Abstract
BACKGROUND: In a multicentre, single-arm, observational, phase IV study, we evaluated 24-week treatment adherence of relapsing multiple sclerosis (RMS) patients using an electronic auto-injection device (RebiSmart(®)) for subcutaneous injection of interferon (IFN) β-1a. METHODS: A total of 162 adult participants with RMS were enrolled into the study to use RebiSmart(®) to self-administer IFN β-1a 44 μg three times weekly for a maximum of 96 weeks. The number of administered injections was recorded in the electronic device log. Adherence to treatment was defined as the administration of ≥80% of expected injections. Cognitive impairment and injection anxiety were assessed via questionnaires. RESULTS: Overall, 91.8 and 82.9% of participants were adherent to treatment at weeks 12 and 24, respectively. By weeks 12 and 24, 8.2 and 13.9% of participants had discontinued treatment. There were no statistically significant differences in adherence rates at weeks 12 and 24 according to cognitive impairment status or injection anxiety. By week 24, 69.9% of participants were less fearful of injection than when they started the study. According to participant evaluations, the absence of a visible needle, comfort settings, and the calendar for tracking the injection schedule were all important features of the RebiSmart(®) injection system. At week 24, 99.3% of participants reported that they would like to continue using RebiSmart(®) as their injector. CONCLUSIONS: RebiSmart(®) use is associated with high treatment adherence, as objectively assessed using electronic injection logs. Future research should examine if RebiSmart(®) use improves long-term treatment outcomes in RMS. This study was registered with ClinicalTrials.gov as NCT01128075, on May 20, 2010.