Baseline demographics and disease severity characteristics, by treatment group*
| Placebo (n=136) | CZP 200 mg Q2W (n=138) | CZP 400 mg Q4W (n=135) | |
|---|---|---|---|
| Demographic characteristics | |||
| Age, years | 47.3±11.1 | 48.2±12.3 | 47.1±10.8 |
| Sex, % female | 58.1 | 53.6 | 54.1 |
| Race, % white | 97.1 | 97.8 | 98.5 |
| Weight, kg | 82.6±19.9† | 85.8±17.7 | 84.8±18.7 |
| BMI, kg/m2 | 29.2±6.7† | 30.5±6.2 | 29.6±6.6 |
| Arthritis characteristics | |||
| Time from psoriatic arthritis diagnosis‡, years | 7.9±7.7 | 9.6±8.5 | 8.1±8.3 |
| CRP§ (mg/L), median (min-max) | 9.0 (0.2–131.0) | 7.0 (0.2–238.0) | 8.7 (0.1–87.0) |
| ESR (mm/h), median (min-max) | 34.0 (6.0–125.0) | 35.0 (5.0–125.0) | 33.0 (4.0–120.0) |
| Tender joint count (0–68 joints) | 19.9±14.7 | 21.5±15.3 | 19.6±14.8 |
| Swollen joint count (0–66 joints) | 10.4±7.6 | 11.0±8.8 | 10.5±7.5 |
| Modified total Sharp score | 24.4±49.7 | 18.0±30.6 | 22.8±46.5 |
| Erosion score | 14.0±27.0 | 10.3±17.3 | 13.4±25.2 |
| Joint space narrowing score | 10.4±23.3 | 7.7±14.5 | 9.4±22.1 |
| Physician's Assessment of Disease Activity, by VAS, mm | 58.7±18.7 | 56.8±18.2 | 58.2±18.9 |
| Patient's Assessment of Disease Activity | 57.0±22.4 | 60.2±21.0 | 60.2±18.4 |
| Patient's Assessment of Arthritis Pain, by VAS, mm | 60.0±22.0 | 59.7±20.7 | 61.1±18.5 |
| HAQ-DI (range 0–3) | 1.3±0.7 | 1.3±0.7 | 1.3±0.6 |
| Enthesitis, %¶ | 66.9 | 63.8 | 62.2 |
| LEI** | 2.9±1.6 | 3.1±1.7 | 2.9±1.6 |
| Dactylitis, %†† | 25.7 | 25.4 | 28.1 |
| LDI** | 65.6±90.4 | 45.3±36.0 | 56.8±75.9 |
| Psoriasis characteristics | |||
| Psoriasis BSA ≥3%, % | 63.2 | 65.2 | 56.3 |
| PASI, median (min-max)‡‡ | 7.1 (0.3–55.2) | 7.0 (0.6–72.0) | 8.1 (0.6–51.8) |
| Nail involvement, % | 75.7 | 66.7 | 77.8 |
| mNAPSI | 3.4±2.2 | 3.1±1.8 | 3.4±2.2 |
| Concomitant MTX at baseline, % | 61.8 | 63.8 | 65.2 |
| No concomitant DMARDs at baseline, % | 35.3 | 28.3 | 25.9 |
| Prior use of DMARDs, % | |||
| 1 | 54.4 | 44.2 | 53.3 |
| ≥2 | 44.1 | 52.9 | 44.5 |
| Prior use of NSAIDs, % | 83.8 | 81.9 | 91.1 |
| Prior TNF inhibitor exposure, % | 19.1 | 22.5 | 17.0 |
*Except where indicated otherwise, values are the mean±SD. There were no significant differences between treatment groups at baseline.
†n=135.
‡From the start date of the primary disease.
§Normal range of CRP <8.0 mg/L.
¶Presence of enthesitis at baseline defined as a baseline Leeds Enthesitis Index score >0.
**LDI and LEI reported for patients with dactylitis and enthesitis, respectively, at baseline.
††Presence of dactylitis at baseline assessed using Leeds Dactylitis Index.
‡‡PASI—scores for those patients with psoriasis body surface area ≥3% at baseline.
BMI, body mass index; BSA, body surface area; CRP, c-reactive protein; CZP, certolizumab pegol; DI, disability index; DMARDs, disease modifying antirheumatic drugs; ESR, erythrocyte sedimentation rate; HAQ, Health Assessment Questionnaire; LDI, Leeds Dactylitis Index; LEI, Leeds Enthesitis Index; mNAPSI, Modified Nail Psoriasis Severity Index; MTX, methotrexate; NSAIDs, non-steroidal anti-inflammatory drugs; PASI, Psoriasis Area and Severity Index; Q2W, every 2 weeks; Q4W, every 4 weeks; TNF, tumour necrosis factor; VAS, visual analogue scale.