Gilenya – Lymphocyte Levels in Clinical Practice

Lymphocyte levels also play an important role in monitoring the active substance Fingolimod (Gilenya). However, the considerations here are quite different from those for Dimethyl fumarate (Tecfidera – Lymphocyte levels in clinical practice from March 30, 2017). Fingolimod (Gilenya) is taken as a tablet once a day and is often used in Germany when first-line drugs do not show the desired effect. Patients taking Fingolimod rarely complain about tolerance problems, but due to the side effect profile of the substance, the differential blood count and liver values must be checked every 3 months.

A special characteristic of Fingolimod is that both the total number of white blood cells (leukocytes) and the absolute number of lymphocytes (calculation of the absolute lymphocyte count see “Short excursion – the white blood cells“) are significantly reduced – you can immediately tell from the blood count whether patients are taking Fingolimod.

This phenomenon is related to the mechanism of action of Fingolimod. The substance causes the lymphocytes, which are responsible for the emergence of autoimmune diseases in addition to learned (adaptive) immune defense, to be retained in secondary lymphatic organs (i.e., the lymph nodes). Fingolimod binds to a specific receptor that helps the lymphocytes return from the lymph node to the peripheral blood. If this receptor is blocked, the lymphocytes are effectively trapped in the lymph nodes, which means that the number of lymphocytes that can be measured in peripheral blood is lowered. This reduction can sometimes be very significant, often the lymphocyte counts fall below a value of 200/µl.

In contrast to many other drugs, this low value is not based on a reduction in white blood cells, as Fingolimod does not lead to the destruction of lymphocytes, but causes the cells to have to reside in another compartment (room) of the body – they are still there, but just not measurable in the blood.

Accordingly, many experts are no longer so alarmed when patients fall below the limit of < 200 lymphocytes/µl. On the one hand, this limit was chosen arbitrarily, on the other hand, there is no evidence from clinical studies that a low or even very low lymphocyte count leads to a higher risk of infection. Therefore, it is questionable whether the entire therapy with Fingolimod should be questioned because of a once-exceeded limit. Especially if it has led to a good effect with clinical stability. Of course, we have to take note of the limits and – if they confirm the values at a control measurement – react to them, but a single or slight undershooting of the limit of 200/µl is initially no reason for panic.

I think the article shows that the changes in the blood count that are observed with various MS drugs are based on completely different mechanisms of action and therefore different limits exist ((with Dimethyl fumarate (Tecfidera) you should react at the latest at values < 500/µl, with Fingolimod (Gilenya) the number of 200/µl should not be undershot)). Furthermore, different considerations and consequences are associated with the consideration of lymphocytes and their limits – while a rapid decrease in lymphocytes at the beginning of therapy with Dimethyl fumarate is a warning sign, the decrease in lymphocytes with Fingolimod is an expression of the mechanism of action and thus a “normal” observation. In any case, the evaluation of the lymphocytes should be reflected and not rushed, because discontinuing an effective drug also carries risks – if in doubt, you should seek advice, because in no case does falling below the respective limits represent an acute threat.

To summarize the facts about Fingolimod: The lymphocyte levels should be looked at regularly, here an interval of 3 months is recommended, preferably together with the control of the liver values. There is a limit for the absolute lymphocyte count, which is 200/µl for Gilenya. However, this value is more of an empirical value than a scientifically proven limit. Accordingly, one should not react hastily when the limit is undershot. It may be worth consulting with an MS expert to weigh up the benefits and risks of therapy.

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