Characteristic | Week 52 CZP completers* (N=508) | CZP ITT population (N=783) | Dose reduction population (N=436) |
---|---|---|---|
Age, mean (SD), years | 51.5 (11.4) | 51.9 (11.7) | 51.3 (11.1) |
Gender, % female | 83.1 | 83.0 | 83.5 |
Disease duration, mean (SD), years | 6.1 (4.1) | 6.1 (4.3) | 6.1 (4.1) |
Number of prior DMARDs (except MTX), mean (SD) | 1.3 (1.3) | 1.3 (1.3) | 1.2 (1.2) |
RF positive (≥14 IU/mL), % | 84.6 | 81.5 | 84.4 |
Tender/painful joint count, mean (SD) | 31.0 (12.7) | 30.9 (12.8) | 31.0 (12.4) |
Swollen joint count, mean (SD) | 22.3 (9.9) | 21.6 (9.8) | 22.3 (9.8) |
Pain VAS, mean (SD) | 63.0 (18.0) | 62.9 (18.7) | 63.0 (17.9) |
HAQ-DI, mean (SD) | 1.7 (0.6) | 1.7 (0.6) | 1.7 (0.6) |
DAS28 (ESR), median (min, max) | 7.0 (4, 9) | 6.9 (4, 9) | 7.0 (4, 9) |
*Week 52 CZP completers are defined as patients randomised to CZP who completed the 52-week feeder study and reconsented to enrol in the OLE study.
CZP, certolizumab pegol; DAS, Disease Activity Score; ESR, Erythrocyte Sedimentation Rate; HAQ-DI, Health Assessment Questionnaire – Disability Index; ITT, intent-to-treat; MTX, methotrexate; OLE, open-label extension; RAPID, Rheumatoid Arthritis Prevention of Structural Damage; RF, Rheumatoid Factor; VAS, visual analogue scale.