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Table 1 Demographics and baseline disease characteristics (ITT population, unless otherwise specified)

From: Efficacy and safety of biosimilar CT-P17 versus reference adalimumab in subjects with rheumatoid arthritis: 24-week results from a randomized study

 

CT-P17 (N = 324)

EU-adalimumab (N = 324)

Age (years), median (range)

53.5 (18–75)

54.0 (19–75)

Sex, n (%)

 Male

75 (23.1)

59 (18.2)

 Female

249 (76.9)

265 (81.8)

Race, n (%)

 White

299 (92.3)

298 (92.0)

 Mestizo

24 (7.4)

26 (8.0)

 Native Peruvian

1 (0.3)

0

Ethnicity, n (%)

 Hispanic or Latino

29 (9.0)

34 (10.5)

 Non-Hispanic or non-Latino

295 (91.0)

290 (89.5)

RA disease duration (years), mean (SD)

6.79 (6.76)

6.59 (6.81)

SDAI at screening, n (%)

 SDAI ≤ 26

30 (9.3)

34 (10.5)

 SDAI > 26

294 (90.7)

290 (89.5)

SDAI, mean (SD)

40.0 (11.5)

39.8 (11.1)

CDAI, mean (SD)

39.0 (11.0)

38.7 (10.8)

DAS28-CRP, mean (SD)

5.538 (0.8738)

5.547 (0.8525)

Tender joint count, mean (SD)

20.5 (10.2)

20.1 (10.1)

Swollen joint count, mean (SD)

14.0 (6.33)

14.0 (6.46)

Subject’s assessment of pain, mean (SD)a

69.7 (18.7)

70.0 (16.2)

Subject’s global assessment of disease activity, mean (SD)a

69.8 (17.8)

69.6 (16.3)

Physician’s global assessment of disease activity, mean (SD)a

67.5 (14.7)

67.0 (15.5)

HAQ estimate of physical ability, mean (SD)

1.41 (0.59)

1.48 (0.56)

CRP (mg/dl), mean (SD)

0.975 (1.60)

1.10 (1.91)

ESR (mm/h), mean (SD)

42.3 (15.98)

42.9 (16.94)

  1. Note: There were no significant differences between the CT-P17 and EU-adalimumab groups for any parameter (p > 0.05). For age (years), mean (SD) values were used for the statistical analysis
  2. aAssessed by 100-mm visual analog scale
  3. Anti-CCP anti-cyclic citrullinated peptide, CDAI Clinical Disease Activity Index, CRP C-reactive protein, DAS28 Disease Activity Score in 28 joints, ESR erythrocyte sedimentation rate, EU-adalimumab European Union-approved adalimumab, HAQ Health Assessment Questionnaire, ITT intention-to-treat, RA rheumatoid arthritis, RF rheumatoid factor, SD standard deviation, SDAI Simplified Disease Activity Index