Journal Title
Title of Journal: Adv Ther
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Abbravation: Advances in Therapy
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Publisher
Springer Healthcare
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Authors: Uwe Klaus Zettl Ulrike BauerSteinhusen Thomas Glaser Jörg Czekalla Klaus Hechenbichler Volker Limmroth Michael Hecker
Publish Date: 2016/04/18
Volume: 33, Issue: 5, Pages: 834-847
Abstract
Multiple sclerosis MS is a chronic inflammatory disease of the central nervous system requiring longterm treatment which is often hampered by nonadherence to selfapplicable 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 patientsPatients who recently started with subcutaneous injections of interferon beta1b were recruited in this prospective noninterventional national cohort study for an observational period of 2 years after successful completion of the initial dose escalationTherapy persistence as assessed by the dropout rate within 104 weeks was about 50 in both study cohorts In male patients the dropout rate was 10 lower when using a PDA compared to the nonPDA group Use of a PDA with an injection reminder function increased adherence to the injection schedule every other day by a mean of 245 injections over 24 months in comparison to use of a PDA without injection reminder functionPersistence 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 therapyThe 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 GmbHUwe Klaus Zettl received speaking fees and financial support for research activities from Almirall Bayer HealthCare Biogen Merck Serono Novartis Sanofi and Teva Ulrike BauerSteinhusen 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 TevaThe 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 ClinicalTrialsgov with the identifier NCT00902135 Written informed consent was obtained from each patient before enrollment into the study
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