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Alemtuzumab-Related Lymphocyte Subset Dynamics and Disease Activity or Autoimmune Adverse Events: Real-World Evidence
Background and objectives: alemtuzumab is a monoclonal anti-CD52 antibody acting on B and T cells in highly active multiple sclerosis (MS). We analyzed changes in lymphocyte subsets after alemtuzumab administration in relation to disease activity and autoimmune adverse events. Methods: lymphocyte su...
Autores principales: | , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
MDPI
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10002781/ https://www.ncbi.nlm.nih.gov/pubmed/36902555 http://dx.doi.org/10.3390/jcm12051768 |
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author | Signoriello, Elisabetta Lus, Giacomo Saccà, Francesco Puthenparampil, Marco Coppola, Cinzia Di Pietro, Andrea Puoti, Gianfranco Criscuolo, Maria Cristina Foschi, Matteo Miele, Giuseppina Abbadessa, Gianmarco Brescia Morra, Vincenzo Gallo, Paolo Bonavita, Simona Sormani, Maria Pia Signori, Alessio |
author_facet | Signoriello, Elisabetta Lus, Giacomo Saccà, Francesco Puthenparampil, Marco Coppola, Cinzia Di Pietro, Andrea Puoti, Gianfranco Criscuolo, Maria Cristina Foschi, Matteo Miele, Giuseppina Abbadessa, Gianmarco Brescia Morra, Vincenzo Gallo, Paolo Bonavita, Simona Sormani, Maria Pia Signori, Alessio |
author_sort | Signoriello, Elisabetta |
collection | PubMed |
description | Background and objectives: alemtuzumab is a monoclonal anti-CD52 antibody acting on B and T cells in highly active multiple sclerosis (MS). We analyzed changes in lymphocyte subsets after alemtuzumab administration in relation to disease activity and autoimmune adverse events. Methods: lymphocyte subset counts were assessed longitudinally using linear mixed models. Subset counts at baseline and during follow-up were correlated with relapse rate, adverse events, or magnetic resonance (MRI) activity. Results: we recruited 150 patients followed for a median of 2.7 years (IQR: 1.9–3.7). Total lymphocytes, CD4, CD8, and CD20 significantly decreased in all patients over 2 years (p < 0.001). Previous treatment with fingolimod increased the risk of disease activity and adverse events (p = 0.029). We found a higher probability of disease reactivation in males and in patients with over three active lesions at baseline. Higher EDSS scores at baseline and longer disease duration predicted the switch to other treatments after alemtuzumab. Discussion and conclusions: Our real-world study supports data from clinical trials in which lymphocyte subsets were not useful for predicting disease activity or autoimmune disease during treatment. The early use of an induction therapy such as alemtuzumab in patients with a lower EDSS score and short history of disease could mitigate the risk of treatment failure. |
format | Online Article Text |
id | pubmed-10002781 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
spelling | pubmed-100027812023-03-11 Alemtuzumab-Related Lymphocyte Subset Dynamics and Disease Activity or Autoimmune Adverse Events: Real-World Evidence Signoriello, Elisabetta Lus, Giacomo Saccà, Francesco Puthenparampil, Marco Coppola, Cinzia Di Pietro, Andrea Puoti, Gianfranco Criscuolo, Maria Cristina Foschi, Matteo Miele, Giuseppina Abbadessa, Gianmarco Brescia Morra, Vincenzo Gallo, Paolo Bonavita, Simona Sormani, Maria Pia Signori, Alessio J Clin Med Article Background and objectives: alemtuzumab is a monoclonal anti-CD52 antibody acting on B and T cells in highly active multiple sclerosis (MS). We analyzed changes in lymphocyte subsets after alemtuzumab administration in relation to disease activity and autoimmune adverse events. Methods: lymphocyte subset counts were assessed longitudinally using linear mixed models. Subset counts at baseline and during follow-up were correlated with relapse rate, adverse events, or magnetic resonance (MRI) activity. Results: we recruited 150 patients followed for a median of 2.7 years (IQR: 1.9–3.7). Total lymphocytes, CD4, CD8, and CD20 significantly decreased in all patients over 2 years (p < 0.001). Previous treatment with fingolimod increased the risk of disease activity and adverse events (p = 0.029). We found a higher probability of disease reactivation in males and in patients with over three active lesions at baseline. Higher EDSS scores at baseline and longer disease duration predicted the switch to other treatments after alemtuzumab. Discussion and conclusions: Our real-world study supports data from clinical trials in which lymphocyte subsets were not useful for predicting disease activity or autoimmune disease during treatment. The early use of an induction therapy such as alemtuzumab in patients with a lower EDSS score and short history of disease could mitigate the risk of treatment failure. MDPI 2023-02-22 /pmc/articles/PMC10002781/ /pubmed/36902555 http://dx.doi.org/10.3390/jcm12051768 Text en © 2023 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/). |
spellingShingle | Article Signoriello, Elisabetta Lus, Giacomo Saccà, Francesco Puthenparampil, Marco Coppola, Cinzia Di Pietro, Andrea Puoti, Gianfranco Criscuolo, Maria Cristina Foschi, Matteo Miele, Giuseppina Abbadessa, Gianmarco Brescia Morra, Vincenzo Gallo, Paolo Bonavita, Simona Sormani, Maria Pia Signori, Alessio Alemtuzumab-Related Lymphocyte Subset Dynamics and Disease Activity or Autoimmune Adverse Events: Real-World Evidence |
title | Alemtuzumab-Related Lymphocyte Subset Dynamics and Disease Activity or Autoimmune Adverse Events: Real-World Evidence |
title_full | Alemtuzumab-Related Lymphocyte Subset Dynamics and Disease Activity or Autoimmune Adverse Events: Real-World Evidence |
title_fullStr | Alemtuzumab-Related Lymphocyte Subset Dynamics and Disease Activity or Autoimmune Adverse Events: Real-World Evidence |
title_full_unstemmed | Alemtuzumab-Related Lymphocyte Subset Dynamics and Disease Activity or Autoimmune Adverse Events: Real-World Evidence |
title_short | Alemtuzumab-Related Lymphocyte Subset Dynamics and Disease Activity or Autoimmune Adverse Events: Real-World Evidence |
title_sort | alemtuzumab-related lymphocyte subset dynamics and disease activity or autoimmune adverse events: real-world evidence |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10002781/ https://www.ncbi.nlm.nih.gov/pubmed/36902555 http://dx.doi.org/10.3390/jcm12051768 |
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