Risk of MACE with tofacitinib versus TNFi by history of ASCVD. (A) HRs (95% CIs) are based on two simple Cox proportional hazard models (one for comparing combined tofacitinib doses versus TNFi, and the other for comparing tofacitinib 5 mg and 10 mg two times per day vs TNFi), with treatment as the only covariate. IRs express number of patients with first events per 100 PY. NNH (PY) should be interpreted as the number of PY of exposure to tofacitinib required to have one additional MACE versus TNFi. NNH (5-year) should be interpreted as the number of patients who would need to be treated for that duration with tofacitinib rather than with a TNFi to result in one additional MACE. *IRD 95% CI excluded 0. †Results reported in Ytterberg et al
8 and included for reference. ‡NNH 95% CIs are reported in online supplemental table 2. (B) Treatment-by-HxASCVD interaction p values for HRs (χ2 test with 1 degree of freedom) and IRD (2-sided, normal approximation of difference in IR). See supplementary material for details. (C) Cumulative probability of patients with adjudicated MACE events, calculated based on the Kaplan-Meier estimate, in patients with history of ASCVD (left panel) and without history of ASCVD (right panel). HRs are shown on a logarithmic scale. Arrows indicate that the CI extends beyond the graph axis. For patients randomised to the tofacitinib 10 mg two-times-per-day group who had their dose of tofacitinib reduced to 5 mg two times per day, the data collected after patients were switched to tofacitinib 5 mg two times per day were counted in the tofacitinib 10 mg two-times-per-day group. BID, two times per day; CI, confidence interval; CV RF, cardiovascular risk factor; HR, hazard ratio; HxASCVD, history of atherosclerotic cardiovascular disease; IR, incidence rate; IRD, incidence rate difference; MACE, major adverse cardiovascular events; n, number of patients with events; N, number of evaluable patients; NNH, number needed to harm; PY, patient-years; TNFi, tumour necrosis factor inhibitor.