Impact of the Betaconnect Auto-Injector on Betaseron Therapy Adherence and Patient Satisfaction
Objectives: To assess the impact of BETACONNECT on patients’ adherence and persistence to Betaseron therapy, and their satisfaction with the device.
Methods: This study is a prospective, observational, multicenter, single-arm trial in patients aged 18 or older diagnosed with RRMS or clinically isolated syndrome (CIS). A total of 144 patients will be recruited from 24 MS centers across United States. The planned observation period is 6 months, and a descriptive interim analysis of adherence and patient satisfaction will be performed at Week 6. Dosing data will be captured directly from BETACONNECT. Primary endpoints include evaluation of adherence via the proportion of the expected number of injections completed during 6 months of treatment (or up to point of early termination), the percentage of patients adherent to Betaseron (ie, received ≥80% of expected injections), and percentage of persistent patients (who remain on therapy) for 6 months. Patient satisfaction will be assessed via a web-based survey at Week 6. A descriptive analysis will be conducted at Week 6 and following 6 months of study. All variables will be summarized using standard statistical measures and a logistic regression on adherence will be conducted.
Results: The study is currently in the recruitment phase, therefore no results are available. Data will be collected in 2016. An interim analysis will be conducted for all patients when all data is received from Week 6, with a full analysis of 6 month data to follow.
Conclusions: The study results will be helpful in understanding the demographic and clinical characteristics that may influence adherence among MS patients using BETACONNECT and identifying factors that are likely to affect adherence to Betaseron therapy.