RT Journal Article
T1 Alemtuzumab outcomes by age: Post hoc analysis from the randomized CARE-MS studies over 8 years.
A1 Bass, Ann D
A1 Arroyo, Rafael
A1 Boster, Aaron L
A1 Boyko, Alexey N
A1 Eichau, Sara
A1 Ionete, Carolina
A1 Limmroth, Volker
A1 Navas, Carlos
A1 Pelletier, Daniel
A1 Pozzilli, Carlo
A1 Ravenscroft, Jennifer
A1 Sousa, Livia
A1 Tintoré, Mar
A1 Uitdehaag, Bernard M J
A1 Baker, Darren P
A1 Daizadeh, Nadia
A1 Choudhry, Zia
A1 Rog, David
A1 CARE-MS I, CARE-MS II, CAMMS03409, and TOPAZ investigators
K1 Age
K1 Alemtuzumab
K1 Efficacy
K1 Long-term
K1 Safety
AB Alemtuzumab significantly improved clinical and MRI outcomes vs. subcutaneous interferon beta-1a (SC IFNB-1a) in the CARE-MS trials (NCT00530348, NCT00548405), with sustained efficacy in 2 consecutive extensions (NCT00930553, NCT02255656 [TOPAZ]). Post hoc analysis of 8-year alemtuzumab efficacy and safety in pooled CARE-MS patients (N=811) stratified by baseline age (≥18 to ≤25, >25 to ≤35, >35 to ≤45, >45 to ≤55 years). Compared with SC IFNB-1a over 2 years across age cohorts, alemtuzumab lowered annualized relapse rates (ARR; 0.22-0.24 vs. 0.38-0.51), improved or stabilized disability (freedom from 6-month confirmed disability worsening [CDW]: 85%-92% vs. 62%-88%; achievement of 6-month confirmed disability improvement [CDI]: 20%-31% vs. 13%-25%), increased proportions free of MRI disease activity (70%-86% vs. 42%-63% per year), and slowed brain volume loss (BVL; -0.45% to -0.87% vs. -0.50% to -1.39%). Through Year 2, the treatment effect with alemtuzumab did not significantly differ among age groups for ARR (p-interaction=0.6325), 6-month CDW-free (p-interaction=0.4959), 6-month CDI (p-interaction=0.9268), MRI disease activity-free (p-interaction=0.6512), and BVL (p-interaction=0.4970). Alemtuzumab remained effective on outcomes through Year 8 across age groups. Age-related increases in malignancies (≤45 years: 0.9%-2.2% vs. >45 years: 8.1%) and deaths (0%-1.7% vs. 7.0%) were observed. Serious infections also increased from the youngest (5.1%) to oldest (12.8%) age cohorts. Alemtuzumab had greater efficacy than SC IFNB-1a over 2 years across comparable age groups, with no significant differences between alemtuzumab-treated age groups. Efficacy on relapse, disability, and MRI outcomes continued through Year 8 across age groups. Age-related increases in serious infections, malignancies, and deaths were observed.
YR 2020
FD 2020-12-24
LK http://hdl.handle.net/10668/17008
UL http://hdl.handle.net/10668/17008
LA en
DS RISalud
RD Apr 10, 2025