Contributions
Abstract: P411
Type: Poster
Abstract Category: Clinical aspects of MS - 11 Comorbidity
Background: Neuropsychological symptoms affect a large proportion of multiple sclerosis (MS) patients but standardized surveys are widely lacking, not only in Germany. The German competence network MS (KKNMS) has initiated a multi-center cohort study with more than 1000 early MS patients to answer clinical, paraclinical and epidemiological questions.
Objectives: To investigate baseline clinical characteristics and early neuropsychological findings in a large cohort of MS and clinically isolated syndrome (CIS).
Methods: The German MS cohort study (NationMS) is a prospective observational long-term study recruiting patients in 22 centres. Adult patients are eligible with a diagnosis of CIS within 6 months or relapsing remitting MS (RRMS) within 24 months (McDonald criteria 2005) when naïve for disease-modifying treatment (DMT). Standardized clinical, paraclinical (including MRI) and neuropsychological data and biomaterial are collected.
Results: Between 2010 and 2014, 1124 evaluable patients were enrolled, including 44.6% CIS and 55.3% RRMS patients with a 2.2:1 female to male ratio and a median age of 31.71 years (IQR 26.06-40.33) at first manifestation. At baseline, median EDSS was 1.5 (IQR 1.0-2.0). Nevertheless, the cohort comprises single severely disabled patients (max. EDSS 6.0). After inclusion, 763 (67.8%) patients started DMT treatment, splitting up in injectables (interferon-beta, glatiramer acetate), oral DMT (dimethyl fumarate, fingolimod, teriflunomide), less frequently natalizumab and single cases with alemtuzumab, mitoxantrone, rituximab, study medications and azathioprine. At least mild fatigue (Fatigue Scale for Motor and Cognitive Functions, FSMC) was detected in 36.5%, depressive symptoms (Beck Depression Inventory II, BDI II) were present in 33.5% and cognitive dysfunction (Multiple Sclerosis Inventory Cognition, MUSIC) was detectable in 14.7% of patients. Explorative correlation analyses indicated weak correlations between EDSS and FSMC (Kendall's tau b (τb) 0.24; CI 0.20-0.29), MUSIC (τb -0.13; CI -0.17;-0.08) or BDI II (τb 0.20; CI 0.16-0.25).
Conclusion: This large cohort depicts baseline characteristics of CIS and early MS and DMT distribution in Germany. A significant proportion of patients experiences neuropsychological symptoms with putative impact on quality of life despite low EDSS in these early disease stages. These symptoms are not detected with routine neurological examination and argue for early implementation of screening batteries.
Disclosure: The Kompetenznetz Multiple Sclerosis (KKNMS) is supported by grants from the German Federal Ministry for Education and Research (BMBF), grant no. 01GI0914 (Bochum), 01GI0916, 01GI1601G (Lübeck), 01GI1601B (Marburg).
O. v. B. reports no disclosures.
T. D. reports no disclosures.
G. A. reports no disclosures.
B.A. received travel grants from Novartis, not related to this work.
A. Z. reports no disclosures.
F. Z. reports no disclosures.
B. T. received personal speaker honoraria and consultancy fees as a speaker and advisor from Bayer Healthcare, Biogen, CSL Behring, GRIFOLS, Merck Serono, Novartis, Octapharma, Roche, Sanofi Genzyme, TEVA und UCB Pharma. His University received unrestricted research grants from Biogen-idec, Novartis, TEVA, Bayer Healthcare, CSL-Behring, GRIFOLS, Octapharma, Sanofi Genzyme und UCB Pharma. EndFragment, none related to this work.
F. T. B. reports no disclosures.
H. T. received speaker honoraria from Bayer, Biogen, Fresenius, Genzyme, Merck, Novartis, Roche, Siemens, Teva,; serves as section editor for the Journal of Neurology, Psychiatry and Brain Research; and receives research support from Fresenius, Genzyme, Merck and Novartis, none related to this work.
T. K. has received travel expenses and personal compensations from Bayer Healthcare, Teva Pharma, Merck-Serono, Novartis, Sanofi-Aventis/Genzyme, Roche and Biogen as well as grant support from Bayer-Schering AG, Novartis and Chugai Pharma, none related to this work.
M. S. has received honoraria for scientific lectures or consultancy from Bayer Healthcare, Biogen, Baxter/Baxalta, CSL Behring, Euroimmune, Grifols, Merck-Serono, Novartis, Roche, Sanofi-Aventis, and Teva. His institution received research support from Bayer Healthcare, Biogen Idec, Genzyme, Merck-Serono, Novartis, and Teva, none related to this work.
C. H. has received research grants and speaker honoraries from Biogen, Genzyme, Roche, Merck, none related to this work.
B. W. received grants from the German Ministry of Education and Research, Dietmar Hopp Foundation and Klaus Tschira Foundation, grants and personal fees from Biogen, Merck Serono, Sanofi Genzyme, Novartis pharmaceuticals, Teva Pharma, and personal fees from Bayer Healthcare, none related to this work.
F. P. serves on the scientific advisory board for Novartis; received speaker honoraria and travel funding from Bayer, Novartis, Biogen Idec, Teva, Sanofi-Aventis/Genzyme, Merck Serono, Alexion, Chugai, MedImmune, and Shire; is an academic editor for PLoS ONE; is an associate editor for Neurology® Neuroimmunology & Neuroinflammation; consulted for SanofiGenzyme, Biogen Idec, MedImmune, Shire, and Alexion; and received research support from Bayer, Novartis, Biogen Idec, Teva, Sanofi-Aventis/Genzyme, Alexion, Merck Serono, German Research Council, Werth Stiftung of the City of Cologne, German Ministry of Education and Research, Arthur Arnstein Stiftung Berlin, EU FP7 Framework Program, Arthur Arnstein Foundation Berlin, Guthy Jackson Charitable Foundation, and National Multiple Sclerosis of the USA, none related to this work.
A. B. received personal compensation from Merck, Biogen, Bayer Vital, Novartis, TEVA, Roche and Sanofi/Genzyme and grants for congress trips and participation from Biogen, TEVA, Novartis, Sanofi/Genzyme and Merck, none related to this work.
A. B. received personal compensation from Merck, Biogen, Bayer Vital, Novartis, TEVA, Roche and Sanofi/Genzyme and grants for congress trips and participation from Biogen, TEVA, Novartis, Sanofi/Genzyme and Merck, none related to this work.
C. W. received honoraria and/or research funding from Bayer, Biogen, Novartis and TEVA, none related to this work.
F. W. received honoraria from Genzyme, Novartis TEVA and Biogen for speaking or for serving on a scientific advisory board, a travel grant for the attention of a scientific meeting from Merck-Serono and Novartis and grant support from Merck-Serono, Novartis and from the Federal Ministry of Education and Research (BMBF, Projects Biobanking and Omics in ControlMS as part of the Competence Network Multiple Sclerosis), none related to this project.
R. A. L. received Research Support and/or personal compensation for activities with Bayer Health Care, Biogen, Genzyme/Sanofi, Merck, Novartis Pharma, Roche and TEVA Pharma, none related to this work.
U. Z. has received speaker honoraria and/or travel compensation from Biogen Idec GmbH, Bayer Vital GmbH, Bristol Myers Squibb GmbH, CorTec GmbH, Medtronic GmbH, and grants from Biogen Idec GmbH, Servier, and Janssen Pharmaceuticals NV, none related to this work.
U. K. Z. reports no disclosures.
H. W. receives honoraria for acting as a member of Scientific Advisory Boards and as consultant for Biogen, Evgen, MedDay Pharmaceuticals, Merck Serono, Novartis, Roche Pharma AG, Sanofi-Genzyme, as well as speaker honoraria and travel support from Alexion, Biogen, Cognomed, F. Hoffmann-La Roche Ltd., Gemeinnützige Hertie-Stiftung, Merck Serono, Novartis, Roche Pharma AG, Sanofi-Genzyme, TEVA, and WebMD Global. Prof. Wiendl is acting as a paid consultant for Abbvie, Actelion, Biogen, IGES, Novartis, Roche, Sanofi-Genzyme, and the Swiss Multiple Sclerosis Society. His research is funded by the German Ministry for Education and Research (BMBF), Deutsche Forschungsgesellschaft (DFG), Else Kröner Fresenius Foundation, Fresenius Foundation, Hertie Foundation, NRW Ministry of Education and Research, Interdisciplinary Center for Clinical Studies (IZKF) Muenster and RE Children's Foundation, Biogen GmbH, GlaxoSmithKline GmbH, Roche Pharma AG, Sanofi-Genzyme, none related to this project.
B. H. has served on scientific advisory boards for F. Hoffmann-La Roche Ltd, Novartis, Bayer AG, and Genentech; he has served as DMSC member for AllergyCare; he or his institution have received speaker honoraria from Biogen Idec, Teva Neuroscience, Merck Serono, Medimmune, Novartis, Desitin, and F. Hoffmann-La Roche Ltd; his institution has received research support from Chugai Pharmaceuticals and Hoffmann-La-Roche; holds part of two patents; one for the detection of antibodies and T cells against KIR4.1 in a subpopulation of MS patients and one for genetic determinants of neutralizing antibodies to interferon β, none related to this work.
R. G. serves on scientific advisory boards for Teva Pharmaceutical Industries Ltd., Biogen Idec, Bayer Schering Pharma, and Novartis; has received speaker honoraria from Biogen Idec, Teva Pharmaceutical Industries Ltd., Bayer Schering Pharma, and Novartis; serves as editor for Therapeutic Advances in Neurological Diseases and on the editorial boards of Experimental Neurology and the Journal of Neuroimmunology; and receives research support from Teva Pharmaceutical Industries Ltd., Biogen Idec, Bayer Schering Pharma, Genzyme, Merck Serono, and Novartis, none related to this work.
A. S. has received speaker honoraria and/or travel compensation for activities with Almirall Hermal GmbH, Biogen, Merck, Novartis, Roche and Sanofi Genzyme, none related to this work.
Abstract: P411
Type: Poster
Abstract Category: Clinical aspects of MS - 11 Comorbidity
Background: Neuropsychological symptoms affect a large proportion of multiple sclerosis (MS) patients but standardized surveys are widely lacking, not only in Germany. The German competence network MS (KKNMS) has initiated a multi-center cohort study with more than 1000 early MS patients to answer clinical, paraclinical and epidemiological questions.
Objectives: To investigate baseline clinical characteristics and early neuropsychological findings in a large cohort of MS and clinically isolated syndrome (CIS).
Methods: The German MS cohort study (NationMS) is a prospective observational long-term study recruiting patients in 22 centres. Adult patients are eligible with a diagnosis of CIS within 6 months or relapsing remitting MS (RRMS) within 24 months (McDonald criteria 2005) when naïve for disease-modifying treatment (DMT). Standardized clinical, paraclinical (including MRI) and neuropsychological data and biomaterial are collected.
Results: Between 2010 and 2014, 1124 evaluable patients were enrolled, including 44.6% CIS and 55.3% RRMS patients with a 2.2:1 female to male ratio and a median age of 31.71 years (IQR 26.06-40.33) at first manifestation. At baseline, median EDSS was 1.5 (IQR 1.0-2.0). Nevertheless, the cohort comprises single severely disabled patients (max. EDSS 6.0). After inclusion, 763 (67.8%) patients started DMT treatment, splitting up in injectables (interferon-beta, glatiramer acetate), oral DMT (dimethyl fumarate, fingolimod, teriflunomide), less frequently natalizumab and single cases with alemtuzumab, mitoxantrone, rituximab, study medications and azathioprine. At least mild fatigue (Fatigue Scale for Motor and Cognitive Functions, FSMC) was detected in 36.5%, depressive symptoms (Beck Depression Inventory II, BDI II) were present in 33.5% and cognitive dysfunction (Multiple Sclerosis Inventory Cognition, MUSIC) was detectable in 14.7% of patients. Explorative correlation analyses indicated weak correlations between EDSS and FSMC (Kendall's tau b (τb) 0.24; CI 0.20-0.29), MUSIC (τb -0.13; CI -0.17;-0.08) or BDI II (τb 0.20; CI 0.16-0.25).
Conclusion: This large cohort depicts baseline characteristics of CIS and early MS and DMT distribution in Germany. A significant proportion of patients experiences neuropsychological symptoms with putative impact on quality of life despite low EDSS in these early disease stages. These symptoms are not detected with routine neurological examination and argue for early implementation of screening batteries.
Disclosure: The Kompetenznetz Multiple Sclerosis (KKNMS) is supported by grants from the German Federal Ministry for Education and Research (BMBF), grant no. 01GI0914 (Bochum), 01GI0916, 01GI1601G (Lübeck), 01GI1601B (Marburg).
O. v. B. reports no disclosures.
T. D. reports no disclosures.
G. A. reports no disclosures.
B.A. received travel grants from Novartis, not related to this work.
A. Z. reports no disclosures.
F. Z. reports no disclosures.
B. T. received personal speaker honoraria and consultancy fees as a speaker and advisor from Bayer Healthcare, Biogen, CSL Behring, GRIFOLS, Merck Serono, Novartis, Octapharma, Roche, Sanofi Genzyme, TEVA und UCB Pharma. His University received unrestricted research grants from Biogen-idec, Novartis, TEVA, Bayer Healthcare, CSL-Behring, GRIFOLS, Octapharma, Sanofi Genzyme und UCB Pharma. EndFragment, none related to this work.
F. T. B. reports no disclosures.
H. T. received speaker honoraria from Bayer, Biogen, Fresenius, Genzyme, Merck, Novartis, Roche, Siemens, Teva,; serves as section editor for the Journal of Neurology, Psychiatry and Brain Research; and receives research support from Fresenius, Genzyme, Merck and Novartis, none related to this work.
T. K. has received travel expenses and personal compensations from Bayer Healthcare, Teva Pharma, Merck-Serono, Novartis, Sanofi-Aventis/Genzyme, Roche and Biogen as well as grant support from Bayer-Schering AG, Novartis and Chugai Pharma, none related to this work.
M. S. has received honoraria for scientific lectures or consultancy from Bayer Healthcare, Biogen, Baxter/Baxalta, CSL Behring, Euroimmune, Grifols, Merck-Serono, Novartis, Roche, Sanofi-Aventis, and Teva. His institution received research support from Bayer Healthcare, Biogen Idec, Genzyme, Merck-Serono, Novartis, and Teva, none related to this work.
C. H. has received research grants and speaker honoraries from Biogen, Genzyme, Roche, Merck, none related to this work.
B. W. received grants from the German Ministry of Education and Research, Dietmar Hopp Foundation and Klaus Tschira Foundation, grants and personal fees from Biogen, Merck Serono, Sanofi Genzyme, Novartis pharmaceuticals, Teva Pharma, and personal fees from Bayer Healthcare, none related to this work.
F. P. serves on the scientific advisory board for Novartis; received speaker honoraria and travel funding from Bayer, Novartis, Biogen Idec, Teva, Sanofi-Aventis/Genzyme, Merck Serono, Alexion, Chugai, MedImmune, and Shire; is an academic editor for PLoS ONE; is an associate editor for Neurology® Neuroimmunology & Neuroinflammation; consulted for SanofiGenzyme, Biogen Idec, MedImmune, Shire, and Alexion; and received research support from Bayer, Novartis, Biogen Idec, Teva, Sanofi-Aventis/Genzyme, Alexion, Merck Serono, German Research Council, Werth Stiftung of the City of Cologne, German Ministry of Education and Research, Arthur Arnstein Stiftung Berlin, EU FP7 Framework Program, Arthur Arnstein Foundation Berlin, Guthy Jackson Charitable Foundation, and National Multiple Sclerosis of the USA, none related to this work.
A. B. received personal compensation from Merck, Biogen, Bayer Vital, Novartis, TEVA, Roche and Sanofi/Genzyme and grants for congress trips and participation from Biogen, TEVA, Novartis, Sanofi/Genzyme and Merck, none related to this work.
A. B. received personal compensation from Merck, Biogen, Bayer Vital, Novartis, TEVA, Roche and Sanofi/Genzyme and grants for congress trips and participation from Biogen, TEVA, Novartis, Sanofi/Genzyme and Merck, none related to this work.
C. W. received honoraria and/or research funding from Bayer, Biogen, Novartis and TEVA, none related to this work.
F. W. received honoraria from Genzyme, Novartis TEVA and Biogen for speaking or for serving on a scientific advisory board, a travel grant for the attention of a scientific meeting from Merck-Serono and Novartis and grant support from Merck-Serono, Novartis and from the Federal Ministry of Education and Research (BMBF, Projects Biobanking and Omics in ControlMS as part of the Competence Network Multiple Sclerosis), none related to this project.
R. A. L. received Research Support and/or personal compensation for activities with Bayer Health Care, Biogen, Genzyme/Sanofi, Merck, Novartis Pharma, Roche and TEVA Pharma, none related to this work.
U. Z. has received speaker honoraria and/or travel compensation from Biogen Idec GmbH, Bayer Vital GmbH, Bristol Myers Squibb GmbH, CorTec GmbH, Medtronic GmbH, and grants from Biogen Idec GmbH, Servier, and Janssen Pharmaceuticals NV, none related to this work.
U. K. Z. reports no disclosures.
H. W. receives honoraria for acting as a member of Scientific Advisory Boards and as consultant for Biogen, Evgen, MedDay Pharmaceuticals, Merck Serono, Novartis, Roche Pharma AG, Sanofi-Genzyme, as well as speaker honoraria and travel support from Alexion, Biogen, Cognomed, F. Hoffmann-La Roche Ltd., Gemeinnützige Hertie-Stiftung, Merck Serono, Novartis, Roche Pharma AG, Sanofi-Genzyme, TEVA, and WebMD Global. Prof. Wiendl is acting as a paid consultant for Abbvie, Actelion, Biogen, IGES, Novartis, Roche, Sanofi-Genzyme, and the Swiss Multiple Sclerosis Society. His research is funded by the German Ministry for Education and Research (BMBF), Deutsche Forschungsgesellschaft (DFG), Else Kröner Fresenius Foundation, Fresenius Foundation, Hertie Foundation, NRW Ministry of Education and Research, Interdisciplinary Center for Clinical Studies (IZKF) Muenster and RE Children's Foundation, Biogen GmbH, GlaxoSmithKline GmbH, Roche Pharma AG, Sanofi-Genzyme, none related to this project.
B. H. has served on scientific advisory boards for F. Hoffmann-La Roche Ltd, Novartis, Bayer AG, and Genentech; he has served as DMSC member for AllergyCare; he or his institution have received speaker honoraria from Biogen Idec, Teva Neuroscience, Merck Serono, Medimmune, Novartis, Desitin, and F. Hoffmann-La Roche Ltd; his institution has received research support from Chugai Pharmaceuticals and Hoffmann-La-Roche; holds part of two patents; one for the detection of antibodies and T cells against KIR4.1 in a subpopulation of MS patients and one for genetic determinants of neutralizing antibodies to interferon β, none related to this work.
R. G. serves on scientific advisory boards for Teva Pharmaceutical Industries Ltd., Biogen Idec, Bayer Schering Pharma, and Novartis; has received speaker honoraria from Biogen Idec, Teva Pharmaceutical Industries Ltd., Bayer Schering Pharma, and Novartis; serves as editor for Therapeutic Advances in Neurological Diseases and on the editorial boards of Experimental Neurology and the Journal of Neuroimmunology; and receives research support from Teva Pharmaceutical Industries Ltd., Biogen Idec, Bayer Schering Pharma, Genzyme, Merck Serono, and Novartis, none related to this work.
A. S. has received speaker honoraria and/or travel compensation for activities with Almirall Hermal GmbH, Biogen, Merck, Novartis, Roche and Sanofi Genzyme, none related to this work.