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• W1533517811 abstract "Objective: To study the effect of the body mass index (BMI) on treatment outcomes of multiple sclerosis (MS) with fingolimod, specifically its effect on treatment induced lymphopenia.Background: Fingolimod is a sphingosin-1-phosphate receptor agonist, approved for treating patients with relapsing forms of MS. The clinical effects seen in MS have been attributed to its capacity to sequester circulating lymphocytes, especially T lymphocytes, into secondary lymphoid tissues. In the pivotal studies, fingolimod treatment led to a reduction in circulating lymphocytes to a mean of about 0.5x109/l. About 20% of patients who received fingolimod 0.5mg/d reached nadir of lymphocyte counts under 0.2x109/l. Since fingolimod is lipophilic the question arose if individual differences in the BMI may account for differences in the lymphopenia induced by this drug.Design/Methods: A prospective, multi-center, single-arm, open-label study of 446 RRMS patients receiving 0.5mg/d fingolimod. Peripheral venous blood samples were obtained at baseline, 1, 4, as well as 6 months after treatment initiation. Total lymphocyte counts and several lymphocyte subpopulations were analyzed by flow cytometric analysis (FACS). These results were compared to the individual BMI.Results: Fingolimod was well tolerated. The analysis revealed a lasting decrease of total Lymphocyte counts and predominantly of CD4+ cell numbers. Also, cell numbers of naive and effector memory T cells were decreased for the whole 6-month period. A correlation with the individual BMI did not reveal any significant impact on these cell populations. Study analysis is still ongoing and more data specifically in the context of the clinical presentation of the patients enrolled in this study will be analyzed.Conclusions: The oral application of fingolimod translates into strong and permanent effects predominantly on CD4+ lymphocytes, regardless of the patient’s BMI.Study supported by: This work was supported by an unrestrictional grant of Novartis Pharma GmbH, Germany. Disclosure: Dr. Dehmel has received personal compensation for activities with Genzyme Corp. and Novartis. Dr. Warnke has received personal compensation for activities with Teva Neuroscience. Dr. Mausberg has nothing to disclose. Dr. Wolffram has nothing to disclose. Dr. Diaz Lorente has received personal compensation for activities with Novartis as an employee. Dr. Hartung has received personal compensation for activities with Bayer Pharmaceuticals Corp., CSL Behring, Biogen Idec, Genzyme Corp., Grifols, Merck Serono, Novartis, Roche Diagnostics Corp., Teva Neuroscience, and Sanofi-Aventis Pharmaceuticals Inc. as a consultant and speaker. Dr. Kieseier has received personal compensation for activities with Bayer Pharmaceuticals Corp., Schering AG, Biogen Idec, Merck Serono, Novartis, Roche Diagnostics Corp., Sanofi-Aventis Pharmaceuticals Inc., and Teva Neuroscience. Dr Kieseier has received research support from Bayer Schering, Biogen Idec, Merck Serono, and Teva Neuroscience." @default.
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• W1533517811 date "2014-04-08" @default.
• W1533517811 modified "2023-09-26" @default.
• W1533517811 title "Efficacy of Fingolimod Therapy Does Not Dependent on the Individual Body Mass Index in Patients with MS (P7.223)" @default.
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