Table 1.
Baseline characteristics of patients entering phase III tofacitinib trials by exposure group
| Tofacitinib 5 mg twice daily (N=1587; PY=1464.18) |
Tofacitinib 10 mg twice daily (N=1609; PY=1501.03) | Placebo (N=681; PY=202.71) |
Adalimumab (N=204; PY=178.04) |
Methotrexate (N=186; PY=152.07) | |
|---|---|---|---|---|---|
| Age, median years (range) | 54 (18–86) | 54 (18–86) | 54 (18–82) | 54 (24–78) | 50.5 (20–80) |
| Female, n (%) | 1310 (82.5) | 1355 (84.2) | 553 (81.2) | 162 (79.4) | 145 (78.0) |
| Race, n (%) | |||||
| White | 976 (61.5) | 1006 (62.5) | 439 (64.5) | 148 (72.5) | 127 (68.3) |
| Black | 58 (3.7) | 47 (2.9) | 24 (3.5) | 3 (1.5) | 4 (2.2) |
| Asian | 394 (24.8) | 375 (23.3) | 166 (24.4) | 29 (14.2) | 33 (17.7) |
| Other | 159 (10) | 181 (11.2) | 52 (7.6) | 24 (11.8) | 22 (11.8) |
| RA duration, mean, years | 7.4 | 7.7 | 9.3 | 8.1 | 2.6 |
| Diabetes mellitus, n (%) | 130 (8.2) | 127 (7.9) | 48 (7.0) | 16 (7.8) | 8 (4.3) |
| COPD, n (%) | 125 (7.9) | 134 (8.3) | 64 (9.4) | 11 (5.4) | 9 (4.8) |
| Smoking history, n (%) | 534 (33.7) | 520 (32.3) | 254 (37.4) | 71 (35.1) | 61 (32.8) |
| BMI, mean (range) | 26.9 (14.3–70.8) | 27.0 (12.1–63.3) | 27.2 (14.7–55.1) | 27.1 (13.9–45.7) | 26.7 (14.9–49.4) |
| RA severity (DAS28-3 CRP) | 5.4 | 5.4 | 5.3 | 5.3 | 5.6 |
| Concomitant DMARD, n (%) | |||||
| Methotrexate | 904 (57.0) | 902 (56.1) | 520 (76.4) | 199 (97.5) | 1 (0.5) |
| Leflunomide | 91 (5.7) | 84 (5.2) | 34 (5.0) | 0 (0) | 0 (0) |
| Hydroxychloroquine | 152 (9.6) | 157 (9.8) | 51 (7.5) | 2 (<1.0) | 26 (14.0) |
| Baseline glucocorticoid use, n (%) | 866 (54.6) | 834 (51.8) | 376 (55.2) | 116 (56.9) | 79 (42.5) |
| >0 mg to <5 mg daily | 114 (7.2) | 113 (7.0) | 48 (7.0) | 16 (7.8) | 10 (5.4) |
| 5 to 10 mg daily | 731 (46.1) | 698 (43.4) | 315 (46.3) | 90 (44.1) | 68 (36.6) |
| >10 mg daily | 9 (<1.0) | 9 (<1.0) | 5 (<1.0) | 7 (3.4) | 0 (0) |
| Unknown dose | 24 (1.5) | 20 (1.2) | 19 (2.8) | 3 (1.5) | 3 (1.6) |
BMI, body mass index; COPD, chronic obstructive pulmonary disease; DAS28-3 CRP, Disease Activity Score using 28-joint counts and the C reactive protein level; DMARD, disease-modifying antirheumatic drugs; PY, person-years exposure; RA, rheumatoid arthritis.