Lymphopenia after Gilenya

Warnke C, Dehmel T, Ramanujam R, Holmen C, Nordin N, Wolfram K, Leussink VI, Hartung HP, Olsson T, Kieseier BC.Initial lymphocyte count and low BMI may affect fingolimod-induced lymphopenia. Neurology. 2014 Oct 31. pii: 10.1212/WNL.0000000000001049. [Epub ahead of print]

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 × billion lymphocytes/Litre was reached in 15%
(95% confidence interval [CI] 12%-17%) of all 856 patients. Patients
with lower starting lymphocyte counts (below 1.6 billion cells/litre)
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

Lymphopaenia has become a hot topic with the report of PML in someone who was lymphopenic after taking Tecfidera. Lymphopaenia in the blood is thought to be the functional mechanism of action of many drugs as it is stopping the availability of white cells getting into the brain. It happens with Lemtrada and it happens with Gilenya too. This report indicates that low starting white cell counts and low body mass index (maybe you get relatively more drug per killogram from a standard sized pill) were a risk factor for lymphopaenia. Have there been cases of PML in people taking Gilenya? Yes there have been, but many have been associated from the switch over from natiluzimab and the infection may have been sub clinical during Tysabri infusions. 

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