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December 8, 2025BloodOpen Access

Final results from a prospective, multicenter, non-interventional study (BESREMi-PASS) on the safety of ropeginterferon alfa-2b in 229 patients with polycythemia vera

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Authors

VBVeronika Buxhofer‐AuschJohannes Kepler University of LinzARAndreas ReiterGSI Helmholtz Centre for Heavy Ion ResearchAWAlbert WoelflerMedical University of Graz

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Implication

Prospective study reports low hepatotoxicity and adverse drug reactions in polycythemia vera patients, indicating the safety of ropeginterferon alfa-2b treatment.

Key Points

  • This study evaluates the safety and hepatotoxicity risk of ropeginterferon alfa-2b in patients with polycythemia vera.
  • Phase 4, prospective, non-interventional study
  • Conducted in Austria, Germany, and Romania across multiple sites
  • Involves ropeg-naïve patients aged ≥18 years
  • Monitored liver parameters and treatment-emergent adverse events over 18 months
  • 14.0% of patients experienced significant elevations in liver parameters in the first 6 months
  • Only one hepatobiliary adverse drug reaction reported (grade 2 hepatic cirrhosis)
  • Thromboembolic events occurred in 4.8% of patients, all with pre-existing cardiovascular conditions
  • Overall low rate of hepatotoxicity consistent with prior trials

Cite This Study

Buxhofer‐Ausch et al. (2025) studied this question.

synapsesocial.com/papers/69362f4b4fa91c937236d7b8https://doi.org/10.1182/blood-2025-2032
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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1Real-life use of ropeg-interferon α2b in Polycythemia Vera: patient selection and clinical outcomes2024
  2. 2Real-life use of ropeg-interferon α2b in polycythemia vera: patient selection and clinical outcomes2024 · 9 citations
  3. 3Long-term outcomes of ropeginterferon alfa-2b-njft in polycythemia vera: a review of safety, efficacy, and potential disease modification2026
  4. 4Effective Management of Polycythemia Vera With Ropeginterferon Alfa-2b Treatment2024 · 25 citations
  5. 5Long-term efficacy and safety of ropeginterferon alfa-2b under its hidat regimen for the treatment of polycythemia vera2025