Patients with polycythemia vera (PV) demonstrated reduced symptom burden and improved quality of life with long-term ropeginterferon alfa-2b compared with hydroxyurea or the best available treatment (BAT), according to the results of the final analysis of the PROUD-PV/CONTINUATION-PV studies presented at the EHA 2022 Hybrid Congress.
Previous analyses of the PROUD-PV/CONTINUATION-PV studies demonstrated efficacy of ropeginterferon alfa-2b. This final analysis focused on patient-centered outcomes for 95 patients over 6 years of treatment.
In PROUD-PV, patients with PV who were cytoreductive-naïve or pretreated with hydroxyurea were randomly assigned to ropeginterferon alpha-2b or hydroxyurea for 1 year. In CONTINUATION-PV, patients in the hydroxyurea arm could cross-over to BAT. Patient-reported outcomes were recorded in patient diaries and included PV-related symptom burden.
At baseline, patient-reported PV symptoms were present among 9.5% of patients in each arm. In the sixth year of treatment, PV-related symptoms were experienced by 15.7% of patients treated with ropeginterferon alpha-2b compared with 20.7% of patients in the control arm.
A greater proportion of patients in the ropeginterferon alfa-2b arm did not require phlebotomy to maintain their hematocrit below 45%, with 81.4% not requiring phlebotomy compared with 60.0% of patients in the control arm (P =.005).
Ropeginterferon alfa-2b also reduced the JAK2V617F allele burden, with a burden less than 1% achieved among 20.7% of patients compared with 1.4% in the control arm (P =.0001). Event-free survival was also higher in the ropeginterferon alfa-2b arm (P =.04).
The authors concluded that “long-term ropeginterferon alfa-2b therapy fulfils treatment goals important to patients with PV: a good quality of life as indicated by low symptom burden and phlebotomy requirement, the potential influence to myelofibrosis risk, and better event-free survival [vs] BAT.”
Disclosures: Disclosures are not available for this presentation.
Gisslinger H, Klade C, Georgiev P, et al. Ropeginterferon alfa-2b achieves patient-specific treatment goals in polycythemia vera: final results from the PROUD-PV/CONTINUATION-PV studies. Presented at EHA 2022; June 9-12, 2022. Abstract S196.