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Table 2 COMFORT-I & II trials on ruxolitinib

From: Dysregulation of JAK-STAT pathway in hematological malignancies and JAK inhibitors for clinical application

Methodology COMFORT-I COMFORT-II
Design 1:1 randomization, vs. placebo 2:1 randomization, vs. best available therapy
Number of patients 155 (ruxolitib) vs. 154 (placebo) 146 (ruxolitinib) vs. 73 (BAT)
Dose of ruxolitinib 15-20 mg twice daily based on platelet count 15-20 mg twice daily based on platelet count
Primary end point reduction in spleen size > 35% at 24 week reduction of spleen size > 35% at 48 week
Results   
35% reduction in spleen size 42% vs. 0.7% at 24 week 28% vs. 0% at 48 week
Duration of spleen response * 67% patient maintained the spleen response for 48 weeks 80% maintained the response at 12 month follow up
Major Adverse events: Anemia (45%), Thrombocytopenia (13%), headache, pyrexia Anemia, Diarrhea, Arthralgia, fatigue, abdominal pain
Discontinuation Rate 11% vs. 10.6% 8% vs. 5%
  1. BAT, best available therapy; * , secondary end-points ; QOL, quality of life ; ns, non significant.