Table 2.
Baseline characteristics of the patients entering the phase III tofacitinib trials, by treatment exposure group*
| Tofacitinib | Placebo (n = 681) | Adalimumab (n = 204) | ||
|---|---|---|---|---|
| 5 mg BID (n = 1,216) | 10 mg BID (n = 1,214) | |||
| Age, median (range) years | 54 (19–86) | 54 (18–86) | 54 (18–82) | 54 (24–78) |
| Female, no. (%) | 1,027 (84) | 1,031 (85) | 553 (81) | 162 (79) |
| Race, no. (%) | ||||
| White | 737 (61) | 741 (61) | 439 (64) | 148 (72) |
| Black | 45 (4) | 35 (3) | 24 (3) | 3 (1) |
| Asian | 327 (27) | 314 (26) | 166 (24) | 29 (14) |
| Other | 107 (9) | 124 (10) | 52 (8) | 24 (12) |
| Duration of RA, mean years | 8.7 | 9.1 | 9.3 | 8.1 |
| Diabetes mellitus, no. (%) | 108 (9) | 103 (9) | 48 (7) | 16 (8) |
| COPD, no. (%) | 104 (9) | 105 (9) | 64 (9) | 11 (5) |
| Smoking history, no. (%) | 408 (34) | 406 (33) | 254 (37) | 71 (35) |
| BMI, mean (range) kg/m2 | 27 (14–71) | 27 (14–58) | 27 (15–55) | 27 (14–46) |
| Severity of RA, mean DAS28-CRP | 5.4 | 5.3 | 5.3 | 5.3 |
| Concomitant DMARDs, no. (%) | ||||
| Methotrexate | 903 (74) | 899 (74) | 520 (76) | 199 (97) |
| Leflunomide | 91 (7) | 84 (7) | 34 (5) | 0 (0) |
| Hydroxychloroquine | 115 (9) | 104 (9) | 51 (7) | 2 (<1) |
| Baseline corticosteroids | 700 (58) | 675 (56) | 385 (57) | 116 (57) |
*
BID = twice daily; RA = rheumatoid arthritis; COPD = chronic obstructive pulmonary disease; BMI = body mass index; DAS28-CRP = Disease Activity Score in 28 joints (3-variable) using the C-reactive protein level; DMARDs = disease-modifying antirheumatic drugs.