Skip to main content

Table 1 Baseline patient demographics and disease characteristics for Period I

From: FKB327, an adalimumab biosimilar, versus the reference product: results of a randomized, Phase III, double-blind study, and its open-label extension

 

FKB327

n = 366*

RP

n = 362

Total

N = 728

Mean age (SD), years

53.0 (12.0)

53.6 (12.3)

53.3 (12.2)

Gender, n (%)

 Male

85 (23.2)

78 (21.5)

163 (22.4)

 Female

281 (76.8)

284 (78.5)

565 (77.6)

Race, n (%)

 White

311 (85.0)

308 (85.1)

619 (85.0)

 Black or African-American

2 (0.5)

4 (1.1)

6 (0.8)

 Other

53 (14.5)

50 (13.8)

103 (14.1)

Mean disease duration (SD), years

8.6 (8.3)

8.3 (7.6)

8.5 (8.0)

Rheumatoid factor status, n (%)

 Positive

277 (75.7)

277 (76.5)

554 (76.1)

 Negative

88 (24.0)

83 (22.9)

171 (23.5)

 Missing

1 (0.3)

2 (0.6)

3 (0.4)

Mean DAS28-CRP (SD)

6.1 (0.9)

6.1 (0.9)

6.1 (0.9)

Mean CRP level (SD), mg/L

25.0 (26.7)

26.6 (28.4)

25.8 (27.6)

Mean tender joint count (68-joint count; SD)

26.2 (14.5)

25.9 (14.5)

26.1 (14.5)

Mean swollen joint count (66-joint count; SD)

16.2 (9.1)

16.0 (9.0)

16.1 (9.0)

Mean patient assessment of disease activity (SD)

68.0 (17.9)

68.2 (18.2)

68.1 (18.0)

Mean physician assessment of disease activity (SD)

68.4 (14.6)

66.4 (15.0)

67.4 (14.8)

Mean patient assessment of pain (SD)

66.7 (18.7)

67.9 (18.6)

67.3 (18.6)

Mean Health Assessment Questionnaire score (SD)

1.8 (0.5)

1.8 (0.5)

1.8 (0.5)

Prior medication for RA

 At least one biologic, n (%)

65 (17.8)

67 (18.5)

132 (18.1)

 At least one DMARD,§ n (%)

236 (64.5)

229 (63.3)

465 (63.9)

 At least one TNF inhibitor, n (%)

22 (6.0)

27 (7.5)

49 (6.7)

Concomitant medication for RA

 Mean MTX dose (SD), mg/week

15.8 (5.0)

15.8 (4.6)

15.8 (4.8)

 At least one oral steroid and at least one NSAID, n (%)

137 (37.4)

149 (41.2)

286 (39.3)

  1. *n = 365 for CRP level, tender joint count, swollen joint count, patient assessment of disease activity, patient assessment of pain, and Health Assessment Questionnaire; n = 364 for DAS28-CRP and physician assessment of disease activity
  2. n = 727 for CRP level, tender joint count, swollen joint count, patient assessment of disease activity, patient assessment of pain and Health Assessment Questionnaire; n = 726 for DAS28-CRP and physician assessment of disease activity
  3. Includes the categories American Indian or Alaska Native (n = 2), Asian (n = 2), and other (n = 99)
  4. §Both biologic and non-biologic DMARDs were included
  5. CRP C-reactive protein, DAS28-CRP disease activity score 28 based on C-reactive protein, DMARD disease-modifying anti-rheumatic drug, MTX methotrexate, NSAID non-steroidal anti-inflammatory drug, RA rheumatoid arthritis, RP reference product, SD standard deviation, TNF tumor necrosis factor