Open-label tofacitinib and double-blind atorvastatin in rheumatoid arthritis patients: a randomised study
This randomised, placebo-controlled, multicentre phase 2 study evaluated the efficacy and safety of atorvastatin versus placebo in modifying lipids in 111 patients with active rheumatoid arthritis (RA) receiving tofacitinib. All patients took tofacitinib 10 mg twice daily for 12 weeks, and after the first 6 weeks patients were randomised 1:1 to receive either atorvastatin 10 mg once daily (n=50) or matched placebo (n=48) in a double-blind phase for a further 6 weeks. Tofacitinib-induced elevations of lipids were seen in patients who received placebo during the double-blind phase, but patients randomised to receive atorvastatin at week 6 achieved significantly reduced levels of total cholesterol (-21.1%, p<0.0001), low-density lipoprotein (LDL) cholesterol (-35.3%, p<0.0001), triglycerides, and apoprotein B to values lower than those seen at week 0. ACR responses were seen in both groups but these were numerically higher in the atorvastatin group compared with the placebo group. The study demonstrated the addition of atorvastatin to tofacitinib significantly reduced the lipid elevations in patients with RA and did not reduce the efficacy of tofacitinib on RA disease activity.