PURPOSE: The aim of this article is to provide unique and detailed data on how patients rate the RebiSmart 2.0 in the specific User Study Questionnaire (USQ) domains, and the relationship between their rating and individual level of disability, baseline demographic/socioeconomic factors, and adherence. PATIENTS AND METHODS: Twelve-month, phase IV, observational, multicenter study (no placebo or comparator) to evaluate the ease of use of the RebiSmart autoinjector for self-injection during treatment of CIS/RRMS subjects with Rebif 44 mcg sc three times a week by USQ. A total of 290 subjects participated in the study, with 249 (85.86%) completing the entire study period. RESULTS: The endpoint results demonstrated a very high proportion (>95%) of patients with a positive evaluation of the overall convenience of RebiSmart at each study visit. At the end of the study, all patients would recommend the device to others who need Rebif therapy. The proportion of patients rating the RebiSmart ease of use by individual domains (self-injection steps, changing the cartridge, using the device away from home) as "very easy to use" or "easy to use" and the proportion of patients rating the RebiSmart functions as "helpful" or "very helpful" were more than 80% for each domain at each study visit. CONCLUSION: These findings are in line with the potential benefits of RebiSmart to treatment adherence. They demonstrate an overall, very good perception of the device by patients and its individual functions.

Department of Neurology University Hospital Hradec Kralove Hradec Kralove Czech Republic

Department of Neurology University Hospital Plzen Plzen Czech Republic

Department of Rehabilitation and Sports Medicine 2nd Faculty of Medicine Charles University Prague and Motol University Hospital Prague Czech Republic

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