Subjects not responding to initial GVHD treatment
. | Steroids + placebo; n = 23 . | Steroids + daclizumab; n = 26 . |
|---|---|---|
| GVHD response to initial therapy, no. (%) | ||
| Flare, new organ | 0 (0) | 3 (12) |
| Flare, prior organ | 6 (26) | 6 (23) |
| Progression, new organ | 2 (9) | 5 (19) |
| Progression, prior organ | 6 (26) | 9 (35) |
| Stable, no response | 7 (30) | 3 (12) |
| Other reason for treatment failure* | 2 (9) | 0 (0) |
| Second-line GVHD therapies, no. | ||
| Daclizumab | 16 | 4 |
| Denileukin diftitox | 3 | 7 |
| Mycophenolate mofetil | 14 | 11 |
| Infliximab | 1 | 4 |
| Rapamycin | 1 | 5 |
| Antithymocyte globulin | 1 | 0 |
. | Steroids + placebo; n = 23 . | Steroids + daclizumab; n = 26 . |
|---|---|---|
| GVHD response to initial therapy, no. (%) | ||
| Flare, new organ | 0 (0) | 3 (12) |
| Flare, prior organ | 6 (26) | 6 (23) |
| Progression, new organ | 2 (9) | 5 (19) |
| Progression, prior organ | 6 (26) | 9 (35) |
| Stable, no response | 7 (30) | 3 (12) |
| Other reason for treatment failure* | 2 (9) | 0 (0) |
| Second-line GVHD therapies, no. | ||
| Daclizumab | 16 | 4 |
| Denileukin diftitox | 3 | 7 |
| Mycophenolate mofetil | 14 | 11 |
| Infliximab | 1 | 4 |
| Rapamycin | 1 | 5 |
| Antithymocyte globulin | 1 | 0 |
One subject had mycophenolate mofetil added as a steroid-sparing agent before study day 42; a second subject was unblinded, although GVHD was improving