Ropeginterferon alfa-2b-njft

(Besremi®)

Besremi®

Drug updated on 10/25/2024

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

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Summary
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  • This summary is based on the review of one randomized controlled trial(s). [1]
  • At 12 months, ropeginterferon alfa-2b achieved complete haematological response with normal spleen size in 21% of patients, compared to 28% for hydroxyurea. However, without the spleen criterion, the response rates were 43% and 46%, respectively, with no statistically significant difference (p = 0.63).
  • At 36 months, ropeginterferon alfa-2b showed significantly better outcomes than hydroxyurea, with a complete haematological response in 53% of patients versus 38% for hydroxyurea (p = 0.044). Without the spleen criterion, the response rates were 71% for ropeginterferon alfa-2b versus 51% for hydroxyurea (p = 0.012).
  • These trials focused on patients aged 18 years or older with early-stage polycythaemia vera, and no specific subgroup analyses or variations in effectiveness among different populations were reported.
  • Ropeginterferon alfa-2b was associated with increased liver enzymes, with 6% of patients experiencing elevated gamma-glutamyltransferase and 3% having elevated alanine aminotransferase. In comparison, hydroxyurea caused more blood-related adverse events, with 5% of patients experiencing leucopenia and 4% experiencing thrombocytopenia.
  • Treatment-related serious adverse events occurred in 2% of ropeginterferon alfa-2b patients and 4% of hydroxyurea patients. One treatment-related death due to acute leukemia was reported in the hydroxyurea group.

Product Monograph / Prescribing Information

Document TitleYearSource
Besremi (ropeginterferon alfa-2b-njft) Prescribing Information.2024PharmaEssentia Corporation, Burlington, MA

Randomized Controlled Trials