MS Patients Using RebiSmart™ Maintain Good Treatment Adherence; Measure Endpoints

Background: Poor treatment adherence in patients with multiple sclerosis (MS) may be associated with increased risk of severe relapse. RebiSmart^TM is the first electronic auto-injector for subcutaneous interferon beta-1a (IFN) treatment of relapsing MS (RMS) and was designed to reduce several barriers to optimal adherence.

Objectives: We evaluated adherence to self-injected thrice-weekly subcutaneous IFN for treatment-naive patients with RMS over 24 weeks. Here we present an interim analysis of the MEASURE study primary and secondary endpoints.

Methods: MEASURE (NCT01128075) was a multi-center, two-arm, non-comparative, observational, 96-week Phase IV study to evaluate medication adherence when using RebiSmart^TM in treatment-naive patients with RMS. Adherence data were automatically recorded by the electronic device injection log, which records every injection successfully completed. Adherence was calculated as 100 x the number of injections the patient administered, divided by the expected number of injections over the 24-week treatment period. A cut-off of ≥80% was used to define adherence and compliance to treatment and analyses were performed on effects reported for Week 24. Treatment persistence and patient experience questions were also evaluated.

Results: Interim results show that 86.4% of patients (n=110) demonstrated good adherence at 24 weeks, with a mean adherence rate of 90.5%. Furthermore, 88.2% of patients were compliant and 93.6% of patients persisted on treatment to 24 weeks. Patients reported the bothersome level of time and preparation required for the injection with RebiSmart^TM on a scale of 1 (not at all bothersome) to 5 (very bothersome). 91.0% of patients rated the injection experience 1 or 2 at the 24-week point of the study. 31.8% of patients found the injection process less bothersome at Week 24 compared to Week 4 and 99.2% of patients stated that they would continue to use RebiSmart^TM.

Conclusions: RebiSmart^TM may be an effective device to overcome barriers to adherence due to its ease of use. Patients maintained high levels of adherence, compliance, and persistence in this study.