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Neurology. 2014 Dec 2;83(23):2153-7. doi: 10.1212/WNL.0000000000001049. Epub 2014 Oct 31.

Initial lymphocyte count and low BMI may affect fingolimod-induced lymphopenia.

Author information

1
From 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.
2
From 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. bernd.kieseier@uni-duesseldorf.de.

Abstract

OBJECTIVE:

To assess whether pretreatment-lymphocyte counts, treatment before fingolimod, age, sex, or body mass index (BMI) affects the risk of fingolimod-induced lymphopenia in patients with relapsing-remitting multiple sclerosis (RRMS).

METHODS:

Data were obtained from a German multicenter, single-arm, open-label study of patients with RRMS treated with fingolimod, and findings were validated in an independent Swedish national pharmacovigilance study.

RESULTS:

Four hundred eighteen patients with RRMS from Germany and 438 patients from Sweden were included. A nadir ≤0.2 × 10(9) lymphocytes/L was reached in 15% (95% confidence interval [CI] 12%-17%) of all 856 patients. Patients with lower starting lymphocyte counts (below 1.6 × 10(9)/L) and patients with BMI lower than 18.5 kg/m(2) (women only) were at higher risk of developing lymphopenia with values ≤0.2 × 10(9)/L in the combined analysis, increasing the risk in these subgroups to 26% (95% CI 20%-31%) or 46% (95% CI 23%-71%), respectively. In the German cohort, infection rates were similar in patients who developed severe lymphopenia and those who did not.

CONCLUSIONS:

Our findings suggest that patients with low baseline lymphocyte counts and underweight women in which fingolimod treatment will be initiated should possibly be monitored more closely.

PMID:
25361781
DOI:
10.1212/WNL.0000000000001049
[Indexed for MEDLINE]

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