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. 2016 Mar 31;11(3):e0152347.
doi: 10.1371/journal.pone.0152347. eCollection 2016.

The Swiss Multiple Sclerosis Cohort-Study (SMSC): A Prospective Swiss Wide Investigation of Key Phases in Disease Evolution and New Treatment Options

Collaborators, Affiliations

The Swiss Multiple Sclerosis Cohort-Study (SMSC): A Prospective Swiss Wide Investigation of Key Phases in Disease Evolution and New Treatment Options

Giulio Disanto et al. PLoS One. .

Abstract

The mechanisms leading to disability and the long-term efficacy and safety of disease modifying drugs (DMDs) in multiple sclerosis (MS) are unclear. We aimed at building a prospective cohort of MS patients with standardized collection of demographic, clinical, MRI data and body fluids that can be used to develop prognostic indicators and biomarkers of disease evolution and therapeutic response. The Swiss MS Cohort (SMSC) is a prospective observational study performed across seven Swiss MS centers including patients with MS, clinically isolated syndrome (CIS), radiologically isolated syndrome or neuromyelitis optica. Neurological and radiological assessments and biological samples are collected every 6-12 months. We recruited 872 patients (clinically isolated syndrome [CIS] 5.5%, relapsing-remitting MS [RRMS] 85.8%, primary progressive MS [PPMS] 3.5%, secondary progressive MS [SPMS] 5.2%) between June 2012 and July 2015. We performed 2,286 visits (median follow-up 398 days) and collected 2,274 serum, plasma and blood samples, 152 cerebrospinal fluid samples and 1,276 brain MRI scans. 158 relapses occurred and expanded disability status scale (EDSS) scores increased in PPMS, SPMS and RRMS patients experiencing relapses. Most RRMS patients were treated with fingolimod (33.4%), natalizumab (24.5%) or injectable DMDs (13.6%). The SMSC will provide relevant information regarding DMDs efficacy and safety and will serve as a comprehensive infrastructure available for nested research projects.

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Conflict of interest statement

Competing Interests: J.F. Louvion is employed by Rodano Tech. The Department of Neurology, Regional Hospital Lugano (EOC), Lugano, Switzerland receives financial support from Teva, Merck Serono, Biogen, Bayer Schering, Genzyme and Novartis. The submitted work is not related to these agreements. Claudio Gobbi, Chiara Zecca and Giulio Disanto receive no other financial support related to the submitted work. J. Kuhle’s institution (University Hospital Basel) received in the last 3 years and used exclusively for research support: consulting fees from Novartis, Protagen AG; speaker fees from the Swiss MS Society, Biogen, Novartis, Roche, Genzyme; travel expenses from Merck Serono, Novartis; grants from ECTRIMS Research Fellowship Programme, University of Basel, Swiss MS Society, Swiss National Research Foundation, Bayer (Schweiz) AG, Genzyme, Novartis. Ö. Yaldizli received honoraria for lectures from Teva (2011) and Bayer Schering (2012) both paid to University Hospital Basel. ÖY received research funding from MAGNIMS / ECTRIMS, the University of Basel, the Swiss MS Society and Free Academy Basel, Switzerland. None of these is related to this work. The Department of Radiology, University Hospitals Basel, Switzerland receives financial support from Bayer Healthcare, Bracco and Guerbet and has a research agreement with SIEMENS Medical Solutions. The submitted work is not related to these agreements. C. Stippich receives no other financial support related to the submitted work. H.P. Mattle has received speaker’s fees by Bayer, Biogen, Covidien, Daiichi Sankyo, Neuravi, Novartis, Sanofi/Genzyme, Serono, Teva and consulting fees by AstraZeneca, Bayer, Biogen, Boehringer Ingelheim, Covidien, Daiichi Sankyo, Genzyme, Merck-Serono, Neuravi, Novartis, Pfizer, Sanofi/Genzyme, Servier, Teva. C.P. Kamm received honoraria for lectures/consulting and/or grants for studies from Biogen, Novartis, Teva, Merck-Serono, Genzyme, Bayer Schweiz AG and the Swiss MS society. J. Vehoff has received honoraria and travel expenses from Biogen, Bayer, Teva, Novartis, Genzyme (Sanofi Aventis) and Merck. T. Sprenger's institution, the University Hospital Basel, has received payments that were used exclusively for research support for consultation and speaking activities for Mitsubishi Pharma, Eli Lilly, Genzyme, Novartis, ATI, Actelion, Electrocore, Biogen and Allergan. T Sprenger has received grants from the Swiss MS Society, Swiss National Research Foundation, EFIC-Grünenthal and Novartis Pharmaceuticals Switzerland. P.H. Lalive received honoraria for speaking from Biogen, CSL Bering, Merck Serono, Novartis, Sanofi-Aventis, Teva; consulting fees from Biogen, Geneuro, Genzyme, Merck Serono, Novartis, Sanofi-Aventis, Teva; research grants from Biogen, Merck Serono, Novartis. T. Derfuss serves on scientific advisory boards for Novartis Pharma, Merck Serono, Biogen, Genzyme, Mitsubishi Pharma, TEVA Pharma, GeNeuro, and Bayer Schering Pharma; has received funding for travel and/or speaker honoraria from Biogen, Novartis, Merck Serono, and Bayer Schering Pharma; and receives research support from the Swiss National Research Foundation, Biogen, Novartis Pharma, the European Union, and the Swiss MS Society. J. Lorscheider received grant support from Biogen and travel support from Novartis. M. Schluep has not received financial support related to this work. S. Mueller received honoraria for travel, honoraria for lectures/consulting and/or grants for studies from Biogen, Novartis, Teva, Merck-Serono, Genzyme and Bayer Schweiz AG. R. Du Pasquier has served on scientific advisory boards for Biogen, Merck Serono, Teva, and Novartis; has received funding for travel or speaker honoraria from Abbvie, Biogen, Teva, Merck Serono, and Bayer Schering Pharma. L. Kappos: institution (University Hospital Basel) received in the last 3 years and used exclusively for research support: steering committee/consulting fees from Actelion, Addex, Bayer HealthCare, Biogen, Biotica, Genzyme, Lilly, Merck, Mitsubishi, Novartis, Ono, Pfizer, Receptos, Sanofi-Aventis, Santhera, Siemens, Teva, UCB, and Xenoport; speaker fees from Bayer HealthCare, Biogen, Merck, Novartis, Sanofi-Aventis, and Teva; support of educational activities from Bayer HealthCare, Biogen, CSL Behring, Genzyme, Merck, Novartis, Sanofi-Aventis, and Teva; royalties from Neurostatus Systems GmbH; grants from Bayer HealthCare, Biogen, the European Union, Merck, Novartis, Roche, Roche Research Foundations, the Swiss Multiple Sclerosis Society, and the Swiss National Research Foundation. There are no patents, products in development or marketed products to declare. This does not alter the authors' adherence to all the PLOS ONE policies on sharing data and materials.

Figures

Fig 1
Fig 1. Number of recruited SMSC patients between June 2012 and July 2015.
Fig 2
Fig 2. Distribution of age at baseline of all SMSC patients coloured by gender.
Fig 3
Fig 3. Distribution of EDSS at baseline of all SMSC patients coloured by disease course.
Fig 4
Fig 4. Boxplots of age at first symptom in CIS, RRMS-SPMS (combined) and PPMS patients, together with age at onset of progression in SPMS patients.
Fig 5
Fig 5. Boxplots of change in EDSS between baseline and most recent visit stratified by disease course at most recent visit and presence of relapses between baseline and most recent visit.
Only patients with at least two study visits are included.

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