Effects of Baricitinib on Lipid, Apolipoprotein, and Lipoprotein Particle Profiles in a Phase 2b Study in Patients with Active Rheumatoid Arthritis

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https://www.ncbi.nlm.nih.gov/pubmed/28029752

Kremer J¹, Genovese MC², Keystone E³, Taylor PC⁴, Zuckerman SH⁵, Ruotolo G⁵, Schlichting DE⁵, Crotzer VL⁵, Nantz E⁵, Beattie SD⁵, Macias WL⁵.

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Abstract

Objective To assess the effects of baricitinib on lipid profile in patients with moderate-to-severe rheumatoid arthritis. Methods Once-daily baricitinib (1, 2, 4, or 8-mg) or placebo was studied in 301 randomized patients. Changes in lipid profile, particle size, and number were assessed at weeks 12/24; associations with clinical efficacy were evaluated. Apolipoproteins were assessed at weeks 4/12 for the placebo, and 4- and 8-mg baricitinib groups. Results Baricitinib treatment resulted in dose-dependent increases by week 12 in serum lipids (low-density lipoprotein cholesterol [LDL-C]: 3.4 mg/dL increase from baseline to week 12 (1-mg) to 11.8 mg/dL (8-mg); high-density lipoprotein cholesterol [HDL-C]: 3.3 mg/dL (1-mg) to 8.1 mg/dL (8-mg); triglycerides: 6.4 mg/dL (1-mg) to 15.4 mg/dL (8-mg) baricitinib). Group-wise mean increases in LDL-C were coincident with mean increases in large LDL particles and mean reductions in small dense LDL particles. Increases from baseline to week 12 in apolipoprotein A-I, B, and total CIII were observed with 4-mg (9.5%, 6.8%, and 23.0%, respectively) and 8-mg (12.2%, 7.1%, and 19.7%, respectively) baricitinib with no increase in LDL-associated CIII (4-mg: -4.5%; 8-mg: -9.0). Baricitinib reduced HDL-associated serum amyloid A at 4-mg (-36.0%) and 8-mg (-32.0%); a significant reduction in lipoprotein (a) was observed only with 8-mg (-16.6%). Increased HDL cholesterol at week 12 correlated with improved Disease Activity Scores and Simplified Disease Activity Index; changes in total cholesterol, LDL cholesterol, and triglycerides did not reveal a similar relationship. Conclusion Baricitinib-associated increases in serum lipids were observed. HDL-C increases correlated with improved clinical outcomes. This article is protected by copyright. All rights reserved.