Results from the single-use autoinjector for self-administration of subcutaneous interferon beta-1a in patients with relapsing multiple sclerosis (MOSAIC) study
Source: Expert Opinion on Drug Delivery, Volume 8, Number 12, December 2011 , pp. 1543-1553(11)
Publisher: Informa Healthcare
Abstract: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.
Document Type: Research Article
Affiliations: 1: 1 Hope Neurology, 10810 Parkside Drive, ##G15, Knoxville, 37934, TN, USA ++1 865 218 6222; ++1 865 218 6220;, Email: firstname.lastname@example.org 2: 2 PA, Asheville, NC, USA 3: 3 Josephson, Wallack, Munshower Neurology, Indianapolis, IN, USA 4: 4 The Schapiro Center for Multiple Sclerosis at the Minneapolis Clinic of Neurology, Minneapolis, MN, USA 5: 5 Tampa Neurology Associates, South Tampa MS Center, Tampa, FL, USA 6: 6 Pfizer Inc, Groton, CT, USA 7: 7 EMD Serono, Inc., Rockland, MA, USA
Publication date: December 1, 2011