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.