4.3 Article

DORADA adherence study: full view into RebiSmart subdomains parameters in multiple sclerosis treatment

Journal

CURRENT MEDICAL RESEARCH AND OPINION
Volume 37, Issue 4, Pages 589-596

Publisher

TAYLOR & FRANCIS LTD
DOI: 10.1080/03007995.2021.1880886

Keywords

Multiple sclerosis; compliance; adherence; interferon beta-1a; auto-injector; RebiSmart

Funding

  1. Ministry of Health of the Czech Republic [FN HK 00179906]
  2. Charles University in Prague, Czech Republic [PROGRES Q40]
  3. project PERSONMED-Center for the Development of Personalized Medicine in Age-Related Diseases [Reg.Nr.CZ.02.1.01/0.0/0.0/17_048/0007441]
  4. ERDF
  5. state budget of the Czech Republic

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The study demonstrates high satisfaction among patients with the overall convenience and ease of use of RebiSmart 2.0. Over 80% of patients rated the device as very easy or easy to use in various domains, and all patients would recommend it to others in need of Rebif therapy.
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.

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