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Publications (2)4.87 Total impact

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    ABSTRACT: 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 (IFNβ-1a).Methods This prospective, multicenter, open-label, single-arm, 12-week, Phase IIIb study enrolled patients aged 18–65 years with relapsing MS receiving IFNβ-1a 44 μg 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.ResultsOf 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 IFNβ-1a, with injection site reactions the most frequently reported.Conclusion These data show that patients found the electronic autoinjector for delivery of subcutaneous IFNβ-1a reliable and easy to use, suggesting the device may help patients with relapsing MS to administer self-injections.
    Multiple Sclerosis and Related Disorders. 04/2012; 1(2):87–94.
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    ABSTRACT: Patients with multiple sclerosis (MS) often receive long-term injectable therapy, and difficulties associated with self-injection can affect treatment adherence and efficacy. The objective of this study was to evaluate an investigational, ready-to-use, single-use autoinjector for self-injection of subcutaneous (sc) interferon beta-1a (IFNβ-1a). In this multicenter, open-label, single-arm study, patients with relapsing MS who were receiving IFNβ-1a sc 44 μg three times weekly for ≥ 12 weeks continued therapy using a single-use autoinjector and completed a user trial questionnaire at baseline and weeks 6 and 12. The primary endpoint was the proportion of patients rating the autoinjector as easy or very easy to use at week 12. At 12 weeks, 86% of 109 patients included in the intent-to-treat population rated the autoinjector easy or very easy to use (95% confidence interval, 80% - 93%), and the most important perceived benefit was its overall convenience. The majority (74%) of patients reported the device as somewhat or extremely convenient to use, and most (83%) agreed or strongly agreed that the device made injections simple. The single-use autoinjector was well received and supported by favorable ratings for simplified injections and convenience. The results suggest that the device may improve overall injection experience in patients with relapsing MS.
    Expert Opinion on Drug Delivery 12/2011; 8(12):1543-53. · 4.87 Impact Factor