Convenience Comparison Study of Reconstitution Devices for the Blood Coagulation Factor VIII Products Rurioctocog Alfa Pegol and Antihemophilic Factor (Recombinant)

Abstract

Hitoshi Ueda,1 Misato Toyoda,1 Morio Arai,2 Michio Sakai3 1Japan Medical Office, Takeda Pharmaceutical Company Limited, Tokyo, Japan; 2Takeda Development Center-Japan, Takeda Pharmaceutical Company Limited, Tokyo, Japan; 3Pediatrics Department, Munakata Suikokai General Hospital, Fukuoka, JapanCorrespondence: Hitoshi UedaHead of Rare Disease Medical Engagement, Japan Medical Office, Takeda Pharmaceutical Company Limited, 1-1, Nihonbashi-Honcho 2-chome, Chou-ku, Tokyo 103-8668, JapanTel [phone]Fax [phone]Email [email protected]: The Baxject® II Hi-Flow device has previously been used to reconstitute the factor VIII products antihemophilic factor (recombinant) (ADVATE®) and rurioctocog alfa pegol (ADYNOVATE®).Methods: In this crossover study in healthy men, the convenience of an advanced device, Baxject III® with and without a nonslip sleeve, was compared with that of Baxject II Hi-Flow. The primary endpoint was the operational time for reconstitution; secondary endpoints included participants’ assessment of the usability of the devices for reconstitution and their preference for using each of the devices.Results: Twelve healthy adult men (mean ± standard deviation [SD] age: 36.7 ± 7.0 years) and 12 healthy elderly men (mean ± SD age: 70.3 ± 4.8 years) participated in the study. In the adult group, the mean operational time for reconstitution was shorter using Baxject III (mean ± SD: 19.7 ± 2.7 and 19.9 ± 5.2 seconds with and without a nonslip sleeve, respectively) than when using Baxject II Hi-Flow (49.6 ± 7.2 seconds, P < 0.0001 for both comparisons). Adult participants rated preference (P < 0.0001) and ease of reconstitution (P < 0.0001) as higher for Baxject III with a nonslip sleeve than for Baxject II Hi-Flow. Results were consistent regardless of age group or the use of the nonslip sleeve.Conclusion: Owing to the convenience of Baxject III, this device will improve the reconstitution process for patients with hemophilia treated with rurioctocog alfa pegol or antihemophilic factor (recombinant) at home.Keywords: coagulation factor VIII product, reconstitution device, crossover comparison study, hemophilia treatment, usability

Keywords

• coagulation factor viii product
• reconstitution device
• crossover comparison study
• hemophilia treatment
• usability