Ropeginterferon alfa-2b-njft

(Besremi®)

Ropeginterferon alfa-2b-njft

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Drug updated on 5/17/2024

Dosage FormInjection (subcutaneous; 500 mcg/mL)
Drug ClassInterferon alfa-2b
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of adults with polycythemia vera.

Summary
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  • Ropeginterferon alfa-2b-njft (Besremi) is utilized for the management of adults with polycythemia vera, a variant of myeloproliferative neoplasm. This medication provides an extended administration interval, which could potentially enhance patient compliance.
  • Two studies from Randomized Controlled Trials were analyzed to collect data on the drug's safety and effectiveness in comparison to hydroxyurea.
  • In terms of safety, ropeginterferon alfa-2b-njft showed predominantly grade 3 and grade 4 treatment-related adverse events such as increased γ-glutamyltransferase and increased alanine aminotransferase. Nevertheless, serious treatment-related adverse events were lower in the ropeginterferon alfa-2b-njft group (2%) compared to the hydroxyurea group (4%).
  • As for effectiveness, initial results at 12 months did not show non-inferiority in terms of hematological response compared with hydroxyurea. Yet, by 36 months, it surpassed hydroxyurea in complete hematological response, suggesting that its benefits escalate over time.
  • A notable difference was observed at 36 months, with an improved disease burden more frequently in the ropeginterferon alfa-2b-njft group (53%) than in the hydroxyurea group (38%), demonstrating superior longer-term efficacy.
  • The trials involved adult patients with early-stage polycythemia vera, including those without a history or less than three years of previous use of cytoreductive therapy like hydroxyurea, and patients intolerant or resistant to existing therapeutic options, thereby offering alternatives for subgroups in need.