Table 1.
Baseline patient demographic and clinical characteristics (ITT population)
| 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) |
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
aRandomization stratified by geographic region (North America and Western Europe; Japan; Republic of Korea and Taiwan; Latin America; rest of world)