Long-term follow-up of patients with relapsing multiple sclerosis from the CLARITY/CLARITY Extension cohort of CLASSIC-MS: An ambispective study. (May 2023)

• Record Type: Journal Article
• Authors: Giovannoni, Gavin; Boyko, Alexey; Correale, Jorge; Edan, Gilles; Freedman, Mark S; Montalban, Xavier; Rammohan, Kottil; Stefoski, Dusan; Yamout, Bassem; Leist, Thomas; Aydemir, Aida; Borsi, Laszlo; Verdun di Cantogno, Elisabetta
• Is Part Of: Multiple sclerosis. Volume 29:Number 6(2023)
• Page Start: 719
• Page End: 730
• Publication Date: 2023-05
• Subjects: Cladribine tablets -- CLARITY -- CLARITY Extension -- disability -- disease-modifying therapy -- employment -- Expanded Disability Status Scale -- multiple sclerosis; Central nervous system -- Diseases -- Periodicals; Myelin sheath -- Diseases -- Periodicals; Inflammation -- Periodicals; Multiple sclerosis -- Periodicals; Central Nervous System Diseases -- Periodicals; Demyelinating Diseases -- Periodicals; Inflammation -- Periodicals; Multiple Sclerosis -- Periodicals; Système nerveux central -- Maladies -- Périodiques; Gaine de myéline -- Maladies -- Périodiques; Inflammation (Pathologie) -- Périodiques; Sclérose en plaques -- Périodiques; Electronic journals; 616.834005
• DOI: 10.1177/13524585231161494
• Languages: English
• ISSNs: 1352-4585

Abstract

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.