Patient assessment of an electronic device for subcutaneous self-injection of interferon ß-1a for multiple sclerosis: an observational study in the UK and Ireland

Abstract

Caroline D’Arcy1, Del Thomas2, Dee Stoneman3, Laura Parkes31West London Neuroscience Centre, Charing Cross Hospital, London, UK; 2Wye Valley NHS Trust, Hereford, UK; 3Merck Serono Ltd, Feltham, Middlesex, UKBackground: Injectable disease-modifying drugs (DMDs) reduce the number of relapses and delay disability progression in patients with relapsing–remitting multiple sclerosis (RRMS). Regular self-injection can be stressful and impeded by MS symptoms. Auto-injection devices can simplify self-injection, overcome injection-related issues, and increase treatment satisfaction. This study investigated patient responses to an electronic auto-injection device.Methods: Patients with RRMS (n = 63), aged 18–65 years, naïve to subcutaneous (sc) interferon (IFN) ß-1a therapy, were recruited to a Phase IV, observational, open-label, multicenter study (NCT01195870). Patients self-injected sc IFN ß-1a using the RebiSmart™ (Merck Serono S.A. – Geneva, Switzerland) electronic auto-injector for 12 weeks, including an initial titration period if recommended by the prescribing physician. In week 12, patients completed a questionnaire comprising of a visual analog scale (VAS) to rate how much they liked using the device, a four-point response question on ease of use (‘very difficult’, ‘difficult’, ‘easy’, or ‘very easy’), and a list of ten device functions to rank, based upon their experiences.Results: Six patients (9.5%) discontinued the study: one switched to manual injection; two discontinued all treatment; three changed therapy. In total, 59 out of 63 patients (93.7%) completed the VAS; 54 out of 59 (91.5%; 95% confidence interval: 81.3%–97.2%) ‘liked’ using the electronic auto-injector (score ≥6), whereas 57 out of 59 (96.6%) rated the device overall as ‘easy’ or ‘very easy’ to use. Device features rated as most useful were the hidden needle (mean [standard deviation] score: 3.3 [3.01]; n = 56), confirmation sound (3.9 [2.45]), and multidose cartridge (4.6 [2.32]). The least useful functions were the dose history list (8.0 [2.57]) and dose history calendar (7.5 [2.30]).Conclusions: These findings suggest that the electronic auto-injector may be suitable for patients who are new to injectable DMD therapy. Devices that simplify the injection process may help to ensure that patients receive the full benefits of treatment.Keywords: multiple sclerosis, interferon beta-1a, injection device, training, drug delivery