The Concizumab Pen-Injector is Easy to Use and Preferred by Hemophilia Patients and Caregivers: A Usability Study Assessing Pen-Injector Handling and Preference.

Autor: Kahr Rasmussen N; Medical & Science Innovation, Novo Nordisk A/S, Søborg, Denmark., Berg B; Clinical Operations, Novo Nordisk A/S, Søborg, Denmark., Christiansen ASL; Biostatistics, Novo Nordisk A/S, Søborg, Denmark., Neergaard JS; Medical & Science Innovation, Novo Nordisk A/S, Søborg, Denmark., Ter-Borch G; Clinical Operations, Novo Nordisk A/S, Søborg, Denmark., Hildebrand EA; Research Collective LLC, Tempe, AZ, USA., Gonczi M; Research Collective LLC, Tempe, AZ, USA., Sparre T; Medical & Science Innovation, Novo Nordisk A/S, Søborg, Denmark.
Jazyk: angličtina
Zdroj: Patient preference and adherence [Patient Prefer Adherence] 2024 Aug 14; Vol. 18, pp. 1713-1727. Date of Electronic Publication: 2024 Aug 14 (Print Publication: 2024).
DOI: 10.2147/PPA.S470091
Abstrakt: Introduction: Concizumab is a once-daily prophylactic treatment developed for patients with hemophilia A or B (HA/HB) with or without inhibitors. It is the first treatment for hemophilia patients to be delivered subcutaneously using a pre-filled, multi-dose pen-injector with a 4 mm, 32 G needle.
Aim: To investigate patient and caregiver handling and preference for the concizumab pen-injector compared with current injection systems used to treat hemophilia.
Methods: This preference and handling study was conducted in accordance with authority guidelines for approval of new devices and included adults and adolescents with HA/HB with or without inhibitors and caregivers currently administering factor replacement therapy or factor VIII mimetic (emicizumab) therapy. All participants underwent a training session, followed by a test session during which participants independently administered a single pen-injection into an injection pad or manikin. Time to train, time to prepare and inject, and number of complete independent injections handling the pen were assessed. Participants evaluated handling and preference via the Hemophilia Device Handling and Preference Assessment Questionnaire.
Results: 80 participants (44 adults, 21 adolescents, 15 caregivers) currently using factor replacement therapy (n=41, 51%) or emicizumab (n=39, 49%) participated. Average training time and time to complete an injection were 7 min 49s and 1 min 21s. In total, 98% of independent complete injections were achieved at first attempt. 98% (n=78; 95% confidence interval [CI] 91-100%) of participants assessed the pen-injector as either "easy" or "very easy" to use. 88% of participants preferred the pen-injector (n=70; 95% CI 78-94%) over their current injection system, and 9% (n=7) reported "no preference".
Conclusion: Participants found the concizumab pen-injector easy to learn and easy to use and preferred it over their current injection systems.
Competing Interests: NKR, BB, ASLC, JSN, GTB, and TS are employees of Novo Nordisk. EH and MG are employees of Research Collective, LLC, Tempe, Arizona, USA. Novo Nordisk is the sponsor of the trial. The study was conducted by an independent CRO. The authors report no other conflicts of interest in this work.
(© 2024 Kahr Rasmussen et al.)
Databáze: MEDLINE
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