RESUMO
BACKGROUND: For patients with multiple sclerosis (MS), electronic autoinjectors may improve convenience and reduce discomfort associated with chronic injections. OBJECTIVE: To assess ease of use, patient satisfaction, and functional reliability of an investigational electronic autoinjector for self-injection of subcutaneous interferon beta-1a (IFNß-1a). METHODS: This prospective, multicenter, open-label, single-arm, 12-week, Phase IIIb study enrolled patients aged 18-65 years with relapsing MS receiving IFNß-1a 44µg subcutaneously 3 times weekly for ≥12 weeks before enrollment. Thereafter, patients continued their regimen using an electronic autoinjector. The primary endpoint was the proportion of patients rating the autoinjector 'easy to use' or 'very easy to use' on a User Trial Questionnaire at week 12. Secondary endpoints included patient responses to questions regarding device reliability, patient satisfaction, and convenience. RESULTS: Of 103 patients enrolled, 88 completed the study. The primary objective was met, with most patients (78%) indicating the device was 'easy to use' or 'very easy to use' at week 12 (worst-case imputation). In an analysis of secondary endpoints, over 60% of patients responded favorably to each of the User Trial questions regarding device ease-of-use and their satisfaction with the device. Overall convenience was judged the most important benefit of the device. Adverse events reported were consistent with the known safety profile of IFNß-1a, with injection site reactions the most frequently reported. CONCLUSION: These data show that patients found the electronic autoinjector for delivery of subcutaneous IFNß-1a reliable and easy to use, suggesting the device may help patients with relapsing MS to administer self-injections.
