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

Author:

Spelman Tim1ORCID,Ozakbas Serkan2,Alroughani Raed3ORCID,Terzi Murat4,Hodgkinson Suzanne5,Laureys Guy6,Kalincik Tomas7ORCID,Van Der Walt Anneke8ORCID,Yamout Bassem9,Lechner-Scott Jeannette10ORCID,Soysal Aysun11,Kuhle Jens12,Sanchez-Menoyo Jose Luis13,Blanco Morgado Yolanda14,Spitaleri Daniele LA15,van Pesch Vincent16,Horakova Dana17ORCID,Ampapa Radek18,Patti Francesco19ORCID,Macdonell Richard20,Al-Asmi Abdullah21,Gerlach Oliver22,Oh Jiwon23ORCID,Altintas Ayse24,Tundia Namita25,Wong Schiffon L25,Butzkueven Helmut26

Affiliation:

1. MSBase Foundation, Melbourne, VIC, Australia

2. Dokuz Eylul University, Izmir, Turkey

3. Al-Amiri Hospital, Kuwait City, Kuwait

4. Department of Neurology, 19 Mayis University, Samsun, Turkey

5. Liverpool Hospital, Sydney, NSW, Australia

6. University Hospital Ghent, Ghent, Belgium

7. MS Centre, Department of Neurology, Royal Melbourne Hospital, Melbourne, VIC, Australia/CORe, Department of Medicine, University of Melbourne, Melbourne, VIC, Australia

8. Department of Neuroscience, Central Clinical School, Monash University, Melbourne, VIC, Australia

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

10. 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

11. Bakirkoy Education and Research Hospital for Psychiatric and Neurological Diseases, Istanbul, Turkey

12. 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 (RC2NB), University Hospital and University of Basel, Basel, Switzerland

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

14. Center of Neuroimmunology, Service of Neurology, Hospital Clinic de Barcelona, Barcelona, Spain

15. Azienda Ospedaliera di Rilievo Nazionale San Giuseppe Moscati Avellino, Avellino, Ital

16. Cliniques Universitaires Saint-Luc (UCLouvain), Brussels, Belgium

17. Department of Neurology and Center of Clinical Neuroscience, First Faculty of Medicine, Charles University in Prague and General University Hospital, Prague, Czech Republic

18. Nemocnice Jihlava, Jihlava, Czech Republic

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

20. Department of Neurology, Austin Health, Melbourne, VIC, Australia

21. Neurology Unit, Department of Medicine, College of Medicine & Health Sciences and Sultan Qaboos University Hospital, Sultan Qaboos University (SQU), Al Khodh, Oman

22. 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

23. Division of Neurology, St. Michael’s Hospital, University of Toronto, Toronto, ON, Canada

24. Koc University School of Medicine and Koc University Research Center for Translational Medicine (KUTTAM), Istanbul, Turkey

25. EMD Serono Research & Development Institute, Inc., Billerica, MA, USA, an affiliate of Merck KGaA

26. MSBase Foundation, Melbourne, VIC, Australia/Department of Neuroscience, Central Clinical School, Monash University, Melbourne, VIC, Australia

Abstract

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.

Publisher

SAGE Publications

Subject

Neurology (clinical),Neurology

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