Response assessment at days 28 and 56 after randomization
| . | Treatment arm . | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Etanercept, n = 46 . | Mycophenolate, n = 45 . | Denileukin, n = 47 . | Pentostatin, n = 42 . | |||||||||
| n . | % . | 95% CI . | n . | % . | 95% CI . | n . | % . | 95% CI . | n . | % . | 95% CI . | |
| Day 28 | ||||||||||||
| Complete response | ||||||||||||
| All organs | 12/46 | 26 | 9-43 | 27/45 | 60 | 46-74 | 25/47 | 53 | 39-68 | 16/42 | 38 | 23-53 |
| Skin | 12/36 | 33 | 21/35 | 60 | 17/35 | 49 | 14/34 | 41 | ||||
| Lower gastrointestinal tract | 4/12 | 33 | 12/18 | 67 | 5/14 | 36 | 7/17 | 4162 | ||||
| Upper gastrointestinal tract | 5/10 | 50 | 11/12 | 92 | 10/14 | 71 | 8/13 | 40 | ||||
| Liver | 2/6 | 33 | 5/7 | 71 | 3/7 | 43 | 2/5 | |||||
| Excluding patients who received MMF prophylaxis | 9/32 | 28 | 13-44 | 27/45 | 60 | 46-74 | 15/31 | 48 | 31-66 | 11/28 | 39 | 21-57 |
| Complete and partial response | 22/46 | 48 | 33-62 | 35/45 | 78 | 66-90 | 28/47 | 60 | 46-74 | 26/42 | 62 | 47-77 |
| GVHD progression | 7/46 | 15 | 5-25 | 1/45 | 2 | 0-7 | 3/47 | 6 | 0-13 | 4/42 | 10 | 0.6-18 |
| Day 56 | ||||||||||||
| Complete response | ||||||||||||
| All organs | 20/46 | 44 | 29-58 | 33/45 | 73 | 60-86 | 26 | 55 | 41-70 | 26/42 | 62 | 47-77 |
| Excluding patients who received MMF prophylaxis | 17/32 | 53 | 36-70 | 33/45 | 73 | 60-86 | 19/31 | 61 | 44-78 | 18/28 | 64 | 47-82 |
| Treatment failure | 11/46 | 24 | 12-36 | 4/45 | 9 | .6-17 | 12/47 | 26 | 13-38 | 12/42 | 29 | 15-42 |
| . | Treatment arm . | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Etanercept, n = 46 . | Mycophenolate, n = 45 . | Denileukin, n = 47 . | Pentostatin, n = 42 . | |||||||||
| n . | % . | 95% CI . | n . | % . | 95% CI . | n . | % . | 95% CI . | n . | % . | 95% CI . | |
| Day 28 | ||||||||||||
| Complete response | ||||||||||||
| All organs | 12/46 | 26 | 9-43 | 27/45 | 60 | 46-74 | 25/47 | 53 | 39-68 | 16/42 | 38 | 23-53 |
| Skin | 12/36 | 33 | 21/35 | 60 | 17/35 | 49 | 14/34 | 41 | ||||
| Lower gastrointestinal tract | 4/12 | 33 | 12/18 | 67 | 5/14 | 36 | 7/17 | 4162 | ||||
| Upper gastrointestinal tract | 5/10 | 50 | 11/12 | 92 | 10/14 | 71 | 8/13 | 40 | ||||
| Liver | 2/6 | 33 | 5/7 | 71 | 3/7 | 43 | 2/5 | |||||
| Excluding patients who received MMF prophylaxis | 9/32 | 28 | 13-44 | 27/45 | 60 | 46-74 | 15/31 | 48 | 31-66 | 11/28 | 39 | 21-57 |
| Complete and partial response | 22/46 | 48 | 33-62 | 35/45 | 78 | 66-90 | 28/47 | 60 | 46-74 | 26/42 | 62 | 47-77 |
| GVHD progression | 7/46 | 15 | 5-25 | 1/45 | 2 | 0-7 | 3/47 | 6 | 0-13 | 4/42 | 10 | 0.6-18 |
| Day 56 | ||||||||||||
| Complete response | ||||||||||||
| All organs | 20/46 | 44 | 29-58 | 33/45 | 73 | 60-86 | 26 | 55 | 41-70 | 26/42 | 62 | 47-77 |
| Excluding patients who received MMF prophylaxis | 17/32 | 53 | 36-70 | 33/45 | 73 | 60-86 | 19/31 | 61 | 44-78 | 18/28 | 64 | 47-82 |
| Treatment failure | 11/46 | 24 | 12-36 | 4/45 | 9 | .6-17 | 12/47 | 26 | 13-38 | 12/42 | 29 | 15-42 |
Shown are the number and proportion of responders at days 28 and 56 of therapy in the 4 randomized cohorts and in a subset excluding those who had received MMF for GVHD prophylaxis within the 7 days before study enrollment. Treatment failure includes no response, progression, or addition of new therapy before day 56.