Baseline* demographics and disease characteristics for patients who entered the withdrawal and re-treatment periods
| Patients who entered the withdrawal period† | Patients who entered the re-treatment period‡ | |||||||
| Abatacept+MTX (n=84) | Abatacept (n=66) | MTX (n=73)§ | Total (n=223) | Abatacept+MTX (n=55) | Abatacept (n=48) | MTX (n=43) | Total (n=146) | |
| Age, years (median) | 47.1±12.4 (48.0) | 44.5±12.2 (43.5) | 49.0±12.8 (48.0) | 47.0±12.5 (46.0) | 46.1±11.5 (44.0) | 44.1±12.1 (44.5) | 47.7±12.7 (48.0) | 45.9±12.0 (45.5) |
| Weight, years (median) | 72.2±16.0 (69.0) | 69.4±14.9 (69.0) | 76.3±18.3 (74.0) | 72.7±16.6 (70.0) | 71.5±16.5 (68.2) | 70.9±14.7 (69.3) | 74.7±17.2 (74.0) | 72.3±16.1 (69.7) |
| RA duration, years | 0.58±0.52 | 0.64±0.57 | 0.47±0.47 | 0.56±0.52 | 0.59±0.54 | 0.65±0.58 | 0.49±0.49 | 0.58±0.54 |
| RF positive, n (%) | 81 (96.4) | 63 (95.5) | 70 (95.9) | 214 (96.0) | 55 (100.0) | 45 (93.8) | 42 (97.7) | 142 (97.3) |
| SJC (28 joints) | 15.3±11.7 | 17.1±12.7 | 15.1±11.8 | 15.8±12.0 | 17.2±13.0 | 19.7±13.3 | 17.8±13.4 | 18.2±13.2 |
| Patient Global Assessment (0–100 mm VAS) | 59.8±21.9 | 56.8±22.0 | 57.1±19.3 | 58.0±21.0 | 62.3±23.0 | 58.6±20.5 | 59.1±19.5 | 60.2±21.1 |
| DAS28-CRP | 5.4±1.2 | 5.4±1.1 | 5.3±1.3 | 5.3±1.2 | 5.6±1.3 | 5.6±1.2 | 5.5±1.3 | 5.6±1.2 |
| HAQ-DI | 1.4±0.7 | 1.3±0.6 | 1.3±0.6 | 1.3±0.7 | 1.5±0.7 | 1.4±0.7 | 1.5±0.6 | 1.4±0.7 |
Data are mean±SD unless indicated otherwise. In the total randomised population, 31.9% (112/351) of patients were receiving oral and/or injectable corticosteroids at baseline: 31.1% (37/119) with abatacept plus MTX, 34.5% (40/116) with abatacept monotherapy and 30.2% (35/116) with MTX monotherapy.
*Baseline is day 1 of the initial randomised treatment period.
†For the following assessments, patient numbers in the abatacept plus MTX, abatacept and MTX arms and total population, respectively, were weight, 83, 66, 73 and 222; SJC, 84, 65, 73 and 222; Patient Global Assessment, 82, 63, 72 and 217; DAS28-CRP, 81, 63, 72 and 216; HAQ-DI, 80, 63, 67 and 210.
‡For the following assessments, patient numbers in the abatacept plus MTX, abatacept and MTX arms and total population, respectively, were SJC, 55, 47, 43 and 145; Patient Global Assessment, 54, 45, 42 and 141; DAS28-CRP, 53, 45, 42 and 140; HAQ-DI, 55, 46, 40 and 141.
§Baseline characteristics for patients entering the withdrawal period were summarised using the database lock for the first analysis (7 November 2013). Two patients in the MTX group entered the withdrawal period after the first database lock and therefore were not included.
DAS28-CRP, Disease Activity Score 28-C reactive protein; HAQ-DI, Health Assessment Questionnaire–Disability Index; MTX, methotrexate; RA, rheumatoid arthritis; RF, rheumatoid factor; SD, standard deviation; SJC, swollen joint count; VAS, Visual Analogue Scale.