Outcomes
Variable . | Steroids + placebo; n = 49 . | Steroids + daclizumab; n = 53 . | P . |
|---|---|---|---|
| Follow-up of surviving subjects, median mo (range) | 10 (3-30) | 11 (3-28) | NA |
| GVHD response 42 d after enrollment, no. (%) | 26 (53) | 27 (51) | .85 |
| Alive without GVHD on d 100, no. (%) | 32 (65) | 22 (42) | .02 |
| Within the first 100 transplant days | |||
| No. of hospital d (range) | 36 (15-89) | 44 (9-99) | .04 |
| Total days of antibiotics (range) | 13 (0-64) | 14 (0-58) | .42 |
| Total days of antifungal agents (range) | 10 (0-64) | 12 (0-61) | .96 |
| Total days of antiviral agents (range) | 20 (0-64) | 14 (0-49) | .63 |
| Total steroid dose, mg/kg prednisone (range) | 70.8 (16.2-191.5) | 67.7 (18.6-151.3) | .74 |
| Hyperglycemia requiring insulin, no. (%) | 17 (35) | 21 (43) | .53 |
| Steroid myopathy, no. (%) | 5 (10) | 2 (4) | .26 |
| Steroid psychosis, no. (%) | 1 (2) | 2 (4) | .99 |
| Overall survival at d 100 after transplantation, % ± SE | 94 ± 3 | 77 ± 6 | .02 |
| Overall survival at 1 y after transplantation, % ± SE | 60 ± 8 | 29 ± 7 | .002 |
| Disease-free survival at 1 y after transplantation, % ± SE | 56 ± 8 | 25 ± 7 | .005 |
| Cumulative incidence of chronic GVHD, % ± SE | 64 ± 8 | 49 ± 7 | .16 |
| Cumulative incidence of relapse at 1 y, % ± SE | 17 ± 6 | 29 ± 7 | .19 |
Variable . | Steroids + placebo; n = 49 . | Steroids + daclizumab; n = 53 . | P . |
|---|---|---|---|
| Follow-up of surviving subjects, median mo (range) | 10 (3-30) | 11 (3-28) | NA |
| GVHD response 42 d after enrollment, no. (%) | 26 (53) | 27 (51) | .85 |
| Alive without GVHD on d 100, no. (%) | 32 (65) | 22 (42) | .02 |
| Within the first 100 transplant days | |||
| No. of hospital d (range) | 36 (15-89) | 44 (9-99) | .04 |
| Total days of antibiotics (range) | 13 (0-64) | 14 (0-58) | .42 |
| Total days of antifungal agents (range) | 10 (0-64) | 12 (0-61) | .96 |
| Total days of antiviral agents (range) | 20 (0-64) | 14 (0-49) | .63 |
| Total steroid dose, mg/kg prednisone (range) | 70.8 (16.2-191.5) | 67.7 (18.6-151.3) | .74 |
| Hyperglycemia requiring insulin, no. (%) | 17 (35) | 21 (43) | .53 |
| Steroid myopathy, no. (%) | 5 (10) | 2 (4) | .26 |
| Steroid psychosis, no. (%) | 1 (2) | 2 (4) | .99 |
| Overall survival at d 100 after transplantation, % ± SE | 94 ± 3 | 77 ± 6 | .02 |
| Overall survival at 1 y after transplantation, % ± SE | 60 ± 8 | 29 ± 7 | .002 |
| Disease-free survival at 1 y after transplantation, % ± SE | 56 ± 8 | 25 ± 7 | .005 |
| Cumulative incidence of chronic GVHD, % ± SE | 64 ± 8 | 49 ± 7 | .16 |
| Cumulative incidence of relapse at 1 y, % ± SE | 17 ± 6 | 29 ± 7 | .19 |
NA indicates not applicable.