Table 1.
Patient characteristics in each of the phase III clinical studies, OSKIRA-1, -2 and -3.
| Study | OSKIRA 1 | OSKIRA 2 | OSKIRA 3 | p | |
|---|---|---|---|---|---|
| N | 206 | 197 | 71 | ||
| Gender, n (%) | Females | 173 (84%) | 169 (86) | 55 (78) | > 0.1 |
| Age | 53.0 (12.0) | 54.4 (12.5) | 54.1 (12.7) | > 0.1 | |
| BMI | 28.0 (6.1) | 28.0 (6.4) | 29.7 (6.7) | > 0.1 | |
| Ethnicity, n (%) | African decent | 4 (2) | 13 (6.6) | 6 (8.4) | < 0.0001 |
| ASIAN | 1 (0.5) | 20 (10.2) | 0 | ||
| Caucasian | 108 (52.4) | 150 (76.1) | 37 (52.1) | ||
| Hispanic or Latino | 93 (45.1) | 12 (6.1) | 28 (39.4) | ||
| Other | 0 | 2 (1.0%) | 0 | ||
| Disease duration, years (SD) | 9.1 (7.9) | 7.5 (8.6) | 10.2 (7.8) | < 0.0001 | |
| Disease activity score, mean (SD) | 5.9 (0.8) | 5.6 (0.9) | 5.6 (0.4) | > 0.1 | |
| Presence of erosions at baseline | Yes | 100 (49.8) | 93 (47.2) | 37 (52.1) | > 0.1 |
| Previous conventional DMARDs | Yes | 76 (36.9) | 64 (32.5) | 22 (31.0) | > 0.1 |
| Previous anti-TNFa treatment | Yes | 10 (4.9%) | 36 (18.3%) | 71 (100%) | < 0.0001 |
| Previous other biologics | Yes | 0 (0%) | 0 (0%) | 0 (0%) | > 0.1 |
| Escape at week 12 | Yes | 66 (32.0) | 90 (45.7) | 25 (35.2) | 0.016 |
Data is presented as mean (SD) or frequency (%) as appropriated. Significant difference between studies was estimated by either χ2 or Kruskal-Wallis test (alpha = 0.05)