Drug updated on 5/17/2024
Dosage Form | Injection (subcutaneous; 500 mcg/mL) |
Drug Class | Interferon alfa-2b |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of adults with polycythemia vera.
Latest News
Summary
- 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.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Besremi (ropeginterferon alfa-2b-njft) Prescribing Information. | 2021 | PharmaEssentia Corporation, Burlington, MA |
Health Technology Assessments
Document Title | Year | Source |
---|---|---|
Assessment report: Besremi. | 2019 | EMA |
Randomized Controlled Trials
Document Title | Sex Distribution | Year | Source |
---|---|---|---|
ROP-ET: a prospective phase III trial investigating the efficacy and safety of ropeginterferon alfa-2b in essential thrombocythemia patients with limited treatment options. | Data not availableSubjects F: null% M: null% | 2024 | Annals of Hematology |
Ropeginterferon alfa-2b versus standard therapy for polycythaemia vera (PROUD-PV and CONTINUATION-PV): a randomised, non-inferiority, phase 3 trial and its extension study. | Data not availableSubjects F: null% M: null% | 2020 | The Lancet. Haematology |
Sex Distribution:
Year:
2024
Source:Annals of Hematology
Sex Distribution:
Year:
2020
Source:The Lancet. Haematology
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Appropriate management of polycythaemia vera with cytoreductive drug therapy: European LeukemiaNet 2021 recommendations. | 2022 | The Lancet |