Table 1

Demographic and baseline disease characteristics of patients in ORAL Surveillance and the tofacitinib RA, PsA and UC development programmes

ORAL SurveillanceTofacitinib development programme
N=4362RA*
N=7964
PsA
N=783
UC
N=1157
Female, % (n)78.2% (3410)81.9% (6522)54.7% (428)41.3% (478)
Duration of disease (years), mean/median10.4/8.08.1/5.67.7/5.58.2/6.3
Age, mean (SD)61.2 (7.1)52.6 (12.1)48.7 (12.0)41.3 (13.9)
≥65 years of age, % (n)31.0% (1353)15.9% (1270)9.2% (72)6.7% (77)
Smoking status†, % (n)
 Current26.7% (1166)17.2% (1366)17.9% (140)5.1% (59)
 Past21.5% (937)17.4% (1388)20.2% (158)30.9% (357)
 Never51.8% (2259)62.7% (4996)61.9% (485)64.0% (740)
History of other CV risk factors, % (n)
 Diabetes mellitus17.4% (759)8.2% (651)13.7% (107)4.1% (48)‡
 Hyperlipidaemia35.2% (1534)19.3% (1534)21.3% (107)NA
 Hypertension66.0% (2878)35.4% (2818)39.1% (306)13.9% (161)‡
 Coronary artery disease11.4% (497)1.6% (126)5.6% (44)1.6% (18)
 ASCVD14.7% (640)3.4% (274)6.5% (51)3.9% (45)
Treatment history, % (n)
 Prior TNFi7.6% (330)15.6% (1245)48.1% (377)54.4% (1124)
 Statin at baseline‡23.4% (1020)7.8% (620)12.8% (100)6.4% (74)
 Aspirin at baseline‡15.3% (667)6.9% (551)6.4% (50)NA
  • *Excluding ORAL Surveillance.

  • †In the tofacitinib RA development programme, 2.7% (N=214) of patients had unknown smoking status. Patients <65 years old with unknown smoking status were not included in the low-risk group. 25 patients in the high-risk group had unknown smoking status.

  • ‡Based on day 1 of treatment.

  • ASCVD, atherosclerotic cardiovascular disease; CV, cardiovascular; n, number of patients with characteristic; NA, not available; RA, rheumatoid arthritis; TNFi, tumour necrosis factor inhibitor; UC, ulcerative colitis.