Response and effectiveness
In a study of over 1200 people with MS, the annualized relapse rate was significantly lower in patients treated with Gilenya than in patients who received placebo (an inactive treatment). After two years, 70% of those taking the drug reported no relapse, compared to 46% of those taking a placebo. Over a 24-month period, the mean (median) number of new or newly enlarging T2 lesions was 2.5 with Gilenya and 9.8 with placebo. Other studies have yielded comparable results.
Gilenya stays in the blood for a long time, and it takes 1 to 2 months for lymphocyte counts to return to normal. A person's immune system will remain compromised for up to two months after stopping Gilenya treatment, increasing their risk of infection.
Gilenya reduces blood lymphocytes to approximately 60% of baseline within four to six hours of the first dose, according to research. With continued dosing, the lymphocyte count decreased until it reached a low point (known as the nadir count) of blood lymphocyte count that corresponded to 30% of baseline or 500 cells/mcL after two weeks.
On at least one occasion, some studies have reported nadir counts of 200 cells/mL in patients.
Gilenya is a disease-modifying drug that cuts the number of relapses of multiple sclerosis (MS) in half (50%). Any relapses that occur should be milder. Gilenya takes about two weeks to reach its maximum effect, which is a lymphocyte count of 30% of baseline, or around 500 cells/mcL.
There is a chance that if you stop taking Gilenya, your MS symptoms will worsen. This effect is extremely rare, with only 35 documented cases in the last 8 years. Recovery times varied. 17 patients recovered partially, 8 experienced permanent disability or no recovery, and 6 eventually returned to the level of disability they had before or during Gilenya treatment. Several patients who could walk without assistance before stopping Gilenya ended up needing wheelchairs or becoming completely bedridden.
Gilenya doses greater than 0.5mg once daily are associated with more side effects and little additional benefit.
