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Adherence to Long-Term Interferon Beta-1b Injection Therapy in Patients with Multiple Sclerosis Using an Electronic Diary

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Multiple sclerosis (MS) is a chronic inflammatory disease of the central nervous system requiring long-term treatment, which is often hampered by non-adherence to self-applicable therapies, provoking continued disease activity and health care system burdens. This study assessed the influence of a personal digital assistant (PDA) with diary function (n = 339 patients) on persistence and adherence to an interferon beta treatment regimen in comparison to a paper patient diary (n = 330 patients).


Patients who recently started with subcutaneous injections of interferon beta-1b were recruited in this prospective, non-interventional, national cohort study for an observational period of 2 years after successful completion of the initial dose escalation.


Therapy persistence as assessed by the drop-out rate within 104 weeks was about 50% in both study cohorts. In male patients, the drop-out rate was 10% lower when using a PDA compared to the non-PDA group. Use of a PDA with an injection reminder function increased adherence to the injection schedule (every other day) by a mean of 24.5 injections over 24 months in comparison to use of a PDA without injection reminder function.


Persistence in this study was in the published range of observational MS studies. Furthermore, in male patients continuation of therapy might be positively influenced by use of a PDA, and both female and male patients might benefit from an integrated reminder function. In conclusion, electronic diaries reminding patients of upcoming injections can promote an improved adherence to MS therapy.

Trial registration identifier: NCT00902135.


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The BETAPATH study was funded by Bayer Vital GmbH (Leverkusen, Germany). The sponsor had a role in the design and conduct of the study, analysis of the data, and preparation of the manuscript. The article processing charges for this publication were funded by Bayer Vital GmbH. 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. Medical writing services from Dr. Carmen Koch, employee of KW medipoint, were funded by Bayer Vital GmbH.


Uwe Klaus Zettl received speaking fees and financial support for research activities from Almirall, Bayer HealthCare, Biogen, Merck Serono, Novartis, Sanofi, and Teva. Ulrike Bauer-Steinhusen, Thomas Glaser, and Jörg Czekalla are employees of Bayer Vital GmbH and Bayer Pharma AG, respectively. Klaus Hechenbichler declares no potential conflicts of interest in connection with this paper. Volker Limmroth received speaking fees and financial support for research activities from Bayer HealthCare, Biogen, Genzyme, Novartis, Roche, Sanofi, and Teva. Michael Hecker received speaking fees and travel support from Bayer HealthCare, Biogen, Novartis, and Teva.

Compliance with Ethics Guidelines

The study was conducted in accordance with ethical principles outlined in the International Committee on Harmonization (ICH) Good Clinical Practice (GCP) guidelines and in the Declaration of Helsinki. The study was approved by the Ethics Committee of the Ärztekammer Nordrhein and registered at with the identifier NCT00902135. Written informed consent was obtained from each patient before enrollment into the study.

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Correspondence to Michael Hecker.

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Zettl, U.K., Bauer-Steinhusen, U., Glaser, T. et al. Adherence to Long-Term Interferon Beta-1b Injection Therapy in Patients with Multiple Sclerosis Using an Electronic Diary. Adv Ther 33, 834–847 (2016).

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