Table 1.
Patient demographic and clinical characteristics at baseline in TP2 (ITT population)
| ADL-PF/ADL-PF (n=283) |
ADL-EU/ADL-EU (n=135) |
ADL-EU/ADL-PF (n=134) |
|
| Demographics | |||
| Gender, n (%) | |||
| Female | 229 (80.9) | 108 (80.0) | 95 (70.9) |
| Male | 54 (19.1) | 27 (20.0) | 39 (29.1) |
| Age, mean (SD), years | 51.3 (13.7) | 53.6 (12.1) | 53.4 (13.4) |
| Weight, mean (SD), kg | 74.6 (17.7) | 76.2 (20.4) | 75.7 (18.7) |
| BMI, mean (SD), kg/m2 | 27.5 (6.2) | 28.4 (7.4) | 27.5 (6.4) |
| Race, n (%) | |||
| White | 250 (88.3) | 113 (83.7) | 116 (86.6) |
| Black | 6 (2.1) | 7 (5.2) | 2 (1.5) |
| Asian | 14 (4.9) | 8 (5.9) | 6 (4.5) |
| Other | 13 (4.6) | 7 (5.2) | 10 (7.5) |
| Clinical characteristics | |||
| RA duration, mean (SD), years | 6.9 (7.3) | 7.1 (6.6) | 6.6 (7.0) |
| Swollen joint count (66), mean (SD) | 15.1 (7.7) | 17.1 (9.6) | 17.0 (10.3) |
| Tender joint count (68), mean (SD) | 23.7 (11.9) | 26.8 (14.7) | 25.5 (15.0) |
| hs-CRP, mg/L, mean (SD) | 21.2 (22.5) | 22.0 (24.5) | 22.3 (25.9) |
| DAS28–4(CRP), mean (SD) | 5.9 (0.9) | 6.1 (0.8) | 6.0 (1.0) |
| HAQ-DI, mean (SD) | 1.5 (0.6) | 1.6 (0.7) | 1.7 (0.6) |
| Prior use of one biologic*, n (%) | 8 (2.8) | 4 (3.0) | 1 (0.7) |
| Number of prior and current non-biologic DMARDs (in addition to MTX), mean (SD) | 1.5 (0.9) | 1.5 (0.9) | 1.5 (0.8) |
| MTX dose, mean (SD), mg/week | 15.2 (4.4) | 15.7 (4.7) | 14.7 (4.0) |
| Corticosteroid use, n (%) | 155 (54.8) | 77 (57.0) | 80 (59.7) |
*Includes the use of no more than two doses of one non-adalimumab biologic drug.
ADL-EU, reference adalimumab sourced from the European Union; ADL-PF, PF-06410293; BMI, body mass index; CRP, C-reactive protein; DAS28-4(CRP), Disease Activity Score-28: 4 components using CRP; DMARD, disease-modifying antirheumatic drug; HAQ-DI, Health Assessment Questionnaire–Disability Index; hs-CRP, high-sensitivity CRP; ITT, intent-to-treat; MTX, methotrexate; RA, rheumatoid arthritis; TP2, treatment period 2.