Early predictive risk factors for dimethyl fumarate-associated lymphopenia in patients with multiple sclerosis.


Journal

Multiple sclerosis and related disorders
ISSN: 2211-0356
Titre abrégé: Mult Scler Relat Disord
Pays: Netherlands
ID NLM: 101580247

Informations de publication

Date de publication:
Mar 2022
Historique:
received: 03 12 2021
revised: 16 01 2022
accepted: 03 02 2022
pubmed: 13 2 2022
medline: 8 4 2022
entrez: 12 2 2022
Statut: ppublish

Résumé

Lymphopenia is a major concern in MS patients treated with dimethyl-fumarate (DMF) as it increases the risk of progressive multifocal leukoencephalopathy. A pronounced reduction in absolute lymphocyte counts (ALCs) early after treatment initiation has been suggested to be associated with the occurrence of lymphopenia thereafter. To identify risk factors for DMF-induced lymphopenia and evaluate whether the degree of decrease in the ALCs three months after initiation of DMF treatment is a predictor of the subsequent development of lymphopenia. In this real-world Spanish prospective multicenter study conducted in MS patients who started DMF between 2014 and 2019, we analyzed the association between DMF-related lymphopenia and the percentage of early ALCs decline using regression models, considering both, significant lymphopenia (grades 2 + 3) and severe lymphopenia (grade 3). The cutoff values of early ALCs declines were obtained using the ROC curve. Among 532 MS patients treated with DMF, 193 (36.3%) developed any grade of lymphopenia. Older age and lower ALCs at treatment onset predicted the risk for lymphopenia but the best predictive risk factor was the reduction of ALCs within the three first months of treatment. Specifically, a reduction in ALCs≥21.2% was associated with a 6.5-fold higher risk of developing significant lymphopenia, and a decrease in ALCs≥40.2% with a 12.7-fold higher risk of developing severe lymphopenia. A pronounced reduction in ALCs early after initiation of DMF in MS patients is the best predictive risk factor for the subsequent development of significant lymphopenia.

Sections du résumé

BACKGROUND BACKGROUND
Lymphopenia is a major concern in MS patients treated with dimethyl-fumarate (DMF) as it increases the risk of progressive multifocal leukoencephalopathy. A pronounced reduction in absolute lymphocyte counts (ALCs) early after treatment initiation has been suggested to be associated with the occurrence of lymphopenia thereafter.
OBJECTIVES OBJECTIVE
To identify risk factors for DMF-induced lymphopenia and evaluate whether the degree of decrease in the ALCs three months after initiation of DMF treatment is a predictor of the subsequent development of lymphopenia.
METHODS METHODS
In this real-world Spanish prospective multicenter study conducted in MS patients who started DMF between 2014 and 2019, we analyzed the association between DMF-related lymphopenia and the percentage of early ALCs decline using regression models, considering both, significant lymphopenia (grades 2 + 3) and severe lymphopenia (grade 3). The cutoff values of early ALCs declines were obtained using the ROC curve.
RESULTS RESULTS
Among 532 MS patients treated with DMF, 193 (36.3%) developed any grade of lymphopenia. Older age and lower ALCs at treatment onset predicted the risk for lymphopenia but the best predictive risk factor was the reduction of ALCs within the three first months of treatment. Specifically, a reduction in ALCs≥21.2% was associated with a 6.5-fold higher risk of developing significant lymphopenia, and a decrease in ALCs≥40.2% with a 12.7-fold higher risk of developing severe lymphopenia.
CONCLUSIONS CONCLUSIONS
A pronounced reduction in ALCs early after initiation of DMF in MS patients is the best predictive risk factor for the subsequent development of significant lymphopenia.

Identifiants

pubmed: 35150979
pii: S2211-0348(22)00184-5
doi: 10.1016/j.msard.2022.103669
pii:
doi:

Substances chimiques

Immunosuppressive Agents 0
Dimethyl Fumarate FO2303MNI2

Types de publication

Journal Article Multicenter Study

Langues

eng

Sous-ensembles de citation

IM

Pagination

103669

Informations de copyright

Copyright © 2022. Published by Elsevier B.V.

Auteurs

Susana Sainz de la Maza (S)

Multiple Sclerosis Unit, Department of Neurology, Hospital Universitario Ramón y Cajal, Universidad de Alcalá, IRYCIS, Madrid, Spain.

Julia Sabin Muñoz (J)

Multiple Sclerosis Unit, Department of Neurology, Hospital Universitario Puerta de Hierro Majadahonda, Madrid, Spain.

Belén Pilo de la Fuente (B)

Multiple Sclerosis Unit, Department of Neurology, Hospital Universitario de Getafe, Universidad Europea de Madrid - Facultad de Medicina.

Israel Thuissard (I)

Faculty of Biomedical and Health Sciences, Universidad Europea de Madrid, Madrid, Spain.

Cristina Andreu-Vázquez (C)

Faculty of Biomedical and Health Sciences, Universidad Europea de Madrid, Madrid, Spain.

Victoria Galán Sánchez-Seco (V)

Multiple Sclerosis Unit, Department of Neurology, Hospital Universitario 12 de Octubre, Madrid, Spain.

Paula Salgado-Cámara (P)

Multiple Sclerosis Unit, Department of Neurology, Hospital Universitario 12 de Octubre, Madrid, Spain.

Lucienne Costa-Frossard (L)

Multiple Sclerosis Unit, Department of Neurology, Hospital Universitario Ramón y Cajal, Universidad de Alcalá, IRYCIS, Madrid, Spain.

Enric Monreal (E)

Multiple Sclerosis Unit, Department of Neurology, Hospital Universitario Ramón y Cajal, Universidad de Alcalá, IRYCIS, Madrid, Spain.

Lucía Ayuso-Peralta (L)

Department of Neurology, Hospital Universitario Príncipe de Asturias, Madrid, Alcalá de Henares, Spain.

Lorena García-Vasco (L)

Department of Neurology, Hospital Universitario Príncipe de Asturias, Madrid, Alcalá de Henares, Spain.

José Manuel García-Domínguez (JM)

Multiple Sclerosis Unit, Department of Neurology, Hospital Universitario Gregorio Marañón, Madrid, Spain.

María Luisa Martínez-Ginés (ML)

Multiple Sclerosis Unit, Department of Neurology, Hospital Universitario Gregorio Marañón, Madrid, Spain.

Carmen Muñoz Fernández (C)

Department of Neurology, Hospital Universitario Torrecárdenas, Almería, Spain.

Judit Díaz-Díaz (J)

Department of Neurology, Hospital Universitario Clínico San Carlos, IdISSC, Madrid, Spain.

Celia Oreja-Guevara (C)

Department of Neurology, Hospital Universitario Clínico San Carlos, IdISSC, Madrid, Spain; Department of Medicine, Faculty of Medicine, Universidad Complutense, Madrid, Spain.

Mayra Gómez-Moreno (M)

Department of Neurology, Hospital Universitario Infanta Leonor, Madrid, Spain.

Hugo Martín (H)

Department of Neurology, Hospital Universitario Infanta Cristina, Madrid, Spain.

Laura Rubio-Flores (L)

Department of Neurology, Hospital Universitario General de Villalba, Madrid, Spain.

María Rosario Blasco (MR)

Multiple Sclerosis Unit, Department of Neurology, Hospital Universitario Puerta de Hierro Majadahonda, Madrid, Spain.

Luisa María Villar-Guimerans (LM)

Department of Immunology, Hospital Universitario Ramón y Cajal, Universidad de Alcalá, IRYCIS, Madrid, Spain.

Yolanda Aladro (Y)

Multiple Sclerosis Unit, Department of Neurology, Hospital Universitario de Getafe, Universidad Europea de Madrid - Facultad de Medicina. Electronic address: yolanda.aladro@salud.madrid.org.

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Classifications MeSH