TABLE 1.
Baseline demographic and disease characteristics for patients in JAKARTA and JAKARTA2 by baseline platelet count
| Characteristic | JAKARTA | JAKARTA2 | ||||
|---|---|---|---|---|---|---|
| Platelet count 50 to <100 × 109/l | Platelet count ≥100 × 109/l | Platelet count 50 to <100 × 109/l | Platelet count ≥100 × 109/l | |||
| Placebo (n = 18) | Fedratinib 400 mg (n = 14) | Placebo (n = 77) | Fedratinib 400 mg (n = 82) | Fedratinib 400 mg (n = 33) | Fedratinib 400 mg (n = 64) | |
| Platelet count, median (range), 109/l, a | 67 (52–95) | 65 (31–92) | 234 (103–1075) | 240 (112–1155) | 76 (48–98) | 193 (102–929) |
| Age, median (range), years | 66.5 (38–82) | 68.0 (50–86) | 66.0 (27–85) | 62.5 (39–79) | 66.0 (51–78) | 68.0 (38–83) |
| Disease setting, n (%) | ||||||
| Primary MF | 14 (78) | 8 (57) | 43 (56) | 54 (66) | 19 (58) | 34 (53) |
| Post‐PV MF | 1 (6) | 4 (29) | 26 (34) | 20 (24) | 11 (33) | 14 (22) |
| Post‐ET MF | 3 (17) | 2 (14) | 8 (10) | 8 (10) | 3 (9) | 16 (25) |
| Risk status, n (%) | ||||||
| Intermediate b | 7 (39) | 5 (36) | 39 (51) | 52 (63) | 21 (64) | 42 (66) |
| High | 11 (61) | 9 (64) | 38 (49) | 30 (37) | 12 (36) | 22 (34) |
| Time since MF diagnosis, median (range), months | 14 (0.2–126) | 56 (0.8–171) | 34 (0.8–413) | 42 (1–311) | 78 (8–216) | 36 (4–300) |
| RBC transfusion‐dependent, n (%) | 2 (11) | 2 (14) | 4 (5) | 6 (7) | 3 (9) | 11 (17) |
| Spleen volume, median (range), ml |
2400 (670–6054) |
2867 (1058–5049) |
2773.5 (662–7911) |
2652 (316–6430) |
2917 (785–5811) |
2870 (737–7815) |
| MFSAF TSS, mean [SD] | n = 13 | n = 67 | n = 78 | n = 31 | n = 59 | |
| 13.6 [13.6] | 11.8 [10.6] | 15.0 [11.6] | 18.5 [13.8] | 21.0 [12.6] | 20.5 [12.0] | |
| Number of prior MF therapies, n (%) | ||||||
| 1 | NA | NA | NA | NA | 8 (24) | 12 (19) |
| 2 | NA | NA | NA | NA | 17 (52) | 30 (47) |
| ≥3 | NA | NA | NA | NA | 8 (24) | 22 (34) |
| Prior ruxolitinib duration, median (range), months | NA | NA | NA | NA | 15.7 (6.1–56) | 9.6 (1.1–62) |
| Reason for ruxolitinib discontinuation, c n (%) | ||||||
| Intolerant | NA | NA | NA | NA | 16 (48) | 16 (25) |
| Resistant | NA | NA | NA | NA | 16 (48) | 48 (75) |
Abbreviations: ET, essential thrombocythaemia; MF, myelofibrosis; MFSAF, Myelofibrosis Symptom Assessment Form; PV, polycythaemia vera; RBC, red blood cell; SD, standard deviation; TSS, total symptom score.
a
Platelet count on cycle 1, day 1. Every patient had a platelet count ≥50 × 109/l at the screening visit.
b
Includes patients from both trials with intermediate‐2 risk MF and patients from JAKARTA2 with intermediate‐1 risk MF with symptoms.
c
Per investigator assessment.