Table 1.
Placebo (N = 157) | CZP 200 mg Q2W † (N = 351) | CZP 400 mg Q2W (N = 342) | |
---|---|---|---|
Demographics | |||
Age (years), mean ± SD | 46.0 ± 13.3 | 46.1 ± 13.4 | 45.2 ± 12.6 |
Male, n (%) | 95 (60.5) | 238 (67.8) | 210 (61.4) |
White, n (%) | 146 (93.0) | 331 (94.3) | 322 (94.2) |
Geographic region, n (%) | |||
North America | 71 (45.2) | 136 (38.7) | 133 (38.9) |
Europe | 86 (54.8) | 215 (61.3) | 209 (61.1) |
Weight (kg), mean ± SD | 92.2 ± 25.8 | 92.6 ± 22.3 | 89.2 ± 22.7 |
BMI (kg/m2), mean ± SD | 31.2 ± 7.8 | 31.0 ± 7.1 | 30.1 ± 7.1 |
Baseline disease characteristics | |||
Duration of psoriasis at screening (years), mean ± SD | 17.7 ± 12.7 | 18.5 ± 13.1 | 18.2 ± 12.0 |
Concurrent psoriatic arthritis (self‐reported), n (%) | 25 (15.9) | 59 (16.8) | 65 (19.0) |
PASI, mean ± SD | 18.8 ± 6.8 | 20.3 ± 8.1 | 20.2 ± 7.5 |
DLQI ‡ mean ± SD | 13.4 ± 7.7 | 13.6 ± 7.2 | 14.5 ± 7.1 |
BSA (%), mean ± SD | 23.5 ± 13.6 | 25.6 ± 15.9 | 25.5 ± 14.9 |
PGA, n (%) | |||
3: moderate | 112 (71.3) | 242 (68.9) | 239 (69.9) |
4: severe | 45 (28.7) | 109 (31.1) | 103 (30.1) |
Any prior systemic psoriasis treatment, n (%) | 111 (70.7) | 249 (70.9) | 247 (72.2) |
Prior biologic use § n (%) | 40 (25.5) | 106 (30.2) | 107 (31.3) |
Anti‐TNF | 24 (15.3) | 49 (14.0) | 43 (12.6) |
Anti‐IL‐17 | 13 (8.3) | 54 (15.4) | 43 (12.6) |
†CZP 200 mg Q2W patients received loading dose of CZP 400 mg at Weeks 0, 2 and 4. ‡For DLQI: Placebo, N = 154; CZP 200 mg Q2W, N = 346; CZP 400 mg Q2W, N = 340. §Patients may have had exposure to >1 prior biologic but ≤2 per exclusion criteria; one patient in the CZP 400 mg Q2W group in CIMPASI‐2 had prior exposure to three biologics, which was a protocol violation.
BMI, body mass index; BSA, body surface area; CZP, certolizumab pegol; DLQI, Dermatology Life Quality Index; IL, interleukin; PASI, psoriasis area and severity index; PGA, physician's global assessment; Q2W, every 2 weeks; TNF, tumour necrosis factor.