REVOLADE, in combination with IST, has shown to be effective in treatment-naive SAA patients 1

In study NCT01623167, the NIH investigated 3 different regimens11

  • Objective: determine if efficacy would be improved by adding REVOLADE to standard IST in previously untreated SAA patients2‚Äč

Study Design

  • Single-arm, open-label, sequential cohort trial in patients 2 years of age or older (N=153)1

  • Primary end point: complete hematologic response at 6 months, defined by meeting the following 3 criteria: an absolute neutrophil count of >1000/microL, a hemoglobin level of >10 g/dL, and a platelet count of >100,000/microL1,2

  • REVOLADE was initiated at 150 mg in combination with h-ATG, 40 mg/kg/day,
    based on actual body weight, administered intravenously on Days 1 to 4 of the 6-month treatment period, and cyclosporine, 3 mg/kg, based on actual body weight, orally every 12 hours (total daily dose of 6 mg/kg/day) for 6 months starting on Day 11

  • The cohorts differed by REVOLADE regimen and the initiation of low-dose cyclosporine (maintenance dose) for patients who achieved a hematologic response at 6 months1 

    • Some patients in Cohort 2 and all patients in Cohort 3 and Cohort 3 + Extension cohort received low-dose CsA for an additional 18 months1

CsA, cyclosporine A; h-ATG, horse antithymocyte globulin; NIH, National Institutes of Health; SAA, severe aplastic anemia.