Abstract
Two different Janus kinase (JAK) inhibitors-baricitinib and tofacitinib-are effective and licensed in active rheumatoid arthritis (RA). There have been recent concerns about potential thromboembolic risks with these drugs. Concerns about baricitinib focus on clinical trial findings. Using all publically available data, we estimate thromboembolic risks are approximately five events per 1000 patient years with 4 mg baricitinib daily. Concerns about tofacitinib have been raised by analyses of the Federal Drug Administration Adverse Event Reporting System (FAERs). These show some evidence of increased risks of pulmonary thrombosis, though not pulmonary embolism or venous thrombosis. Observational studies suggest in the general population and non-RA controls there are one to four thromboembolic events per 1000 patient years. In RA, thromboembolic risks increase to three to seven per 1000 patient years. The impact of biologics and disease-modifying anti-rheumatic drugs (DMARDs) on disease risk appears minimal, and the number of thromboembolic events is between four and eight per 1000 patient years. In the short term, full details of thromboembolic events in trials of JAK inhibitors need to be published. As the numbers of thromboembolic events will be small and patients enrolled in trials are not representative of all RA patients who may receive JAK inhibitors, this information is unlikely to provide definitive answers. Consequently, in the longer term, large observational studies are needed to accurately quantify thromboembolic risks attributable to JAK inhibitors and other drugs used to treat RA, and differentiate these from risks attributable to RA itself and its comorbidities.
Citation
Hider, S. (2018). Thromboembolism with Janus Kinase (JAK) Inhibitors for Rheumatoid Arthritis: How Real is the Risk?. Drug Safety, https://doi.org/10.1007/s40264-018-0651-5
Journal Article Type | Article |
---|---|
Acceptance Date | Feb 16, 2018 |
Publication Date | Jul 1, 2018 |
Publicly Available Date | May 26, 2023 |
Journal | Drug safety |
Print ISSN | 0114-5916 |
Publisher | Springer Verlag |
DOI | https://doi.org/10.1007/s40264-018-0651-5 |
Public URL | https://keele-repository.worktribe.com/output/410986 |
Publisher URL | http://doi.org/10.1007/s40264-018-0651-5 |
PMID | 29500799 |
Files
20180515_Current Opinion for Drug Safety Thromboembolism With JAK Inhibitors 7th Feburary 2018 final version.pdf
(137 Kb)
PDF
Publisher Licence URL
https://creativecommons.org/licenses/by-nc/4.0/
You might also like
Downloadable Citations
About Keele Repository
Administrator e-mail: research.openaccess@keele.ac.uk
This application uses the following open-source libraries:
SheetJS Community Edition
Apache License Version 2.0 (http://www.apache.org/licenses/)
PDF.js
Apache License Version 2.0 (http://www.apache.org/licenses/)
Font Awesome
SIL OFL 1.1 (http://scripts.sil.org/OFL)
MIT License (http://opensource.org/licenses/mit-license.html)
CC BY 3.0 ( http://creativecommons.org/licenses/by/3.0/)
Powered by Worktribe © 2024
Advanced Search