Table 1 Demographics and baseline characteristics
Safety population (n = 2,484*) | Patients enrolled early (n = 400) | Patients enrolled late (n = 400) | |
|---|---|---|---|
Female, n (%) | 1906 (76.7) | 302 (75.5) | 326 (81.5) |
Age (years), mean ± SD | 56.4 ± 12.4 (n = 2,474) | 55.1 ± 12.1 | 56.9 ± 12.4 |
Duration of disease before study, years, mean ± SD | 11.7 ± 9.6 (n = 2,168) | 12.3 ± 9.3 | 11.9 ± 9.9 |
RF-positive, n (%) | 1477 (77.3) (n = 1,910) | 277 (78.5) (n = 353) | 232 (77.6) (n = 299) |
Treatment duration (months) over all study courses, mean ± SD | 17.2 ± 13.7 (n = 2,484) | 22.4 ± 17.0 | 9.1 ± 7.9 |
No. of previous DMARD baseline treatments including TNF antagonists, median | 4 | 5 | 4 |
No. of previous conventional DMARD baseline treatments, median | 3 | 3 | 2 |
No. of baseline TNF antagonists, median† | 1 | 2 | 1 |
Previous TNF antagonists, n (%)† | |||
0 | 510 (20.5) | 66 (16.5) | 89 (22.3) |
1 | 827 (33.3) | 93 (23.3) | 163 (40.8) |
2 | 785 (31.6) | 135 (33.8) | 122 (30.5) |
3 | 362 (14.6) | 106 (26.5) | 26 (6.5) |
No. of different TNF antagonists per patient, mean ± SD | 1.4 ± 1.0 | 1.7 (1.0) | 1.2 (0.9) |
Most frequent previous | |||
DMARD baseline treatments, n (%) | |||
Leflunomide | 1690 (68.0) | 285 (71.3) | 256 (64.0) |
Methotrexate | 1661 (66.9) | 291 (72.8) | 276 (69.0) |
Adalimumab | 1385 (55.8) | 245 (61.3) | 200 (50.0) |
Etanercept | 1360 (54.8) | 265 (66.3) | 205 (51.3) |
Sulphasalazine | 1145 (46.1) | 215 (53.8) | 168 (42.0) |
Infliximab | 736 (29.6) | 171 (42.8) | 80 (20.0) |
Baseline DAS28, mean ± SD‡ | 5.7 ± 1.2 (n = 1,954) | 5.9 ± 1.2 (n = 384) | 5.4 ± 1.3 (n = 349) |
Baseline HAQ, mean ± SD‡ | 1.6 ± 0.7 (n = 2,078) | 1.74 ± 0.70 (n = 389) | 1.56 ± 0.73 (n = 384) |
Time between first and second course (months), mean ± SD‡ | 9.6 ± 4.4 (n = 1,306) | 10.5 ± 4.9 (n = 250) | 6.8 ± 1.6 (n = 143) |