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

Abstract

BackgroundMultiple 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.MethodsIn 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.ResultsAt 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.ConclusionsMost 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 registrationNCT00735007

Injectable Multiple Sclerosis Medications

“…In addition, since the time that this survey was conducted, the formulation for SC IFNβ-1a has changed, and the new formulation seems to produce fewer ISRs than the previous formulation, although this difference may depend on the delivery device used. 39,40 The present findings reaffirm the importance of patient education on injectable DMT use and ISRs, and also suggest strategies for anticipating which patients may experience more severe ISRs. All patients should receive instruction on strategies for reducing ISR incidence and severity, including education regarding ways to manage side effects, such as site rotation and site massage.…”

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 the ADVANCE study, patient compliance was > 99% in all study arms [7]. An evaluation of patient adherence was beyond the scope of this current study; it should be noted that adherence assessments often rely on subjective, sometimes retrospective patient reporting which can lead to inaccurate results [14]. To date, we are not aware of any published head-to-head controlled studies evaluating MS therapy adherence with autoinjectors versus traditional PFSs.…”

“…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].…”

The Evolving Role of the Multiple Sclerosis Nurse - Implications of Future Management Directions

“…First, it has been demonstrated that using smaller (narrower) needles and autoinjectors improves patient experiences and improves adherence. [22][23][24] Second, rotation of the injection site can reduce ISRs, pain and trauma and may improve compliance. 25 In addition, autoinjectors can be helpful for patients with limited mobility or dexterity and provide the ability to administer injections at body sites that were previously inaccessible.…”