Efficacy and Safety of Ropeginterferon Alfa-2b in Low-Risk Polycythemia Vera.

PURPOSE: Conventional management of low-risk polycythemia vera (PV), consisting of phlebotomy and aspirin, often fails to adequately control symptoms and hematologic parameters. This study evaluated the efficacy and safety of ropeginterferon alfa-2b (Ropeg) in low-risk PV patients requiring cytoreductive therapy.

MATERIALS AND

METHODS

In this sub-analysis of an open-label, multicenter trial, 42 patients received Ropeg for 48 weeks. The primary endpoint was a reduction in phlebotomy frequency, while secondary endpoints included complete hematologic response (CHR), changes in JAK2V617F allele burden, and safety.

RESULTS

Among 42 patients, Ropeg significantly reduced mean phlebotomy frequency per year from 3.0 to 0.5 (p < 0.05) and improved CHR rates (69.1% at 48 weeks). The JAK2V617F allele burden decreased, and hydroxyurea-naïve patients showed better responses. The most frequently reported treatment-related adverse events included elevated liver enzymes and alopecia. Most adverse events were mild or moderate, with no grade 4 or 5 events reported.

CONCLUSION

These findings suggest that Ropeg is a promising treatment option for low-risk PV by effectively reducing the need for phlebotomy and demonstrating efficacy and safety.