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. 2021 Jun 25;11(1):13340.
doi: 10.1038/s41598-021-92722-x.

Chances and challenges of a long-term data repository in multiple sclerosis: 20th birthday of the German MS registry

Lisa-Marie Ohle  1 , David Ellenberger  1 , Peter Flachenecker  2 , Tim Friede  3 , Judith Haas  4 , Kerstin Hellwig  5 , Tina Parciak  6 , Clemens Warnke  7 , Friedemann Paul  8 , Uwe K Zettl  9 , Alexander Stahmann  10
Affiliations
Free PMC article

Chances and challenges of a long-term data repository in multiple sclerosis: 20th birthday of the German MS registry

Lisa-Marie Ohle et al. Sci Rep. .
Free PMC article

Abstract

In 2001, the German Multiple Sclerosis Society, facing lack of data, founded the German MS Registry (GMSR) as a long-term data repository for MS healthcare research. By the establishment of a network of participating neurological centres of different healthcare sectors across Germany, GMSR provides observational real-world data on long-term disease progression, sociodemographic factors, treatment and the healthcare status of people with MS. This paper aims to illustrate the framework of the GMSR. Structure, design and data quality processes as well as collaborations of the GMSR are presented. The registry's dataset, status and results are discussed. As of 08 January 2021, 187 centres from different healthcare sectors participate in the GMSR. Following its infrastructure and dataset specification upgrades in 2014, more than 196,000 visits have been recorded relating to more than 33,000 persons with MS (PwMS). The GMSR enables monitoring of PwMS in Germany, supports scientific research projects, and collaborates with national and international MS data repositories and initiatives. With its recent pharmacovigilance extension, it aligns with EMA recommendations and helps to ensure early detection of therapy-related safety signals.

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Conflict of interest statement

Lisa-Marie Ohle reports no disclosure relevant to the content of the submitted manuscript, her work on the project was funded by a grant from the innovation fund of the German Federal Joint Committee (01VSF18038). David Ellenberger reports no disclosure relevant to the content of the submitted manuscript. Peter Flachenecker has received speaker’s fees and honoraria for advisory boards from Almirall, Bayer, Biogen Idec, Celgene, Genzyme, Novartis, Merck-Serono, Roche and Teva. He has participated in pharmaceutical company sponsored trials by Roche. None resulted in a conflict of interest. Tim Friede has received personal fees for consultancies (including data monitoring committees) in the past three years from Bayer, Biosense Webster, Boehringer Ingelheim, Cardialysis, CSL Behring, Daiichi Sankyo, Enanta, Fresenius Kabi, Galapagos, Janssen, Liva Nova, Novartis, Parexel, Penumbra, Roche, SGS, Vifor; all outside the submitted work. Judith Haas reports no disclosure relevant to the content of the submitted manuscript. Kerstin Hellwig reports no disclosure relevant to the content of the submitted manuscript. Tina Parciak reports no disclosure relevant to the content of the submitted manuscript. Friedemann Paul has received speaking fees, travel support, honoraria from advisory boards, and/or financial support for research activities from Bayer, Novartis, Biogen, Teva, Sanofi-Aventis/Genzyme, Merck Serono, Alexion, Chugai, MedImmune, Shire, German Research Council, Werth Stiftung of the City of Cologne, German Ministry of Education and Research, EU FP7 Framework Program, Arthur Arnstein Foundation Berlin, Guthy Jackson Charitable Foundation, and National Multiple Sclerosis of the USA. He serves as academic editor for PLoS ONE and associate editor for Neurology, Neuroimmunology and Neuroinflammation. None resulted in a conflict of interest. Clemens Warnke has received institutional support from Novartis, Alexion, Sanofi-Genzyme, Biogen, Janssen, and Roche. Uwe K. Zettl has received speaking fees, travel support and /or financial support for research activities from Alexion, Almirall, Bayer, Biogen, Bristol-Myers-Squibb, Janssen, Merck Serono, Novartis, Octapharm, Roche, Sanofi Genzyme, Teva as well as EU, BMBF, BMWi and DFG. None resulted in a conflict of interest. Alexander Stahmann has no personal pecuniary interests to disclose, other than being the lead of the German MS Registry, which receives funding from a range of public and corporate sponsors, recently including The German Innovation Fund (G-BA), The German MS Trust, German MS Society, Biogen, Celgene (Bristol Myers Squibb), Merck Serono, Novartis, Roche and Sanofi. None resulted in a conflict of interest.

Figures

Figure 1
Figure 1
Distribution of 187 MS centres participating in the GMSR across Germany. These include 70 specialised MS centres (red circle), 95 MS centres (orange triangle), and 22 MS rehabilitation centres (purple cross). GMSR German Multiple Sclerosis registry. The map was created with R 4.0 based on data from gadm.org.
Figure 2
Figure 2
Number of recorded visits per years (by January 2021). Total (cumulative) number of patients included in the GMSR by the end of each year is shown by the black solid line, while the number of patients with actual baseline or follow-up visits during the resp. year is shown by the dashed line. The number of visits per year is show as bars, distinguishing baseline and follow-up visits. GMSR German Multiple Sclerosis registry.
Figure 3
Figure 3
Current EDSS distribution among patients (n = 33,059) in the GMSR. EDSS expanded disability status scale, GMSR German Multiple Sclerosis registry.
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