Placebo (n=136) | CZP 200 mg Q2W (n=138) | CZP 400 mg Q4W (n=135) | All patients (N=409) | |
---|---|---|---|---|
Demographic characteristics* | ||||
Age, years | 47.3±11.1 | 48.2±12.3 | 47.1±10.8 | 47.6±11.4 |
Sex, % female | 58.1 | 53.6 | 54.1 | 55.3 |
Weight, kg | 82.6±19.9† | 85.8±17.7 | 84.8±18.7 | 84.4±18.8‡ |
BMI, kg/m2 | 29.2±6.7† | 30.5±6.2 | 29.6±6.6 | 29.8±6.5‡ |
Arthritis characteristics | ||||
Tender joint count (0–68 joints) | 19.9±14.7 | 21.5±15.3 | 19.6±14.8 | 20.3±14.9 |
Swollen joint count (0–66 joints) | 10.4±7.6 | 11.0±8.8 | 10.5±7.5 | 10.7±8.0 |
Physician's assessment of disease activity, by VAS, mm | 58.7±18.7 | 56.8±18.2 | 58.2±18.9 | 57.9±18.6 |
Psoriasis characteristics | ||||
Psoriasis BSA ≥3%, n (%) | 86 (63.2) | 90 (65.2) | 76 (56.3) | 252 (61.6) |
PASI, median (min–max)§ | 7.1 (0.3–55.2) | 6.8 (0.6–72.0) | 8.1 (0.6–51.8) | 7.2 (0.3–72.0) |
Concomitant medication¶ | ||||
MTX use, % | 61.8 | 63.8 | 65.2 | 63.6 |
CS use, % | 28.7 | 36.2 | 25.9 | 30.0 |
There were no significant differences between treatment groups at baseline.
*Except where indicated otherwise, values are the mean±SD.
†n=135.
‡n=408.
§PASI scores for those patients with psoriasis body surface area ≥3% at baseline.
¶Refers to concomitant use of MTX or any CS taken for at least 1 day during the 24-week double-blind treatment period.
BMI, body mass index; BSA, body surface area; CS, corticosteroid; CZP, certolizumab pegol; MTX, methotrexate; PASI, Psoriasis Area and Severity Index; Q2W, every 2 weeks; Q4W, every 4 weeks; RS, randomised set; VAS, visual analogue scale.