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.
Study Type
OBSERVATIONAL
Enrollment
150
Ropeginterferon 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 frame: From enrollment to the end of treatment or at least 12 months of treatment
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.
Time frame: Baseline to first documented CHR or PR (up to 24 months)
Duration of Hematologic Response
Interval between first documented CHR or PR and loss of that response, death, or last follow-up.
Time frame: From first CHR/PR to loss or last follow-up (up to 24 months)
Progression-Free Survival (PFS)
Time from treatment initiation to progression to post-PV myelofibrosis, acute myeloid leukemia, or death from any cause
Time frame: Baseline to event or last follow-up (up to 24 months)
Thromboembolic Event Rate
Proportion of patients experiencing arterial or venous thrombotic or embolic events during treatment with Ropeginterferon.
Time frame: Baseline to last follow-up (up to 24 months)
Incidence of Treatment-Emergent Adverse Events
Incidence of Treatment-Emergent Adverse Events \[Safety and Tolerability\]) CTCAE v6.
Time frame: Baseline to last follow-up (up to 24 months)
Treatment Discontinuation
Proportion of patients who discontinue Ropeginterferon for adverse events, lack of efficacy, or other clinical reasons.
Time frame: Baseline to last follow-up (up to 24 months)
Dose Modifications and Adherence
Number and proportion of patients with significant dose changes (reductions or increases) and estimated adherence (planned vs observed dosing intervals).
Time frame: Baseline to last follow-up (up to 24 months)
Normalization of Hematologic Parameters
Proportion of patients achieving target hematologic values: hematocrit \<45%, leukocytes \<10000/mm³, platelets \<400000/mm³.
Time frame: Baseline and at scheduled visits (3,6,9,12,18,24 months)
JAK2 V617F Allele Burden
Assessment of JAK2 V617F allele burden dynamics during Ropeginterferon treatment and correlation with hematologic response.
Time frame: Baseline and at scheduled visits (3,6,9,12,18,24 months)
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