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- Title
Canadian clinical experience on switching from standard half‐life recombinant factor VIII (rFVIII), octocog alfa, to extended half‐life rFVIII, damoctocog alfa pegol, in persons with haemophilia A ≥ 12 years followed in a Comprehensive Hemophilia Care Program in Canada
- Authors
Matino, Davide; Germini, Federico; Chan, Anthony K. C.; Decker, Kay; Iserman, Emma; Chelle, Pierre; Edginton, Andrea N.; Oladoyinbo, Olayide; Trinari, Elisabetta; Keepanasseril, Arun; Iorio, Alfonso
- Abstract
Introduction: Damoctocog alfa pegol (BAY 94–9027, Jivi®) is an extended half‐life recombinant factor (F)VIII replacement, indicated for the treatment of haemophilia A in patients aged ≥12 years. Following introduction of damoctocog alfa pegol in Canada in 2020, there have been no reports on routine clinical effectiveness and satisfaction, when switching from a previous FVIII product in Canada. Aim: To report changes in pharmacokinetics, effectiveness, utilization and patient satisfaction when switching to damoctocog alfa pegol prophylaxis from previous standard half‐life octocog alfa (BAY 81–8973, Kovaltry®) treatment. Methods: A single‐centre, intra‐patient comparison of pharmacokinetics and clinical outcomes was performed. Blood samples drawn once pre‐dose and ≥2 times post‐dose were measured by a one‐stage assay to assess pharmacokinetic parameters including area under the curve (AUC, primary endpoint). Patient‐reported outcomes data were collected using the Patient‐Reported Outcomes, Burdens and Experiences questionnaire (PROBE). Clinical outcomes included annualized bleeding rate (ABR) and factor utilization. Results: Dose‐normalized AUC was significantly increased after switch to damoctocog alfa pegol from octocog alfa. Median (quartile [Q]1; Q3) annualized bleeding rates were 0.67 (0.00; 1.33) with damoctocog alfa pegol and 1.33 (0.00; 2.67) with octocog alfa. Half of the patients receiving damoctocog alfa pegol prophylaxis experienced zero bleeds (n = 9, 50.0%) versus 38.9% (n = 7) of patients treated with octocog alfa. Patients' good quality of life was maintained. Conclusion: This study provides routine clinical evidence supporting the benefits of switching from octocog alfa to damoctocog alfa pegol for patients with severe haemophilia A.
- Subjects
CANADA; HEMOPHILIACS; BLOOD coagulation factor VIII; HEMOPHILIA; PATIENT satisfaction; HEMOPHILIA treatment
- Publication
Haemophilia, 2024, Vol 30, Issue 2, p345
- ISSN
1351-8216
- Publication type
Article
- DOI
10.1111/hae.14960