10 Jul Real World Study of Hemophilia A Patients Receiving Recombinant Antihemophilic Factor
MedicalResearch.com Interview with:
Prof. Dr. med. Johannes Oldenburg
Chairman and Director
Institute of Experimental Haematology and Transfusion Medicine
University Clinic Bonn AöR, Germany
MedicalResearch.com: What is the background for this study?
Response: Prophylaxis for hemophilia A is the standard of care treatment for patients because it can help prevent spontaneous bleeds, as even a single bleed may cause joint damage and impact their quality of life.1,2
The Antihemophilic factor (recombinant) (rAHF) Hemophilia A (HA) outcome Database (AHEAD) study, which has been running for 6 years, evaluates long-term, real-world outcome data on effectiveness, safety and joint health in patients with hemophilia A who are receiving rAHF (ADVATE®) and ADYNOVI.
MedicalResearch.com: What are the main findings?
Response: Interim analysis results from the study – presented at the World Federation of Hemophilia Virtual Summit 2020 (WFH 2020) – demonstrate that the number of hemophilia A patients who were able to achieve zero bleeds increased over the years by receiving rAHF. For those receiving prophylaxis, the number of patients with zero bleeds increased from 34% in year 1 to 53% in year 6. For those receiving on-demand treatment, it increased from 28% in year 1 to 38% in year 6. The results also show that those receiving rAHF prophylaxis generally reported slightly better health‐related quality of life (HRQoL) than those receiving rAHF on-demand.3
MedicalResearch.com: What should readers take away from your report?
Response:The latest data update from the AHEAD study continues to provide real-world data on long-term outcome with rAHF which add to the body of evidence that highlight the importance of personalized hemophilia management strategies in supporting patients and their physicians to achieve agreed treatment goals. We want the bleeding disorders community to understand the role of rAHF as an important option for hemophilia A, a condition which requires life-long monitoring and management.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: The AHEAD study is still ongoing and the estimated study completion date is currently set at January 2025. From now to then, we want to continue this research and provide data updates and further analyses from the study as these become available.
MedicalResearch.com: Is there anything else you would like to add?
Response: Prof. Dr. med. Johannes Oldenburg is one of the lead investigators of the AHEAD study which is funded by Takeda Pharmaceutical Company Limited.
ADVATE® is a full-length (derived from the complete FVIII gene) recombinant FVIII product that is processed without any blood-based additives, marketed by Baxalta US Inc., a Takeda company. ADVATE® is approved in the EU for the treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency) in all age groups.
For more information, please refer to the ADVATE® Summary of Product Characteristics here.
For US specific safety information, please refer to the ADVATE® US Prescribing Information here.
1. Gringeri, A., Ewenstein, B. & Reininger, A. The burden of bleeding in haemophilia: is one bleed too many? Haemophilia. 2014;20:459-463.
2. Carcao, M. & Srivastava, A. Factor VIII/factor IX prophylaxis for severe hemophilia. Semin Hematol. 2016;53:3-9.
3. WFH 2020 Virtual Summit. Abstract MED‐FP‐005 (363). Effectiveness, safety, and health‐related quality of life outcomes in patients with hemophilia A receiving antihemophilic factor (recombinant) in a real‐world setting: results of a 6‐year interim analysis of the AHEAD International study.
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