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

BackgroundInjectable 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.MethodsPatients with RRMS (n = 63), aged 18–65 years, naïve to subcutaneous (sc) interferon (IFN) β-1a therapy, were recruited to a Phase IV, observational, open-label, multicenter study (NCT01195870). Patients self-injected sc IFN β-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.ResultsSix 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]).ConclusionsThese 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.

Single-use autoinjector for peginterferon-β1atreatment of relapsing-remitting multiple sclerosis: safety, tolerability and patient evaluation data from the Phase IIIb ATTAIN study

“…Nevertheless, the consistency of these outcomes with those reported in Year 1 of the ADVANCE study lends support to the direction of the findings reported here. Data from this sub-study also compare well with tolerability and satisfaction data reported using other IFN self-injection devices [10][11][12][13][14][15][16][17][18]. In a 12-month open-label observational Phase IV study, 213 intent-to-treat patients self-administered 30 µg intramuscular IFN-b 1a once weekly via an autoinjector pen.…”

“…In a 6-month interim analysis, > 95% of patients reported being satisfied or very satisfied with the autoinjector, and reported injection fear and anxiety decreased between day 1 and month 6 [11]. Although these studies cannot be directly compared with the current study given the differences in form of IFN, formulation, dose and frequency, in addition to differences in study designs and patient populations, a common theme across the studies is that autoinjectors improve patient satisfaction/ease-of-use [10][11][12][13][14][15][16][17][18], with further evidence of > 95% of patient-reported adherence after 6 months of IFN-b 1a administration via an autoinjector [11]. In the ADVANCE study, patient compliance was > 99% in all study arms [7].…”

Safe and Effective Use of the Once Weekly Dulaglutide Single-Dose Pen in Injection-Naïve Patients With Type 2 Diabetes

“…24 Studies in other disease areas (eg, multiple sclerosis) have demonstrated the clinical benefits and favorable patient perceptions associated with easy-to-use and easy-to-train therapies that are self-injectable. 25,26 A positive self-injection experience, including successful injection, minimal to no pain, ease of use, confidence in ability to use the device, and a once weekly injection schedule, is an important consideration for patients and providers when initiating injectable therapy for T2D.…”

Autoinjector Preference Among Patients with Multiple Sclerosis: Results From A National Survey

“…Over time, these agents underwent improvements with respect to injection tolerability as well as handling (e.g., titration at therapy initiation). 2,4 The invention of injection devices reduced the need for manual injection [5][6][7][8][9][10] and its use significantly reduced the occurrence of injection site reactions. 11 Moreover, their use was found to be a predictor of adherence.…”

“…These features comprise reminder functionsas forgetfulness is a major obstacle for self-administered therapies 2,3,13 -simplicity, adjustability of injection speed and depth, optical and acoustic signaling at the beginning/ end of the injection process, hidden needle, low-force safety release to ensure the device is positioned on the skin correctly at the time of injection, and an LED-display for visualization of the injection progress. 6,8,10,14,15 Several autoinjection devices for application of immunomodulatory drugs are currently available in the MS market and characterized by different handling, features, and design. Among these, the Betaconnect ® (Medicom Innovation Partner A/S, Struer, Denmark) and the RebiSmart™ (Ares Trading SA, Coinsins, Switzerland) are the only electronic devices in the MS therapy field, all others are mechanical devices.…”