Gilenya May Help Control Severe Respiratory Disease in COVID-19

Gilenya (fingolimod), which works to modulate immune system activity in multiple sclerosis (MS), may benefit people with severe respiratory disease associated with COVID-19, a case report highlights.

The study, “Severe COVID-19 infection in a patient with multiple sclerosis treated with fingolimod,” was published in the journal Multiple Sclerosis and Related Disorders.

Marketed by Novartis, Gilenya was the first oral disease-modifying therapy (DMT) approved by the U.S. Food and Drug Administration (FDA) and the European Commission to treat people with relapsing-remitting multiple sclerosis (RRMS). The FDA subsequently extended its use to relapsing forms of MS.

The medication works by retaining immune cells in lymphoid organs (e.g., lymph nodes) where they are produced, preventing them from reaching and attacking the brain and spinal cord. By doing so, Gilenya effectively reduces inflammation, disease progression, and the risk of MS relapses.

A potential consequence of its use is that patients may develop lymphopenia, or an abnormally low number of white blood cells circulating in the blood. For this reason, patients on Gilenya are at a slightly higher risk of respiratory tract infections.

Physicians in Germany reported the case of an RRMS patient who had been on Gilenya treatment for years when she infected with the coronavirus, known as severe acute respiratory syndrome coronavirus 2 (SARS CoV-2).

The 57-year-old woman arrived at a hospital complaining of shortness of breath (dyspnea), fever, and a dry cough that had lasted for seven days.

A chest CT scan revealed she had several lung opacities (white regions) indicative of fluid accumulation due to interstitial pneumonia in both lungs, indicating “a severe COVID-19 infection,” the investigators wrote.

The woman was put on supplemental oxygen and transferred to the hospital’s intensive care unit.

Lab tests showed she had high levels of C-reactive protein (a marker of inflammation) and lymphopenia associated with Gilenya treatment.

Her neutrophil (a type of immune cell) and platelet counts were within the normal range, but liver function tests showed a slight elevation in levels of several liver enzymes that were indicative of liver inflammation.

A swab test confirmed she was positive for SARS CoV-2. No additional bacterial or viral infections were detected.

Treatment with Gilenya, which the woman began in 2011, was stopped and she was put on noninvasive ventilation to help with breathing. Her blood oxygen levels started to improve within two days, and her breathing was normal at four days. The next day she was transferred from intensive care unit to complete her recovery.

Gilenya’s effect on immune cells responsible for defending against external threats appears minimal, the doctors wrote, even though it works by lowering levels of circulating immune cells involved in autoimmunity.

“Thus, despite severe lymphopenia … immune responses to SARS CoV-2 presumably were preserved in our patient,” they  wrote.

The immune regulatory properties of Gilenya and its ability to promote the integrity of blood vessels in the lungs “may be of value to control severe respiratory disease,” the team concluded, recommending further studies “to explore the risks and therapeutic effects of fingolimod in COVID-19 patients.”