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. 2021 Jul 27;11(7):135. doi: 10.1038/s41408-021-00526-z

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.