Table 1.
Phase II patient characteristics at week 52
| Variable | ETN25+MTX |
MTX |
PBO |
||||
|---|---|---|---|---|---|---|---|
| N | Mean (SD) or N (%) | N | Mean (SD) or N (%) | N | Mean (SD) or N (%) | p Value* | |
| Demographics | |||||||
| Age, years | 39 | 43.07 (11.65) | 49 | 45.08 (11.32) | 32 | 45.13 (11.64) | 0.665 |
| Female | 39 | 28 (71.8) | 49 | 28 (57.1) | 32 | 21 (65.6) | 0.356 |
| Body mass index | 39 | 25.14 (4.42) | 49 | 25.23 (3.91) | 32 | 26.42 (5.05) | 0.404 |
| Smoking status | |||||||
| Non-smoker | 39 | 23 (59.0) | 49 | 23 (46.9) | 32 | 19 (59.4) | 0.348 |
| Has stopped | 6 (15.4) | 13 (26.5) | 9 (28.1) | ||||
| Smoker | 10 (25.6) | 13 (26.5) | 4 (12.5) | ||||
| Current alcohol use | 39 | 17 (43.6) | 49 | 23 (46.9) | 32 | 16 (50.0) | 0.864 |
| West Europe | 39 | 24 (61.5) | 49 | 32 (65.3) | 3 | 17 (53.1) | 0.544 |
| Medical/medication history | |||||||
| RA duration, months | 39 | 2.96 (2.33) | 49 | 3.09 (2.71) | 32 | 3.81 (3.14) | 0.374 |
| Prior corticosteroids use | 39 | 13 (36.1) | 49 | 14 (28.6) | 32 | 15 (46.9) | 0.255 |
| Prior NSAID use | 39 | 28 (77.8) | 49 | 38 (77.6) | 32 | 21 (65.6) | 0.438 |
| Prior DMARDs use | 39 | 4 (11.1) | 49 | 5 (10.2) | 32 | 8 (25.0) | 0.176 |
| Number of diseases† | 39 | 2.41 (2.45) | 49 | 2.39 (2.50) | 32 | 2.22 (1.93) | 0.933 |
| Clinical outcomes | |||||||
| Patient general health score | 39 | 8.72 (11.74) | 49 | 7.31 (7.33) | 32 | 13.19 (16.37) | 0.086 |
| Pain assessment score | 39 | 6.62 (7.68) | 49 | 5.78 (8.05) | 32 | 10.91 (17.87) | 0.128 |
| Patient global assessment score | 39 | 5.56 (6.41) | 49 | 4.80 (7.16) | 32 | 10.41 (16.64) | 0.050 |
| Physician global assessment score | 39 | 4.67 (5.72) | 49 | 3.53 (4.18) | 32 | 5.41 (7.53) | 0.336 |
| DAS28 | 39 | 1.78 (0.56) | 49 | 1.69 (0.61) | 32 | 1.93 (0.40) | 0.162 |
| HAQ | 39 | 0.16 (0.29) | 48 | 0.18 (0.37) | 31 | 0.27 (0.38) | 0.392 |
| Swollen joint count | 39 | 0.03 (0.16) | 49 | 0.08 (0.28) | 32 | 0.06 (0.25) | 0.541 |
| Tender joint count | 39 | 0.31 (0.57) | 49 | 0.33 (0.63) | 32 | 0.50 (0.80) | 0.411 |
| FACIT score | 38 | 44.7 (7.05) | 48 | 44.45 (7.94) | 32 | 42.74 (7.96) | 0.514 |
| PASS (acceptable) | 38 | 36 (94.7) | 49 | 49 (100.0) | 32 | 30 (93.8) | 0.173 |
| Quality of life | |||||||
| EQ-5D index | 38 | 0.90 (0.14) | 46 | 0.90 (0.13) | 31 | 0.86 (0.15) | 0.327 |
| EQ-5D VAS | 38 | 92.08 (11.24) | 46 | 86.67 (21.39) | 32 | 84.25 (20.12) | 0.182 |
| SF-36 mental component summary score | 39 | 53.09 (7.20) | 48 | 54.15 (6.20) | 31 | 52.22 (7.59) | 0.473 |
| SF-36 physical component summary score | 39 | 51.73 (5.20) | 48 | 50.96 (5.54) | 31 | 48.77 (8.10) | 0.130 |
| Job/workplace | |||||||
| Employment status | |||||||
| Full time | 39 | 23 (59.0) | 49 | 33 (67.3) | 32 | 22 (68.8) | 0.825 |
| Part-time | 7 (17.9) | 8 (16.3) | 6 (18.8) | ||||
| Self-employed | 9 (23.1) | 8 (16.3) | 4 (12.5) | ||||
| Work habit | |||||||
| Usually sit | 39 | 11 (28.2) | 49 | 24 (49.0) | 32 | 13 (40.6) | 0.230 |
| Stand/walk | 19 (48.7) | 16 (32.7) | 11 (34.4) | ||||
| Light loads | 3 (7.7) | 7 (14.3) | 4 (12.5) | ||||
| Heavy loads | 6 (15.4) | 2 (4.1) | 4 (12.5) | ||||
| Number of work hours per week | 39 | 36.41 (13.98) | 49 | 37.26 (12.49) | 32 | 40.07 (10.54) | 0.448 |
| Number of work days per week | 39 | 5.01 (0.86) | 49 | 4.84 (0.89) | 32 | 4.94 (0.79) | 0.642 |
| Annual income (€) | 39 | 21952.05 (18987.67) | 49 | 24741.60 (21396.33) | 32 | 20398.33 (14242.74) | 0.578 |
*For continuous variables, ANOVA model was used for the comparison across treatment groups. For categorical variables, χ2 test or Fisher's exact test was performed for the comparison.
†Counting all diseases recorded in medical history categories: cardiovascular history, medical history, RA extra-articular manifestations and other medical history.
ANOVA, analysis of variance; DAS28, disease activity score based on a 28-joint count; EQ-5D, EuroQol-5 Dimensions; SF-36: short form-36; ETN25+MTX, etanercept 25 mg plus methotrexate; FACIT, functional assessment of chronic illness therapy; HAQ, health assessment questionnaire; PASS, patient acceptable symptom state; PBO, placebo; RA, rheumatoid arthritis.