Effectiveness of recombinant factor IX Fc fusion protein (rFIXFc, eftrenonacog alfa) in patients with hemophilia B: An analysis of a postmarketing surveillance study

Key Points

• The study aims to evaluate the safety and efficacy of recombinant factor IX Fc fusion protein (rFIXFc) in patients with hemophilia B.
• Conducted a postmarketing surveillance using data from 137 hemophilia B patients in Japan.
• Assessed safety indicators including inhibitors, shock, anaphylaxis, and thrombosis during observation.
• Evaluated efficacy based on physician assessments and annual bleeding rates.
• 94.5% of patients on regular therapy showed significant or effective responses.
• Average annual bleeding rate decreased from 5.4 to 2.4 after rFIXFc treatment.
• 76.5% of patients experienced reduced infusion frequency.