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Table 1 Baseline disease characteristics and PRO scores in the ITT population

From: Impact of certolizumab pegol on patient-reported outcomes in rheumatoid arthritis and correlation with clinical measures of disease activity

 

Placebo (n = 212)

CZPa (n = 851)

Clinical characteristics

 Disease duration, yr, median (min–max)

6.3 (0.3–49.0)

5.43 (0.2–52.0)

 Tender joint count, mean (SD)b

14.7 (6.6)

14.7 (6.6)

 Swollen joint count, mean (SD)b

11.1 (5.2)

11.8 (5.6)

 DAS28(CRP), mean (SD)

5.7 (0.9)

5.7 (0.9)

 DAS28(ESR), mean (SD)

6.4 (0.9)

6.4 (0.9)

Baseline patient-reported outcomes

 Fatigue Assessment Scale score, mean (SD) (0––10)

6.4 (2.2)

6.2 (2.2)

 Medical Outcomes Study Sleep Problem Index II score, mean (SD) (0–100)

48.1 (19.9)

47.6 (19.5)

 Pain VAS score, mean (SD) (0–100)

62.3 (22.9)

58.8 (23.3)

 PtGA VAS score, mean (SD) (0–100)

61.6 (20.7)

59.2 (22.1)

 RADAI-TS, mean (SD) (0–10)

5.7 (1.9)

5.6 (1.8)

 RAPID3, mean (SD) (0–30)

15.5 (5.4)

14.7 (5.5)

  1. CRP C-reactive protein, CZP certolizumab pegol, DAS28 Disease Activity Score in 28 joints, ESR erythrocyte sedimentation rate, PRO patient-reported outcome, SD standard deviation, VAS visual analog scale, FAS Fatigue Assessment Scale, PtGA Patient Global Assessment of Disease Activity, ITT intention to treat, RADAI-TS Rheumatoid Arthritis Disease Activity Index total score, RAPID3 Routine Assessment of Patient Index Data 3
  2. aCZP dose: 400 mg at weeks 0, 2, and 4 (loading dose), then 200 mg at weeks 6, 8, and 10
  3. b28-joint assessment