Scott, I, Hider, SL and Scott, DL (2018) Thromboembolism with JAK Inhibitors for Rheumatoid Arthritis: How Real is the Risk? Drug Safety. ISSN 1179-1942

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20180515_Current Opinion for Drug Safety Thromboembolism With JAK Inhibitors 7th Feburary 2018 final version.pdf - Accepted Version
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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.

Item Type: Article
Additional Information: This is the accepted author manuscript (AAM). The final published version (version of record) is available online via Springer at http://doi.org/10.1007/s40264-018-0651-5 - please refer to any applicable terms of use of the publisher.
Subjects: R Medicine > RC Internal medicine > RC666 Diseases of the circulatory (Cardiovascular) system
Depositing User: Symplectic
Date Deposited: 15 May 2018 11:01
Last Modified: 15 May 2018 11:08
URI: http://eprints.keele.ac.uk/id/eprint/4904

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