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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), years53.0 (12.0)53.6 (12.3)53.3 (12.2)
Gender, n (%)
 Male85 (23.2)78 (21.5)163 (22.4)
 Female281 (76.8)284 (78.5)565 (77.6)
Race, n (%)
 White311 (85.0)308 (85.1)619 (85.0)
 Black or African-American2 (0.5)4 (1.1)6 (0.8)
 Other53 (14.5)50 (13.8)103 (14.1)
Mean disease duration (SD), years8.6 (8.3)8.3 (7.6)8.5 (8.0)
Rheumatoid factor status, n (%)
 Positive277 (75.7)277 (76.5)554 (76.1)
 Negative88 (24.0)83 (22.9)171 (23.5)
 Missing1 (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/L25.0 (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/week15.8 (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