I just happened on this thread quite by chance as a link to it came in my google alerts email.
I can tell you from first hand experience that Fingolimod (FTY720) has been my "miracle drug". I'm in the Phase III TRANSFORMS clinical trial where 2 different doses of Fingo were pitted against Avonex. All participants had to take 1 pill a day and one IM shot once a week. There was no placebo involved -- you either got real Avonex or one of the 2 doses of the real Fingolimod.
I entered the study on 8/20/07 having had MS for 8 years and only taken Copaxone to that point. For 2 years immediately prior to the study I had been relapsing every 3 months with a 3 month recovery period. I was without insurance, sporadic Medicaid coverage, and my neuro had suffered a stroke and was no longer seeing patients so I was without a doctor since he had been the only one in our small town who would take MS patients with medicaid.
I was at the end of my rope and physically/mentally exhausted by the relapses and, looking back now I realize, very close to suicide.
It was by chance that I went to an MS meeting looking for some moral support that I met a neuro from Jacksonville (and hour and a half away) who told us of the trial and the fact that he was the lead investigator. He was very excited because rarely are there trials that lack a placebo. If we were to enter, we were sure to be on some form of medication.
It was all I needed to hear. Within a couple of weeks I was undergoing preliminary testing. I was accepted into the trial and here are my results to date:
I have not had a relapse since April 07.
All of my symptoms have drastically improved.
The only side effects I have had were increased URIs during the first 6 months, and increased UTIs during the first 6 months.
Since the TRANSFORMS study was only a year long comparison study, at the end of 2008 I was invited to join the extension study. During this phase, all patients, even the ones who had been on the real Avonex, would now be placed on the real Fingolimod. The only blind part would be knowing which dose.
The official extension was to last a year but I have since passed that mark and continue on. I am tested/checked every 3 months. Last month I was finally unblinded and told of various results involving my personal experience.
I had been on the real Fingolimod since the first day. I was and still am on the .5mg (low) dose. My MRI has remained stable and unchanged throughout the study. My EDSS score has improved by 2 points bringing me from a 3 to a 1.
I have gone from not being able to walk at all without 2 canes or a walker to not even knowing where my cane is! I can run and jump -- 2 things I thought I would never do again.
I have my life back. I can keep up with my 11 year old son now. I am happier than I have been since being diagnosed (almost 11 years ago now).
There were 8 people involved at my study center. Only 4 chose to be in the extension phase. I found this to be alarming so I asked my trial nurse if she could share the reasons for their choice.
She told me 2 of them were young women who both wished to start families within the next few years, another patient found the long commute to be too much of a bother, and the fourth was moving out of state.
None of them left because they had a negative experience.
I know there is much buzz about Fingolimod and it's potential to come to market this year. I figured maybe I could give a little first hand experience info to people who might be curious.
I know I will really miss it once it gets approved because I have no coverage for medicine and it might be pretty expensive. I only get it for free until the day it hits the market.
I hope this doesn't sound like I'm sugar coating things... there are potentially negative side effects, but I was fortunate not to have experienced any of them -- most likely due to the fact that I have been on the low dose since the majority of adverse events have been seen in the high dose group.
These could include elevated liver enzymes, slight asthma, macular edema, changes in heart rate and blood pressure, increase in upper respiratory infections to name a few. Also, there were 2 deaths from complications involving HSV related viruses (one had contracted chicken pox and the other had viral meningitis).
So there are possible serious complications, but I have not personally experienced any. And you have to remember that there is a big long insert of scary side effects for simple stuff like Tylenol, too. You have to be your own best advocate and weigh the risks/benefits.
The fact that it's a pill is only icing on the cake for me. If it were a shot I would still be just as enthusiastic. It's the results that impress me.
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