Patient-rated suitability of a novel electronic device for self-injection of subcutaneous interferon beta-1a in relapsing multiple sclerosis: an international, single-arm, multicentre, Phase IIIb study

Virginia Devonshire, Txomin Arbizu, Bjorn Borre, Michael Lang, Alessandra Lugaresi, Barry Singer, Elisabetta Verdun di Cantogno, Peter Cornelisse, Virginia Devonshire, Txomin Arbizu, Bjorn Borre, Michael Lang, Alessandra Lugaresi, Barry Singer, Elisabetta Verdun di Cantogno, Peter Cornelisse

Abstract

Background: Multiple sclerosis (MS) currently requires long-term treatment with disease-modifying drugs, administered parenterally up to once daily. The need for regular self-injection can be a barrier to treatment for many patients. Autoinjectors can help patients overcome problems or concerns with self-injection and could, therefore, improve treatment adherence. This study was performed to assess the suitability of a new electronic device for the subcutaneous (sc) administration of interferon (IFN) beta-1a, 44 mcg three times weekly, for relapsing MS.

Methods: In this Phase IIIb, multicentre, single-arm study, patients with relapsing MS who had been consistently self-injecting sc IFN beta-1a using an autoinjector for at least 6 weeks were taught to use the new device and self-administered treatment for 12 weeks thereafter. Patient-rated suitability of the device was assessed at the end of Week 12 using the Patient User Trial Questionnaire. Patient satisfaction with, and evaluation of, the injection process was assessed using the MS Treatment Concern Questionnaire. Trainers evaluated the device using the Trainer User Trial Questionnaire.

Results: At Week 12, 71.6% (73/102) of patients considered the device 'very suitable' or 'suitable' for self-injection; 92.2% (94/102) reported some degree of suitability and only 7.8% (8/102) found the device 'not at all suitable'. At Weeks 4, 8 and 12, most patients reported that injection preparation and clean-up, performing injections and ease of device use in the previous 4 weeks compared favourably with, or was equivalent to, their previous experience of self-injection. Injection-related pain, injection reactions and 'flu-like' symptoms remained stable over the 12 weeks. Each device feature was rated 'very useful' or 'useful' by at least 80% of patients. All trainers and 95.2% (99/104) of patients found device functions 'very easy' or 'easy' to use. Overall convenience was considered the most important benefit of the device.

Conclusions: Most patients considered the new electronic injection device suitable for the sc injection of IFN beta-1a. They found the device easy to use with useful features, and reported benefits such as overall convenience. The device may, therefore, increase treatment adherence in patients with MS, particularly those with injection-related issues.

Trial registration: NCT00735007.

Figures

Figure 1
Figure 1
Patient-rated suitability of the new device for self-injection of the new formulation of subcutaneous interferon beta-1a at Week 12: intent-to-treat population (n = 102, 4 missing).
Figure 2
Figure 2
Proportion of patients reporting device features as 'useful' or 'very useful' at Week 12 (n = 104 except for 'pre-programmed dose' [n = 103]).
Figure 3
Figure 3
Local tolerability of injections during 12-week study period (safety population, n = 106).

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Source: PubMed

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