Table 1.
Patient characteristics at baseline: safety set
| Placebo→CZP (n=13) | CZP (n=27) | All patients (N=40) | |
|---|---|---|---|
| Demographic characteristics: mean (SD), unless noted | |||
| Age, years | 48.3 (14.4) | 51.3 (12.6) | 50.4 (13.1) |
| Sex, % female | 76.9 | 81.5 | 80.0 |
| Weight, kg | 75.9 (30.4) | 74.0 (18.7) | 74.6 (22.8) |
| Time since diagnosis, years | 5.9 (5.1) | 4.8 (3.8) | 5.1 (4.2) |
| Concomitant MTX use, % | 92.3 | 85.2 | 87.5 |
| Prior anti-TNF therapy, % | 15.4 | 22.2 | 20.0 |
| Disease characteristics: mean (SD), unless noted | |||
| CRP, mg/L* | 6.2 (247.5) | 3.8 (171.0) | 4.4 (194.9) |
| DAS28(CRP) | 5.3 (1.2) | 5.1 (1.1) | 5.1 (1.1) |
| IgM rheumatoid factor positive† (%) | 92.3 | 92.6 | 92.5 |
| Anti-CCP positive‡ (%) | 92.3 | 96.3 | 95.0 |
| Tender joint count (28 joints) | 13.8 (7.4) | 13.0 (7.8) | 13.3 (7.6) |
| Swollen joint count (28 joints) | 9.9 (6.3) | 10.0 (6.4) | 10.0 (6.3) |
| HAQ-DI | 1.4 (0.5) | 1.2 (0.6) | 1.3 (0.6) |
| MRI synovitis score§ | 7.4 (5.2) | 7.3 (5.3) | 7.4 (5.2) |
| MRI osteitis score¶ | 7.1 (7.3) | 7.2 (9.9) | 7.2 (9.0) |
| MRI bone erosion Score** | 7.0 (11.0) | 5.0 (7.2) | 5.7 (8.5) |
*Data show geometric mean (geometric coefficient of variation (%)).
†Rheumatoid factor positive ≥14 IU/mL.
‡Anti-CCP positive ≥20 ELISA units.
§On a scale from 0 to 21.
¶On a scale of 0–69.
**On a scale of 0–230.
CCP, cyclic citrullinated peptide; CRP, C reactive protein; CZP, certolizumab pegol; DAS, Disease Activity Score; HAQ-DI, Health Assessment Questionnaire-Disability Index; IgM, immunoglobulin M; MTX, methotrexate; TNF, tumour necrosis factor.