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

• Main Authors: Ueda H, Toyoda M, Arai M, Sakai M
• Format: Article
• Language: English
• Published: Dove Medical Press 2020-12-01
• Series: International Journal of General Medicine
• Subjects: coagulation factor viii product; reconstitution device; crossover comparison study; hemophilia treatment; usability
• Online Access: https://www.dovepress.com/convenience-comparison-study-of-reconstitution-devices-for-the-blood-c-peer-reviewed-article-IJGM

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 [e-mail]: 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