CZP 200 mg Q2W | CZP 400 mg Q4W | |||||
---|---|---|---|---|---|---|
Week 0 CZP (n=138) | PBO→CZP week 16 (n=30) | PBO→CZP week 24 (n=30) | Week 0 CZP (n=135) | PBO→CZP week 16 (n=29) | PBO→CZP week 24 (n=31) | |
Demographic characteristics | ||||||
Age, years | 48.2±12.3 | 48.0±11.6 | 47.8±11.4 | 47.1±10.8 | 49.3±10.0 | 45.0±10.7 |
Sex, % female | 53.6 | 56.7 | 63.3 | 54.1 | 65.5 | 51.6 |
Race, % white | 97.8 | 100 | 100 | 98.5 | 96.6 | 93.5 |
Weight, kg | 85.8±17.7 | 82.8±18.7 | 81.1±16.5 | 84.8±18.7 | 78.9±21.5 | 87.3±23.4 |
BMI, kg/m2 | 30.5±6.2 | 28.9±5.5 | 28.5±4.1 | 29.6±6.6 | 28.1±7.0 | 30.9±9.3 |
Arthritis characteristics | ||||||
Time from psoriatic arthritis diagnosis,* years | 9.6±8.5 | 7.7±7.3 | 7.3±7.5 | 8.1±8.3 | 10.6±10.3 | 6.3±5.7 |
CRP† (mg/L), median (minimum–maximum) | 7.0 (0.3–238.0) | 6.5 (0.2–100.0) | 8.7 (0.3–32.3) | 9.1 (0.1–87.0) | 10.3 (1.1–80.7) | 10.3 (0.7–60.0) |
ESR (mm/h), median (minimum–maximum) | 35.0 (5.0–125.0) | 32.5 (15–91) | 32.0 (20–95) | 33.0 (4.0–120.0) | 35.0 (10–92) | 31.0 (6–70) |
Tender joint count (0–68 joints) | 21.5±15.3 | 19.4±15.2 | 17.0±13.8 | 19.6±14.8 | 18.4±11.2 | 21.2±16.0 |
Swollen joint count (0–66 joints) | 11.0±8.8 | 10.0±7.9 | 9.7±7.0 | 10.5±7.5 | 10.0±6.2 | 10.0±7.5 |
HAQ-DI (range 0–3) | 1.3±0.7 | 1.3±0.6 | 1.2±0.6 | 1.3±0.6 | 1.5±0.6 | 1.1±0.7 |
Modified total Sharp score | 15.4±27.9 | 25.3±50.2 | 18.5±24.8 | 20.9±45.3 | 37.0±79.2 | 15.5±30.3 |
Erosion score | 9.4±16.2 | 15.7±29.6 | 10.7±14.0 | 12.9±25.3 | 21.7±43.3 | 9.7±17.4 |
Joint space narrowing score | 6.0±12.4 | 9.7±20.9 | 7.8±12.0 | 8.0±20.5 | 15.2±36.2 | 5.7±13.5 |
Psoriasis characteristics | ||||||
Psoriasis BSA ≥3%, n (%) | 90 (65.2) | 18 (60.0) | 20 (66.7) | 76 (56.3) | 20 (69.0) | 16 (51.6) |
PASI,‡ median (minimum–maximum) | 7.0 (0.6–72.0) | 9.1 (0.5–20.1) | 4.6 (0.3–20.4) | 8.1 (0.6–51.8) | 7.7 (0.6–37.9) | 6.0 (1.2–36.9) |
Prior use of synthetic DMARDs, n (%) | ||||||
1 | 61 (44.2) | 17 (56.7) | 18 (60.0) | 68 (50.4) | 11 (37.9) | 17 (54.8) |
≥2 | 74 (53.6) | 12 (40.0) | 12 (40.0) | 64 (47.4) | 17 (58.6) | 14 (45.2) |
Concomitant use of NSAIDs to week 96, n (%) | 106 (76.8) | 25 (83.3) | 20 (66.7) | 105 (77.8) | 22 (75.9) | 26 (83.9) |
Prior anti-TNF exposure, n (%) | 31 (22.5) | 9 (30.0) | 3 (10.0) | 23 (17.0) | 7 (24.1) | 2 (6.5) |
Concomitant use of MTX to week 96, n (%) | 90 (65.2) | 18 (60.0) | 20 (66.7) | 87 (64.4) | 19 (65.5) | 20 (64.5) |
Data are shown for the Randomised Set. Except where indicated otherwise, values are the mean±SD.
*From the start date of primary disease.
†Normal range of CRP <8.0 mg/L.
‡PASI scores reported for patients with psoriasis body surface area ≥3% at baseline.
BMI, body mass index; BSA, body surface area; CRP, C reactive protein; CZP, certolizumab pegol; ESR, erythrocyte sedimentation rate; HAQ-DI, Health Assessment Questionnaire Disability Index; MTX, methotrexate; NSAID, non-steroidal anti-inflammatory drugs; PASI, Psoriasis Area and Severity Index; PBO, placebo; Q2W, every 2 weeks; TNF, tumour necrosis factor.