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

Autor: Darren P Baker, Carlos Navas, Carolina Ionete, Mar Tintoré, Zia Choudhry, Rafael Arroyo, David Rog, Nadia Daizadeh, Aaron Boster, Bernard M. J. Uitdehaag, Sara Eichau, Lívia Sousa, Topaz investigators, Jennifer Ravenscroft, Volker Limmroth, Carlo Pozzilli, Alexey Boyko, Ann D Bass, Care-Ms I, Care-Ms Ii, Camms, Daniel Pelletier
Přispěvatelé: Neurology, Amsterdam Neuroscience - Neuroinfection & -inflammation, Institut Català de la Salut, [Bass AD] Neurology Center of San Antonio, San Antonio, TX, USA. [Arroyo R] Hospital Universitario Quirónsalud Madrid (RA), Pozuelo de Alarcón, Madrid, Spain. [Boster AL] Boster MS Center, Columbus, OH, USA. [Boyko AN] Pirogov Russian National Research University, Department of Neuroimmunology of the Federal Center of Brain and Neurosciences, Moscow, Russia. [Eichau S] Hospital Universitario Virgen Macarena, Seville, Spain. [Ionete C] University of Massachusetts Memorial Medical Center, Worcester, MA, USA. [Tintoré M] Vall d'Hebron Hospital Universitari, Barcelona, Spain, Vall d'Hebron Barcelona Hospital Campus
Jazyk: angličtina
Rok vydání: 2020
Předmět:
medicine.medical_specialty
Efficacy
Disease
Other subheadings::Other subheadings::/drug therapy [Other subheadings]
Antibodies
Monoclonal
Humanized
03 medical and health sciences
0302 clinical medicine
Age
Multiple Sclerosis
Relapsing-Remitting
Age groups
Long-term
Diagnosis::Diagnostic Techniques and Procedures::Diagnostic Imaging::Tomography::Magnetic Resonance Imaging [ANALYTICAL
DIAGNOSTIC AND THERAPEUTIC TECHNIQUES
AND EQUIPMENT]
Internal medicine
Post-hoc analysis
medicine
Humans
diagnóstico::técnicas y procedimientos diagnósticos::diagnóstico por imagen::tomografía::imagen por resonancia magnética [TÉCNICAS Y EQUIPOS ANALÍTICOS
DIAGNÓSTICOS Y TERAPÉUTICOS]
Treatment effect
030212 general & internal medicine
Child
Esclerosi múltiple - Imatgeria per ressonància magnètica
Alemtuzumab
business.industry
Multiple sclerosis
Nervous System Diseases::Autoimmune Diseases of the Nervous System::Demyelinating Autoimmune Diseases
CNS::Multiple Sclerosis [DISEASES]
diagnóstico::pronóstico::resultado del tratamiento [TÉCNICAS Y EQUIPOS ANALÍTICOS
DIAGNÓSTICOS Y TERAPÉUTICOS]
Age cohorts
General Medicine
Middle Aged
Diagnosis::Prognosis::Treatment Outcome [ANALYTICAL
DIAGNOSTIC AND THERAPEUTIC TECHNIQUES
AND EQUIPMENT]
medicine.disease
Brain volume loss
Treatment Outcome
Neurology
enfermedades del sistema nervioso::enfermedades autoinmunitarias del sistema nervioso::enfermedades autoinmunes desmielinizantes del SNC::esclerosis múltiple [ENFERMEDADES]
Avaluació de resultats (Assistència sanitària)
Safety
Neurology (clinical)
business
Esclerosi múltiple - Tractament
030217 neurology & neurosurgery
Interferon beta-1a
medicine.drug
Zdroj: Multiple Sclerosis and Related Disorders, 49:102717. Elsevier
Scientia
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 & CARE-MS I, CARE-MS II, CAMMS03409, and TOPAZ investigators 2021, ' Alemtuzumab outcomes by age : Post hoc analysis from the randomized CARE-MS studies over 8 years ', Multiple Sclerosis and Related Disorders, vol. 49, 102717 . https://doi.org/10.1016/j.msard.2020.102717
ISSN: 2211-0348
DOI: 10.1016/j.msard.2020.102717
Popis: Alemtuzumab; Efficacy; Safety Alemtuzumab; Eficacia; Seguridad Alemtuzumab; Eficàcia; Seguretat 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. The study was supported by Sanofi and Bayer HealthCare Pharmaceuticals.
Databáze: OpenAIRE
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