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Table 1 Baseline patient demographics and disease characteristics

From: A phase III randomized study to evaluate the efficacy and safety of CT-P13 compared with reference infliximab in patients with active rheumatoid arthritis: 54-week results from the PLANETRA study

 

CT-P13 3 mg/kg (n = 302)

RP 3 mg/kg (n = 304)

Total (N = 606)

Age, median, years (range)

50 (18–75)

50 (21–74)

50 (18–75)

 Sex, n (%)

   

 Female

245 (81.1)

256 (84.2)

501 (82.7)

 Male

57 (18.9)

48 (15.8)

105 (17.3)

Ethnicity, n (%)

   

 Asian

34 (11.3)

37 (12.2)

71 (11.7)

 Black

2 (0.7)

1 (0.3)

3 (0.5)

 White

220 (72.8)

222 (73.0)

442 (72.9)

 Other

46 (15.2)

44 (14.5)

90 (14.9)

Height, cm, median (range)

162.3 (144.0–186.0)

162.0 (124.0–190.0)

162.0 (124.0–190.0)

Weight, kg, median (range)

69.0 (36.5–134.0)

68.0 (36.0–136.0)

68.6 (36.0–136.0)

BMI, kg/m2, median (range)

26.3 (13.9–49.8)

25.4 (15.0–53.1)

25.9 (13.9–53.1)

Anti-CCP antibody-positive, n (%)

228 (75.5)

233 (76.6)

461 (76.1)

IgA RF-positive, n (%)

131 (43.4)

134 (44.1)

265 (43.7)

IgM RF-positive, n (%)

225 (74.5)

220 (72.4)

445 (73.4)

IgG RF-positive, n (%)

173 (57.3)

171 (56.3)

344 (56.8)

Joint count

   

 TJC, 68 joints

25.6 ± 13.9

24.0 ± 12.9

24.8 ± 13.4

 SJC, 66 joints

16.2 ± 8.7

15.2 ± 8.3

15.7 ± 8.5

 TJC, 28 joints

15.9 ± 6.4

15.1 ± 6.1

15.5 ± 6.2

 SJC, 28 joints

12.0 ± 4.9

11.2 ± 4.7

11.6 ± 4.8

Duration of prior MTX therapy, weeks

97.7 ± 141.2

89.4 ± 96.5

93.6 ± 120.8

MTX dose, mg

15.6 ± 3.1

15.6 ± 3.2

15.6 ± 3.1

CDAI

40.9 ± 11.5

39.3 ± 11.1

40.1 ± 11.3

SDAI

42.8 ± 11.9

41.2 ± 11.7

42.0 ± 11.8

CRP, mg/dl

1.9 ± 2.5

1.9 ± 2.2

1.9 ± 2.4

ESR, mm/h

46.6 ± 22.4

48.5 ± 22.6

47.5 ± 22.5

DAS28-CRP

5.9 ± 0.8

5.8 ± 0.9

5.8 ± 0.9

HAQ

1.6 ± 0.6

1.6 ± 0.6

1.6 ± 0.6

Patient assessment of pain

65.9 ± 17.4

65.5 ± 17.2

65.7 ± 17.3

Patient global assessment of disease activity

65.7 ± 17.2

65.4 ± 17.0

65.5 ± 17.1

Physician global assessment of disease activity

64.7 ± 14.3

65.0 ± 13.5

64.8 ± 13.9

  1. BMI body mass index, CCP cyclic citrullinated peptide, CDAI Clinical Disease Activity Index, CRP C-reactive protein, DAS28 Disease Activity Score in 28 joints, ESR erythrocyte sedimentation rate, HAQ Health Assessment Questionnaire, Ig immunoglobulin, MTX methotrexate, RF rheumatoid factor, RP reference product (i.e., reference infliximab), SD standard deviation, SDAI Simplified Disease Activity Index, SJC swollen joint count, TJC tender joint count
  2. Except where indicated otherwise, values are mean ± SD