Effect of concomitant azoles on ruxolitinib treatment patterns (safety analysis set)
| . | Patients with SR-aGVHD (REACH2; n = 152) . | Patients with SR-cGVHD (REACH3; n = 165) . | ||
|---|---|---|---|---|
| With azoles (n = 117) . | Without azoles (n = 35) . | With azoles (n = 116) . | Without azoles (n = 49) . | |
| Ruxolitinib dose intensity up to day 28 (REACH2) or week 24 (REACH3), mg/d | ||||
| Mean (standard deviation) | 18.1 (3.0) | 18.6 (2.7) | 17.0 (4.0) | 18.5 (2.9) |
| Median (range) | 20.0 (9.0-21.0) | 20.0 (8.4-20.0) | 19.4 (4.8-20.5) | 19.9 (5.5-20.0) |
| Ruxolitinib dose modifications, n (%) | 97 (82.9) | 21 (60.0) | 83 (71.6) | 31 (63.3) |
| Ruxolitinib discontinuations, n (%) | 108 (92.3) | 33 (94.3) | 62 (53.4) | 23 (46.9) |
| Reasons for ruxolitinib discontinuation, n (%) | ||||
| Completed study treatment | 29 (24.8) | 4 (11.4) | 1 (0.9) | 0 |
| AE | 24 (20.5) | 5 (14.3) | 25 (21.6) | 5 (10.2) |
| Lack of efficacy | 19 (16.2) | 11 (31.4) | 13 (11.2) | 9 (18.4) |
| Death | 15 (12.8) | 6 (17.1) | 5 (4.3) | 0 |
| Other∗ | 21 (17.9) | 7 (20.0) | 18 (15.5) | 9 (18.4) |
| . | Patients with SR-aGVHD (REACH2; n = 152) . | Patients with SR-cGVHD (REACH3; n = 165) . | ||
|---|---|---|---|---|
| With azoles (n = 117) . | Without azoles (n = 35) . | With azoles (n = 116) . | Without azoles (n = 49) . | |
| Ruxolitinib dose intensity up to day 28 (REACH2) or week 24 (REACH3), mg/d | ||||
| Mean (standard deviation) | 18.1 (3.0) | 18.6 (2.7) | 17.0 (4.0) | 18.5 (2.9) |
| Median (range) | 20.0 (9.0-21.0) | 20.0 (8.4-20.0) | 19.4 (4.8-20.5) | 19.9 (5.5-20.0) |
| Ruxolitinib dose modifications, n (%) | 97 (82.9) | 21 (60.0) | 83 (71.6) | 31 (63.3) |
| Ruxolitinib discontinuations, n (%) | 108 (92.3) | 33 (94.3) | 62 (53.4) | 23 (46.9) |
| Reasons for ruxolitinib discontinuation, n (%) | ||||
| Completed study treatment | 29 (24.8) | 4 (11.4) | 1 (0.9) | 0 |
| AE | 24 (20.5) | 5 (14.3) | 25 (21.6) | 5 (10.2) |
| Lack of efficacy | 19 (16.2) | 11 (31.4) | 13 (11.2) | 9 (18.4) |
| Death | 15 (12.8) | 6 (17.1) | 5 (4.3) | 0 |
| Other∗ | 21 (17.9) | 7 (20.0) | 18 (15.5) | 9 (18.4) |
Includes failure to meet protocol continuation, disease relapse, physician decision, graft loss, patient decision, and protocol deviation.