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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 × 109 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 × 109/L) and patients with BMI lower than 18.5 kg/m2 (women only) were at higher risk of developing lymphopenia with values ≤0.2 × 109/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.
GLOSSARY
- BMI=
- body mass index;
- CI=
- confidence interval;
- MS=
- multiple sclerosis;
- OR=
- odds ratio;
- RRMS=
- relapsing-remitting multiple sclerosis
Footnotes
↵* These authors contributed equally to this work.
Go to Neurology.org for full disclosures. Funding information and disclosures deemed relevant by the authors, if any, are provided at the end of the article.
- Received April 4, 2014.
- Accepted in final form September 3, 2014.
- © 2014 American Academy of Neurology
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