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. 2021 Apr:49:102717.
doi: 10.1016/j.msard.2020.102717. Epub 2020 Dec 24.

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

Ann D Bass  1 , Rafael Arroyo  2 , Aaron L Boster  3 , Alexey N Boyko  4 , Sara Eichau  5 , Carolina Ionete  6 , Volker Limmroth  7 , Carlos Navas  8 , Daniel Pelletier  9 , Carlo Pozzilli  10 , Jennifer Ravenscroft  11 , Livia Sousa  12 , Mar Tintoré  13 , Bernard M J Uitdehaag  14 , Darren P Baker  15 , Nadia Daizadeh  15 , Zia Choudhry  15 , David Rog  16 ; CARE-MS I, CARE-MS II, CAMMS03409, and TOPAZ investigators
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Free article

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

Ann D Bass et al. Mult Scler Relat Disord. 2021 Apr.
Free article

Abstract

Background: 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]).

Methods: 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).

Results: 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.

Conclusions: 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.

Keywords: Age; Alemtuzumab; Efficacy; Long-term; Safety.

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