Patient demographics and baseline characteristics for all tofacitinib-treated patients (all tofacitinib cohort) in completed studies in the RA, PsO and PsA development programmes, stratified by average tofacitinib dose*
| RA | PsO | PsA | ||||
| Average tofacitinib 5 mg twice daily (N=3969) | Average tofacitinib 10 mg twice daily (N=3995) | Average tofacitinib 5 mg twice daily (N=920) | Average tofacitinib 10 mg twice daily (N=2743) | Average tofacitinib 5 mg twice daily (N=458) | Average tofacitinib 10 mg twice daily (N=325) | |
| Age (years), mean (SD) | 53.3 (12.4) | 52.0 (11.6) | 45.5 (13.3) | 44.5 (12.7) | 49.2 (11.9) | 48.0 (12.2) |
| ≥65 years of age, n (%) | 722 (18.2) | 548 (13.7) | 71 (7.7) | 149 (5.4) | 42 (9.2) | 30 (9.2) |
| ≥50 years of age, n (%) | 2606 (65.7) | 2481 (62.1) | 386 (42.0) | 1015 (37.0) | 238 (52.0) | 160 (49.2) |
| Female, n (%) | 3236 (81.5) | 3286 (82.3) | 323 (35.1) | 794 (28.9) | 258 (56.3) | 170 (52.3) |
| Race, n (%) | ||||||
| White | 2417 (60.9) | 2753 (68.9) | 794 (86.3) | 2341 (85.3) | 434 (94.8) | 305 (93.8) |
| Black | 121 (3.0) | 131 (3.3) | 27 (2.9) | 51 (1.9) | 0 (0) | 3 (0.9) |
| Asian | 1126 (28.4) | 686 (17.2) | 42 (4.6) | 207 (7.5) | 11 (2.4) | 12 (3.7) |
| Other/unknown | 305 (7.7) | 425 (10.6) | 57 (6.2) | 144 (5.2) | 13 (2.8) | 5 (1.5) |
| BMI (kg/m2), mean (SD) (N1) | 26.7 (6.2) (3961) | 27.5 (6.5) (3993) | 29.7 (6.5) (919) | 29.9 (6.8) (2740) | 29.5 (5.9) (458) | 29.8 (6.2) (325) |
| BMI ≥30 kg/m2, n (%) (N1) | 982 (24.8) (3961) | 1156 (29.0) (3993) | 384 (41.8) (919) | 1160 (42.3) (2740) | 196 (42.8) (458) | 137 (42.2) (325) |
| Smoking status, n (%) | ||||||
| Never smoked | 2522 (63.5) | 2474 (61.9) | 353 (38.4) | 1059 (38.6) | 289 (63.1) | 196 (60.3) |
| Smoker | 648 (16.3) | 718 (18.0) | 365 (39.7) | 1015 (37.0) | 92 (20.1) | 48 (14.8) |
| Ex-smoker | 689 (17.4) | 699 (17.5) | 202 (22.0) | 669 (24.4) | 77 (16.8) | 81 (24.9) |
| Unknown | 110 (2.8) | 104 (2.6) | 0 | 0 | 0 | 0 |
| Comorbidities, n (%) | ||||||
| Diabetes | 365 (9.2) | 286 (7.2) | 128 (13.9) | 371 (13.5) | 61 (13.3) | 46 (14.2) |
| Hypertension | 1405 (35.4) | 1413 (35.4) | 219 (23.8) | 595 (21.7) | 180 (39.3) | 119 (36.6) |
| Coronary heart disease | 13 (0.3) | 17 (0.4) | 24 (2.6) | 66 (2.4) | 23 (5.0) | 16 (4.9) |
| Myocardial infarction | 50 (1.3) | 50 (1.3) | 8 (0.9) | 24 (0.9) | 6 (1.3) | 9 (2.8) |
| History of hyperlipidemia, n (%) | 740 (18.6) | 794 (19.9) | 220 (23.9) | 641 (23.4) | 94 (20.5) | 73 (22.5) |
| Previous heart failure, n (%) | 28 (0.7) | 14 (0.4) | 0 | 7 (0.3) | 0 | 3 (0.9) |
| Previous VTE (DVT or PE), n (%) | 40 (1.0) | 48 (1.2) | 2 (0.2) | 9 (0.3) | 3 (0.7) | 7 (2.2) |
| CRP >2.87 mg/L, n (%) (N1) | 3158 (80.2) (3939) | 3188 (80.5) (3958) | 378 (47.0) (804) | 1119 (48.7) (2297) | 288 (62.9) (458) | 198 (60.9) (325) |
| Concomitant medication, n (%) | ||||||
| Steroids | 2070 (52.2) | 2184 (54.7) | 0† | 0† | 109 (23.8) | 62 (19.1) |
| Anticoagulants | 316 (8.0) | 344 (8.6) | 75 (8.2) | 188 (6.9) | 34 (7.4)‡ | 34 (10.5)‡ |
| Antiplatelet agents | 280 (7.1) | 339 (8.5) | 78 (8.5) | 194 (7.1) | 31 (6.8)‡ | 23 (7.1)‡ |
| OCT or HRT‡ | 347 (8.7) | 334 (8.4) | 75 (0.2) | 186 (6.8) | 40 (8.7) | 37 (11.4) |
| Antidepressants‡ | 278 (7.0) | 367 (9.2) | 54 (5.9) | 132 (4.8) | 56 (12.2) | 37 (11.4) |
| Statins‡ | 182 (4.6) | 438 (11.0) | 127 (13.8) | 360 (13.1) | 58 (12.7) | 42 (12.9) |
| Aspirin | 246 (6.2) | 305 (7.6) | 70 (7.6) | 172 (6.3) | 28 (6.1)‡ | 22 (6.8)‡ |
| Prior MTX use, n (%) | 3610 (91.0) | 3047 (76.3) | 276 (30.0) | 881 (32.1) | 432 (94.3) | 293 (90.2) |
| Prior csDMARD use (other than MTX), n (%) | 1655 (41.7) | 2084 (52.2) | 83 (9.0) | 307 (11.2) | 205 (44.8) | 165 (50.8) |
| Prior TNFi use, n (%) | 463 (11.7) | 782 (19.6) | 140 (15.2) | 440 (16.0) | 190 (41.5) | 187 (57.5) |
| Prior non-TNFi bDMARD use, n (%) | 177 (4.5) | 237 (5.9) | 53 (5.8) | 161 (5.9) | 24 (5.2) | 22 (6.8) |
*Patients were assigned to average tofacitinib 5 or 10 mg twice daily if the average total daily dose over the course of observation was <15 or ≥15 mg, respectively.
†Concomitant steroids were not allowed in PsO trials.
‡Day 1 use.
bDMARD, biologic disease-modifying antirheumatic drug; BMI, body mass index; CRP, C-reactive protein; csDMARD, conventional synthetic disease-modifying antirheumatic drug; DVT, deep vein thrombosis; HRT, hormone replacement therapy; MTX, methotrexate; n, number of patients with characteristic; N1, total number of patients for that characteristic; N, total number of patients; OCT, oral contraceptives; PE, pulmonary embolism; PsA, psoriatic arthritis; PsO, psoriasis; RA, rheumatoid arthritis; SD, standard deviation; TNFi, tumour necrosis factor inhibitor; VTE, venous thromboembolism (DVT or PE).