dc.identifier.citation |
Sainz de la Maza, S., Sabin Muñoz, J., Pilo de la Fuente, B., Thuissard, I., Andreu-Vázquez, C., Galán Sánchez-Seco, V., Salgado-Cámara, P., Costa-Frossard, L., Monreal, E., Ayuso-Peralta, L., García-Vasco, L., García-Domínguez, J. M., Martínez-Ginés, M. L., Muñoz Fernández, C., Díaz-Díaz, J., Oreja-Guevara, C., Gómez-Moreno, M., Martín, H., Rubio-Flores, L., Blasco, M. R., … Dimethyl Fumarate Study Group (2022). Early predictive risk factors for dimethyl fumarate-associated lymphopenia in patients with multiple sclerosis. Multiple sclerosis and related disorders, 59, 103669. https://doi.org/10.1016/j.msard.2022.103669 |
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dc.description.abstract |
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: 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: 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: 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: 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. |
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