This retrospective study aims to evaluate the effectiveness and safety of Ropeginterferon Alfa-2b (BESREMI) in patients with Polycythemia Vera (PV). Eligible patients have a confirmed PV diagnosis according to current criteria, have received at least one dose of Ropeginterferon, and have complete clinical and laboratory data available. The primary objective is to analyze the time course of hematologic response (complete or partial, CHR/PR) according to ELN criteria, and to identify clinical and treatment-related factors associated with achieving and maintaining response. Secondary objectives include time to response, duration of response, progression-free survival, thromboembolic event rate, safety and tolerability, treatment discontinuation, dose modifications and adherence, normalization of hematologic parameters, and changes in JAK2 V617F allele burden. Data will be collected retrospectively from medical records at participating centers.
Confirmed diagnosis of Polycythemia Vera according to updated diagnostic criteria
Have received at least one dose of Ropeginterferon Alfa-2b (BESREMI).
Complete clinical and laboratory data availability for review (e.g., hematologic parameters, treatment response, adverse events).
Followed at one of the participating study centers.
Have received experimental or non-approved treatments for PV during the observation period.
Lack sufficient clinical or laboratory data to allow inclusion in the analysis.
The study will include patients diagnosed with Polycythemia Vera (PV) according to current diagnostic criteria who have received at least one administration of Ropeginterferon Alfa-2b (BESREMI) as part of their disease management. Eligible patients must have complete clinical and laboratory information available and must be followed at one of the participating centers. All participants must provide written informed consent prior to inclusion in the study.
Cohort
Retrospective
Ropeginterferon alfa-2b (BESREMi®)
DrugRopeginterferon Alfa-2b was administered in accordance with the approved prescribing information.
Longitudinal Analysis of Hematologic Response (CR/PR) to Ropeginterferon Alfa-2b in polycythemia vera
Definition: Proportion of patients achieving Complete Hematologic Response (CHR) or Partial Response (PR) at each scheduled timepoint (3, 6, 9, 12, 18 and 24 months), classified according to the ELN criteria and identification of baseline and on-treatment factors associated with (a) first attainment of CHR/PR and (b) maintenance (duration) of CHR/PR. Assessment timepoints: Baseline, 3, 6, 9, 12, 18 and 24 months (or last available follow-up). Summary metrics: Proportion (%) in CHR and PR at each timepoint
Time to Hematologic Response
Time (in months) from the first day of Ropeginterferon Alfa-2b treatment to achievement of CHR or PR hematologic response according to ELN criteria.
Duration of Hematologic Response
Interval between first documented CHR or PR and loss of that response, death, or last follow-up.
Progression-Free Survival (PFS)
Time from treatment initiation to progression to post-PV myelofibrosis, acute myeloid leukemia, or death from any cause
Thromboembolic Event Rate
Proportion of patients experiencing arterial or venous thrombotic or embolic events during treatment with Ropeginterferon.
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