An observational study demonstrating the adherence and ease of use of the injector device, RebiSmart®

ABSTRACT

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.

KEYWORDS:

• Multiple Sclerosis
• patients
• adherence
• treatment
• use
• RebiSmart

Declaration of Interest

M Vališ received compensation for travel, speaker honoraria and consultant fees from Biogen Idec, Novartis, Merck Serono, Roche, Sanofi Genzyme, and Teva. J Šarláková received compensation for travel and consultant fees from Merck Serono and Roche. S Halusková received compensation for travel and consultant fees from Biogen Idec, Novartis, Merck Serono and Roche. P Potužník received honoraria and travel grants from the following pharmaceutical companies: Biogen, Genzyme, Merck Serono, Novartis. M Peterka received honoraria and travel grants from the following pharmaceutical companies: Biogen, Genzyme, Merck Serono, Novartis, Roche, and Teva Pharma. P Štourač received compensation for travel, speaker honoraria and consultant fees from Biogen Idec, Novartis, Merck Serono, Roche, Sanofi Genzyme, and Teva. J Mareš received compensation for travel, speaker´s honoraria from Biogen Idec, Novartis, Merck Serono, Roche, Sanofi Genzyme, and Teva. Z Pavelek received honoraria and travel grants from the following pharmaceutical companies: Biogen, Genzyme, Merck Serono, Novartis, Roche, and Teva Pharma. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer Disclosures

Peer reviewers on this manuscript have received an honorarium from Expert Opinion on Drug Delivery for their review work, but have no other relevant financial relationships to disclose.

Additional information

Funding

This study was supported by Merck spol. s.r.o., Prague, the Czech Republic, an affiliate of Merck KGaA, Darmstadt, Germany. 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.