Background/Purpose: RA is associated with an increased risk for cardiovascular (CV) disease. Hyperlipidemia is a recognized risk factor for CVD. This study followed the changes in lipid levels after 3 months of therapy with biologic agents.

Methods: Patients (pts) with at least moderate disease activity (CDAI >10) initiating a biologic DMARD participated in an ongoing comparative effectiveness study (CERTAIN) nested within CORRONA. Characteristics, including lipid values in pts initiating a TNF-α inhibitor (TNFi) or non‐TNFi (rituximab [RTX], abatacept [ABA] or tocilizumab [TCZ]), were measured at baseline and 3 months. Adult Treatment Panel III (ATP-3) guideline lipid categories were used to evaluate lipid levels: LDL (optimal < 100), HDL (low < 40), total cholesterol (TC) (desirable < 200) and triglycerides (TG) (normal < 150). TC/HDL ratio (desirable ≤ 5) thresholds were determined by American Heart Association (AHA) recommendations and were used to categorize pts into low/normal risk and elevated risk for CV disease. We describe the proportion of pts who shifted lipid level categories from baseline to 3 months of therapy for each biologic. Pts who started or stopped lipid-lowering therapy between baseline and 3 month follow up visit were excluded from this analysis.

Results: 715 initiations of a biologic were analyzed. Baseline characteristics: age 55.6 ± 13.3, female 76.1%, and baseline CDAI 28.7 ± 12.7.  History of prior CVD was present in 7.0% of pts; 3.1% had diabetes mellitus and 39.4% were obese (BMI>30). 55.9% of pts received TNFi, 5.9% RTX, 20.14% ABA and 18.0% TCZ. Changes in lipid levels after three months of therapy and shifts between lipid categories are listed in Table 1. Of all pts with an optimal LDL at baseline, 24.2% had LDL shifted to an above optimal level at 3 months and of those pts with an above optimal LDL at baseline, 12.4% shifted to an optimal level at 3 months; for TC, of pts at a desirable level at baseline, 18.3% shifted to a higher than desirable level at 3 months and of pts at a higher than desirable level at baseline, 20.4% shifted to a desirable level at 3 months. For TC/HDL ratio, of pts at a desirable level at baseline, 41.4% shifted to a higher than desirable level at 3 months whereas of pts with a higher than desirable level at baseline, 4.4% shifted to a desirable level at 3 months. Similar bi-directional changes were noted for all biologics.

Conclusion: In this study, lipid level alterations were noted after three months of therapy with biologic agents. Notably for some pts, lipid levels increased while in others levels decreased over three months. Further studies with long-term follow-up would be needed to determine the clinical significance of lipids and systemic inflammation for CVD risk.