A new analysis demonstrated that Gilenya (fingolimod) reduced the risk of disability progression in people with relapsing-remitting multiple sclerosis (RRMS), regardless of treatment history. This analysis of the phase three two-year FREEDOMS study was presented at the 63rd annual meeting of the American Academy of Neurology (AAN).
In the two-year FREEDOMS study Gilenya reduced relapses by 54 percent compared to placebo. Also, Gilenya showed a 30 percent reduction in the risk of three-month confirmed disability progression as compared to placebo over two years.
The FREEDOMS analysis presented this week at AAN showed that 0.5 mg Gilenya-treated participants who were new to therapy had a 37 percent reduction in the risk of three-month confirmed disability progression compared to placebo. For those previously treated with alternate therapies, Gilenya 0.5 mg led to a 30 percent reduction in risk.
Consistent favorable effects on disability progression were observed for Gilenya-treated participants compared to placebo for subgroups defined by age, gender, and disease severity as defined by EDSS score, relapse activity prior to study, Magnetic Resonance Imaging (MRI) lesion burden, or lesion activity at the time of the start of the study.
Gilenya is the first oral treatment in a new class of drugs called Sphingosine 1-Phosphate Receptor (S1PR) modulators. Approved in more than 35 countries including US, Canada and Germany, Gilenya has been studied in phase III clinical trials of over 2500 patients with relapsing-remitting MS.
As shown in animal models, Gilenya stops many of the white blood cells (lymphocytes) from leaving the lymph nodes. Exactly how Gilenya works in MS is unknown, but it is thought that it results in fewer white blood cells entering the CNS to attack and damage the myelin sheath. If Gilenya treatment is stopped for any reason, the number of white blood cells circulating in the body increases over the first few days and gradually returns to normal within 1 to 2 months.
The most common side effects are headache, liver enzyme elevations, influenza, diarrhoea, back pain, and cough. Other Gilenya-related side effects include transient, generally asymptomatic, heart rate reduction and atrio-ventricular block upon treatment initiation, mild blood pressure increase, macular edema, and mild bronchoconstriction.
The rates of infections overall, including serious infections, were comparable among treatment groups, although a slight increase in lower respiratory tract infections (primarily bronchitis) was seen in patients treated with Gilenya. The number of malignancies reported across the clinical trial program was small, with comparable rates between the Gilenya and control groups.