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Predictors of treatment switching in the Big Multiple Sclerosis Data Network
T. Spelman, M. Magyari, H. Butzkueven, A. Van Der Walt, S. Vukusic, M. Trojano, P. Iaffaldano, D. Horáková, J. Drahota, F. Pellegrini, R. Hyde, P. Duquette, J. Lechner-Scott, SA. Sajedi, P. Lalive, V. Shaygannejad, S. Ozakbas, S. Eichau, R....
Status neindexováno Jazyk angličtina Země Švýcarsko
Typ dokumentu časopisecké články
NLK
Directory of Open Access Journals
od 2010
Free Medical Journals
od 2010
PubMed Central
od 2010
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od 2010
Open Access Digital Library
od 2010-01-01
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od 2010-01-01
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od 2010
- Publikační typ
- časopisecké články MeSH
BACKGROUND: Treatment switching is a common challenge and opportunity in real-world clinical practice. Increasing diversity in disease-modifying treatments (DMTs) has generated interest in the identification of reliable and robust predictors of treatment switching across different countries, DMTs, and time periods. OBJECTIVE: The objective of this retrospective, observational study was to identify independent predictors of treatment switching in a population of relapsing-remitting MS (RRMS) patients in the Big Multiple Sclerosis Data Network of national clinical registries, including the Italian MS registry, the OFSEP of France, the Danish MS registry, the Swedish national MS registry, and the international MSBase Registry. METHODS: In this cohort study, we merged information on 269,822 treatment episodes in 110,326 patients from 1997 to 2018 from five clinical registries. Patients were included in the final pooled analysis set if they had initiated at least one DMT during the relapsing-remitting MS (RRMS) stage. Patients not diagnosed with RRMS or RRMS patients not initiating DMT therapy during the RRMS phase were excluded from the analysis. The primary study outcome was treatment switching. A multilevel mixed-effects shared frailty time-to-event model was used to identify independent predictors of treatment switching. The contributing MS registry was included in the pooled analysis as a random effect. RESULTS: Every one-point increase in the Expanded Disability Status Scale (EDSS) score at treatment start was associated with 1.08 times the rate of subsequent switching, adjusting for age, sex, and calendar year (adjusted hazard ratio [aHR] 1.08; 95% CI 1.07-1.08). Women were associated with 1.11 times the rate of switching relative to men (95% CI 1.08-1.14), whilst older age was also associated with an increased rate of treatment switching. DMTs started between 2007 and 2012 were associated with 2.48 times the rate of switching relative to DMTs that began between 1996 and 2006 (aHR 2.48; 95% CI 2.48-2.56). DMTs started from 2013 onwards were more likely to switch relative to the earlier treatment epoch (aHR 8.09; 95% CI 7.79-8.41; reference = 1996-2006). CONCLUSION: Switching between DMTs is associated with female sex, age, and disability at baseline and has increased in frequency considerably in recent years as more treatment options have become available. Consideration of a patient's individual risk and tolerance profile needs to be taken into account when selecting the most appropriate switch therapy from an expanding array of treatment choices.
Bakirkoy Education and Research Hospital for Psychiatric and Neurological Diseases Istanbul Türkiye
Biogen Digital Health Biogen Spain Madrid Spain
Biogen International GmbH Zug Switzerland
Center of Neuroimmunology Service of Neurology Hospital Clinic de Barcelona Barcelona Spain
CSSS Saint Jérôme Saint Jerome QC Canada
Department of Clinical Neuroscience Karolinska Institute Stockholm Sweden
Department of Neurology Aarhus University Hospital Aarhus Denmark
Department of Neurology Copenhagen University Hospital Herlev and Gentofte København Denmark
Department of Neurology Faculty of Health Sciences University Fernando Pessoa Porto Portugal
Department of Neurology Hospital Clinico San Carlos Madrid Spain
Department of Neurology Hospital of Southern Jutland University of Southern Denmark Aabenraa Denmark
Department of Neurology Hospital Universitario Virgen Macarena Sevilla Spain
Department of Neurology Nordsjællands Hospital Hillerød Denmark
Department of Neurology Physiotherapy and Occupational Therapy Gødstrup Hospital Herning Denmark
Department of Neuroscience Central Clinical School Monash University Melbourne VIC Australia
Division of Neurology Department of Medicine Amiri Hospital Sharq Kuwait
Dokuz Eylul University Konak Izmir Türkiye
Faculty of Medicine Division of Neurology Geneva University Hospital Geneva Switzerland
Groene Hart Ziekenhuis Gouda Netherlands
Hacettepe University Ankara Türkiye
Isfahan University of Medical Sciences Isfahan Iran
Medical Faculty 19 Mayis University Samsun Türkiye
Monash Health Melbourne VIC Australia
MSBase Foundation Melbourne VIC Australia
Nemocnice Jihlava Jihlava Czechia
Neuro Rive Sud Longueuil QC Canada
NIDO | Centre for Research and Education Gødstrup Hospital Herning Denmark
Rashid Hospital Dubai United Arab Emirates
Royal Victoria Hospital Belfast United Kingdom
St Vincent's University Hospital Dublin Ireland
University Newcastle Callaghan NSW Australia
University of Montreal Hospital Research Centre and Universite de Montreal Montreal QC Canada
Citace poskytuje Crossref.org
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- $a Predictors of treatment switching in the Big Multiple Sclerosis Data Network / $c T. Spelman, M. Magyari, H. Butzkueven, A. Van Der Walt, S. Vukusic, M. Trojano, P. Iaffaldano, D. Horáková, J. Drahota, F. Pellegrini, R. Hyde, P. Duquette, J. Lechner-Scott, SA. Sajedi, P. Lalive, V. Shaygannejad, S. Ozakbas, S. Eichau, R. Alroughani, M. Terzi, M. Girard, T. Kalincik, F. Grand'Maison, O. Skibina, SJ. Khoury, B. Yamout, MJ. Sa, O. Gerlach, Y. Blanco, R. Karabudak, C. Oreja-Guevara, A. Altintas, S. Hughes, P. McCombe, R. Ampapa, K. de Gans, C. McGuigan, A. Soysal, J. Prevost, N. John, J. Inshasi, L. Stawiarz, A. Manouchehrinia, L. Forsberg, F. Sellebjerg, A. Glaser, L. Pontieri, H. Joensen, PV. Rasmussen, T. Sejbaek, MB. Poulsen, JR. Christensen, M. Kant, M. Stilund, H. Mathiesen, J. Hillert, Big MS Data Network: a collaboration of the Czech MS Registry, the Danish MS Registry, Italian MS Registry, Swedish MS Registry, MSBase Study Group, and OFSEP
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- $a BACKGROUND: Treatment switching is a common challenge and opportunity in real-world clinical practice. Increasing diversity in disease-modifying treatments (DMTs) has generated interest in the identification of reliable and robust predictors of treatment switching across different countries, DMTs, and time periods. OBJECTIVE: The objective of this retrospective, observational study was to identify independent predictors of treatment switching in a population of relapsing-remitting MS (RRMS) patients in the Big Multiple Sclerosis Data Network of national clinical registries, including the Italian MS registry, the OFSEP of France, the Danish MS registry, the Swedish national MS registry, and the international MSBase Registry. METHODS: In this cohort study, we merged information on 269,822 treatment episodes in 110,326 patients from 1997 to 2018 from five clinical registries. Patients were included in the final pooled analysis set if they had initiated at least one DMT during the relapsing-remitting MS (RRMS) stage. Patients not diagnosed with RRMS or RRMS patients not initiating DMT therapy during the RRMS phase were excluded from the analysis. The primary study outcome was treatment switching. A multilevel mixed-effects shared frailty time-to-event model was used to identify independent predictors of treatment switching. The contributing MS registry was included in the pooled analysis as a random effect. RESULTS: Every one-point increase in the Expanded Disability Status Scale (EDSS) score at treatment start was associated with 1.08 times the rate of subsequent switching, adjusting for age, sex, and calendar year (adjusted hazard ratio [aHR] 1.08; 95% CI 1.07-1.08). Women were associated with 1.11 times the rate of switching relative to men (95% CI 1.08-1.14), whilst older age was also associated with an increased rate of treatment switching. DMTs started between 2007 and 2012 were associated with 2.48 times the rate of switching relative to DMTs that began between 1996 and 2006 (aHR 2.48; 95% CI 2.48-2.56). DMTs started from 2013 onwards were more likely to switch relative to the earlier treatment epoch (aHR 8.09; 95% CI 7.79-8.41; reference = 1996-2006). CONCLUSION: Switching between DMTs is associated with female sex, age, and disability at baseline and has increased in frequency considerably in recent years as more treatment options have become available. Consideration of a patient's individual risk and tolerance profile needs to be taken into account when selecting the most appropriate switch therapy from an expanding array of treatment choices.
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