- 52-week VERIFY study shows rusfertide maintains hematocrit control in polycythemia vera.
- 77.9% of patients switching from placebo to rusfertide achieved phlebotomy eligibility absence.
- Four-year THRIVE study shows a 13-fold reduction in annual phlebotomy rate.
- Rusfertide's safety profile remains consistent with prior observations.
Study Overview
The 52-week results from the Phase 3 VERIFY study demonstrate that rusfertide provides sustained hematocrit control and reduces the need for phlebotomy in patients with polycythemia vera (PV). The study involved 293 patients, with 147 receiving rusfertide and 146 on placebo, later transitioning to open-label rusfertide.
Key Findings
61.9% of patients treated with rusfertide maintained absence of phlebotomy eligibility from baseline to Week 52. Patients crossing over from placebo to rusfertide at 32 weeks showed a similar response rate, with 77.9% achieving absence of phlebotomy eligibility between Weeks 40-52. The mean hematocrit remained below 43% through Week 52 for those on rusfertide.
Long-Term Data
The combined REVIVE and THRIVE studies revealed a 13-fold reduction in the annual rate of phlebotomies from baseline. The mean annualized phlebotomy rate decreased from 9.2 to 0.7 phlebotomies per year for patients continuing into the THRIVE study.
Safety Profile
Rusfertide was generally well-tolerated, with common adverse events including injection site reactions, anemia, and fatigue, mostly of grade 1 or 2 severity. Serious adverse events occurred in 8.1% of rusfertide-treated patients, consistent with previous observations.
