Table 1.
Baseline demographics and disease characteristics of patients included in the AMPLE study (N = 646) by patient type
| Baseline demographics and disease characteristics of patients | Cohort 1: Patients with seropositive, erosive, early RA | Cohort 2: Patients with RA | ||
|---|---|---|---|---|
| Abatacept SC (n = 38) | Adalimumab SC (n = 45) | Abatacept SC (n = 280) | Adalimumab SC (n = 283) | |
| Age, years | 52.9 (13.2) | 53.7 (12.8) | 51.2 (12.5) | 50.6 (12.7) |
| Weight, kg | 75.6 (16.4) | 83.4 (21.0) | 81.5 (20.7) | 79.6 (20.7) |
| Female sex, n (%) | 31 (81.6) | 30 (66.7) | 228 (81.4) | 240 (84.8) |
| Race, white, n (%) | 32 (84.2) | 37 (82.2) | 225 (80.4) | 219 (77.4) |
| Geographic region, n (%) | ||||
| North America | 36 (94.7) | 42 (93.3) | 194 (69.3) | 193 (68.2) |
| South America | 2 (5.3) | 3 (6.7) | 86 (30.7) | 90 (31.8) |
| Disease duration, years | 0.3 (0.1) | 0.3 (0.1) | 2.1 (1.4) | 2.0 (1.3) |
| Disease duration category, n (%) | ||||
| ≤ 6 months | 38 (100.0) | 45 (100.0) | 30 (10.7) | 23 (8.1) |
| > 6 months to ≤ 2 years | 0 (0) | 0 (0) | 123 (43.9) | 148 (52.3) |
| > 2 to ≤ 5 years | 0 (0) | 0 (0) | 125 (44.6) | 110 (38.9) |
| > 5 years | 0 (0) | 0 (0) | 2 (0.7) | 2 (0.7) |
| TJC-28 | 24.3 (15.3) | 28.8 (15.7) | 25.6 (15.3) | 25.9 (15.8) |
| SJC-28 | 14.3 (9.4) | 18.1 (10.6) | 16.0 (9.9) | 15.5 (9.8) |
| Patient pain assessmenta | 62.2 (21.9) | 63.9 (23.3) | 63.2 (22.4) | 65.8 (21.6) |
| Physical function (HAQ-DI) | 1.5 (0.7) | 1.4 (0.7) | 1.5 (0.7) | 1.5 (0.7) |
| Patient global assessmenta | 61.5 (23.0) | 62.1 (23.3) | 61.1 (22.1) | 61.5 (22.4) |
| Physician global assessmenta | 57.8 (21.9) | 63.3 (17.1) | 58.9 (18.2) | 58.1 (19.1) |
| CRP, mg/dL | 1.9 (2.3) | 1.6 (2.1) | 1.5 (2.1) | 1.5 (2.9) |
| DAS28 (CRP) | 5.5 (1.1) | 5.7 (1.1) | 5.5 (1.1) | 5.5 (1.1) |
| DAS28 (CRP), n (%) | ||||
| < 3.2 | 0 (0) | 2 (4.4) | 8 (2.9) | 7 (2.5) |
| 3.2–5.1 | 16 (42.1) | 9 (20.0) | 95 (33.9) | 92 (32.5) |
| > 5.1 | 22 (57.9) | 34 (75.6) | 177 (63.2) | 184 (65.0) |
| mTSS | 19.2 (31.9) | 17.4 (23.3) | 19.9 (33.2) | 19.7 (29.8) |
| MTX dose, mg/week | 16.8 (3.7) | 15.3 (3.0) | 17.6 (6.6) | 17.6 (6.5) |
| Anti-CCP2 positive, n (%) | 31 (81.6) | 42 (93.3) | 191 (68.2) | 204 (72.1) |
| RF positive, n (%) | 36 (94.7) | 43 (95.6) | 227 (81.1) | 250 (88.3) |
| Elevated ESR, n (%) | 1 (2.6) | 3 (6.7) | 48 (17.1) | 39 (13.8) |
| Elevated CRP, n (%) | 0 (0) | 4 (8.9) | 51 (18.2) | 36 (12.7) |
Data are presented as the mean, with the standard deviation given in parenthesis, unless stated otherwise
All randomized and treated patients were included in the analysis
Anti-CCP2 Anti-cyclic citrullinated peptide-2, CRP C-reactive protein, DAS28 (CRP) Disease Activity Score in 28 joints using CRP, ESR erythrocyte sedimentation rate, HAQ-DI Health Assessment Questionnaire-Disability Index, mTSS modified total Sharp score, MTX methotrexate, RA rheumatoid arthritis, RF rheumatoid factor, SC subcutaneous, SJC-28, 28 swollen joint count, TJC-28 28 tender joint count
aAssessed using a visual analogue scale (100 mm where 0 = none and 100 = worst possible)