Summary

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• Besremi (ropeginterferon alfa-2b-njft) is indicated for the treatment of adults with polycythemia vera.
• This summary is based on the review of two randomized controlled trial(s). ^[1-2]
• In the PROUD-PV trial, hydroxyurea demonstrated a higher percentage of complete hematological response with normal spleen size at 12 months compared to ropeginterferon alfa-2b (28% vs. 21%).
• In the CONTINUATION-PV trial at 36 months, ropeginterferon alfa-2b showed a higher percentage of complete hematological response with improved disease burden compared to hydroxyurea (53% vs. 38%, p=0.044) and without the spleen criterion (71% vs. 51%, p=0.012).
• In the PROUD-PV and CONTINUATION-PV trials, the most frequently reported Grade 3 and 4 adverse events for ropeginterferon alfa-2b were increased γ-glutamyltransferase (6%) and increased alanine aminotransferase (3%), while for hydroxyurea, leucopenia (5%) and thrombocytopenia (4%) were most common. Treatment-related serious adverse events occurred in 2% of patients treated with ropeginterferon alfa-2b and 4% of those treated with hydroxyurea. One treatment-related death (acute leukemia) was reported in the hydroxyurea group.
• There is no safety information available in the reviewed studies for the ROP-ET trial as the study is ongoing.
• There is no population types or subgroups information available in the reviewed studies.