Table 1.
Trials of anti-JAK2 efficacy and safety meeting inclusion criteria.
Number of patients enrolled in each arm | Primary endpoint | Previous ruxolitinib exposure | Platelets count at baseline | Minimal treatment period | Results | |
---|---|---|---|---|---|---|
COMFORT-1 [37] | Ruxolitinib (n = 155) | SVR | No | ≥100.109/L | 24 weeks | Ruxolitinib was superior to placebo for spleen response (p < 0.001). |
Placebo (n = 154) | ||||||
COMFORT-2 [5] | Ruxolitinib (n = 146) | SVR | No | ≥50.109/L | 48 weeks, data available at 24 weeks | Ruxolitinib was superior to BAT for spleen response (p < 0.001). |
BAT (n = 73) | ||||||
JAKARTA-1 [38] | Fedratinib 400 mg daily (n = 96) | SVR | No | ≥50.109/L | 24 weeks | Fedratinib (all arms) was superior to placebo for spleen response (p < 0.001). |
Fedratinib 500 mg daily (n = 97) | ||||||
Placebo (n = 96) | ||||||
PERSIST-1 [39] | Pacritinib (n = 220) | SVR | No | Not specified | 24 weeks | Pacritinib was superior to BAT including watchful waiting for spleen response (p = 0.0003). |
BAT excluding anti JAK (n = 107) | ||||||
PERSIST-2 [40] | Pacritinib 400 mg once daily (n = 104 (75a)) | SVR, total symptom score reduction | Previous ruxolitinib exposure or not | Must be <100.109/L | 24 weeks | Pacritinib (all arms) was superior to BAT including ruxolitinib for spleen response (p = 0.001) and for symptom response (p = 0.08). |
Pacritinib 200 mg twice daily (n = 107 (74a)) | ||||||
BAT (n = 100 (72a)) | ||||||
SIMPLIFY-1 [28] | Momelotinib (n = 215) | SVR | No | ≥50.109/L | 24 weeks | Momelotinib was noninferior to ruxolitinib for spleen response (p = 0.011) but not for symptom response (p = 0.98). Momelotinib treatment was associated with a reduced transfusion requirement (p < 0.019). |
Ruxolitinib (n = 217) | ||||||
SIMPLIFY-2 [27] | Momelotinib (n = 104) | SVR | Yes, after ruxolitinib exposure | Not specified | 24 weeks | Momelotinib was not superior to BAT for spleen response (p = 0.90) but was superior in symptom response (p = 0.0006). |
BAT (n = 52) |
SVR spleen volume reduction, BAT best available therapy.
aOnly patients who completed at least 22 weeks of follow-up after randomization and before clinical hold were taken into account.