Table 1.
Selected demographics and baseline disease characteristics in ORAL Surveillance
| Tofacitinib 5 mg two times per day (N=1455) | Tofacitinib 10 mg two times per day (N=1456) | TNFi (N=1451) |
|
| Age (years), mean (SD) | 60.8 (6.8) | 61.4 (7.1) | 61.3 (7.5) |
| ≥65 years, n (%) | 413 (28.4) | 478 (32.8) | 462 (31.8) |
| Male sex, n (%) | 286 (19.7) | 332 (22.8) | 334 (23.0) |
| RA disease duration (years), mean (SD) | 10.4 (8.8) | 10.2 (9.0) | 10.6 (9.3) |
| Smoking status, n (%) | |||
| Current smoker | 411 (28.2) | 402 (27.6) | 353 (24.3) |
| Past smoker | 309 (21.2) | 302 (20.7) | 326 (22.5) |
| Never smoked | 735 (50.5) | 752 (51.6) | 772 (53.2) |
| Geographical region, n (%)* | |||
| North America | 402 (27.6) | 409 (28.1) | 432 (29.8) |
| ROW | 1053 (72.4) | 1047 (71.9) | 1019 (70.2) |
| BMI (kg/m2), mean (SD) (number of patients with missing values) | 29.7 (6.5) (7) | 29.7 (6.3) (3) | 29.8 (6.6)(7) |
| ≥30 kg/m2, n (%) | 606 (41.6) | 594 (40.8) | 617 (42.5) |
| ≥35 kg/m2, n (%) | 256 (17.6) | 261 (17.9) | 267 (18.4) |
| Concomitant medication use at baseline (day 1) | |||
| Opioids, n (%) | 293 (20.1) | 283 (19.4) | 288 (19.8) |
| Oral corticosteroids, n (%) | 776 (53.3) | 773 (53.1) | 774 (53.3) |
| Oral corticosteroid dose (mg/day), mean (range)† | 6.0‡ (0.7–20.0) | 6.1§ (0.6–20.0) | 6.1¶ (0.3–20.0) |
| Medical history, n (%) | |||
| Diabetes | 243 (16.7) | 261 (17.9) | 255 (17.6) |
| Chronic lung disease (COPD or ILD) | 178 (12.2) | 173 (11.9) | 172 (11.9) |
| Extra-articular disease | 532 (36.6) | 521 (35.8) | 552 (38.0) |
| Nodules | 301 (20.7) | 268 (18.4) | 287 (19.8) |
| Coronary artery disease | 161 (11.1) | 172 (11.8) | 164 (11.3) |
| Heart failure | 18 (1.2) | 23 (1.6) | 18 (1.2) |
| Infection | 574 (39.5) | 549 (37.7) | 556 (38.3) |
| Positive for anticitrullinated protein antibodies, n (%) | 1093 (75.1) | 1129 (77.5) | 1119 (77.1) |
| HAQ-DI, mean (SD) (number of patients with missing values) | 1.6 (0.6) (11) | 1.6 (0.6) (18) | 1.6 (0.6) (25) |
| DAS28-4(CRP), mean (SD) (number of patients with missing values) | 5.8 (0.9) (11) | 5.8 (0.9) (17) | 5.8 (0.9) (26) |
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.
*In North America (the USA, Puerto Rico and Canada), patients randomised to TNFi received adalimumab 40 mg once every 2 weeks; in the ROW, patients randomised to TNFi received etanercept 50 mg once weekly.
†In patients taking oral corticosteroids at baseline with known dosing information.
‡n=769.
§n=771.
¶n=773.
BMI, body mass index; COPD, chronic obstructive pulmonary disease; DAS28-4(CRP), Disease Activity Score in 28 joints, C-reactive protein; HAQ-DI, Health Assessment Questionnaire-Disability Index; ILD, interstitial lung disease; n, number of patients meeting baseline criteria; N, number of evaluable patients; RA, rheumatoid arthritis; ROW, rest of the world; SD, standard deviation; TNFi, tumour necrosis factor inhibitor.