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(ECTRIMS) Relapse incidence in women & men (MSBase)

 
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PostPosted: Sun Oct 06, 2013 3:54 pm    Post subject: (ECTRIMS) Relapse incidence in women & men (MSBase) Reply with quote

Presented at the annual ECTRIMS conference in Copenhagen, October 2-5, 2013:

Quote:
MS and gender

Thursday, October 03, 2013, 14:55 - 15:07

Relapse incidence in women and men throughout the course of multiple sclerosis: an MSBase cohort study

T. Kalincik, V. Vivek, V. Jokubaitis, J. Lechner-Scott, M. Trojano, G. Izquierdo, A. Lugaresi, F. Grand'Maison, R. Hupperts, C. Oreja-Guevara, R. Bergamaschi, G. Iuliano, R. Alroughani, V. Van Pesch, M.P. Amato, M. Slee, F. Verheul, R. Fernandez-Bolanos, M. Fiol, D. La Spitaleri, E. Cristiano, O. Gray, J. Cabrera-Gomez, V. Shaygannejad, J. Herbert, S. Vucic, M. Needham, T. Petkovska-Boskova, C. Sirbu, P. Duquette, M. Girard, P. Grammond, C. Boz, G. Giuliani, M. Rio, M. Barnett, S. Flechter, F. Moore, B. Singhal, E. Bacie Bacile, M. Saladino, C. Shaw, E. Skromne, N. Vella, T. Spelman, D. Liew, T. Kilpatrick, H. Butzkueven on behalf of the MSBase Study Group

Introduction:

Only one large retrospective cohort study and several smaller analyses examined predictors of relapse incidence in MS. Sex, age and MS duration were suggested as determinants of relapse activity. While in relapsing-remitting MS women are overrepresented in the ratio of 3:1 to men, in primary progressive disease both sexes are represented equally. A lower probability of relapse in men could be the reason for this change, with primary progressive (PP) MS representing the “extreme” of low relapse activity.

Aims:

To evaluate effect of sex on the incidence of MS relapses. To assess the hypothesis that the female-to-male ratio increases gradually with relapse activity and that PPMS represents a non-relapsing extreme along this continuum. To directly compare effects of age and MS duration on relapse incidence.

Methods:

Annualised relapse rates were calculated using the MSBase registry. Patients with incomplete data or less than one year of follow-up were excluded. Patients with PPMS were only included in the sex ratio analysis. Relapse incidences over 40 years of MS duration or up to 70 years of age were compared between females and males using Andersen-Gill and Poisson models. Female-to-male ratios stratified by annual relapse count were evaluated across disease duration and patient age and compared between relapse-onset and PPMS. All models were adjusted for therapy and pregnancy.

Results:

Among 11,570 eligible patients with relapse-onset MS (82,552 patient-years), 48,362 relapses were recorded. Relapse frequency was 17.7% higher in females compared to males. Within the initial five years, the female-to-male ratio increased from 2.3:1 to 3.3:1 in patients with 0 to >=4 relapses per year, respectively. The magnitude of this sex effect increased at longer MS duration and older age. However, the female-to-male ratio in patients with relapse-onset MS and zero relapses in any given year was double that of the patients with PPMS. Patient age was a more important determinant of decline in relapse incidence than disease duration.

Conclusions:

Females are predisposed to higher relapse activity than males. However, this sex-related effect does not explain the markedly lower female-to-male ratio in PPMS. Decline in relapse activity over time is more closely related to patient age than MS duration. This information helps us better understand the effects of sex and time on relapse incidence and define PPMS as an entity distinct from the relapse-onset MS.

_____________

Tomas Kalincik received compensation for travel from Novartis, Biogen Idec, Sanofi Aventis, Teva and Merck Serono.

Vivo Vivek did not declare any competing interests.

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.

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. 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 is a Consultant of “Fondazione Cesare Serono”. Francois Grand’Maison received honoraria from Biogen Idec, Genzyme, Novartis and Roche.

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.

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.

Thor Petersen received funding or speaker honoraria from Biogen Idec, Merck Serono, Novartis, Bayer Schering, Sanofi-Aventis, Roche, and Genzyme. 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.

Gerardo Iuliano had travel/accommodations/meeting expenses funded by Bayer Schering, Biogen Idec, Merck Serono, Novartis, Sanofi Aventis, and Teva Raed Alroughani received honororia from Biologix, Bayer, Merck Sorono, GSK and Novartis, and served on advisory board for Biologix, Novartis and Merck Sorono.

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. Maria Pia Amato received honoraria as consultant on scientific advisory boards by Biogen-Idec, Bayer-Schering, Merck-Serono, Teva and Sanofi-Aventis; has received research grants by Biogen-Idec, Bayer-Schering, Merck-Serono, Teva and Novartis.

Mark Slee has participated in, but not received honoraria for, advisory board activity for Biogen Idec, MerckSerono, BayerSchering, Sanofi Aventis and Novartis.

Freek Verheul did not declare any competing interests.

Ricardo Fernandez-Bolanos did not declare any competing interests.

Marcela Fiol received honoraria from Merck-Serono and Bayer.

Daniele La Spitaleri received honoraria as a consultant on scientific advisory boards by Bayer-Schering, Novartis and Sanofi-Aventis and compensation for travel from Novartis, Biogen Idec, Sanofi Aventis, Teva and Merck-Serono.

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.

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.

Jose Antonio Cabrera-Gomez did not declare any competing interests.

Vahid Shaygannejad did not declare any competing interests.

Joseph Herbert did not declare any competing interests.

Steve Vucic did not declare any competing interests.

Merilee Needham has received honoraria as a consultant from Novartis.

Tatjana Petkovska-Boskova did not declare any competing interests.

Carmen-Adella Sirbu received speaking honoraria from Teva, and travel grants from Bayer-Schering and Teva.

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 and a research grant from Canadian Institutes of Health Research.

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.

Cavit Boz did not declare any competing interests.

Giorgio Giuliani did not declare any competing interests.

Maria Edite Rio did not declare any competing interests.

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 Biogen Idec.

Sholmo Flechter did not declare any competing interests. Fraser Moore has participated in clinical trials sponsored by EMD Serono and Novartis.

Bhim Singhal received consultancy honoraria and compensation for travel from Biogen-Idec and Merck-Serono.

Elizabeth Alejandra Bacile Bacile did not declare any competing interests.

Aldo Savino did not declare any competing interests.

Maria Laura Saladino did not declare any competing interests.

Cameron Shaw did not declare any competing interests.

Eli Skromne received speaking honoraria from Biogen-Idec, Novartis and Teva.

Norbert Vella received compensation for travel and honoraria from Novartis, Biogen Idec, Glaxo-Smith-Kline.

Dieter Poehlau received speaking honoraria from Biogen Idec, Novartis, Merck Serono, Almirall, Teva, Sanofi Aventis, and research funding from Biogen Idec and Novartis.

Vilija Jokubaitis did not declare any competing interests.

Timothy Spelman received compensation for travel from Biogen Idec.

Danny Liew did not declare any competing interests.

Trevor Kilpatrick has served on scientific advisory boards for GlaxoSmithKline, Neurosciences Victoria, and the Victorian Neurotrauma Initiative; has received funding for travel from Bayer Schering Pharma, CSL and Merck Serono; served on the editorial board of Therapeutic Advances in Neurological Disorders and receives research support from Bayer Schering Pharma, Biogen Idec, the Australian Research Council, the National Health and Medical Research Council of Australia, MS Research Australia, and the National Multiple Sclerosis Society.

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.

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