M Faranoush1, H Abolghasemi2, F Mahboudi3, Gh Toogeh4, M Karimi5, P Eshghi6, M Managhchi4, H Hoorfar7, B Keikhaei Dehdezi8, A Mehrvar9, B Khoeiny10, B Vaziri3, K Kamyar10, R Heshmat4, M R Baghaeipour11, N B Mirbehbahani12, R Fayazfar13, M Ahmadinejad14, M Naderi15. 1. Iran university of Medical Sciences, Rasool Akram Hospital, Tehran, Iran. 2. Pediatric Congenital Hematologic Disorders Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran h.abolghasemi@ibto.ir. 3. Biotechnology Research Center, Pasteur Institute of Iran, Tehran Iran. 4. Thrombosis and Hemostasis Research Center, Tehran University of Medical Sciences, Imam Khomeini Hospital, Tehran, Iran. 5. Hematology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran. 6. Pediatric Congenital Hematologic Disorders Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran. 7. Isfahan University of Medical Sciences, Isfahan, Iran. 8. Ahwaz University of Medical Sciences, Ahwaz, Iran. 9. MAHAK Children's Hospital, Tehran, Iran. 10. Aryogen Zist Darou Company, Karaj, Iran. 11. Iranian Comprehensive Hemophilia Care Center, Tehran, Iran. 12. Golestan University of Medical Sciences, Gorgan, Iran. 13. MD, Kerman University of Medical Sciences, Kerman, Iran. 14. High Institute of Research, Iranian Blood Transfusion Organization, Tehran, Iran. 15. Zahedan University of Medical Sciences, Ahwaz, Iran.
Abstract
INTRODUCTION: This study compared the efficacy of Aryoseven with Novoseven to control bleeding episodes in patients with hemophilia A with inhibitors. METHODS:Sixty-six patients were randomized into 2 groups, with 4 consecutive block randomization. These groups received Aryoseven and Novoseven dosages of 90 to 120 μg/kg intravenously every 2 hours. RESULTS:Median (interquartile range) level of factor VIII (FVIII) inhibitor in groups A and B was 15.0 and 19.0 Bethesda Unit (BU) preadministration. Bleeding onset in group A was 1246 ± 1104 minutes and in group B was 2301 ± 1693 minutes (P = .311). The Kavakli global response scores and treatment success rate was comparable in both the groups. The side effects in groups A (9.7%) and B (2.9%) were comparable. CONCLUSION:Biosimilar recombinant activated FVII is found to be as effective as Novoseven in the treatment of acute joint bleeding in patients with hemophilia with inhibitors. Its usage will decrease the gaps in hemophilia.
RCT Entities:
INTRODUCTION: This study compared the efficacy of Aryoseven with Novoseven to control bleeding episodes in patients with hemophilia A with inhibitors. METHODS: Sixty-six patients were randomized into 2 groups, with 4 consecutive block randomization. These groups received Aryoseven and Novoseven dosages of 90 to 120 μg/kg intravenously every 2 hours. RESULTS: Median (interquartile range) level of factor VIII (FVIII) inhibitor in groups A and B was 15.0 and 19.0 Bethesda Unit (BU) preadministration. Bleeding onset in group A was 1246 ± 1104 minutes and in group B was 2301 ± 1693 minutes (P = .311). The Kavakli global response scores and treatment success rate was comparable in both the groups. The side effects in groups A (9.7%) and B (2.9%) were comparable. CONCLUSION: Biosimilar recombinant activated FVII is found to be as effective as Novoseven in the treatment of acute joint bleeding in patients with hemophilia with inhibitors. Its usage will decrease the gaps in hemophilia.
Authors: Hans H Brackmann; Wolfgang Schramm; Johannes Oldenburg; Viridiana Cano; Peter L Turecek; Claude Négrier Journal: Hamostaseologie Date: 2020-07-27 Impact factor: 2.145