I tore open the envelope (not really, but it sounds more dramatic then "I clicked the little line of text furiously") and found the first report from the Phase III clinical trials (that's me they're talking about).
Here's the whole story (click here).
I read it with this odd sense of pride mixed with curiosity. Like I was going to see my name mentioned or something. Or "1 patient experience this. And this, and this, and oh yeah, this."
"Her data was deemed contaminated by the fact that she is a scientifically proven hypochondriac so anything that spews forth from her facial orifice can only be taken with a grain of sodium."
Basel, December 12, 2008 - Initial results from the one-year Phase III TRANSFORMS study show the investigational oral compound FTY720 (fingolimod) has superior efficacy to a current standard of care for patients with relapsing-remitting multiple sclerosis (MS). Patients on oral FTY720 experienced significantly fewer relapses than those treated with the injectable medicine interferon beta-1a (Avonex®*).
The study, the first one-year head-to-head Phase III trial against a standard of care in MS, met its primary endpoint for both doses of FTY720.
The annualized relapse rate at one year for patients given FTY720 0.5 mg was 0.16, representing a 52% reduction compared to a relapse rate of 0.33 for interferon beta-1a (p<0.001). The FTY720 1.25 mg dose also showed a significant reduction in relapses with a rate of 0.20 representing a 38% reduction against interferon beta-1a (p<0.001). No statistically significant difference was seen between the two FTY720 doses.
Comprehensive analyses of the TRANSFORMS study data are ongoing, and detailed results are planned to be presented at a leading scientific congress in 2009. Regulatory submissions remain on track to be completed in the US and EU at the end of 2009.
They didn't mention me at all. Go figure. They referred to us all as a group. No, more a statistical number. After all we have given of ourselves over the past year. I feel so cheap. Like I was just another notch on the ol' test tube.
Of course I'm kidding. I'm so excited I'm approaching giddiness.
So, I'm no rocket surgeon, so those percentages are a little confusing to me. I understand the part about Avonex having a 33% reduction in relapses. That's pretty straight forward. So, if I had 3 attacks a year I could expect to only have 2 while on Avonex, right?
The part I don't understand is the "52%" reduction in relapses that Fingolimod has over Avonex. It would seem to me that number is a percentage of Avonex's number. It's one of those math problems I always got wrong in school, so bear with me.
If Avonex users had 33% less attacks than someone who was on no treatment, and people who were on Fingolimod had 52% less attacks as compared to Avonex, then really the efficacy percentage for Fingolimod is what? 49%? I have no clue what that data told me. All I know is that it sounded good, right? It's good news?
But I'm bound and determined to understand this, so let's go back to school and figure it out....
If a train carrying 3 relapses is headed toward a tunnel going through a forest where a tree fell when nobody was around at a speed of 25 mph and Jane has a bottle of Fingolimod, how many relapses would still be on the train when it reaches the tunnel, IF nobody has yet claimed to have heard the tree fall?
Oh well, forget it. I thought I was getting someplace with all this, but I guess I'd just better be happy to know it *sounded* like good news. Fingolimod had a big number and Avonex had a smaller number. Big number good. I think.
Is it any wonder at ALL that, when my 10 year old came home with compound fractions to multiply, we ended up having to Google it? I will never forget, from now until the day I die, that it's numerator times numerator and denominator times denominator. I think.
Since Avonex is one of the current standards of treatment for MS, and many, many people take it hoping to lessen the severity of their disease, this is actually GREAT news about FTY720!!
Looking at the data report of the adverse events, I can now see why they were making such a big TaDoo over my little black moles I'd had all my life. 7 cases of skin cancer. That's nothing to sneeze at.
And I finally have clarification about the one poor fellow who ended up in a coma after the viral encephalitis. He must have died. It's rather sobering to realize that clinical trials can sometimes go terribly wrong.
That's the whole reason for us lab rats to volunteer. We offer up our bodies to be subjected to all the unknowns so that the FDA can say "Nope. Not safe for human consumption." and the masses are protected from something that might have hurt them.
I am doing it for a way less altruistic reason...I wanted something to slow this monster down for ME. If that ends up helping the rest of you, then I'm thrilled. But believe me, I didn't lie awake at night before entering the trial, tossing and turning because I wasn't helping blaze a trail to help all of MSkind. Nope, I was tossing and turning trying to get comfy when my spasticity and neuropathy were driving me nuts. I did it for me.
I'm just so happy that maybe a lot of other people will eventually be able to enjoy the same level of benefits I have from this stuff. From what the press release says, it's on track for submission to the FDA in 2009, so really people, it's not far off.
It really ISN'T the old "in the next 5 years." spiel we've all heard for the last 10. There really is a pill coming...and soon! Just hang in there.