Gilenya is just 60% as effective as Tysabri.

[ms man]

That's what my Neuro says.That and the fact that Tysabri has really worked for me are the reasons I haven't switched to Gilenya.

That may change in the future.

[wkikta]

I believe that Gilenya shows that it measurably helps 60+ percent of the people, the CRABS are about 30-35%, Tysabri is greater than 70%. If one is working well for you, why ever change. All of the 'new' pill medications do have a greater risk of negative side-effects. From drugs dot com: "It is not known if Gilenya is safe and effective..."

The CRABS are the 'safest' treatment.

[ms man]

I believe that Gilenya shows that it measurably helps 60+ percent of the people, the CRABS are about 30-35%, Tysabri is greater than 70%. If one is working well for you, why ever change. All of the 'new' pill medications do have a greater risk of negative side-effects. From drugs dot com: "It is not known if Gilenya is safe and effective..."

The CRABS are the 'safest' treatment.

You're making some good points.The only reason I would change to Gilenya is the convinience of popping a pill as opposed to having to travel to go and get an IV.I'm just glad that the researchers are hard at work and come out with new MS meds regularly.

[Just a small town girl]

I'd be interested in hearing what the only 60% as effective stat is based on. I know that a lot of neuros tout gilenya as 50% more effective than Avonex and traditional CRABs but that's based on the head to head trial with Avonex. I didn't think that there was a similar trial with Ty.

The drugs.com quote actually specifies that is not known if Gilenya is safe and effective for children under 18. This statement is on Gilenya warnings because the drug wasn't tested for this demographic. So just to be clear Gilenya was approved by the FDA for adults because it has been shown to be safe and effective for adults in clinical trials.

Since its a new drug there's always the risk that it could have long term side effects that are unknown, but the clinical trials on this drug were far more extensive than most.

[Nick]

I'm not sure your neuro is right

If you're happy with what you're on, that's great and the end of the discussion. But with respect Gilenya is equally or more effective than other treatments, and the statistics you offer or were given are wrong. Still, don't believe me or anyone else --read the entire research report submitted to the FDA. It's at
http://www.fda.gov/downloads/Advisor.../UCM214675.pdf

[Nick]

A little more info

The studies show that Gilenya avoided relapses in about 70%+ if the study group. Tysabi did by 66%. Specfically (quoting from p. 19 of the FDA submission on Gilenya, but with their data sources):

In Phase 3 studies, natalizumab (Tysabri®) reduced relapses by two-thirds, delaying disability progression and reducing MRI lesion activity (Polman et al 2006; Rudick et al 2006). However, in addition to an approximate 5% rate of neutralizing antibodies (loss of efficacy and hypersensitivity reactions), in approximately 0.1% of natalizumab patients, a fatal, or seriously disabling CNS infection, progressive multifocal leukoencepalopathy (PML) has been reported (Kleinschmidt-DeMasters et al 2005;
Langer-Gould et al 2005). This overall rate appears to be higher in those on therapy for > 2 years and virtually not seen with therapy of < 1year. The product is thus recommended predominantly as a second-line therapy.

I understand that Tysabri was initially removed from the market and then reinstated after the FDA insisted on a "black box warning" on it.

I'm not trying to trash Tysabri --if it works or if a physician or patient are pleased, that's great. But it's simply not true or close to true that Gilenya ins 60% as effective as Tysabri.

[0485c10]

I'm uncertain if i agree with you gregg....there have been studies that betaseron is just as effective as both if they are able to eliminate poor performers from the studies---that's why the crab drug people are working to develop a test that will identify how a person will respond before starting the med...i kind of think your study is the same--just a matter of identifying the rules before making the conclusion.

[0485c10]

The product is thus recommended predominantly as a second-line therapy.

me i'm excited about lemtrada when it comes out next year out of fast track phase iii trial---that's more effective than either of the and it infusion only once a year..a adit its the once a year that excites me the most, the part of it being more effective is just an added plus.

[ms man]

If you're happy with what you're on, that's great and the end of the discussion. But with respect Gilenya is equally or more effective than other treatments, and the statistics you offer or were given are wrong. Still, don't believe me or anyone else --read the entire research report submitted to the FDA. It's at
http://www.fda.gov/downloads/Advisor.../UCM214675.pdf