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Comparative effectiveness of cladribine tablets versus other oral disease-modifying treatments for multiple sclerosis: Results from MSBase registry

T. Spelman, S. Ozakbas, R. Alroughani, M. Terzi, S. Hodgkinson, G. Laureys, T. Kalincik, A. Van Der Walt, B. Yamout, J. Lechner-Scott, A. Soysal, J. Kuhle, JL. Sanchez-Menoyo, Y. Blanco Morgado, D. Spitaleri, V. van Pesch, D. Horakova, R. Ampapa,...

. 2023 ; 29 (2) : 221-235. [pub] 20221126

Language English Country England, Great Britain

Document type Journal Article, Research Support, Non-U.S. Gov't

BACKGROUND: Effectiveness of cladribine tablets, an oral disease-modifying treatment (DMT) for multiple sclerosis (MS), was established in clinical trials and confirmed with real-world experience. OBJECTIVES: Use real-world data to compare treatment patterns and clinical outcomes in people with MS (pwMS) treated with cladribine tablets versus other oral DMTs. METHODS: Retrospective treatment comparisons were based on data from the international MSBase registry. Eligible pwMS started treatment with cladribine, fingolimod, dimethyl fumarate, or teriflunomide tablets from 2018 to mid-2021 and were censored at treatment discontinuation/switch, death, loss to follow-up, pregnancy, or study period end. Treatment persistence was evaluated as time to discontinuation/switch; relapse outcomes included time to first relapse and annualized relapse rate (ARR). RESULTS: Cohorts included 633 pwMS receiving cladribine tablets, 1195 receiving fingolimod, 912 receiving dimethyl fumarate, and 735 receiving teriflunomide. Individuals treated with fingolimod, dimethyl fumarate, or teriflunomide switched treatment significantly more quickly than matched cladribine tablet cohorts (adjusted hazard ratio (95% confidence interval): 4.00 (2.54-6.32), 7.04 (4.16-11.93), and 6.52 (3.79-11.22), respectively). Cladribine tablet cohorts had significantly longer time-to-treatment discontinuation, time to first relapse, and lower ARR, compared with other oral DMT cohorts. CONCLUSION: Cladribine tablets were associated with a significantly greater real-world treatment persistence and more favorable relapse outcomes than all oral DMT comparators.

Academic MS Center Zuyderland Department of Neurology Zuyderland Medical Center Sittard Geleen The Netherlands School for Mental Health and Neuroscience Maastricht University Maastricht The Netherlands

Al Amiri Hospital Kuwait City Kuwait

Azienda Ospedaliera di Rilievo Nazionale San Giuseppe Moscati Avellino Avellino Ital

Bakirkoy Education and Research Hospital for Psychiatric and Neurological Diseases Istanbul Turkey

Center of Neuroimmunology Service of Neurology Hospital Clinic de Barcelona Barcelona Spain

Cliniques Universitaires Saint Luc Brussels Belgium

Department of Medical and Surgical Sciences and Advanced Technologies GF Ingrassia Catania Italy

Department of Neurology 19 Mayis University Samsun Turkey

Department of Neurology and Center of Clinical Neuroscience 1st Faculty of Medicine Charles University Prague and General University Hospital Prague Czech Republic

Department of Neurology Austin Health Melbourne VIC Australia

Department of Neurology Galdakao Usansolo University Hospital Osakidetza Basque Health Service Biocruces Bizkaia Health Research Institute Galdakao Spain

Department of Neuroscience Central Clinical School Monash University Melbourne VIC Australia

Division of Neurology St Michael's Hospital University of Toronto Toronto ON Canada

Dokuz Eylul University Izmir Turkey

EMD Serono Research and Development Institute Inc Billerica MA USA an affiliate of Merck KGaA

Koc University School of Medicine and Koc University Research Center for Translational Medicine Istanbul Turkey

Liverpool Hospital Sydney NSW Australia

MS Centre Department of Neurology Royal Melbourne Hospital Melbourne VIC Australia CORe Department of Medicine University of Melbourne Melbourne VIC Australia

MSBase Foundation Melbourne VIC Australia

MSBase Foundation Melbourne VIC Australia Department of Neuroscience Central Clinical School Monash University Melbourne VIC Australia

Multiple Sclerosis Centre Neurology Departments of Head Spine and Neuromedicine Biomedicine and Clinical Research University Hospital Basel and University of Basel Basel Switzerland Research Center for Clinical Neuroimmunology and Neuroscience University Hospital and University of Basel Basel Switzerland

Nemocnice Jihlava Jihlava Czech Republic

Neurology Institute Harley Street Medical Center Abu Dhabi United Arab Emirates American University of Beirut Medical Center Beirut Lebanon

Neurology Unit Department of Medicine College of Medicine and Health Sciences and Sultan Qaboos University Hospital Sultan Qaboos University Al Khodh Oman

School of Medicine and Public Health University of Newcastle Newcastle NSW Australia Department of Neurology John Hunter Hospital Hunter New England Health Newcastle NSW Australia

University Hospital Ghent Ghent Belgium

References provided by Crossref.org

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$a BACKGROUND: Effectiveness of cladribine tablets, an oral disease-modifying treatment (DMT) for multiple sclerosis (MS), was established in clinical trials and confirmed with real-world experience. OBJECTIVES: Use real-world data to compare treatment patterns and clinical outcomes in people with MS (pwMS) treated with cladribine tablets versus other oral DMTs. METHODS: Retrospective treatment comparisons were based on data from the international MSBase registry. Eligible pwMS started treatment with cladribine, fingolimod, dimethyl fumarate, or teriflunomide tablets from 2018 to mid-2021 and were censored at treatment discontinuation/switch, death, loss to follow-up, pregnancy, or study period end. Treatment persistence was evaluated as time to discontinuation/switch; relapse outcomes included time to first relapse and annualized relapse rate (ARR). RESULTS: Cohorts included 633 pwMS receiving cladribine tablets, 1195 receiving fingolimod, 912 receiving dimethyl fumarate, and 735 receiving teriflunomide. Individuals treated with fingolimod, dimethyl fumarate, or teriflunomide switched treatment significantly more quickly than matched cladribine tablet cohorts (adjusted hazard ratio (95% confidence interval): 4.00 (2.54-6.32), 7.04 (4.16-11.93), and 6.52 (3.79-11.22), respectively). Cladribine tablet cohorts had significantly longer time-to-treatment discontinuation, time to first relapse, and lower ARR, compared with other oral DMT cohorts. CONCLUSION: Cladribine tablets were associated with a significantly greater real-world treatment persistence and more favorable relapse outcomes than all oral DMT comparators.
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