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Table 1 Baseline characteristics

From: Guselkumab demonstrated an independent treatment effect in reducing fatigue after adjustment for clinical response—results from two phase 3 clinical trials of 1120 patients with active psoriatic arthritis

 

DISCOVER-1

DISCOVER-2

Guselkumab 100 mg Q4W

Guselkumab 100 mg Q8W

Placebo

Guselkumab 100 mg Q4W

Guselkumab 100 mg Q8W

Placebo

N

128

127

126

245

248

246

Age (years)

47 (12)

49 (12)

49 (11)

46 (12)

45 (12)

46 (12)

Male, n (%)

66 (52%)

68 (54%)

61 (48%)

142 (58%)

129 (52%)

117 (48%)

BMI (kg/m2)

29.9 (5.5)

29.9 (6.4)

29.6 (5.7)

29.1 (5.9)

28.7 (6.3)

29.0 (6.4)

PsA disease duration (years)

6.6 (6.3)

6.4 (5.9)

7.2 (7.6)

5.5 (5.9)

5.1 (5.5)

5.8 (5.6)

Components of ACR20 and MDA

 Number of swollen joints (0–66)

8.6 (5.8)

10.9 (9.3)

10.1 (7.1)

12.9 (7.8)

11.7 (6.8)

12.3 (6.9)

 Number of tender joints (0–68)

17.7 (13.1)

20.2 (14.5)

19.8 (14.4)

22.4 (13.5)

19.8 (11.9)

21.6 (13.1)

 CRP (mg/dL), median (IQR)

0.6 (0.3–1.3)

0.7 (0.4–1.9)

0.8 (0.3–1.5)

1.2 (0.6–2.3)

1.3 (0.7–2.5)

1.2 (0.5–2.6)

 PASI score (0–72)

9.5 (10.1)

8.4 (9.8)

7.7 (8.8)

10.8 (11.7)

9.7 (11.7)

9.3 (9.8)

 HAQ-DI (0–3)

1.1 (0.6)

1.2 (0.6)

1.1 (0.6)

1.2 (0.6)

1.3 (0.6)

1.3 (0.6)

 Patient’s global assessment of arthritis (VAS 0–10)

6.1 (2.0)

6.5 (2.0)

6.1 (2.2)

6.4 (1.9)

6.5 (1.9)

6.5 (1.8)

 Patient’s global assessment of pain (VAS 0–10)

5.9 (2.0)

6.0 (2.1)

5.8 (2.2)

6.2 (2.0)

6.3 (2.0)

6.3 (1.8)

 Physician’s global assessment (VAS 0–10)

6.2 (1.6)

6.2 (1.7)

6.3 (1.7)

6.6 (1.5)

6.6 (1.6)

6.7 (1.5)

 Patients with enthesitis, n (%)

73 (57%)

72 (57%)

77 (61%)

170 (69%)

158 (64%)

178 (72%)

  Leeds Enthesitis Index score (1–6)

3.0 (1.5)

2.7 (1.6)

2.8 (1.6)

3.0 (1.7)

2.6 (1.5)

2.8 (1.6)

 SF-36 PCS score (0–100)

35.9 (8.3)

34.1 (7.6)

33.8 (8.5)

33.3 (7.1)

32.6 (7.9)

32.4 (7.0)

 MCS score (0–100)

46.5 (9.8)

47.0 (11.1)

48.7 (9.6)

48.4 (11.0)

47.4 (10.8)

47.2 (12.0)

FACIT-Fatigue score (0–52)

31.4 (10.1)

29.5 (11.3)

30.2 (9.9)

30.8 (9.6)

29.3 (9.9)

29.1 (9.5)

  1. Data are mean (SD) unless otherwise indicated
  2. ACR20 ≥20% improvement in American College of Rheumatology criteria, BMI body mass index, CRP C-reactive protein, FACIT Functional Assessment of Chronic Illness Therapy, HAQ-DI Health Assessment Questionnaire-Disability Index, IQR interquartile range, MDA minimal disease activity, PASI Psoriasis Area and Severity Index, PsA psoriatic arthritis, SD standard deviation, Q4W every 4 weeks, Q8W every 8 weeks, SF-36 PCS/MCS 36-item Short-Form physical/mental component summary, VAS visual analog scale
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Arthritis Research & Therapy

ISSN: 1478-6362

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