Drug updated on 10/25/2024
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
- 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 Title | Year | Source |
---|---|---|
Besremi (ropeginterferon alfa-2b-njft) Prescribing Information. | 2024 | PharmaEssentia Corporation, Burlington, MA |
Randomized Controlled Trials
Document Title | Sex Distribution | Year | Source |
---|---|---|---|
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:
2020
Source:The Lancet. Haematology