Severe dyspnoea with alteration of the diffusion capacity of the lung associated with fingolimod treatment.

In phase II clinical trial, fingolimod at a dose of 5.0mg (ten times higher than the currently approved dose) induced dyspnoea and decreased forced expiratory flow in some patients, probably trought an airways constriction S1P4-mediated. In phase III trials, respiratory adverse events associated with fingolimod treatment as dyspnoea, cough, oropharingeal pain and nasal congestion are reported with the same incidence of placebo. Here we report two cases of severe dyspnoea with alteration of the diffusion capacity of the lung associated with fingolimod treatment, which led to permanent treatment withdrawal.