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.

• MeSH
• Self Administration MeSH
• Interferon beta-1a therapeutic use   MeSH
• Humans MeSH
• Persons with Disabilities * MeSH
• Multiple Sclerosis, Relapsing-Remitting * drug therapy   MeSH
• Multiple Sclerosis * drug therapy   MeSH
• Check Tag
• Humans MeSH
• Publication type
• Journal Article MeSH
• Clinical Trial, Phase IV MeSH
• Multicenter Study MeSH
• Observational Study MeSH
• Research Support, Non-U.S. Gov't MeSH

Background: Adherence to Multiple Sclerosis (MS) treatment is considered one of the crucial factors for ensuring optimal clinical outcomes. Research has shown that the use of self-injector devices improves patient compliance with treatment. Therefore, the main purpose of this study is to evaluate the ease of use of RebiSmart® 2.0 in clinically isolated syndrome/relapsing-remitting MS patients during 12 months treatment period.Methods: A total number of 290 subjects entered into data collection; 249 (86%) of them completed the whole 12 months study period. The primary endpoints and the secondary endpoints were assessed by the User Study Questionnaire. Adherence data were retrieved from RebiSmart® 2.0 (Menu - Dose History) on the respective patient's visit. Outcome measures also included Expanded Disability Status Score, Kurtzke Functional Systems, and Modified Social Support Survey, Modified Social Support Survey-5.Results: This study demonstrated a very high proportion (>95%) of patients with a positive rating of the overall ease of use and the overall convenience of RebiSmart®. The proportion of patients with a positive rating of the ease of use by individual domains and the functions of RebiSmart® were also high (>80%).Conclusion: The findings demonstrate a very good perception of the usability of the device by patients overall and in its individual functions.

• MeSH
• Medication Adherence * MeSH
• Adult MeSH
• Injections MeSH
• Interferon beta-1a administration & dosage   MeSH
• Middle Aged MeSH
• Humans MeSH
• Adolescent MeSH
• Young Adult MeSH
• Surveys and Questionnaires MeSH
• Multiple Sclerosis, Relapsing-Remitting drug therapy   MeSH
• Check Tag
• Adult MeSH
• Middle Aged MeSH
• Humans MeSH
• Adolescent MeSH
• Young Adult MeSH
• Male MeSH
• Female MeSH
• Publication type
• Journal Article MeSH
• Clinical Trial, Phase IV MeSH
• Multicenter Study MeSH
• Observational Study MeSH
• Research Support, Non-U.S. Gov't MeSH