Gilenya: The Good News
As with any medication, the news on Gilenya can be divided into the good and the bad. Let’s talk about the good news first.
- It is a pill. For many patients this medication offers freedom from painful injections. I continue to have patients whose fear of needles makes them absolutely unable to take any of the older, injectable medications. Other patients aren’t afraid of needles, but simply cannot tolerate the side effects from the injectable medications. The introduction of an oral medication meant that for the first time, many patients could start on a medication that could prevent relapses and hopefully slow down or prevent the progression of disability without the associated pain of a needle.
- The medication works in preventing relapses. In the FREEDOMS trial, Gilenya compared to placebo was found to be superior in preventing relapses, preventing disability progression, and in preventing new lesions on the MRI. Compared to placebo, Gilenya reduced the relapse rate by nearly 60 percent. In the TRANFORMS study, Gilenya was directly compared to Avonex, one of the older, first-line medications in MS. Gilenya proved more effective than Avonex. There was a 52 percent reduction in annual relapses in patients taking Gilenya compared to those taking Avonex. Gilenya was also more effective than Avonex in reducing lesion activity and brain volume loss on MRI. There was no evidence of prevention of disability in the TRANFORMS study, perhaps because the length of the trial was relatively short, only 12 months, and disability progression was small in all study groups over this time frame.
- The drug is tolerable. In the FREEDOMS trial, about 20 percent of the patients receiving the approved dose of Gilenya—0.5mg—stopped taking the medication before the trial was over, while nearly 30 percent of patients taking placebo did so. In the TRANFORMS study, the discontinuation rates between patients taking the Gilenya 0.5mg dose and Avonex were equal. In both trials, there were slightly higher rates of discontinuation of the higher dose of Gilenya, but, again, this was not the dose approved by the FDA. Patients on Gilenya will be spared the flu-like symptoms that can be caused by the interferons or the injection-site reactions that can be caused by any of the injectable medications.
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