Long-term follow-up of patients with relapsing multiple sclerosis from the CLARITY/CLARITY Extension cohort of CLASSIC-MS : an ambispective study
Giovannoni, Gavin (Queen Mary and Westfield College (University of London))
Boyko, Alexey (Pirogov Russian National Research Medical University.)
Correale, Jorge (Departamento de Neurologia, FLENI Instituto.)
Edan, Gilles (Department of Neurology, University Hospital of Rennes.)
Freedman, Mark S. (Department of Medicine and the Ottawa Hospital Research Institute.)
Montalban, Xavier (Hospital Universitari Vall d'Hebron)
Rammohan, Kottil (MS Research Center, School of Medicine, University of Miami)
Stefoski, Dusan (Department of Neurological Sciences, Rush Medical College)
Yamout, Bassem (UAE/American University of Beirut Medical Center)
Leist, Thomas (Division of Clinical Neuroimmunology, Comprehensive MS Center, Jefferson University)
Aydemir, Aida (EMD Serono Research & Development Institute, Inc.)
Borsi, Laszlo (Merck Healthcare KGaA.)
Verdun, di Cantogno E (EMD Serono Research & Development Institute, Inc.)
Universitat Autònoma de Barcelona. Departament de Medicina

Data:	2023
Descripció:	12 pàg.
Resum:	Background: CLASSIC-MS evaluated the long-term efficacy of cladribine tablets in patients with relapsing multiple sclerosis. Objective: Report long-term mobility and disability beyond treatment courses received in CLARITY/CLARITY Extension. Methods: This analysis represents CLASSIC-MS patients who participated in CLARITY with/without participation in CLARITY Extension, and received ⩾1 course of cladribine tablets or placebo (N = 435). Primary objective includes evaluation of long-term mobility (no wheelchair use in the 3 months prior to first visit in CLASSIC-MS and not bedridden at any time since last parent study dose (LPSD), i. e. Expanded Disability Status Scale (EDSS) score <7). Secondary objective includes long-term disability status (no use of an ambulatory device (EDSS < 6) at any time since LPSD). Results: At CLASSIC-MS baseline, mean ± standard deviation EDSS score was 3. 9 ± 2. 1 and the median time since LPSD was 10. 9 (range = 9. 3-14. 9) years. Cladribine tablets-exposed population: 90. 6% (N = 394), including 160 patients who received a cumulative dose of 3. 5 mg/kg over 2 years. Patients not using a wheelchair and not bedridden: exposed, 90. 0%; unexposed, 77. 8%. Patients with no use of an ambulatory device: exposed, 81. 2%; unexposed, 75. 6%. Conclusion: With a median 10. 9 years' follow-up after CLARITY/CLARITY Extension, findings suggest the sustained long-term mobility and disability benefits of cladribine tablets.
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	CLARITY ; CLARITY Extension ; Cladribine tablets ; Expanded Disability Status Scale ; Disability ; Disease-modifying therapy ; Employment ; Multiple sclerosis
Publicat a:	Multiple sclerosis, Vol. 29 Núm. 6 (2023) , p. 719-730, ISSN 1477-0970

DOI: 10.1177/13524585231161494
PMID: 37012898

12 p, 1.3 MB

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