Demographics and baseline clinical characteristics with SR-cGVHD (REACH3) by azoles subgroup (full analysis set)
| . | Ruxolitinib (n = 165) . | BAT (n = 164) . | ||
|---|---|---|---|---|
| With azoles (n = 116) . | Without azoles (n = 49) . | With azoles (n = 102) . | Without azoles (n = 62) . | |
| Age, median (range), y | 49.0 (15.0-73.0) | 48.0 (13.0-71.0) | 48.5 (13.0-76.0) | 51.0 (12.0-72.0) |
| Male, n (%) | 77 (66.4) | 32 (65.3) | 61 (59.8) | 31 (50.0) |
| Previous aGVHD, n (%) | 58 (50.0) | 34 (69.4) | 57 (55.9) | 31 (50.0) |
| Grade 1 | 17 (14.7) | 8 (16.3) | 19 (18.6) | 11 (17.7) |
| Grade 2 | 34 (29.3) | 19 (38.8) | 26 (25.5) | 17 (27.4) |
| Grade 3 | 7 (6.0) | 7 (14.3) | 10 (9.8) | 2 (3.2) |
| Grade 4 | 0 | 0 | 2 (2.0) | 1 (1.6) |
| SR-aGVHD | 11 (9.5) | 7 (14.3) | 6 (5.9) | 11 (17.7) |
| SR-cGVHD severity at study entrance, n (%) | ||||
| Mild | 0 | 0 | 0 | 1 (1.6) |
| Moderate | 42 (36.2) | 26 (53.1) | 46 (45.1) | 27 (43.5) |
| Severe | 74 (63.8) | 23 (46.9) | 56 (54.9) | 34 (54.8) |
| Time from cGVHD diagnosis to randomization, median (range), d | 185.5 (7-998) | 120.0 (8-2017) | 122.0 (10-1154) | 186.0 (14-1947) |
| Previous cGVHD therapy, n (%) | ||||
| Steroid only | 42 (36.2) | 28 (57.1) | 47 (46.1) | 34 (54.8) |
| Steroid + CNI | 56 (48.3) | 12 (24.5) | 48 (47.1) | 21 (33.9) |
| Steroid + CNI + other systemic therapy | 7 (6.0) | 3 (6.1) | 2 (2.0) | 2 (3.2) |
| Steroid + other systemic therapy | 10 (8.6) | 4 (8.2) | 4 (3.9) | 5 (8.1) |
| Missing | 1 (0.9) | 2 (4.1) | 1 (1.0) | 0 |
| Azole received as previous medication,∗ n (%) | 97 (58.8) | 86 (52.4) | ||
| Posaconazole | 43 (26.1) | 48 (29.3) | ||
| Fluconazole | 26 (15.8) | 30 (18.3) | ||
| Voriconazole | 25 (15.2) | 9 (5.5) | ||
| Itraconazole | 4 (2.4) | 4 (2.4) | ||
| Isavuconazole | 2 (1.2) | 1 (0.6) | ||
| Fosfluconazole | 1 (0.6) | 0 | ||
| Isavuconazonium sulfate | 1 (0.6) | 1 (0.6) | ||
| . | Ruxolitinib (n = 165) . | BAT (n = 164) . | ||
|---|---|---|---|---|
| With azoles (n = 116) . | Without azoles (n = 49) . | With azoles (n = 102) . | Without azoles (n = 62) . | |
| Age, median (range), y | 49.0 (15.0-73.0) | 48.0 (13.0-71.0) | 48.5 (13.0-76.0) | 51.0 (12.0-72.0) |
| Male, n (%) | 77 (66.4) | 32 (65.3) | 61 (59.8) | 31 (50.0) |
| Previous aGVHD, n (%) | 58 (50.0) | 34 (69.4) | 57 (55.9) | 31 (50.0) |
| Grade 1 | 17 (14.7) | 8 (16.3) | 19 (18.6) | 11 (17.7) |
| Grade 2 | 34 (29.3) | 19 (38.8) | 26 (25.5) | 17 (27.4) |
| Grade 3 | 7 (6.0) | 7 (14.3) | 10 (9.8) | 2 (3.2) |
| Grade 4 | 0 | 0 | 2 (2.0) | 1 (1.6) |
| SR-aGVHD | 11 (9.5) | 7 (14.3) | 6 (5.9) | 11 (17.7) |
| SR-cGVHD severity at study entrance, n (%) | ||||
| Mild | 0 | 0 | 0 | 1 (1.6) |
| Moderate | 42 (36.2) | 26 (53.1) | 46 (45.1) | 27 (43.5) |
| Severe | 74 (63.8) | 23 (46.9) | 56 (54.9) | 34 (54.8) |
| Time from cGVHD diagnosis to randomization, median (range), d | 185.5 (7-998) | 120.0 (8-2017) | 122.0 (10-1154) | 186.0 (14-1947) |
| Previous cGVHD therapy, n (%) | ||||
| Steroid only | 42 (36.2) | 28 (57.1) | 47 (46.1) | 34 (54.8) |
| Steroid + CNI | 56 (48.3) | 12 (24.5) | 48 (47.1) | 21 (33.9) |
| Steroid + CNI + other systemic therapy | 7 (6.0) | 3 (6.1) | 2 (2.0) | 2 (3.2) |
| Steroid + other systemic therapy | 10 (8.6) | 4 (8.2) | 4 (3.9) | 5 (8.1) |
| Missing | 1 (0.9) | 2 (4.1) | 1 (1.0) | 0 |
| Azole received as previous medication,∗ n (%) | 97 (58.8) | 86 (52.4) | ||
| Posaconazole | 43 (26.1) | 48 (29.3) | ||
| Fluconazole | 26 (15.8) | 30 (18.3) | ||
| Voriconazole | 25 (15.2) | 9 (5.5) | ||
| Itraconazole | 4 (2.4) | 4 (2.4) | ||
| Isavuconazole | 2 (1.2) | 1 (0.6) | ||
| Fosfluconazole | 1 (0.6) | 0 | ||
| Isavuconazonium sulfate | 1 (0.6) | 1 (0.6) | ||
CNI, calcineurin inhibitor.
Previous medication defined as any nonstudy medication started before first dose of ruxolitinib or BAT in the randomized phase, regardless of concomitant azole use.