Demographics and baseline disease characteristics
| BMI category, kg/m2 | Tofacitinib 5 mg twice daily (N=1589) | Tofacitinib 10 mg twice daily (N=1611) | Placebo (N=680) | ||||||
| <25 (N1=686) | 25 to <30 (N1=515) | ≥30 (N1=388) | <25 (N1=696) | 25 to <30 (N1=472) | ≥30 (N1=443) | <25 (N1=308) | 25 to <30 (N1=186) | ≥30 (N1=186) | |
| Age in years, mean (SD) | 50.5 (12.9) | 54.1 (11.4) | 53.9 (9.9) | 49.6 (12.9) | 53.0 (11.6) | 53.8 (10.3) | 50.4 (12.8) | 54.9 (11.7) | 53.7 (10.1) |
| Race, n (%) | |||||||||
| White | 327 (47.7) | 336 (65.2) | 313 (80.7) | 337 (48.4) | 326 (69.1) | 344 (77.7) | 139 (45.1) | 144 (77.4) | 155 (83.3) |
| Black | 10 (1.5) | 25 (4.9) | 23 (5.9) | 8 (1.2) | 12 (2.5) | 27 (6.1) | 11 (3.6) | 2 (1.1) | 11 (5.9) |
| Asian | 283 (41.3) | 91 (17.7) | 21 (5.4) | 284 (40.8) | 73 (15.5) | 20 (4.5) | 133 (43.2) | 24 (12.9) | 9 (4.8) |
| Other | 66 (9.6) | 63 (12.2) | 31 (8.0) | 67 (9.6) | 61 (12.9) | 52 (11.7) | 25 (8.1) | 16 (8.6) | 11 (5.9) |
| Geographic region, n (%) | |||||||||
| USA | 67 (9.8) | 93 (18.1) | 142 (36.6) | 60 (8.6) | 92 (19.5) | 162 (36.6) | 29 (9.4) | 44 (23.7) | 86 (46.2) |
| Latin America | 94 (13.7) | 113 (21.9) | 59 (15.2) | 104 (14.9) | 91 (19.3) | 79 (17.8) | 43 (14.0) | 30 (16.1) | 25 (13.4) |
| Europe/Canada | 226 (32.9) | 203 (39.4) | 147 (37.9) | 224 (32.2) | 195 (41.3) | 157 (35.4) | 97 (31.5) | 86 (46.2) | 59 (31.7) |
| Rest of world | 299 (43.6) | 106 (20.6) | 40 (10.3) | 308 (44.3) | 94 (19.9) | 45 (10.2) | 139 (45.1) | 26 (14.0) | 16 (8.6) |
| Smoking history, n (%) | |||||||||
| Never smoked | 501 (73.0) | 344 (66.8) | 209 (53.9) | 520 (74.7) | 307 (65.0) | 264 (59.6) | 220 (71.4) | 103 (55.4) | 101 (54.3) |
| Smoker | 101 (14.7) | 78 (15.2) | 54 (13.9) | 111 (16.0) | 96 (20.3) | 75 (16.9) | 53 (17.2) | 44 (23.7) | 33 (17.7) |
| Ex-smoker | 84 (12.2) | 93 (18.1) | 125 (32.2) | 65 (9.3) | 69 (14.6) | 104 (23.5) | 33 (10.7) | 39 (21.0) | 52 (28.0) |
| TJC, mean (SD) | 24.6 (14.3) | 26.9 (14.9) | 29.0 (16.0) | 24.1 (14.4) | 25.9 (14.3) | 28.8 (15.9) | 23.5 (13.6) | 26.4 (15.2) | 29.9 (16.6) |
| SJC, mean (SD) | 14.7 (8.7) | 15.7 (9.0) | 16.8 (10.3) | 14.7 (8.4) | 15.6 (8.9) | 16.5 (9.9) | 14.5 (8.5) | 16.3 (10.1) | 17.1 (10.6) |
| HAQ-DI, mean (SD) | 1.4 (0.7) | 1.5 (0.7) | 1.6 (0.6) | 1.4 (0.7) | 1.5 (0.7) | 1.6 (0.6) | 1.4 (0.7) | 1.4 (0.6) | 1.6 (0.6) |
| DAS28-4(ESR), mean (SD) | 6.5 (1.0) | 6.5 (1.0) | 6.5 (1.0) | 6.4 (1.0) | 6.4 (1.0) | 6.5 (1.0) | 6.4 (1.0) | 6.4 (0.9) | 6.5 (1.0) |
| DAS28-4(CRP), mean (SD) | 5.6 (1.0) | 5.7 (1.0) | 5.7 (1.0) | 5.6 (1.0) | 5.6 (1.0) | 5.7 (1.0) | 5.5 (1.0) | 5.6 (0.9) | 5.8 (1.0) |
| Pain (VAS), mean (SD) | 57.6 (23.4) | 60.3 (23.9) | 61.7 (21.1) | 58.5 (23.0) | 60.3 (23.9) | 61.2 (22.4) | 56.8 (23.0) | 58.1 (23.3) | 59.5 (22.2) |
| CRP, mg/L, mean (SD) (median) (Q1, Q3) | 20.0 (24.8) (9.7) (3.8, 27.6) | 18.8 (24.8) (9.3) (4.3, 24.1) | 17.3 (20.0) (10.3) (5.0, 22.2) | 19.2 (23.0) (10.0) (3.9, 25.6) | 18.0 (25.9) (8.9) (3.5, 25.3) | 16.7 (18.8) (9.4) (5.3, 21.0) | 17.1 (20.0) (9.3) (4.3, 24.3) | 15.1 (19.2) (8.2) (3.6, 19.9) | 15.2 (17.3) (8.9) (4.9, 19.1) |
| RF+, n (%) | 517 (75.6) | 387 (76.5) | 255 (66.1) | 516 (74.4) | 347 (73.8) | 310 (70.6) | 210 (68.4) | 136 (73.5) | 112 (60.5) |
| Anti-CCP+, n (%) | 565 (82.8) | 396 (78.0) | 273 (70.7) | 545 (78.5) | 359 (76.6) | 310 (71.3) | 246 (81.2) | 134 (73.2) | 119 (64.3) |
| Diabetes, n (%) | 31 (4.5) | 44 (8.5) | 55 (14.2) | 24 (3.5) | 46 (9.8) | 57 (12.9) | 12 (3.9) | 11 (5.9) | 25 (13.4) |
| Hypertension, n (%) | 156 (22.7) | 192 (37.3) | 216 (55.7) | 153 (22.0) | 165 (35.0) | 261 (58.9) | 70 (22.7) | 74 (39.8) | 99 (53.2) |
| Prior TNFi, n (%) | 103 (15.0) | 97 (18.8) | 94 (24.2) | 108 (15.5) | 74 (15.7) | 105 (23.7) | 63 (20.5) | 50 (26.9) | 87 (46.8) |
N1 values may vary for each outcome based on the number of patients assessed.
BMI, body mass index; CCP, cyclic citrullinated peptide; CRP, C-reactive protein; DAS28-4(CRP), Disease Activity Score in 28 joints, C‑reactive protein; DAS28-4(ESR), Disease Activity Score in 28 joints, erythrocyte sedimentation rate; HAQ-DI, Health Assessment Questionnaire-Disability Index; n, number of patients with characteristic; N, number of patients in each treatment group with a baseline BMI value; N1, number of patients in each BMI category; RF, rheumatoid factor; SJC, swollen joint count; TJC, tender joint count; TNFi, tumour necrosis factor inhibitors; VAS, Visual Analogue Scale.