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Alemtuzumab outcomes by age: Post hoc analysis from the randomized CARE-MS studies over 8 years.
Mult Scler Relat Disord. 2020 Dec 24; 49:102717.MS

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.

Authors+Show Affiliations

Neurology Center of San Antonio, 1314 East Sonterra Blvd #601, San Antonio, TX, USA. Electronic address: annofb@hotmail.com.Hospital Universitario Quirónsalud Madrid (RA), c/ Diego de Velázquez, 1 28223 Pozuelo de Alarcón, Madrid, Spain.Boster MS Center, 8000 Ravines Edge Court, Suite 200, Columbus, OH, USA.Pirogov Russian National Research University, Department of Neuroimmunology of the Federal Center of Brain and Neurosciences, Moscow, Russia.Hospital Universitario Virgen Macarena, Avda. Dr. Fedriani, No. 3. 41009, Seville, Spain.University of Massachusetts Memorial Medical Center, 55 Lake Avenue North, Worcester, MA, USA.Klinik für Neurologie und Palliativmedizin, Ostmerheimer Str. 200, 51109 Cologne, Germany.Clínica Universitaria Colombia, Cl. 22b ## 66-46, Bogota, Colombia.Keck School of Medicine of University of Southern California, 1520 San Pablo St, Los Angeles, CA, USA.Department of Human Neuroscience, Sapienza University, University Avenue 30, Rome, Italy.Kansas City MS Center, 10600 Mastin Street, Entrance C, Overland Park, KS, USA.Centro Hospitalar e Universitário de Coimbra, Praceta Prof. Mota Pinto, 3000-075, Coimbra, Portugal.University Hospital Vall d'Hebron, Passeig de la Vall d'Hebron, 119, 129, 08035 Barcelona, Spain.Amsterdam University Medical Centers, PO Box 7057, 1007 MB, Amsterdam, The Netherlands.Sanofi, 50 Binney Street, Cambridge, MA, USA.Sanofi, 50 Binney Street, Cambridge, MA, USA.Sanofi, 50 Binney Street, Cambridge, MA, USA.Manchester Centre for Clinical Neurosciences, Salford Royal NHS Foundation Trust, Stott Lane, Salford, M6 8HD, UK.No affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

33476880

Citation

Bass, Ann D., et al. "Alemtuzumab Outcomes By Age: Post Hoc Analysis From the Randomized CARE-MS Studies Over 8 Years." Multiple Sclerosis and Related Disorders, vol. 49, 2020, p. 102717.
Bass AD, Arroyo R, Boster AL, et al. Alemtuzumab outcomes by age: Post hoc analysis from the randomized CARE-MS studies over 8 years. Mult Scler Relat Disord. 2020;49:102717.
Bass, A. D., Arroyo, R., Boster, A. L., Boyko, A. N., Eichau, S., Ionete, C., Limmroth, V., Navas, C., Pelletier, D., Pozzilli, C., Ravenscroft, J., Sousa, L., Tintoré, M., Uitdehaag, B. M. J., Baker, D. P., Daizadeh, N., Choudhry, Z., & Rog, D. (2020). Alemtuzumab outcomes by age: Post hoc analysis from the randomized CARE-MS studies over 8 years. Multiple Sclerosis and Related Disorders, 49, 102717. https://doi.org/10.1016/j.msard.2020.102717
Bass AD, et al. Alemtuzumab Outcomes By Age: Post Hoc Analysis From the Randomized CARE-MS Studies Over 8 Years. Mult Scler Relat Disord. 2020 Dec 24;49:102717. PubMed PMID: 33476880.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Alemtuzumab outcomes by age: Post hoc analysis from the randomized CARE-MS studies over 8 years. AU - Bass,Ann D, AU - Arroyo,Rafael, AU - Boster,Aaron L, AU - Boyko,Alexey N, AU - Eichau,Sara, AU - Ionete,Carolina, AU - Limmroth,Volker, AU - Navas,Carlos, AU - Pelletier,Daniel, AU - Pozzilli,Carlo, AU - Ravenscroft,Jennifer, AU - Sousa,Livia, AU - Tintoré,Mar, AU - Uitdehaag,Bernard M J, AU - Baker,Darren P, AU - Daizadeh,Nadia, AU - Choudhry,Zia, AU - Rog,David, AU - ,, Y1 - 2020/12/24/ PY - 2020/07/06/received PY - 2020/11/25/revised PY - 2020/12/21/accepted PY - 2021/1/22/pubmed PY - 2021/1/22/medline PY - 2021/1/21/entrez KW - Age KW - Alemtuzumab KW - Efficacy KW - Long-term KW - Safety SP - 102717 EP - 102717 JF - Multiple sclerosis and related disorders JO - Mult Scler Relat Disord VL - 49 N2 - 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. SN - 2211-0356 UR - https://www.unboundmedicine.com/medline/citation/33476880/Alemtuzumab_outcomes_by_age:_Post_hoc_analysis_from_the_randomized_CARE_MS_studies_over_8_years_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S2211-0348(20)30791-4 DB - PRIME DP - Unbound Medicine ER -
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