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

Abstract

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.

Keywords:

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

Transparency

Declaration of funding

This study was partially supported by grants from the Ministry of Health of the Czech Republic (FN HK 00179906) and the Charles University in Prague, Czech Republic (PROGRES Q40) and by the 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, co-financed by ERDF and the state budget of the Czech Republic.

Declaration of financial/other relationships

No potential competing interest was reported by the authors. Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Author contributions

ZP, MV, and MN were involved in the conception and design. MP, PP and MK were involved in the analysis and interpretation of the data. MN and BK drafted this paper and ZP and MV revised it critically for intellectual content. All the authors approved the final version of the manuscript and agreed to be accountable for all aspects of the work.

Acknowledgements

This study was supported by Merck spol. s.r.o., Prague, the Czech Republic, an affiliate of Merck KGaA, Darmstadt, Germany, as well as partially supported by grant projects of the Ministry of Health of the Czech Republic (FN HK 00179906) and of the Charles University in Prague, Czech Republic (PROGRES Q40/15).

Notes

i Rebif is a registered trademark of Merck KGaA, Darmstadt, Germany.

ii Avonex is a registered trademark of Biogen, Cambridge, MA, USA.

iii RebiSmart is a registered trademark of Merck KGaA, Darmstadt, Germany.

iv RebiJect is a registered trademark of Merck KGaA, Darmstadt, Germany.

v BetaJect is a registered trademark of H&B Electronic GmbH & Co. KG, Deckenpfronn, Germany.

vi ExtaviJect is a registered trademark of Novartis Europharm Limited, Dublin, Ireland.