Summary of baseline demographics and characteristics
| Characteristic | PBO+MTX n=213 | CZP+MTX n=655 | All patients n=868 |
|---|---|---|---|
| Mean age, years (SD) | 51.2 (13.0) | 50.4 (13.6) | 50.6 (13.5) |
| Female, n (%) | 170 (79.8) | 497 (75.9) | 667 (76.8) |
| BMI (kg/m2) | |||
| n | 213 | 652 | 865 |
| Mean (SD) | 28.8 (6.4) | 28.0 (6.0) | 28.2 (6.1) |
| Region, n (%) | |||
| Europe and Australia | 107 (50.2) | 354 (54.0) | 461 (53.1) |
| Latin and North America | 106 (49.8) | 301 (46.0) | 407 (46.9) |
| Systemic corticosteroids, n (%)a | 64 (29.5) | 222 (33.7) | 286 (32.6) |
| DAS28(ESR), mean (SD) | 6.8 (0.9) | 6.7 (0.9) | 6.7 (0.9) |
| Moderate disease activity: >3.2 to ≤5.1, n (%) | 10 (4.7) | 20 (3.1) | 30 (3.5) |
| High disease activity: >5.1, n (%) | 203 (95.3) | 635 (96.9) | 838 (96.5) |
| SDAI, mean (SD) | 44.8 (13.9) | 43.5 (13.6) | 43.8 (13.7) |
| CDAI, mean (SD) | 42.6 (12.9) | 41.3 (12.5) | 41.6 (12.6) |
| HAQ-DI, mean (SD) | 1.7 (0.6) | 1.6 (0.6) | 1.6 (0.6) |
| TJC (28 joints), mean (SD) | 16.2 (6.5) | 15.6 (6.5) | 15.8 (6.5) |
| SJC (28 joints), mean (SD) | 13.0 (5.6) | 12.4 (5.5) | 12.5 (5.5) |
| ESR (mm/h), median (min, max) | 44.0 (10.0, 135.0) | 42.0 (2.0, 150.0) | 43.0 (2.0, 150.0) |
| CRP (mg/L), median (min, max) | 10.5 (0.3, 243.2) | 11.1 (0.2, 231.1) | 11.1 (0.2, 243.2) |
| Months since RA was first diagnosed, mean (SD) | 2.9 (2.9) | 2.9 (4.6) | 2.9 (4.3) |
| >4 months, mean (SD) | 7.1 (2.5)b | 7.6 (7.8)c | 7.4 (6.8) |
| ≤4 months, mean (SD) | 1.4 (1.0)d | 1.4 (1.0)e | 1.4 (1.0) |
| Months since first RA symptom, mean (SD)f | 9.6 (11.8)g | 12.4 (32.3)h | 11.7 (28.6) |
| RF positive (≥14 IU/mL), n (%) | 206 (96.7) | 634 (96.8) | 840 (96.8) |
| ACPA positive (≥7 IU/mL), n (%) | 182 (85.4) | 546 (83.4) | 728 (83.9) |
| mTSS, median (min, max) | 2.8 (0, 161) | 3.0 (0, 130) | 3.0 (0, 161) |
| Mean (SD) | 8.5 (17.5) | 7.2 (13.8) | 7.5 (14.8) |
| >4 months, median (min, max) | 5.0 (0, 106)i | 3.0 (0, 38)j | − |
| ≤4 months, median (min, max) | 2.3 (0, 161)k | 2.5 (0, 130)l | − |
| Erosion score, median (min, max) | 1.5 (0, 68) | 1.5 (0, 69) | 1.5 (0, 69) |
| JSN, median (min, max) | 0 (0, 94) | 0 (0, 76) | 0 (0, 94) |
| Presence of erosions, n (%) | 169 (79.3) | 506 (77.3) | 675 (77.8) |
aSafety set, all other data are reported for full analysis set; bn=56; cn=153; dn=157; en=502; fdata were collected retrospectively; gn=208; hn=631; in=43; jn=118; kn=120 and ln=410.
ACPA, anticitrullinated peptide antibody; CDAI, Clinical Disease Activity Index; CRP, C reactive protein; CZP, certolizumab pegol; HAQ-DI, Health Assessment Questionnaire-Disability Index; JSN, joint space narrowing; mTSS, van der Heijde modified total Sharp score; MTX, methotrexate; PBO, placebo; RA, rheumatoid arthritis; RF, rheumatoid factor; SDAI, Simplified Disease Activity Index.