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Isolation and Activation of Murine Lymphocytes
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Initial lymphocyte count and low BMI may affect fingolimod-induced lymphopenia
Clemens Warnke1, Thomas Dehmel1, Ryan Ramanujam1
1From the Department of Neurology (C.W., T.D., K.W., V.I.L., H.-P.H., B.C.K.), Medical Faculty, Heinrich-Heine University, Düsseldorf, Germany; and Department of Clinical Neuroscience (R.R., C.H., N.N., T.O.), Karolinska Institute, Stockholm, Sweden.
Neurology
|November 2, 2014
Summary
Patients with low baseline lymphocyte counts or underweight women initiating fingolimod treatment face a higher risk of severe lymphopenia. Close monitoring is recommended for these relapsing-remitting multiple sclerosis (RRMS) patients.
Area of Science:
- Neurology
- Pharmacology
- Immunology
Background:
- Fingolimod is a disease-modifying therapy for relapsing-remitting multiple sclerosis (RRMS).
- Lymphopenia is a known side effect of fingolimod treatment.
- Identifying risk factors for fingolimod-induced lymphopenia is crucial for patient safety.
Purpose of the Study:
- To investigate the impact of pretreatment lymphocyte counts, prior treatments, age, sex, and body mass index (BMI) on the risk of fingolimod-induced lymphopenia in RRMS patients.
Main Methods:
- Retrospective analysis of data from a German multicenter, single-arm, open-label study.
- Validation of findings using an independent Swedish national pharmacovigilance study.
- Inclusion of 856 RRMS patients (418 German, 438 Swedish).
Main Results:
- 15% of all patients reached a lymphocyte nadir ≤0.2 × 10(9)/L.
- Lower baseline lymphocyte counts ( < 1.6 × 10(9)/L) increased lymphopenia risk to 26%.
- Underweight women (BMI < 18.5 kg/m(2)) had a 46% risk of severe lymphopenia.
Conclusions:
- Low baseline lymphocyte counts and underweight status in women are significant risk factors for severe fingolimod-induced lymphopenia.
- Consider closer monitoring for RRMS patients with these risk factors before initiating fingolimod.
- Infection rates were similar between patients with and without severe lymphopenia in the German cohort.
