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 :)
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 :)
posted by Lauren @ 3:23 PM
4 Comments:
At 2:50 PM,
Denver Refashionista said…
How has the Tysabri worked out for you? Do you feel like it has improved your health? Have you had any relapses since you have been on it?
Please email me if you can.
Nadja
At 1:36 PM,
Lauren said…
Hi Nadja,
To answer your questions, when I was first on Tysabri therapy in early 2005, I had dramatic improvements just two weeks after my very first infusion... my right drop foot was gone, my limp was gone, my slurred speech was gone, my optic neuritis cleared up in my right eye, my balance was just starting to return, and my bladder issues were completely resolved. I put away my walker and only use my cane for balance at that time.
Unfortunately, when Tysabri was temporarily removed from the market for almost 18 months, during that time, I suffered a massive and severe relapse which put me in a wheelchair.
Since restarting Tysabri in October 2006, I have not had one single relapse since that time, and my current MRIs show absolutely no new lesions. Therefore, my MS now remains stable (during the 18 months waiting for Tysabri's return, I was suffering a relapse almost every other month). Both my neurologist and I believe that I would probably be bedridden by now with Tysabri.
My Quality of Life is much better now because I don't wake up afraid anymore, wondering what MS has taken away from me. Now I wake up with new Hope & sustained Hope that one day I will walk again, but even if I don't, my life is still much better than it was without Tysabri.
I hope this information is of some help to you Nadja. Thank you so much for all of your previous comments on my blog... I just didn't have a chance to respond all of them, but thank you.
All my best you,
Lauren :)
At 1:54 PM,
Lauren said…
Oops, I made a typo... part of my comment should have read "Both my neurologist and I believe that I would probably be bedridden by now without Tysabri".
Maybe one day I'll learn to proofread my comments before I post them (heehee).
Lauren ;)
At 10:49 AM,
Anonymous said…
I am on Tysabri--pray for positive results. I want to type more but MS is kicking my butt right now. I have an MBA and would have a PhD or JD if I could type more---frustrated, can you tell??
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