My Tysabri Diary...greeeeeaaaaat news just released today!

http://www.elan.com/News/full.asp?ID=1199030

September 2008
TYSABRI® Demonstrates Sustained Improvement in Functional Outcomes in Multiple Sclerosis Patients According to New Post-Hoc Analysis:


TYSABRI is the Only Marketed MS Treatment to Show Both Significant Slowing in Disability Progression and Sustained Improvement in Physical Disability

MONTREAL--(BUSINESS WIRE)--Sept. 19, 2008--Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) announced that a post-hoc analysis showed TYSABRI® (natalizumab) treatment increases the probability of achieving sustained improvement in physical disability over two years when compared to placebo. This post-hoc analysis provides the first evidence that TYSABRI is associated with a significant improvement in functional outcome, rather than only slowing or preventing progression of disability, in those living with relapsing multiple sclerosis (MS). These findings were derived from a subset analysis of the Phase III AFFIRM trial and were presented today as a poster presentation at the World Congress on Treatment and Research in Multiple Sclerosis in Montreal, Canada. This is the first joint meeting of the Americas Committee on Treatment and Research in Multiple Sclerosis (ACTRIMS) and its counterparts in Europe and Latin America: ECTRIMS and LACTRIMS.

"These results show that TYSABRI treated patients are significantly more likely to experience a sustained improvement in disability compared to placebo patients. This finding from a post-hoc analysis of the pivotal AFFIRM trial supports both the earlier findings from the AFFIRM trial that TYSABRI is associated with an improvement in quality of life as well as anecdotal evidence of recovery of function in some patients." said Frederick E. Munschauer, MD, Smith Professor and Chair, Department of Neurology, State University of New York at Buffalo. "While, like TYSABRI, other therapies have shown a slowing of progression in disability, this analysis represents the first evidence supporting a sustained improvement in function associated with an approved disease modifying therapy."

Post-hoc Disability Analysis of Phase III AFFIRM Study

The proportion of patients exhibiting sustained improvements in physical disability in the AFFIRM study was determined based upon the Expanded Disability Status Scale (EDSS) over two years in patients with relapsing MS. EDSS is one of the oldest and most widely utilized methods of quantifying disability in MS.

Post-hoc analysis of AFFIRM patients assessed sustained improvement in disability among patients with a baseline EDSS score > or = 2.0. Improvement in disability was defined as a one-point decrease in EDSS score sustained for 12 weeks. The cumulative probabilities of 12-week sustained improvement in disability at two years were estimated using the Kaplan-Meier method. Treatment effects were analyzed using the Cox proportional hazards model adjusted for baseline EDSS score. The distribution of sustained improvement by baseline EDSS score for each treatment group was also examined.

TYSABRI produced significant results on the cumulative probability of sustained improvement in disability in those treated over two years compared with placebo. In patients with a baseline EDSS score > or = 2.0, the probability of achieving sustained improvement was 29.6% with TYSABRI (n=417) compared with 18.7% with placebo (n=203) (p=0.006). In patients with an EDSS score > or = 2.0 and highly active disease at baseline, the difference between groups was even greater, 35.5% for TYSABRI (n=103) and 15.4% for placebo (n=40) (p=0.045).

The submitted abstract for this study, entitled "Natalizumab significantly increases the cumulative probability of sustained improvement in physical disability" (ID #P474), is available on the World Congress' website.

About TYSABRI

TYSABRI is a treatment approved for relapsing forms of MS in the US and relapsing-remitting MS in the European Union. According to data that have been published in the New England Journal of Medicine, after two years, TYSABRI treatment led to a 68% relative reduction (p<0.001)>.

Can we all say "Woooohoooo"? I know I can!


((((hugs))))

Love, Lauren :)

My Tysabri Diary....., this is also from my acquaintance as opined above:

"As you all probably know, MS usually starts manifesting itself clinically between the ages of 20-40. It rarely kills. Instead it slowly, but inexorably causes more and more culmulative neurological damage and disability. Patients live with the disease for many decades.

Although in a strict scientific sense, one can not compare results from one trial to another, I believe the overwhelming majority of neurologists would opine that Tysabri is more efficacious than any of the CRABS. If one looks at the results of the large phase 3 trials, the interferons produced a reduction in the progression of disability in the range of 33-36%. Copaxone was not able to demonstrate a statisitical significant reduction in the progression of disability. Tysabri showed a reduction in the progression of disability of apprx. 42%. Now this difference between the interferons and Tysabri does not appear that great (at least for 1 year). But try a bit of compounding as it relates to efficacy. Take that 6-9% difference and compound that out 10 , 20, 30, or 50 years. The differences in disability progression are dramatic.

Of course this assumes that the rates in the reduction of the progresiion of disability remain fairly constant. We have 2 year data. And we have 3 year data showing no significant change in rates.

No one is focusing much at this issue because 1) we don't have any certainty if the rates will continue to hold and 2) everyone is still consumed with the risk side of the equation.

Over time however, as the risk profile becomes more defined, and these tens of thousands of patients are followed for longer periods of time, the true magic of compounding should come into focus.

I submit that when neurologists start to compare the neurological results of patients 4-5 years on Tysabri versus 4-5 years on the CRABS, the results will sway more patients and earlier treatment to Tysabri."

I found his opinions very interesting and very rational ..., have a great day everyone.

((((hugs))))

Love, Lauren :)

My Tysabri Diary..., updated Tysabri information:

The following opinions were expressed by a very learned acquaintance of mine whose wife is currently on Tysabri (I believe she is on her 26th infusion):


"Yes, we got our first two cases of PML since the re-introduction of Tysabri. And yes, cases in monotherapy, but there are positives here which may in the long run prove very beneficial to the opinions of Tysabri....,


1. Both patients are alive and were diagnosed due to the European surveillance program (remember, they do not follow the Touch program that is in place here in the US).


2. One was diagnosed VERY early and is almost completely recovered, having NEVER been hospitalized.


3. The other patient was diagnosed somewhat LATE, given that the patient presented with symptoms suggestive of PML with an atpical MRI. This patient should NEVER have been given more Tysabri and high dose steriods. Yet despite the above, the patient APPEARS to be making a recovery.


4. Again in a sense, these two cases provide a nice range. One diagnosed very early, one diagnosed rather late. Both are alive and APPEAR to be recovering. Both cases are being actively followed by ALL Tysabri prescribing neurologists, via conference calls by Biogen. Should these patients continue to do well, it will go a long way to changing the risk/reward ratio, IMO. The risk was previously assumed to commonly be death, or at best severe permanent disability.


5. In addition to the neurologists, a great many of the CURRENT Tysabri patients have been told of these cases and the fact that the patients ARE ALIVE and APPEAR to be recovering. This is being done via the neurologists and/or the infusion nurses (and most do not want to come off Tysabri).


6. THUS FAR, there have been no new confirmed cases in the last 5 weeks. ALL of the 17 suspected cases in the database have been resolved to satisfaction.


7. Biogen has re-stated their business plan which still includes 100,000 patients on Tysabri by late 2010. They have stated that their projections have always assumed additional cases of PML. In fact, these cases came later than originally expected.


8. Because the second patient had a prior history of immunsuppession, and may in fact have been immunosuppressed BEFORE starting Tysabri, neuros are going to be even more cautious about checking and monitoring the immune status of potential Tysabri patients.


9. Tysabri is now postioned to be used BEFORE the strong immunosuppressive agents. Since Tysabri's re-introducton, a great deal of patients with prior STRONG immunosuppression (and who were still progressing) have already been exposed to Tysabri. Going FOWARD, I believe there will be fewer of these high risk patients going on Tysabri. Again, most patients progressing on the CRABS will now go to Tysabri PRIOR to the strong immunosuppressants."


I hope that some of the above information will also help calm the fears of current Tysabri uses (not many are afraid of PML), and help calm the fears of prospective Tysabri patients.


((((hugs))))

Love, Lauren :)

My Tysabri Diary...,

Hi everyone, I just returned home a little while ago from my 25th Tysabri infusion... once again, no problems, no side effects, no adverse reactions, and no problems with the infusion... my nurse was able to "stick me" with just one jab, yay!

When I asked how the other Tysabri patients were doing, I was told "just fine", no problems there either and no one was concerned about the two new cases of PML in Europe.


So other than that, I have nothing new to report (which is a good thing).

I did want to share an e-mail that I sent to the editor in chief of the AAN recent publication regarding the new guideline that their authors published yesterday (I've received no reply from them as yet, and I really don't expect one either)...., they kind of pi$$ed me off (oops).

I'm off to have an early dinner of pizza and mudslides, and then turn in early... have a wonderful evening everyone,

((((hugs))))
Love, Lauren :)

Subj: AAN's Publication for Use of Natalizumab dated 9/2/08 Date: 9/2/2008 3:22:43 PM Pacific Daylight Time From: LGLBGL2003 To: editorinchief@aan.com

Gentlepersons,

I just reviewed your publication of the New Guideline Published on the Use of Natalizumab for MS:

http://www.aan.com/news/index.cfm?event=read&article_id=6024&page=72.45.45

From a review of the publication above, strong exception is taking to the following language used:

"it is recommended that natalizumab be reserved for use in selected patients with relapsing-remitting disease who have failed other therapies either through continued disease activity or medication intolerance, or who have a particularly aggressive initial disease course.".

This recommendation is in direct conflict with the FDA approved Tysabri label and which furthermore is in direct conflict with the FDA memorandum which previously issued, stating in part: "FDA would like to clarify to the reader that the MS indication for Tysabri was carefully written by FDA and the Sponsor to indicate that its use is generally recommendedfor patients who have had an inadequate response to, or are unable totolerate, alternative multiple sclerosis therapies (e.g., as second-line therapy). However, the indication statement does not explicitly preclude the possibility of first-line therapy in some MS patients as part of the approved use. FDA recognizes that the health care provider needs to consider its use based on the unique circumstances of each patient.

http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4313b1-02-FDA-Errata.pdf ".

In addition, Tysabri is to be used for "relapsing forms" of MS, which include Relapsing-Remitting, Progressive Relapsing, and Secondary Progressive with relapses. The authors of the article indicate that it is for relapsing-remitting disease, which is completely incorrect. The Tysabri label states: "TYSABRI® is indicated as monotherapy for the treatment of patients with relapsing forms of multiple sclerosis to delay the accumulation of physical disability and reduce the frequency of clinical exacerbations.".

While I understand that the AAN is a medical specialty group and as such, does not preclude recommending a narrower scope of Tysabri's use, what in fact the AAN authors of this article are doing is condemning a wide variety of MS patients to suffer additional relapses and disease progression needlessly by relegating treatment first with one of the ABCRs, not to mention a very large patient population of noncompliance to the ABCRs treatment regimes due to their side effects and injection site reactions. Furthermore, said language will make it extremely difficult for insurance companies to provide approval for the use of Tysabri in these patients and as a first-line therapy when first-line therapy use is clearly approved by the FDA. The authors of said article should take into consideration that the health care provider needs to consider its use based on the unique circumstances of each patient.

Your authors begin by commenting: "Strong evidence suggests that natalizumab reduces disease activity and severity in people with relapsing MS by both clinical and MRI measures."..., would it not behoove MS patients to begin treatment as soon as possible with Tysabri in order to achieve these results?

Lastly, your authors state that: "strong evidence suggests an increased risk of developing PML in patients receiving combination therapy with interferon (IFN) and natalizumab"..., considering Tysabri can only be prescribed as a monotherapy to non-immunocompromised MS patients pursuant to the FDA approved label and accompanying RiskMAP, there is no increased risk of developing PML.

As a Tysabri patient for more than two years and a MS patient for more than 32 years, I really must object to the language used by your authors in this publication, and respectfully request a clarified and corrected publication issue which will help truthfully guide physicians when treating their MS patients rather than mislead them into allowing their MS patients to continue suffering possible permanent damage needlessly due to the AAN's authors current language.

I look forward to your prompt reply.

Respectfully submitted,

Lauren Roberts