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Early predictive risk factors for dimethyl fumarate-associated lymphopenia in patients with multiple sclerosis
Susana Sainz de la Maza1, Julia Sabin Muñoz2, Belén Pilo de la Fuente3
1Multiple Sclerosis Unit, Department of Neurology, Hospital Universitario Ramón y Cajal, Universidad de Alcalá, IRYCIS, Madrid, Spain.
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.
Insights
A significant drop in absolute lymphocyte counts (ALCs) within three months of starting dimethyl-fumarate (DMF) treatment is the strongest predictor of developing lymphopenia in multiple sclerosis (MS) patients.
Area of Science:
- Neurology
- Pharmacology
- Immunology
Background:
- Dimethyl-fumarate (DMF) is a treatment for multiple sclerosis (MS).
- Lymphopenia, a reduction in lymphocytes, is a significant concern with DMF treatment, increasing the risk of progressive multifocal leukoencephalopathy (PML).
- Early reduction in absolute lymphocyte counts (ALCs) may predict later lymphopenia development.
Purpose of the Study:
- To identify risk factors for lymphopenia induced by DMF.
- To determine if early ALC decrease predicts subsequent lymphopenia in MS patients on DMF.
Main Methods:
- A real-world, prospective, multicenter study in Spain (2014-2019).
- Analysis of 532 MS patients initiating DMF treatment.
- Regression models used to assess the association between early ALC decline and lymphopenia (grades 2-3 and grade 3).
Main Results:
- 36.3% of patients (193/532) developed lymphopenia.
- Older age and lower baseline ALCs were risk factors.
- A reduction in ALCs ≥21.2% within 3 months increased the risk of significant lymphopenia by 6.5-fold.
- A decrease in ALCs ≥40.2% increased the risk of severe lymphopenia by 12.7-fold.
Conclusions:
- Early and pronounced reduction in ALCs after DMF initiation is the best predictor of significant lymphopenia in MS patients.
- Monitoring early ALC changes can help identify patients at higher risk for DMF-induced lymphopenia.
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