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The Swiss multiple sclerosis cohort study: a prospective nationwide investigation of disease evolution and the effects of new disease modifying drugs
Conference Paper/Poster - Sep 23, 2015
Disanto G., Derfuss T., Louvion J.-F., Kamm C., Mattle H.P., Lotter C., du Pasquier R., Schluepp M., Pot C., Lalive P.H., Kappos L., Stippich C., Sprenger T., Benkert P., Lohrscheider J., Müller Stefanie, Vehoff Jochen, Zecca C., Ramseier S., Achnichts L., Findling O., Nedeltchev K., Radue E.W., Kuhle J.
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Background: Multiple Sclerosis (MS) is a chronic disease affecting approximately 10,000 patients in Switzerland. Many questions concerning the heterogeneity of the disease, the mechanisms leading to disability and the long term efficacy and safety profiles of the several available disease modifying drugs (DMDs) remain unanswered. The Swiss MS Cohort Study (SMSC) is a longterm prospective multicentre observational study performed across 7 MS centers (Aarau, Basel, Berne, Geneva, Lausanne, Lugano and St. Gallen).
Methods: Patients with a diagnosis of relapsing-remitting MS (RRMS), secondary-progressive MS (SPMS), primary-progressive MS (PPMS), clinically isolated syndrome (CIS), radiologically isolated syndrome or neuromyelitis optica are included. Standardized neurological assessments and biological samples are collected every 6-12 months with rigorous quality controls. Expanded Disability Status Scale (EDSS) scores are calculated by certified raters. Cranial MRI are also optionally performed.
Results: Between June 2012 and December 2014, 735 patients (5.7% CIS, 84.8% RRMS, 5.7% SPMS and 2.9% PPMS) have been recruited in the SMSC. Median follow-up time was 379 days (interquartile range (IQR) 242-591) for a total of 1,805 visits. The dropout rate was 2.8% (n=21). A total of 1,797 serum, plasma and blood samples and 137 cerebrospinal fluid samples have been collected; 979 brain MRI scans have been performed. EDSS scores at baseline were higher in SPMS (6.0 (4.0-6.5)) and PPMS (6.0 (3.5-6.0)) than in CIS (1.5 (1.0-2.0)) and RRMS (2.0 (1.5-3.0)). During follow-up 119 relapses have occurred in 106 patients and EDSS scores have increased in PPMS, SPMS and RRMS patients experiencing relapses. At baseline 36.1% of RRMS patients were treated with fingolimod, 25.5% with natalizumab, 14.0% with first line injectable DMDs, 1.5% with other DMDs and 23% were untreated. The mean annualized relapse rate in RRMS patients under treatment with natalizumab was 0.09, with fingolimod 0.20 and first line injectable DMDs 0.47.
Discussion: The SMSC is currently collecting high quality clinical information, biological samples and MRI data in a large cohort of MS patients. This cohort will serve as a comprehensive infrastructure available for the realization of a variety of nested research projects and should provide relevant real world information regarding disease course and DMDs effects in the long term.