Table 1.

IRs of MACE and malignancies in pts with PsA and PsO receiving tofacitinib, stratified by HxCAD, BL 10-yr ASCVD risk and BL MetS

MACEMalignancies
PsAPsOPsAPsO
n/N[n1]IR (95% CI)n/N[n1]IR (95% CI)n/N[n1]IR (95% CI)n/N[n1]IR (95% CI)
HxCAD
Yes1/39[0]0.97 (0.02, 5.38)3/93[0]1.49 (0.31, 4.36)0/39[0]0.00 (0.00, 3.52)0/93[0]0.00 (0.00, 1.83)
No5/744[5]0.25 (0.08, 0.59)20/3570[10]0.22 (0.13, 0.34)15/744[10]0.75 (0.42, 1.24)60/3570[26]0.66 (0.51, 0.85)
BL 10-yr ASCVD risk category
High risk (≥20%)1/35[1]1.26 (0.03, 7.01)7/179[4]1.67 (0.67, 3.43)1/35[1]1.26 (0.03, 7.03)15/179[10]3.57 (2.00, 5.89)
Intermediate risk(≥7.5–<20%)2/121[2]0.62 (0.07, 2.23)9/716[6]0.50 (0.23, 0.95)8/121[7]2.46 (1.06, 4.86)23/716[9]1.28 (0.81, 1.92)
Borderline risk(≥5–<7.5%)1/91[1]0.42 (0.01, 2.32)2/400[0]0.19 (0.02, 0.67)2/91[1]0.83 (0.10, 3.01)5/400[1]0.47 (0.15, 1.09)
Low risk (<5%)1/487[1]0.08 (0.00, 0.42)2/2241[0]0.03 (0.00, 0.13)4/487[1]0.30 (0.08, 0.77)17/2241[6]0.30 (0.17, 0.47)
BL MetS
Yes5/3200.60 (0.20, 1.40)10/11970.34 (0.16, 0.63)10/3201.20 (0.58, 2.21)26/11970.89 (0.58, 1.31)
No1/4630.08 (0.00, 0.44)13/24660.20 (0.11, 0.35)5/4630.40 (0.13, 0.92)34/24660.54 (0.37, 0.75)
  • Follow-up time calculated up to the day of the first event and subject to risk period of 28 days beyond the last dose of study drug.

  • CI, confidence interval; N, total pts; n, pts with MACE/malignancies; n1, pts with MACE/malignancies and BL MetS.