Start Over

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

Authors :: Warnke C
Dehmel T
Ramanujam R
Holmen C
Nordin N
Wolfram K
Leussink VI
Hartung HP
Olsson T
Kieseier BC
Source :: Neurology [Neurology] 2014 Dec 02; Vol. 83 (23), pp. 2153-7. Date of Electronic Publication: 2014 Oct 31.
Publication Year :: 2014
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).<br />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.<br />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.<br />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.<br /> (© 2014 American Academy of Neurology.)