Lipid profile and effect of statin treatment in pooled phase II and phase III baricitinib studies

Taylor, P. C. et al. (2018) Lipid profile and effect of statin treatment in pooled phase II and phase III baricitinib studies. Annals of the Rheumatic Diseases, 77(7), pp. 988-995. (doi:10.1136/annrheumdis-2017-212461) (PMID:29463520) (PMCID:PMC6029633)

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Abstract

Objectives: Lipid profiles are altered by active disease in patients with rheumatoid arthritis (RA) and may be further modified by treatment with Janus kinase inhibitors and other disease-modifying antirheumatic drugs. Methods: Lipid data were analysed from phase II and III studies of 4 mg (n=997) and 2 mg (n=479) oral baricitinib administered once daily in patients with moderate-to-severe active RA. Lipoprotein particle size and number and GlycA were evaluated with nuclear magnetic resonance in one phase III study. The effect of statin therapy on lipid levels was evaluated in patients on statins at baseline and in patients who initiated statins during the study. Results: Treatment with baricitinib was associated with increased levels of total cholesterol, low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C) and triglycerides, but no significant change in LDL-C:HDL-C ratio. Lipid levels plateaued after 12 weeks of treatment. Baricitinib treatment increased large LDL and decreased small, dense LDL particle numbers and GlycA. Lipid changes from baseline were not significantly different between baseline statin users and non-users. In patients who initiated statin therapy during the study, LDL-C, triglycerides (baricitinib 4 mg only) and apolipoprotein B decreased to pre-baricitinib levels; HDL-C and apolipoprotein A-I levels remained elevated. Conclusions: Baricitinib was associated with increased LDL-C, HDL-C and triglyceride levels, but did not alter the LDL-C:HDL-C ratio. Evaluation of cardiovascular event rates during long-term treatment is warranted to further characterise these findings and their possible clinical implications.

Item Type:Articles
Keywords:DMARDs (biologics), lipids, rheumatoid arthritis.
Status:Published
Refereed:Yes
Glasgow Author(s) Enlighten ID:McInnes, Professor Iain
Authors: Taylor, P. C., Kremer, J. M., Emery, P., Zuckerman, S. H., Ruotolo, G., Zhong, J., Chen, L., Witt, S., Saifan, C., Kurzawa, M., Otvos, J. D., Connelly, M. A., Macias, W. L., Schlichting, D. E., Rooney, T. P., de Bono, S., and McInnes, I. B.
College/School:College of Medical Veterinary and Life Sciences > Institute of Infection Immunity and Inflammation
Journal Name:Annals of the Rheumatic Diseases
Publisher:BMJ Publishing Group
ISSN:0003-4967
ISSN (Online):1468-2060
Published Online:20 February 2018
Copyright Holders:Copyright © 2018 The Authors
First Published:First published in Annals of the Rheumatic Diseases 77(7): 988-995
Publisher Policy:Reproduced under a Creative Commons License

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