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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Recombinant factor VIIa analog in the management of hemophilia with inhibitors: Results from a multicenter, randomized, controlled trial of vatreptacog alfa
Journal of Thrombosis and Haemostasis, Volume 12, No. 8, Year 2014
Notification
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Description
Background: Vatreptacog alfa, a recombinant factor VIIa (rFVIIa) analog with three amino acid substitutions and 99% identity to native FVIIa, was developed to improve the treatment of hemophilic patients with inhibitors. Objectives: To confirm the safety and assess the efficacy of vatreptacog alfa in treating bleeding episodes in hemophilic patients with inhibitors. Patients and methods: In this international, multicenter, randomized, double-blind, active-controlled, crossover, confirmatory phase III trial (adept™2) in patients with hemophilia A or B and inhibitors, bleeds were randomized 3 2 to treatment with vatreptacog alfa (one to three doses at 80 μg kg-1) or rFVIIa (one to three doses at 90 μg kg-1). Treatment failures after three doses of trial product (TP) were managed according to the local standard of care. Results: In the 72 patients enrolled, 567 bleeds were treated with TP. Both vatreptacog alfa and rFVIIa gave 93% effective bleeding control at 12 h. Vatreptacog alfa was superior to rFVIIa in secondary efficacy outcomes, including the number of doses used to treat a bleed and sustained bleeding control 24-48 h after the first dose. Eight patients (11%) developed antibodies against vatreptacog alfa, including four with cross-reactivity against rFVIIa and one with an in vitro neutralizing effect to vatreptacog alfa. Conclusions: This large randomized controlled trial confirmed the well-established efficacy and safety profile of rFVIIa, and showed that vatreptacog alfa had similar or better efficacy than rFVIIa. However, because of the development of anti-drug antibodies, a positive benefit-risk profile is unlikely to be achieved with vatreptacog alfa. © 2014 The Authors. Journal of Thrombosis and Haemostasis.
Authors & Co-Authors
Lentz, Steven R.
United States, Iowa City
University of Iowa Carver College of Medicine
Ehrenforth, Silke
Denmark, Bagsvard
Novo Nordisk A/s
Abdul Karim, F.
Malaysia, Kuala Lumpur
National Blood Centre
Matsushita, Tadashi
Japan, Nagoya
Nagoya University Hospital
Weldingh, K. N.
Denmark, Bagsvard
Novo Nordisk A/s
Windyga, Jerzy
Poland, Warsaw
Institute of Haematology and Transfusion Medicine, Warsaw
Mahlangu, Johnny Ndoni
South Africa, Johannesburg
National Health Laboratory Service
Weltermann, Ansgar
Unknown Affiliation
De Paula, Erich V.
Unknown Affiliation
Cerqueira, Mônica Hermida
Unknown Affiliation
Župančić-Šalek, Silva
Unknown Affiliation
Katsarou, Olga I.
Unknown Affiliation
Economou, Marina P.
Unknown Affiliation
Nemes, Laśzló
Unknown Affiliation
Boda, Zoltán
Unknown Affiliation
Santagostino, Elena M.
Unknown Affiliation
Tagariello, G.
Unknown Affiliation
Hanabusa, Hideji
Unknown Affiliation
Fukutake, Katsuyuki
Unknown Affiliation
Taki, M.
Unknown Affiliation
Shima, Midori
Unknown Affiliation
Gorska-Kosicka, M.
Unknown Affiliation
Şerban, Margit A.
Unknown Affiliation
Andreeva, T.
Unknown Affiliation
Savic, Aleksandar
Unknown Affiliation
Elezovic, I.
Unknown Affiliation
Mahlangu, J.
Unknown Affiliation
Tsay, Woei
Unknown Affiliation
Shen, Ming
Unknown Affiliation
Chuansumrit, Ampaiwan
Unknown Affiliation
Angchaisuksiri, Pantep
Unknown Affiliation
Kavaklı, Kaan R.
Unknown Affiliation
Küpesiz, Alphan O.
Unknown Affiliation
Sasmaz, Ilgen
Unknown Affiliation
Madan, Bella
Unknown Affiliation
Rangarajan, Savita
Unknown Affiliation
Giangrande, Paul L.F.
Unknown Affiliation
Saxena, K.
Unknown Affiliation
Recht, Michael
Unknown Affiliation
Kempton, Christine L.
Unknown Affiliation
Barrett, John C.
Unknown Affiliation
Young, Guy Aaron
Unknown Affiliation
Quon, Doris V.K.
Unknown Affiliation
Stopeck, Alison T.
Unknown Affiliation
Lin, J.
Unknown Affiliation
Ameri, Afshin
Unknown Affiliation
Kaicker, S.
Unknown Affiliation
Kuriakose, Philip A.
Unknown Affiliation
Obzut, Dana
Unknown Affiliation
Wang, Michael
Unknown Affiliation
Ortiz, Idith
Unknown Affiliation
Sori, A.
Unknown Affiliation
Statistics
Citations: 52
Authors: 52
Affiliations: 6
Identifiers
Doi:
10.1111/jth.12634
ISSN:
15387933
e-ISSN:
15387836
Research Areas
Disability
Study Approach
Quantitative