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Table 1 Baseline patient demographic and clinical characteristics (ITT population)

From: A comparative clinical study of PF-06410293, a candidate adalimumab biosimilar, and adalimumab reference product (Humira®) in the treatment of active rheumatoid arthritis

  PF-06410293
n = 297
Adalimumab-EU
n = 300
Demographicsa
 Gender, n (%)
  Female 241 (81.1) 229 (76.3)
  Male 56 (18.9) 71 (23.7)
 Age, mean (SD), years 51.5 (13.6) 53.5 (12.9)
 Weight, mean (SD), kg 74.7 (17.5) 76.2 (20.8)
 Body mass index, mean (SD), kg/m2 27.5 (6.1) 28.1 (7.3)
 Race, n (%)
  White 261 (87.9) 256 (85.3)
  Black 6 (2.0) 9 (3.0)
  Asian 16 (5.4) 17 (5.7)
  Other 14 (4.7) 18 (6.0)
 Ethnicity, n (%)
  Hispanic/Latino 25 (8.4) 29 (9.7)
  Not Hispanic/Latino 272 (91.6) 271 (90.3)
Clinical characteristics
 RA duration, mean (SD), years 6.8 (7.2) 6.8 (6.9)
 Positive RF or anti-CCP antibody or both, n (%) 242 (81.5) 245 (81.7)
 Swollen joint count, mean (SD) 15.4 (7.8) 17.0 (9.8)
 Tender joint count, mean (SD) 24.3 (12.3) 26.7 (14.8)
 hs-CRP, mg/L
  Mean (SD) 21.3 (22.7) 22.8 (25.2)
  Median (range) 14.7 (0.2–169) 16.0 (0.2–192)
 DAS28–4(CRP), mean (SD) 5.9 (0.9) 6.1 (0.9)
 HAQ-DI, mean (SD) 1.5 (0.6) 1.7 (0.6)
 Prior use of one biologic drug, n (%) 8 (2.7) 5 (1.7)
 Number of prior and current non-biologic DMARDs (in addition to MTX), mean (SD) 1.5 (0.9) 1.5 (0.9)
 MTX dose, mean (SD), mg/week 15.2 (4.4) 15.2 (4.5)
 Corticosteroid use, n (%) 164 (55.2) 170 (56.7)
  1. Abbreviations: Adalimumab-EU adalimumab sourced from the European Union, CCP cyclic citrullinated peptide, DAS28–4(CRP) Disease Activity Score-28: four components based on high-sensitivity C-reactive protein, DMARD disease-modifying anti-rheumatic drug, HAQ-DI Health Assessment Questionnaire Disability Index, hs-CRP high-sensitivity C-reactive protein, ITT intention-to-treat, MTX methotrexate, n number of patients in each category, RA rheumatoid arthritis, RF rheumatoid factor, SD standard deviation
  2. aRandomization stratified by geographic region (North America and Western Europe; Japan; Republic of Korea and Taiwan; Latin America; rest of world)