TY - JOUR
T1 - Long-term follow-up of patients with relapsing multiple sclerosis from the CLARITY/CLARITY Extension cohort of CLASSIC-MS:
T2 - An ambispective study
AU - Giovannoni, G
AU - Boyko, A
AU - Correale, J
AU - Edan, G
AU - Freedman, MS
AU - Montalban, X
AU - Rammohan, K
AU - Stefoski, D
AU - Yamout, B
AU - Leist, T
AU - Aydemir, A
AU - Borsi, L
AU - Verdun, di Cantogno E
N1 - Publisher Copyright:
© The Author(s), 2023.
PY - 2023/5
Y1 - 2023/5
N2 - 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.
AB - 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.
KW - CLARITY Extension
KW - Cladribine tablets
KW - Clarity
KW - Disability
KW - Disease-modifying therapy
KW - Employment
KW - Expanded Disability Status Scale
KW - Multiple sclerosis
UR - http://europepmc.org/abstract/med/37012898
UR - https://www.scopus.com/pages/publications/85152267913
UR - https://www.mendeley.com/catalogue/530b44c0-baee-3812-a269-2e039346f5e4/
U2 - 10.1177/13524585231161494
DO - 10.1177/13524585231161494
M3 - Article
C2 - 37012898
SN - 1352-4585
VL - 29
SP - 719
EP - 730
JO - Multiple Sclerosis Journal
JF - Multiple Sclerosis Journal
IS - 6
ER -