Demographics and baseline clinical characteristics of patients with SR-aGVHD (REACH2) by azoles subgroup (full analysis set)
| . | Ruxolitinib (n = 154) . | BAT (n = 155) . | ||
|---|---|---|---|---|
| With azoles (n = 117) . | Without azoles (n = 37) . | With azoles (n = 106) . | Without azoles (n = 49) . | |
| Age, median (range), y | 51.0 (13.0-71.0) | 58.0 (12.0-73.0) | 54.0 (13.0-71.0) | 58.0 (16.0-70.0) |
| Male, n (%) | 67 (57.3) | 25 (67.6) | 62 (58.5) | 29 (59.2) |
| Time from transplant to aGVHD grade ≥2 diagnosis, median (range), d | 36.0 (3-380) | 29.0 (7-247) | 34.5 (6-412) | 33.0 (10-190) |
| aGVHD grade,∗ n (%) | ||||
| 2 | 56 (47.9) | 12 (32.4) | 62 (58.5) | 12 (24.5) |
| 3 | 51 (43.6) | 17 (45.9) | 36 (34.0) | 26 (53.1) |
| 4 | 10 (8.5) | 8 (21.6) | 8 (7.5) | 11 (22.4) |
| aGVHD organ involvement at randomization, n (%) | ||||
| Skin | 75 (64.1) | 18 (48.6) | 56 (52.8) | 18 (36.7) |
| Liver | 26 (22.2) | 10 (27.0) | 14 (13.2) | 12 (24.5) |
| Upper GI | 19 (16.2) | 9 (24.3) | 22 (20.8) | 15 (30.6) |
| Lower GI | 71 (60.7) | 25 (67.6) | 76 (71.7) | 39 (79.6) |
| Missing | 4 (3.4) | 0 | 1 (0.9) | 0 |
| Steroid dose at randomization,† median (range), mg/d | 120.0 (16.0-1000.0) | 129.0 (50.0-200.0) | 122.5 (16.0-680.0) | 120.0 (20.0-200.0) |
| Azole received as previous medication,‡ n (%) | 99 (64.3) | 92 (59.4) | ||
| Posaconazole | 62 (40.3) | 49 (31.6) | ||
| Fluconazole | 21 (13.6) | 25 (16.1) | ||
| Voriconazole | 18 (11.7) | 19 (12.3) | ||
| Itraconazole | 5 (3.2) | 7 (4.5) | ||
| Isavuconazole | 3 (1.9) | 1 (0.6) | ||
| Isavuconazonium sulfate | 0 | 1 (0.6) | ||
| . | Ruxolitinib (n = 154) . | BAT (n = 155) . | ||
|---|---|---|---|---|
| With azoles (n = 117) . | Without azoles (n = 37) . | With azoles (n = 106) . | Without azoles (n = 49) . | |
| Age, median (range), y | 51.0 (13.0-71.0) | 58.0 (12.0-73.0) | 54.0 (13.0-71.0) | 58.0 (16.0-70.0) |
| Male, n (%) | 67 (57.3) | 25 (67.6) | 62 (58.5) | 29 (59.2) |
| Time from transplant to aGVHD grade ≥2 diagnosis, median (range), d | 36.0 (3-380) | 29.0 (7-247) | 34.5 (6-412) | 33.0 (10-190) |
| aGVHD grade,∗ n (%) | ||||
| 2 | 56 (47.9) | 12 (32.4) | 62 (58.5) | 12 (24.5) |
| 3 | 51 (43.6) | 17 (45.9) | 36 (34.0) | 26 (53.1) |
| 4 | 10 (8.5) | 8 (21.6) | 8 (7.5) | 11 (22.4) |
| aGVHD organ involvement at randomization, n (%) | ||||
| Skin | 75 (64.1) | 18 (48.6) | 56 (52.8) | 18 (36.7) |
| Liver | 26 (22.2) | 10 (27.0) | 14 (13.2) | 12 (24.5) |
| Upper GI | 19 (16.2) | 9 (24.3) | 22 (20.8) | 15 (30.6) |
| Lower GI | 71 (60.7) | 25 (67.6) | 76 (71.7) | 39 (79.6) |
| Missing | 4 (3.4) | 0 | 1 (0.9) | 0 |
| Steroid dose at randomization,† median (range), mg/d | 120.0 (16.0-1000.0) | 129.0 (50.0-200.0) | 122.5 (16.0-680.0) | 120.0 (20.0-200.0) |
| Azole received as previous medication,‡ n (%) | 99 (64.3) | 92 (59.4) | ||
| Posaconazole | 62 (40.3) | 49 (31.6) | ||
| Fluconazole | 21 (13.6) | 25 (16.1) | ||
| Voriconazole | 18 (11.7) | 19 (12.3) | ||
| Itraconazole | 5 (3.2) | 7 (4.5) | ||
| Isavuconazole | 3 (1.9) | 1 (0.6) | ||
| Isavuconazonium sulfate | 0 | 1 (0.6) | ||
GI, gastrointestinal.
At diagnosis of aGVHD grade ≥2.
Data regarding steroid dose at randomization were missing in 4 and 1 patients treated with ruxolitinib with and without azoles, respectively, and 2 and 2 patients treated with BAT with and without azoles, respectively.
Previous medication defined as any nonstudy medication started before first dose of ruxolitinib or BAT in the randomized phase, regardless of concomitant azole use.