Gilenya: Closing Thoughts
Now that we have briefly reviewed the medication Gilenya, let me discuss what role it plays in the treatment of MS patients. First of all, there is a huge variation in how this medication is being used throughout the country. I know of large MS centers where only a handful of patients have started this medication, and representatives from Novartis (the company which makes the medication) have told me that there are other MS centers in the country where they are using the medication on hundreds of patients.
Compared with the interferons, which were first introduced in 1993, and Copaxone which was approved in 1996 in the United States, Gilenya is a baby with unknown long term side effects. The interferons and Copaxone have been used in hundreds of thousands of patients over this time, and there is probably very little we have to learn about these medications. Most importantly, we know they work (though not nearly as well as we would like), and while they may have intolerable side effects for many patients, they are very safe with no long term, serious consequences. Most doctors that I know are taking a "wait and see approach." The attitude most neurologists have towards Gilenya is, "Ask me about in five years when tens of thousands of people have taken the medication."
Neurologists are generally conservative in their approach to medicine compared to other specialties. There is a fear in the MS community when a new medication is given to a large group of patients over many years that rare, but serious, side effects might emerge. This is especially the case with a medicine like Gilenya where the immune system is prevented from fully functioning in the central nervous system. Certainly, the MS community was burned by its experience with Tysabri, where several fatal cases of a brain infection known as PML led to it being pulled from the market, though it has since been reintroduced.
Many neurologists are fearful of a similar possibility with Gilenya, and only time will tell if this fear is justified. However, the medicine has been out since September 2010 and representatives from the drug company tell me that nearly 20,000 people have taken the medicine in the United States. Fortunately, it seems that fears of significant infections or other significant side effects are not justified at this time.
Personally, I have started a handful of patients on Gilenya, though not a high number, and most of them are very happy with the medication thus far. I feel it is most appropriate for young, otherwise healthy patients who either cannot tolerate the injections or have MS that is poorly controlled by these medications. For such patients Gilenya is appropriate, I believe, especially if they have evidence of exposure to the JC virus, the virus that causes the devastating brain infection PML in a small percentage of patients who take Tysabri. Ultimately it is the job of every patient and doctor to try to balance the risks and benefits of any medication. Only after time, however, will we know exactly what those risks and benefits might be.
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