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Adherence to Subcutaneous IFN β-1a in Multiple Sclerosis: Final Analysis of the Non-Interventional Study READOUTsmart Using the Dosing Log and Readout Function of RebiSmart®

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Abstract

Introduction

Patient adherence is a key determinant of treatment success in multiple sclerosis (MS). The RebiSmart® autoinjector facilitates patient self-injection of subcutaneous interferon β-1a (sc IFN β-1a) and allows quantitative measurement of adherence via its automated dosing log. We evaluated patient adherence and patient-reported cognitive and health-economic outcomes over 2 years in patients using RebiSmart®.

Methods

In this non-interventional, single-arm study, enrolled patients were 12–65 years of age, had relapsing–remitting MS or a single demyelinating event, and had been prescribed 44 or 22 μg sc IFN β-1a. Quantitative adherence (proportion of scheduled injections administered) and qualitative adherence (proportion of weeks with treatment schedule correctly followed) were monitored over 2 years. Other end points included self-assessed adherence, patient-reported outcomes (fatigue, depression and quality of life), cognitive outcomes and health-economic outcomes.

Results

A total of 368 of 392 (93.9%) enrolled patients were analyzed. Mean quantitative adherence was 85.3% overall (months 1–24), 89.6% for months 1–12 and 83.3% for months 13–24. No major impact on quantitative adherence was observed for sex, age (< 37 years vs. ≥ 37 years), prior medication or participation in the patient support program RebiSTAR®. Mean qualitative adherence was 67.0% overall (months 1–24). Self-assessed adherence was reported as being higher than RebiSmart®-monitored adherence. There was a trend toward more MS-related visits to physicians among patients with high adherence.

Conclusions

Patients using RebiSmart® demonstrated high adherence to treatment that was associated with a slight improvement in information processing speed and working memory and an overall tendency for more intensive self-management.

Funding

Merck Serono GmbH, Germany, an affiliate of Merck KGaA, Darmstadt, Germany.

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Acknowledgements

The authors thank the patients and their families, investigators, co-investigators and study teams at each of the participating centers and at Merck KGaA, Darmstadt, Germany. The authors also thank Dr. Michael Obermeier (Senior Biostatistician, GKM Gesellschaft für Therapieforschung mbH) for his contribution as data analyst and statistical supervisor.

Funding

The study and analyses as well as funding of the journal’s article processing charges were supported by Merck Serono GmbH, Germany, an affiliate of Merck KGaA, Darmstadt, Germany. All authors had full access to all of the data in this study and take complete responsibility for the integrity of the data and accuracy of the data analysis.

Medical Writing and other Editorial Assistance

Medical writing assistance was provided by James Yates of inScience Communications, Chester, UK, and funded by Merck Serono GmbH, Darmstadt, Germany.

Authorship

All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this manuscript, take responsibility for the integrity of the work as a whole and have given final approval to the version to be published.

Disclosures

Peter Rieckmann received honoraria for lectures/steering committee meetings from Merck Serono, Biogen Idec, Bayer Schering Pharma, Boehringer-Ingelheim, Sanofi-Aventis, Genzyme, Novartis, Teva Pharmaceutical Industries and Serono Symposia International Foundation. Matthias Schwab received personal compensation for activities with Biogen Idec, Bayer Healthcare, Genzyme, Merck Serono, Novartis and Teva Sanofi. He has received research support from Bayer Healthcare and Novartis. Dieter Poehlau received honoraria for lectures from Almirall, Biogen Idec, Genzyme, Schering, Merck Serono, Sanofi-Aventis, Teva, Aventis, Novartis, Roche and Boehringer. Iris-Katharina Penner received honoraria for speaking at scientific meetings, serving at scientific advisory boards and consulting activities from Adamas Pharma, Almirall, Bayer Pharma, Biogen, Desitin, Genzyme, Merck Serono, Novartis, Roche and Teva. She has received research support from the German MS Society and TEVA. Torsten Wagner is an employee of Merck Serono GmbH, Darmstadt, Germany. Elke Schel is an employee of Merck Serono GmbH, Darmstadt, Germany. Antonios Bayas received honoraria for consultancy and/or as a speaker from Merck Serono, Biogen, Bayer Vital, Novartis, TEVA, Roche and Sanofi/Genzyme; for trial activities from Biogen, Merck Serono and Novartis; and received grants for congress trips and participation from Biogen, Novartis, TEVA, Sanofi/Genzyme and Merck Serono.

Compliance with Ethics Guidelines

All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1964, as revised in 2013. Informed consent was obtained from all patients for being included in the study. The study was approved by the ethics committee of the Regional Medical board Hessen, Germany.

Data Availability

The data sets analyzed during the current study are available from the corresponding author on reasonable request.

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Authors and Affiliations

  1. Hospital for Nervous Diseases, Medical Park Loipl, Bischofswiesen, Germany

    Peter Rieckmann

  2. Hans Berger Department of Neurology, University Hospital Jena, Jena, Germany

    Matthias Schwab

  3. Kamillus Klinik, Asbach, Germany

    Dieter Pöhlau

  4. COGITO Center for Applied Neurocognition and Neuropsychological Research, Düsseldorf, Germany

    Iris-Katharina Penner

  5. Department of Neurology, Medical Faculty, Heinrich-Heine University, Düsseldorf, Germany

    Iris-Katharina Penner

  6. Merck Serono GmbH, Darmstadt, Germany

    Torsten Wagner & Elke Schel

  7. Department of Neurology, Klinikum Augsburg, Augsburg, Germany

    Antonios Bayas

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  1. Peter Rieckmann
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  2. Matthias Schwab
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  3. Dieter Pöhlau
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  7. Antonios Bayas
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Corresponding author

Correspondence to Antonios Bayas.

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Rieckmann, P., Schwab, M., Pöhlau, D. et al. Adherence to Subcutaneous IFN β-1a in Multiple Sclerosis: Final Analysis of the Non-Interventional Study READOUTsmart Using the Dosing Log and Readout Function of RebiSmart®. Adv Ther 36, 175–186 (2019). https://doi.org/10.1007/s12325-018-0839-1

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