Main VOLP outcomes of interest by treatment groups at each visit during phase II
| Variable | Week | ETN25+MTX | MTX | PBO | p Value* | |||||
|---|---|---|---|---|---|---|---|---|---|---|
| N | Mean (SD) or N (%) | N | Mean (SD) or N (%) | N | Mean (SD) or N (%) | ETN+MTX−PBO | MTX−PBO | ETN+MTX−MTX | ||
| Paid work productivity loss in the past 3 months | ||||||||||
| Any paid work loss, N (%) | 52 | 37 | 9 (24.3) | 43 | 6 (14.0) | 22 | 2 (9.1) | 0.295 | 0.819 | 0.403 |
| Any paid work loss, N (%) | 64 | 35 | 9 (25.7) | 39 | 8 (20.5) | 26 | 9 (34.6) | 0.768 | 0.413 | 0.919 |
| Any paid work loss, N (%) | 76 | 36 | 6 (16.7) | 42 | 9 (21.4) | 20 | 7 (35.0) | 0.305 | 0.536 | 0.928 |
| Any paid work loss, N (%) | 91 | 32 | 8 (25.0) | 34 | 8 (23.5) | 14 | 6 (42.9) | 0.496 | 0.477 | 1.000 |
| Paid work loss, hours (SD) | 52 | 37 | 21.77 (43.91) | 43 | 12.82 (44.25) | 22 | 14.00 (55.89) | 0.862 | 0.996 | 0.667 |
| Paid work loss, hours (SD) | 64 | 35 | 25.51 (60.95) | 39 | 32.34 (80.00) | 26 | 57.06 (117.49) | 0.448 | 0.644 | 0.920 |
| Paid work loss, hours (SD) | 76 | 36 | 17.88 (54.20) | 42 | 19.52 (53.47) | 20 | 49.20 (119.61) | 0.558 | 0.587 | 0.993 |
| Paid work loss, hours (SD) | 91 | 32 | 21.85 (54.87) | 34 | 27.55 (79.73) | 14 | 71.89 (141.32) | 0.475 | 0.581 | 0.952 |
| Percentage of time loss (SD) | 52 | 37 | 0.06 (0.13) | 43 | 0.03 (0.09) | 22 | 0.05 (0.21) | 0.992 | 0.903 | 0.479 |
| Percentage of time loss (SD) | 64 | 35 | 0.09 (0.25) | 39 | 0.07 (0.16) | 26 | 0.10 (0.22) | 0.966 | 0.776 | 0.921 |
| Percentage of time loss (SD) | 76 | 36 | 0.06 (0.19) | 42 | 0.04 (0.10) | 20 | 0.11 (0.25) | 0.764 | 0.515 | 0.853 |
| Percentage of time loss (SD) | 91 | 32 | 0.08 (0.25) | 34 | 0.05 (0.15) | 14 | 0.14 (0.27) | 0.834 | 0.591 | 0.853 |
| Unpaid work productivity loss in the past 7 days | ||||||||||
| Any unpaid work loss, N (%) | 52 | 37 | 6 (16.2) | 42 | 4 (9.5) | 31 | 7 (22.6) | 0.749 | 0.299 | 0.677 |
| Any unpaid work loss, N (%) | 64 | 35 | 4 (11.4) | 45 | 7 (15.6) | 31 | 10 (32.3) | 0.122 | 0.168 | 0.854 |
| Any unpaid work loss, N (%) | 76 | 34 | 4 (11.8) | 40 | 8 (20.0) | 19 | 8 (42.1) | 0.026 | 0.187 | 0.729 |
| Any unpaid work loss, N (%) | 91 | 34 | 4 (11.8) | 35 | 4 (11.4) | 15 | 6 (40.0) | 0.077 | 0.075 | 1.000 |
| Unpaid work loss, hours (SD) | 52 | 37 | 2.11 (7.01) | 42 | 0.45 (1.71) | 31 | 3.06 (8.42) | 0.899 | 0.204 | 0.373 |
| Unpaid work loss, hours (SD) | 64 | 35 | 1.00 (3.19) | 45 | 0.91 (2.60) | 31 | 3.42 (6.78) | 0.169 | 0.123 | 0.991 |
| Unpaid work loss, hours (SD) | 76 | 34 | 0.94 (2.72) | 40 | 4.30 (17.99) | 19 | 4.26 (9.30) | 0.275 | 1.000 | 0.538 |
| Unpaid work loss, hours (SD) | 91 | 34 | 2.41 (8.10) | 35 | 0.63 (1.99) | 15 | 3.80 (6.93) | 0.857 | 0.240 | 0.483 |
| Total costs of lost productivity in the past 3 months | ||||||||||
| Any costs of lost productivity, N (%) | 52 | 36 | 11 (30.6) | 37 | 7 (18.9) | 22 | 5 (22.7) | 0.769 | 0.858 | 0.444 |
| Any costs of lost productivity, N (%) | 64 | 33 | 11 (33.3) | 36 | 9 (25.0) | 25 | 13 (52.0) | 0.322 | 0.103 | 0.792 |
| Any costs of lost productivity, N (%) | 76 | 32 | 7 (21.9) | 38 | 12 (31.6) | 18 | 10 (55.6) | 0.052 | 0.248 | 0.607 |
| Any costs of lost productivity, N (%) | 91 | 31 | 9 (29.0) | 29 | 9 (31.0) | 13 | 8 (61.5) | 0.141 | 0.158 | 1.000 |
| Total costs, € (SD) | 52 | 36 | 456.10 (933.67) | 37 | 154.80 (456.13) | 22 | 167.53 (357.51) | 0.242 | 0.994 | 0.210 |
| Total costs, € (SD) | 64 | 33 | 518.63 (1000.84) | 36 | 611.88 (1438.44) | 25 | 1047.65 (1592.03) | 0.326 | 0.535 | 0.953 |
| Total costs, € (SD) | 76 | 32 | 308.86 (716.42) | 38 | 804.81 (2357.20) | 18 | 852.54 (1503.04) | 0.352 | 0.997 | 0.480 |
| Total costs, € (SD) | 91 | 31 | 531.29 (1227.53) | 29 | 444.62 (1293.86) | 13 | 1304.58 (2407.96) | 0.594 | 0.524 | 0.971 |
ETN25+MTX, etanercept 25 mg plus methotrexate; N, the numbers of non-missing values used to generate the statistics; PBO, placebo; VOLP, Valuation of Lost Productivity.
*Bootstrapping method was used for multiple tests.