MS Drug Gilenya May Increase Risk for LymphopeniaDec 30, 2014
New research studies from Sweden and Germany indicate that underweight women with multiple sclerosis who take the MS drug Gilenya (fingolimod) seem to be at increased risk for lymphopenia. The drug also poses a risk for patients who have low lymphocyte levels before they start drug treatment.
Lymphopenia (also known as lymphocytopenia) is a condition in which a person has a deficiency of lymphocytes, which are a subset of white blood cells (leukocytes). Lymphocytes play a crucial role in supporting immune system function, according to EmaxHealth.
Fingolimod can lower the level of circulating lymphocytes. Infections are among the serious side effects reported by the Food and Drug Administration (FDA) and the manufacturer, Novartis Pharma Stein AG. The risk of infection is increased because fingolimod lowers lymphocyte levels. The two new studies cast new light on some of the factors associated with this risk, EmaxHealth reports.
In the German study, 418 individuals with relapsing-remitting multiple sclerosis were enrolled in an open label study in which they took 0.5 mg of fingolimod daily. Blood samples were collected on four separate occasions: immediately before treatment and at months 1, 4, and 6. In the Swedish study, data from 438 patients were used to validate the findings.
Among the findings:
- Women with a body mass index (BMI) less than 18.5 kg/m2 had a 26 percent increased risk for developing lymphopenia. This effect was not seen in men with this BMI.
- Individuals with starting lymphocyte levels of less than 1.6 x 109/L had a 46 percent increased risk of lymphopenia while using the drug.
- Use of Copaxone (glatiramer acetate) before use of Gilenya seemed to help protect against the development of lymphopenia, although the researchers were uncertain about the immunologic effect of this drug.
Previous research indicated that the decline in lymphocytes counts among MS patients taking fingolimod is not associated with meal timing or other medications. Other serious side effects may develop with use of Gilenya, including slow heart rate, macular edema, liver problems, and shortness of breath, EmaxHealth reports.