Alemtuzumab outcomes by age: Post hoc analysis from the randomized CARE-MS studies over 8 years

BackgroundAlemtuzumab significantly improved clinical and MRI outcomes vs. subcutaneous interferon beta-1a (SC IFNB-1a) in the CARE-MS trials (NCT00530348, NCT00548405), with sustained efficacy 2 consecutive extensions (NCT00930553, NCT02255656 [TOPAZ]).MethodsPost hoc analysis of 8-year alemtuzumab safety pooled patients (N=811) stratified by baseline age (≥18 to ≤25, >25 ≤35, >35 ≤45, >45 ≤55 years).ResultsCompared SC IFNB-1a over years across cohorts, lowered annualized relapse rates (ARR; 0.22–0.24 0.38–0.51), or stabilized disability (freedom from 6-month confirmed worsening [CDW]: 85%–92% 62%–88%; achievement improvement [CDI]: 20%–31% 13%–25%), increased proportions free disease activity (70%–86% 42%–63% per year), slowed brain volume loss (BVL; –0.45% –0.87% –0.50% –1.39%). Through Year 2, treatment effect did not differ among groups for ARR (p-interaction=0.6325), CDW-free (p-interaction=0.4959), CDI (p-interaction=0.9268), activity-free (p-interaction=0.6512), BVL (p-interaction=0.4970). Alemtuzumab remained effective on through 8 groups. Age-related increases malignancies (≤45 years: 0.9%–2.2% 8.1%) deaths (0%–1.7% 7.0%) were observed. Serious infections also youngest (5.1%) oldest (12.8%) cohorts.ConclusionsAlemtuzumab had greater than comparable groups, no significant differences between alemtuzumab-treated Efficacy relapse, disability, continued serious infections, malignancies,