トファシチニブで治療された乾癬性関節炎患者の脂質変化と心血 管イベント発生率: フェーズ3と長期試験のプール解析
Serum lipid level increases at month 3 following TOF treatment in PsA were consistent with observation in RA and psoriasis.
The risk of CV disease is higher in people with PsA versus the general population – comparable with the well-documented rates seen in RA and diabetes. The reasons for this are not fully elucidated, but it has been suggested that there is an association between peripheral joint inflammation and lipid dysregulation in PsA.
This post hoc analysis of pooled data from OPAL Broaden, OPAL Beyond and OPAL Balance evaluated CV risk factors and MACE in 738 patients with active PsA receiving TOF 5 or 10 mg BID plus csDMARDs. At Month 3 and 6, changes from baseline in LDL-c and HDL-c appeared to be greater with the TOF 10 mg BID dose, but there were no meaningful changes in lipid ratios. At Month 3 significant reductions in CRP were reported for both doses of TOF versus placebo, and these reductions were maintained to Month 6.
Although the risk of CV disease and cardiometabolic disorders is higher in PsA compared with the general population, this analysis found no further increase in CV risk following treatment with TOF 5 or 10 mg BID. These changes are consistent with observations of lipid levels in other TOF studies in patients with RA and psoriasis.