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Home - 02.10.2013 - Young Scientific Investigators’ Session 2


Young Scientific Investigators’ Session 2

Wednesday, October 02, 2013, 16:24 - 16:36

Predictors of 12-month confirmed disability progression after onset of clinically isolated syndrome (CIS) suggestive of multiple sclerosis

V.G. Jokubaitis, T. Spelman, M. Trojano, G. Izquierdo, F. Grand'Maison, P. Duquette, M. Girard, A. Lugaresi, P. Grammond, R. Hupperts, J.A Cabrera-Gomez, C. Oreja-Guevara, C. Boz, G. Giuliani, R. Fernandez-Bolanos, G. Iuliano, J. Lechner-Scott, F. Verheul, V. van Pesch, T. Petkovska-Boskova, M. Fiol, F. Moore, T. Petersen, E. Cristiano, R. Alroughani, R. Bergamaschi, M. Barnett, M. Slee, J. Herbert, C. Shaw, M.L Saladino, M.P Amato, E. Havrdova, O. Gray, M. Paine, N. Vella, C. Young, A. Savino, L. Kappos, T. Kalincik, D. Liew, H. Butzkueven on behalf of the MSBasis Study Group

Background: The first 12-month confirmed disability progression event after clinically isolated syndrome (CIS) onset likely reflects persistent MS-related disability. Predictors of long-term sustained disability progression at CIS onset are not well characterised in real world datasets, and potential treatment effects are uncertain.
Objective: We assessed the relationship of demographic, clinical, CSF and MRI measures and treatment to time to 12-month confirmed disability progression after a CIS in Multiple Sclerosis
Design/Methods: The MSBase Incident Study (MSBasis) is an ongoing observational prospective cohort study of CIS, and enrolls patients from 59 MS centres worldwide. Data were aggregated in MSBase, including patient profile, date of CIS, expanded disability status scale (EDSS) score, and cerebral MRI. Other diagnostic tests were recorded if performed. Follow-up data included relapses, treatment changes and EDSS score. Predictors for time to 12-month 1 EDSS step (1.5 EDSS steps for baseline EDSS 0, 0.5 for baseline EDSS 6-6.5) confirmed progression were analysed using Weibull hazards regression.
Results: Of 3413 CIS patients, 1994 had complete evaluable datasets including onset MRI (median follow-up 3.0 years). Of these, 309 patients had a first 12-month sustained disability progression event and 1370 (69%) were exposed to at least one MS medication (DMT). Multivariable analyses were adjusted for clinic location. Predictors of time to 12-month confirmed progression included a baseline Kurtzke functional score of >=2 in the pyramidal system (HR 1.44; 95% CI 1.09, 1.90; p =0.011, relative to a score of 0-1), and exposure to DMT was protective (HR for interferon beta (IFB)-1a IM was 0.54; for IFB-1b 0.45; for IFB-1a SC 0.41 and for daily glatiramer acetate 0.33; all p<0.001; all compared to no treatment HR=1). No MRI or CSF findings were independent predictors of time to progression.
Data on predictors of 24-month disability progression will also be presented.
Conclusions: Using survival analysis, the multicentre, multinational MSBasis study has identified independent predictors of first 12-month disability progression, including a strong protective effect of beta-interferon and glatiramer acetate.

Vilija Jokubaitis has received conference travel support from Novartis. Timothy Spelman received compensation for travel and speaking honoraria from Biogen Idec. Maria Trojano received speaking honoraria from Biogen-Idec, Bayer-Schering, Sanofi Aventis, Merck-Serono, Teva and Novartis; has received research grants from Biogen-Idec, Merck-Serono, and Novartis. Guillermo Izquierdo received speaking honoraria from Biogen-Idec, Novartis, Sanofi, Serono and Teva. Francois Grand’Maison received honoraria from Biogen Idec, Genzyme, Novartis and Roche. Pierre Duquette did not declare any competing interests. Marc Girard received consulting fees from Teva Canada Innovation, Biogen Idec, Novartis and Genzyme Sanofi; lecture payments from Teva Canada Innovation, Novartis and EMD Serono. Dr Girard has also received a research grant from Canadian Institutes of Health Research. Alessandra Lugaresi is a Bayer Schering, Biogen Idec, Genzyme, Merck Serono Advisory Board Member. She received travel grants and honoraria from Bayer Schering, Biogen Idec, Merck Serono, Novartis, Sanofi Aventis and Teva, research grants from Bayer Schering, Biogen Idec, Merck Serono, Novartis, Sanofi Aventis and Teva, travel and research grants from the Associazione Italiana Sclerosi Multipla and was a Consultant of “Fondazione Cesare Serono”. Pierre Grammond is a Novartis, Teva-neuroscience, Biogen Idec advisory board member, consultant for Merck Serono, received payments for lectures by Merck Serono, Teva-Neuroscience and Canadian Multiple sclerosis society, and received grants for travel from Teva-Neuroscience and Novartis. Raymond Hupperts received honoraria as consultant on scientific advisory boards from Merck-Serono, Biogen-Idec, Genzyme-Sanofi and Teva, research funding from Merck-Serono and Biogen-Idec, and speaker honoraria from Sanofi-Genzyme. Jose Antonio Cabrera-Gomez did not declare any competing interests. Celia Oreja-Guevara received honoraria as consultant on scientific advisory boards from Biogen-Idec, Bayer-Schering, Merck-Serono, Teva and Novartis; has participated in clinical trials/other research projects by Biogen-Idec, GSK, Teva and Novartis. Cavit Boz did not declare any competing interests. Giorgio Giuliani did not declare any competing interests. Ricardo Fernandez-Bolanos did not declare any competing interests. Gerardo Iuliano had travel/accommodations/meeting expenses funded by Bayer Schering, Biogen Idec, Merck Serono, Novartis, Sanofi Aventis, and Teva Jeannette Lechner-Scott has accepted travel compensation from Novartis, Biogen and Merck Serono. Her institution receives the honoraria for talks and advisory board commitment and also clinic support from Bayer Health Care, Biogen Idec, CSL, Genzyme Sanofi, Merck Serono and Novartis. Freek Verheul did not declare any competing interests. Vincent Van Pesch has served on advisory boards for Biogen Idec and Genzyme; has received travel grants from Biogen Idec, Bayer Schering, Sanofi Aventis, Merck Serono and Novartis Pharma ; has received consultancy fees from Biogen Idec, Teva and Novartis Pharma; has received research grants from Bayer Schering. Tatjana Petkovska-Boskova participated in clinical trial sponsored by BIOGEN and Serono and had travel/accommodation/meeting expenses funded by Bayer Schering and Biogen Idec. Marcela Fiol received honoraria from Merck-Serono and Bayer. Fraser Moore has participated in clinical trials sponsored by EMD Serono and Novartis. Thor Petersen received funding or speaker honoraria from Biogen Idec, Merck Serono, Novartis, Bayer Schering, Sanofi-Aventis, Roche, and Genzyme. Edgardo Cristiano received honoraria as consultant on scientific advisory boards by Biogen-Idec, Bayer-Schering, Merck-Serono, Genzyme and Novartis; has participated in clinical trials/other research projects by Merck-Serono, Roche and Novartis. Raed Alroughani received honororia from Biologix, Bayer, Merck Sorono, GSK and Novartis, and served on advisory board for Biologix, Novartis and Merck Sorono. Roberto Bergamaschi received speaker honoraria from Bayer Schering, Biogen, Novartis, Sanofi-Aventis, Teva; research grants from Bayer Schering, Biogen, Novartis, Sanofi-Aventis, Teva; congress and travel expense compensations from Bayer Schering, Biogen, Novartis, Sanofi-Aventis, Teva. Michael Barnett has served on scientific advisory boards for Biogen-Idec, Novartis and Genzyme and has received conference travel support from Biogen-Idec and Novartis. He serves on steering committees for trials conducted by Novartis. His institution has received research support from Biogen-Idec, Merck-Serono and Novartis. Mark Slee has participated in, but not received honoraria for, advisory board activity for Biogen Idec, MerckSerono, BayerSchering, Sanofi Aventis and Novartis. Norbert Vella received compensation for travel and honoraria from Novartis, Biogen Idec, Glaxo-Smith-Kline. Joseph Herbert did not declare any competing interests. Cameron Shaw did not declare any competing interests. Maria Laura Saladino did not declare any competing interests. Maria Pia Amato has received speaker honoraria and research grants from Biogen Idec, Bayer-Schering, Merck-Serono, Novartis, Teva and Sanofi Genzyme. She served as a member of advisory boards for Biogen Idec, Bayer-Schering, Merck-Serono, Novartis, Teva and Sanofi Genzyme. Eva Havrdova has received consulting and speaker honoraria from Biogen Idec, Bayer, Merck-Serono, Novartis, Teva and Sanofi Genzyme. Orla Gray received honoraria as consultant on scientific advisory boards for Biogen Idec, Merck Serono and Novartis; has received travel grants from Biogen Idec, Merck Serono and Novartis; has participated in clinical trials by Biogen Idec and Merck Serono. Mark Paine did not declare any competing interests. Carolyn Young has served on scientific advisory boards for Biogen Idec, Sanofi-Aventis and Teva, and has received conference expenses from Biogen Idec, Novartis and Teva. Her institution has received research support from Bayer, Biogen Idec, Merck Serono, Novartis, Roche and Teva.Aldo Savino did not declare any competing interests. Ludwig Kappos did not declare any competing interests Tomas Kalincik received compensation for travel from Novartis, Biogen Idec, Sanofi Aventis, Teva and Merck Serono. Danny Liew did not declare any competing interests. Helmut Butzkueven has served on scientific advisory boards for Biogen Idec, Novartis and Sanofi-Aventis and has received conference travel support from Novartis, Biogen Idec and Sanofi Aventis. He serves on steering committees for trials conducted by Biogen Idec and Novartis, and has received research support from Merck Serono, Novartis and Biogen Idec.