Table 1.
Baseline Demographic and Disease characteristics in patients who reached week 24, by treatment group*
| Characteristic | Immediate Combination Therapy (n=315) | Step-Up to Combination Therapy (n=234) | MTX Monotherapy (n=81) |
|---|---|---|---|
| Female: Number (%) | 236 (74.9) | 172 (73.5) | 52 (64.2) |
| Caucasian: Number (%) | 250 (79.4) | 187 (79.9) | 71 (87.7) |
| Age (years): mean (SD) | 49.9 (12.9) | 49.6 (13.0) | 48.2 (11.7) |
| BMI (mg/kg2): mean (SD) | 29.4 (7.4) | 30.0 (7.2) | 28.7 (5.5) |
| Disease Duration (months): | |||
| mean (SD) | 3.6 (6.5) | 3.4 (6.2) | 3.2 (6.3) |
| Median (range) | 1.0 (0-35.8) | 1.0 (0-32.7) | 1.2 (0-33.1) |
| Prednisone Use: Number (%) | 136 (43.2) | 87 (37.2) | 39 (48.2) |
| Total Tender Joints: mean (SD) | 14.0 (6.6) | 14.5 (7.2) | 12.3 (5.5)† |
| Total Swollen Joints: mean (SD) | 12.5 (5.8) | 13.5 (6.2) | 11.4 (5.1)‡ |
| ESR (mm/hr): median (range) | 27 (1-150) | 27 (1-126) | 21 (2-173) |
| DAS28-ESR: mean (SD) | 5.8 (1.1) | 5.9 (1.1) | 5.5 (1.0)§ |
| No. of Erosions: mean (SD) | 3.3 (6.7) | 3.2 (5.5) | 1.9 (2.3) |
| median (range) | 1.5 (0-74.5) | 1.5 (0-42) | 1 (0-10) |
| Modified Sharp Score: | |||
| mean (SD) | 6.9 (15.0) | 6.2 (13.4) | 2.9 (3.6) |
| median (range) | 2 (0-175.5) | 2 (0-117.5) | 1.5 (0-19) |
Patients were randomly assigned to 1 of the following 3 regimens: immediate combination therapy with either methotrexate (MTX) plus etanercept or MTX plus sulfasalazine plus hydroxychloroquine, initial MTX with step-up to combination therapy at 24 weeks if the Disease Activity Score in 28 joints using the erythrocyte sedimentation rate (DAS28-ESR) was ≥ 3.2, or MTX monotherapy. P values across treatment groups were significant for the number of tender joints (P = 0.0148 by Welch analysis of variance [ANOVA]), the number of swollen joints (P = 0.0106 by Welch ANOVA), the median ESR (P = 0.0468 by Wilcoxon-Kruskal-Wallis test), and the DAS28-ESR (P = 0.0027 by ANOVA with Tukey's honestly significant difference used to adjust for multiple comparisons). BMI = body mass index.
P = 0.0286 versus step-up therapy
P = 0.0161 versus step-up therapy
P = 0.0063 versus step-up therapy, and P = 0.0258 versus Immediate Combination Therapy