Use of statins and its association with major adverse cardiovascular events with tofacitinib vs TNF inhibitors in patients with rheumatoid arthritis with and without atherosclerotic cardiovascular disease.

This study aims to assess statin usage and its association with incident major adverse cardiovascular (CV) events (MACE) in patients with rheumatoid arthritis (RA) treated with tofacitinib vs tumour necrosis factor inhibitors (TNFi) in ORAL Surveillance. Patients with RA aged ≥50 years and ≥1 additional CV risk factor received tofacitinib 5 mg (N = 1455) or 10 mg twice a day (N = 1456) or TNFi (N = 1451). Statin treatment was assessed at baseline and during the study. Hazard ratios (HR) were evaluated for MACE in participants with a history of atherosclerotic cardiovascular disease (ASCVD) and in categories of predicted CV risk. Among participants with a history of ASCVD or high CV risk, 53.0% and 26.9%, respectively, used a statin at baseline. Baseline statin use was similar in tofacitinib and TNFi-treated participants. In participants with or without statins, low-density lipoprotein and high-density lipoprotein increased from baseline and to a larger extent with tofacitinib than with TNFi. Occurrence of MACE in participants with a history of ASCVD and no use of statins at any time was higher with tofacitinib vs TNFi (HR 4.07 95% CI 1.20-13.82). In participants with a history of ASCVD and use of statins at baseline or at any time, there was no difference in incident MACE with tofacitinib vs TNFi (HR 1.17 95% CI 0.46-3.00). This post hoc analysis of ORAL Surveillance emphasises the gap in the CV preventive care of patients with RA. Among patients with a history of ASCVD, use of statins may mitigate the previously reported MACE risk observed to accompany tofacitinib use vs TNFi. This trial was registered with NCT number NCT02092467.