Table 1

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, years47.3±11.148.2±12.347.1±10.8
 Sex, % female58.153.654.1
 Race, % white97.197.898.5
 Weight, kg82.6±19.9†85.8±17.784.8±18.7
 BMI, kg/m229.2±6.7†30.5±6.229.6±6.6
Arthritis characteristics
 Time from psoriatic arthritis diagnosis‡, years7.9±7.79.6±8.58.1±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±14.721.5±15.319.6±14.8
 Swollen joint count (0–66 joints)10.4±7.611.0±8.810.5±7.5
 Modified total Sharp score24.4±49.718.0±30.622.8±46.5
  Erosion score14.0±27.010.3±17.313.4±25.2
  Joint space narrowing score10.4±23.37.7±14.59.4±22.1
 Physician's Assessment of Disease Activity, by VAS, mm58.7±18.756.8±18.258.2±18.9
 Patient's Assessment of Disease Activity57.0±22.460.2±21.060.2±18.4
 Patient's Assessment of Arthritis Pain, by VAS, mm60.0±22.059.7±20.761.1±18.5
 HAQ-DI (range 0–3)1.3±0.71.3±0.71.3±0.6
 Enthesitis, %¶66.963.862.2
  LEI**2.9±1.63.1±1.72.9±1.6
 Dactylitis, %††25.725.428.1
  LDI**65.6±90.445.3±36.056.8±75.9
Psoriasis characteristics
 Psoriasis BSA ≥3%, %63.265.256.3
 PASI, median (min-max)‡‡7.1 (0.3–55.2)7.0 (0.6–72.0)8.1 (0.6–51.8)
 Nail involvement, %75.766.777.8
 mNAPSI3.4±2.23.1±1.83.4±2.2
Concomitant MTX at baseline, %61.863.865.2
No concomitant DMARDs at baseline, %35.328.325.9
Prior use of DMARDs, %
 154.444.253.3
 ≥244.152.944.5
Prior use of NSAIDs, %83.881.991.1
Prior TNF inhibitor exposure, %19.122.517.0
  • *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.