Table 1.
Baseline demographics and baseline disease characteristics (SP1, SP2 FAS)
| Study Period 1 | Study Period 2 | |||
|---|---|---|---|---|
| SDZ-ADL N = 177 n (%) |
ref-ADL N = 176 n (%) |
‘Continued SDZ-ADL’ N = 159 n (%) |
‘ref-ADL to SDZ-ADL’ N = 166 n (%) |
|
| Age [y] | 52.8 (12.8) | 53.8 (12.2) | 52.9 (12.5) | 53.5 (12.3) |
| Gender [female] | 153 (86.4) | 142 (80.7) | 135 (84.9) | 132 (79.5) |
| Race [Caucasian] | 152 (85.9) | 152 (86.4) | 139 (87.4) | 144 (86.7) |
| Weight at baseline [kg] | 76.8 (19.2) | 76.3 (17.9) | 77.0 (19.2) | 76.4 (18.0) |
| BMI [kg/m2] | 28.6 (6.7) | 28 (5.5) | 28.5 (6.7) | 28 (5.5) |
| RA disease duration [y] | 8.1 (8.2) | 7.4 (7.7) | 8.0 (8.1) | 7.1 (7.5) |
| Weekly methotrexate dose [mg] | 17.1 (5.1) | 17.6 (4.9) | 17.2 (5.0) | 17.6(4.9) |
| DAS28-CRP | 5.6 (0.9) | 5.7 (0.8) | 5.6 (0.9) | 5.7 (0.8) |
| DAS28-ESR | 6.5 (0.9) | 6.6 (0.9) | 6.5 (0.9) | 6.6 (0.8) |
| Tender 68 joint count | 26.0 (14.8) | 26.2 (13.8) | 25.8 (14.6) | 26 (13.8) |
| Swollen 66 joint count | 15.8 (11.2) | 15.5 (9.5) | 15.5 (10.7) | 15.5 (9.1) |
| Tender 28 joint count | 15.9 (6.9) | 16.0 (6.1) | 15.7 (6.9) | 16.0 (6.1) |
| Swollen 28 joint count | 11.2 (5.4) | 11.4 (5.2) | 11 (5.4) | 11.4 (5.1) |
| CRP [mg/L] | 9.7 (10.9) | 11.4 (15.8) | 9.5 (11.1) | 11.5 (16.1) |
| ESR [mm/h] | 43.1 (18.3) | 46.5 (22.3) | 43.1 (18.8) | 45.9 (21.4) |
| HAQ-DI© score | 1.49 (0.6) | 1.46 (0.6) | 1.48 (0.6) | 1.44 (0.6) |
| Positive rheumatoid factor, n (%) | 140 (79.1) | 135 (76.7) | 126 (79.2) | 130 (78.3) |
| Positive anti-CCP, n (%) | 112 (63.3) | 102 (58.0) | 100 (62.9) | 98 (59) |
| Physician’s global assessment of disease activity (VAS) [mm] | 65.4 (16.4) | 64.3 (16.1) | 65 (16.8) | 64.2 (16.0) |
| Patient’s global assessment of disease activity (VAS) [mm] | 64.4 (17.4) | 65.2 (18.5) | 64.1 (17.7) | 65.3 (18.5) |
| Patient´s global assessment of pain (VAS) [mm] | 64.1 (18.7) | 64.3 (18.3) | 63.9 (18.9) | 64.2 (18.4) |
Data presented as mean (SD) unless indicated otherwise
Rheumatoid factor ≤ 10 UI/mL and anti-CCP < 17 U/mL are considered negative
SP1 FAS study period 1 full analysis set: all randomized patients to whom study drug was administered, SP2 FAS study period 2 full analysis set: all SP1 FAS patients who entered SP2, CCP cyclic citrullinated peptide, CRP C-reactive protein, DAS disease activity score, ESR erythrocyte sedimentation rate, HAQ-DI health assessment questionnaire disability index, ref-ADL reference adalimumab, SD standard deviation, SDZ-ADL Sandoz biosimilar adalimumab, VAS visual analog scale