Demographics at baseline and disease characteristics at randomisation
| Characteristic | ETN50 (n=23) | ETN25 (n=27) | PBO (n=23) | Total (n=73) |
|---|---|---|---|---|
| Age, years | 53.8 (12.1) | 59.6 (9.2) | 56.1 (11.5) | 56.7 (11.0) |
| Female gender, n (%) | 17 (74) | 18 (67) | 16 (70) | 51 (70) |
| Disease duration, years | 11.5 (7.3) | 16.6 (11.0) | 12.3 (6.1) | 13.6 (8.8) |
| Rheumatoid factor positive, n (%) | 15 (68) | 18 (67) | 16 (73) | 49 (69) |
| Prior treatment with DMARDs other than MTX, n (%) | 15 (65) | 17 (63) | 16 (70) | 48 (66) |
| Duration of ETN treatment before study start, years | 3.5 (1.4) | 3.7 (1.6) | 2.9 (1.5) | 3.4 (1.5) |
| DAS28 at start of ETN treatment | 4.9 (1.1) | 5.2 (1.1) | 4.8 (1.1) | 5.0 (1.1) |
| MTX dose | 12.1 (4.3) | 14.5 (5.0) | 15.1 (5.4) | 13.9 (5.0) |
| MTX dose, median (min; max) | 10.0 (7.5; 25.0) | 15.0 (7.5; 25.0) | 15.0 (7.5; 25.0) | 15.0 (7.5; 25.0) |
| Disease characteristics at randomisation | ||||
| DAS28 remission (≤2.6), n (%) | 20 (91) | 21 (78) | 18 (78) | 59 (82) |
| DAS28 LDA (>2.6 to ≤3.2), n (%) | 2 (9) | 5 (19)* | 5 (22) | 12 (17) |
| DAS28 | 1.9 (0.6) | 1.9 (0.9) | 1.9 (0.7) | 1.9 (0.7) |
| Swollen joint count | 0.3 (0.8) | 0.4 (0.8) | 0.2 (0.4) | 0.3 (0.7) |
| Tender joint count | 0.2 (0.5) | 0.4 (0.8) | 0.5 (0.8) | 0.4 (0.7) |
| Pain VAS | 15.6 (18.2) | 13.0 (10.9) | 13.4 (10.1) | 13.9 (13.3) |
| HAQ-DI, median (min; max) | 0.25 (0.0; 1.5) | 0.38 (0.0; 1.5) | 0.13 (0.0; 1.8) | 0.25 (0.0; 1.8) |
| SvdH total score | 37.3 (41.6) | 69.3 (68.8) | 35.4 (30.2) | 48.9 (53.0) |
| SvdH erosion score | 25.1 (26.4) | 43.6 (39.8) | 26.2 (20.9) | 32.5 (31.7) |
| SvdH joint space narrowing score | 12.1 (16.9) | 25.7 (30.0) | 9.2 (10.8) | 16.4 (22.6) |
Modified intention-to-treat population used. All values are mean (SD) unless otherwise stated.
*n=1 patient had DAS28 >3.2–5.1 at randomisation.
DAS28, disease activity score in 28 joints; DMARD, disease-modifying antirheumatic drug; ETN, etanercept; HAQ-DI, Health Assessment Questionnaire Disability Index; LDA, low disease activity; MTX, methotrexate; PBO, placebo; SvdH, Sharp van der Heijde; VAS, visual analogue score.