Table 1.
Demographic and baseline disease characteristics of patients in ORAL Surveillance and the tofacitinib RA, PsA and UC development programmes
| ORAL Surveillance | Tofacitinib development programme | |||
| N=4362 | RA* 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/median | 10.4/8.0 | 8.1/5.6 | 7.7/5.5 | 8.2/6.3 |
| 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) | ||||
| Current | 26.7% (1166) | 17.2% (1366) | 17.9% (140) | 5.1% (59) |
| Past | 21.5% (937) | 17.4% (1388) | 20.2% (158) | 30.9% (357) |
| Never | 51.8% (2259) | 62.7% (4996) | 61.9% (485) | 64.0% (740) |
| History of other CV risk factors, % (n) | ||||
| Diabetes mellitus | 17.4% (759) | 8.2% (651) | 13.7% (107) | 4.1% (48)‡ |
| Hyperlipidaemia | 35.2% (1534) | 19.3% (1534) | 21.3% (107) | NA |
| Hypertension | 66.0% (2878) | 35.4% (2818) | 39.1% (306) | 13.9% (161)‡ |
| Coronary artery disease | 11.4% (497) | 1.6% (126) | 5.6% (44) | 1.6% (18) |
| ASCVD | 14.7% (640) | 3.4% (274) | 6.5% (51) | 3.9% (45) |
| Treatment history, % (n) | ||||
| Prior TNFi | 7.6% (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.