RT Journal Article
T1 Confirmed 6-Month Disability Improvement and Worsening Correlate with Long-term Disability Outcomes in Alemtuzumab-Treated Patients with Multiple Sclerosis: Post Hoc Analysis of the CARE-MS Studies.
A1 Hunter, Samuel F
A1 Aburashed, Rany A
A1 Alroughani, Raed
A1 Chan, Andrew
A1 Dive, Dominique
A1 Eichau, Sara
A1 Kantor, Daniel
A1 Kim, Ho Jin
A1 Lycke, Jan
A1 Macdonell, Richard A L
A1 Pozzilli, Carlo
A1 Scott, Thomas
A1 Sharrack, Basil
A1 Wiendl, Heinz
A1 Chung, Luke
A1 Daizadeh, Nadia
A1 Baker, Darren P
A1 Vermersch, Patrick
A1 CARE-MS I, CARE-MS II, CAMMS03409, and TOPAZ Investigators
K1 Alemtuzumab
K1 Confirmed disability improvement
K1 Confirmed disability worsening
K1 Disease-modifying therapy
K1 Expanded Disability Status Scale
K1 Functional systems
K1 Multiple sclerosis
AB In the 2-year CARE-MS trials (NCT00530348; NCT00548405) in patients with relapsing-remitting multiple sclerosis, alemtuzumab showed superior efficacy versus subcutaneous interferon beta-1a. Efficacy was maintained in two consecutive extensions (NCT00930553; NCT02255656). This post hoc analysis compared disability outcomes over 9 years among alemtuzumab-treated patients according to whether they experienced confirmed disability improvement (CDI) or worsening (CDW) or neither CDI nor CDW. CARE-MS patients were randomized to receive two alemtuzumab courses (12 mg/day; 5 days at baseline; 3 days at 12 months), with additional as-needed 3-day courses in the extensions. CDI or CDW were defined as ≥ 1.0-point decrease or increase, respectively, in Expanded Disability Status Scale (EDSS) score from core study baseline confirmed over 6 months, assessed in patients with baseline EDSS score ≥ 2.0. Improved or stable EDSS scores were defined as ≥ 1-point decrease or ≤ 0.5-point change (either direction), respectively, from core study baseline. Functional systems (FS) scores were also assessed. Of 511 eligible patients, 43% experienced CDI and 34% experienced CDW at any time through year 9 (patients experiencing both CDI and CDW were counted in each individual group); 29% experienced neither CDI nor CDW. At year 9, patients with CDI had a -0.58-point mean EDSS score change from baseline; 88% had stable or improved EDSS scores. Improvements occurred across all FS, primarily in sensory, pyramidal, and cerebellar domains. Patients with CDW had a +1.71-point mean EDSS score change; 16% had stable or improved EDSS scores. Patients with neither CDI nor CDW had a -0.10-point mean EDSS score change; 98% had stable or improved EDSS scores. CDI achievement at any point during the CARE-MS studies was associated with improved disability at year 9, highlighting the potential of alemtuzumab to change the multiple sclerosis course. Conversely, CDW at any point was associated with worsened disability at year 9.
SN 2193-8253
YR 2021
FD 2021-06-24
LK http://hdl.handle.net/10668/18038
UL http://hdl.handle.net/10668/18038
LA en
DS RISalud
RD Apr 6, 2025