25 Jun Real World Study of Rixubis in Patients with Hemophilia B

MedicalResearch.com Interview with:

Dr. med. Wolfhard Erdlenbruch, M.D.
Vice President
Head of Global Medical Affairs Hematology

MedicalResearch.com: What is the background for this study?

Dr. Erdlenbruch

Response: At the World Federation of Hemophilia Virtual Summit 2020 (WFH 2020), results were presented from a real-world, post-marketing surveillance study aimed to evaluate the safety and effectiveness of RIXUBIS® in adult and pediatric patients with hemophilia B in South Korea, entitled “Safety and Effectiveness of Rixubis in Patients with Hemophilia B in South Korea: A Real-World, Prospective, Post-marketing Surveillance Study”.

Data from the study demonstrate the safety and efficacy profile of RIXUBIS® for treatment of bleeds, perioperative/surgery, and prophylaxis in adult and pediatric patients with hemophilia B in the real-world setting in South Korea. The study showed that 86.6% (123/142) of hemostatic effectiveness assessments for RIXUBIS® were reported as good or excellent, and of the 11 adverse events reported, all were mild in severity, with 10 resolved/recovered events not related to RIXUBIS®, and one event (inhibitory antibody development) unconfirmed.¹

RIXUBIS® [Nonacog gamma, recombinant FIX concentrate] is a recombinant coagulation factor IX product, indicated for the control and prevention of bleeding episodes in patients with hemophilia B.

MedicalResearch.com: What should readers take away from your report?

Response: I’m glad that RIXUBIS® has a demonstrated safety profile and effectiveness for the treatment of bleeds, perioperative/surgery, and prophylaxis in adult and pediatric patients with hemophilia B in the real-world setting in South Korea. These results are consistent with data gathered from other studies worldwide, and I hope the study results will benefit patients with hemophilia B by providing them with a treatment option that is safe and effective. 

MedicalResearch.com: What recommendations do you have for future research as a result of this work?

Response: I hope we will continue to generate more real world data supporting the use of RIXUBIS® as a standard of treatment in hemophilia B.

MedicalResearch.com: Is there anything else you would like to add?

Response: RIXUBIS® is an injectable medicine used to replace clotting factor IX that is missing in adults and children with hemophilia B, marketed by Baxalta US Inc., a member of the Takeda group of companies.

For more information, please refer to the RIXUBIS® Summary of Product Characteristics here. 

For US specific safety information, please refer to the RIXUBIS® US Prescribing Information here. 

Reference:
1. WFH 2020 Virtual Summit. iPoster MED-PO-018. Safety and Effectiveness of Rixubis in Patients with Hemophilia B in South Korea: A Real-World, Prospective, Post-marketing Surveillance Study.

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Last Updated on June 25, 2020 by Marie Benz MD FAAD