Expert Opinion on Drug Delivery · 2011 · 17 citations · 10 references
PharmacyNeurologyPharmacotherapyAutoimmunityDrug DeliveryImmunotherapyInjection SafetyInterferon-based TherapyMultiple SclerosisMultiple Sclerosis PharmacotherapyMultiple Sclerosis TherapyQuestionnaire AdministrationRelapsing-remitting Multiple Sclerosis TreatmentSingle-arm Trials
BACKGROUND: Patients with multiple sclerosis (MS) often receive long-term injectable therapy, and difficulties associated with self-injection can affect treatment adherence and efficacy. OBJECTIVE: 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). METHODS: 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. RESULTS: 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. CONCLUSION: 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.
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Diagnostic criteria for multiple sclerosis: 2010 Revisions to the McDonald criteria
Chris H. Polman, Stephen C. Reingold, Brenda Banwell et al. · Annals of Neurology · 2011 · 9.8K citations · Full text
Medicine, Neurology, Neuroscience +10
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