POS0520 ASSOCIATION BETWEEN BASELINE STATIN TREATMENT AND MAJOR ADVERSE CARDIOVASCULAR EVENTS IN PATIENTS WITH RHEUMATOID ARTHRITIS: A POST HOC ANALYSIS OF ORAL SURVEILLANCE

Abstract

BackgroundORAL Surveillance (NCT02092467) was a post-authorisation safety study of tofacitinib vs tumour necrosis factor inhibitors (TNFi) in patients (pts) with rheumatoid arthritis (RA) aged ≥50 years (yrs) with ≥1 additional cardiovascular (CV) risk factor and an inadequate response to methotrexate (MTX). Statins are used to treat coronary artery disease (CAD) and are recommended by the American College of Cardiology/American Heart Association (ACC/AHA) for the management of pts at risk of atherosclerotic CV disease (ASCVD),1 such as those with ≥7.5% 10-yr risk of major adverse CV events (MACE) or diabetes mellitus.ObjectivesTo examine the association between baseline (BL) statin use and MACE in ORAL Surveillance.MethodsPts with RA on stable MTX were randomised 1:1:1 to receive tofacitinib 5 or 10 mg twice daily (BID) or TNFi (adalimumab 40 mg every 2 weeks or etanercept 50 mg once weekly). Pts were stratified post hoc by BL statin use (yes/no). Pts were further categorised by history of CAD (HxCAD), BL CV risk score per ACC/AHA guidelines1 (for pts without HxCAD; 10-yr risk of MACE per the ASCVD-pooled cohort equations risk calculator2 with a 1.5 multiplier applied3), and separately by BL diabetes status. CV risk score/BL diabetes status categories were: high (≥20%)/HxCAD (yes), intermediate (≥7.5–<20%) or low-borderline (<7.5%), and diabetes status (yes). For the overall population and each treatment group, risk of MACE was compared between BL statin use (yes vs no) via Cox analyses for each CV risk category and diabetes status (yes). Incidence rates (IRs; pts with first events/100 pt-yrs) and hazard ratios (HRs; BL statin use: yes vs no) were evaluated for adjudicated MACE.ResultsOf 4362 pts (tofacitinib 5 mg BID, n=1455; tofacitinib 10 mg BID, n=1456; TNFi, n=1451), 497 had a HxCAD, and 3813 without a HxCAD had CV risk scores determined; 789 had BL diabetes. Overall, 1020 (23.4%) pts reported BL statin use. Across CV risk score categories for all treatment groups, <50% of pts received statins at BL, with statin use highest in the high/HxCAD category pts (35.7–40.6%) and pts with diabetes (35.7–44.2%) (Table 1). Across categories, no interpretable associations between BL statin use and MACE were found. However, in the overall population, MACE IRs were lower in pts with vs without BL statin use in the high/HxCAD category, and in pts with diabetes (Figure 1). In pts receiving tofacitinib 5 mg BID and TNFi, MACE IRs were lower in pts with vs without BL statin use across all categories (Figure 1).Table 1.Proportion of pts receiving statins at BL, by CV risk category and presence of diabetesn/N (%)OverallTofacitinibTofacitinibTNFi5 mg BID10 mg BIDHigh (≥20%)/HxCAD525/1370 (38.3)168/435 (38.6)193/475 (40.6)164/460 (35.7)Intermediate (≥7.5–<20%)302/1511 (20.0)110/490 (22.4)94/516 (18.2)98/505 (19.4)Low-borderline (<7.5%)178/1429 (12.5)66/513 (12.9)57/446 (12.8)55/470 (11.7)Diabetes (yes)320/789 (40.6)111/251 (44.2)114/272 (41.9)95/266 (35.7)N, number of pts in each category; n, number of pts receiving BL statinsConclusionIn this post hoc analysis of data from ORAL Surveillance, most pts did not receive BL statin treatment. This suggests suboptimal CV risk management, particularly in pts at high risk of CV events. There was no interpretable association between BL statin use and MACE. However, pts in the higher risk categories, particularly those receiving tofacitinib 5 mg BID, had lower MACE IRs with vs without BL statin use. This analysis did not take into account initiation or dose adjustment of statin treatment during the study, and had low yrs of exposure in some categories.