Thanks for your post.
The article is not from me but from Ken Kam / MarketocracyBetter--You wrote
Best regards
My previous message about MS medications had more to do with the results of the CRABs after all these years. I can remember when they first started becoming available in the mid 90's and the MS docs and pharmas were very excited about them based on the trials.Then how do you explain this post from today from another message board ?
Quality of Life:In a nearly 1000 person clinical trial conducted over 2 years, Tysabri reduced the risk of disability by 42%, with a 67% reduction in the rate of relapses. After two years, 17% of Tysabri patients had seen their MS progress, compared to 29% of placebo patients. 67% of patients were relapse-free for the two years, compared with 41% of those treated with placebo.
Additionally, Tysabri patients had a significant decrease in the burden of disease on the brain (measured by the number and volume of T2 brain lesions) versus placebo patients who saw their burden increase. A 76% reduction in new T1 lesions was noted for Tysabri patients versus placebo.
TYSABRI Shows Improvement in Quality of Life Assessments In the two Phase III TYSABRI clinical trials, AFFIRM and SENTINEL, QoL was assessed using three different measures, the Multiple Sclerosis Quality of Life Inventory (MSQLI), the Short Form-36 Health Survey (SF-36), which is a component of the MSQLI, and a Visual Analogue Scale (VAS). The MSQLI is an MS-specific battery of 10 scales that measure disease impact on QoL including, fatigue, pain, sexual function, bowel and bladder function, visual impairment, mental health and need for social support. SF-36 is comprised of 36 questions designed to assess patients' physical and mental well-being. General well-being was also measured using the VAS.
In the AFFIRM monotherapy study, patients in the TYSABRI-treated group realized a significant improvement in physical measures of the SF-36 compared with a decline in the placebo-treated group (p=0.003). A significant improvement was also seen in the mental component of the SF-36 in patients treated with TYSABRI compared with a decline in the placebo-group (p=0.011). Significant benefits were also seen using the VAS (p=0.007). Improvements on quality of life measures were also observed in the SENTINEL study, in which TYSABRI was added to AVONEX® (Interferon beta-1a).
I understand that to say as well that almost 3/4ths of the people on placebo did not have any disability progression in two years. To be exact, 71% of the people on placebo did not have disability progression in two years; 83% of the people on Tysabri did not have disability progression.After two years, 17% of Tysabri patients had seen their MS progress, compared to 29% of placebo patients.
This is another good example of using "relative" numbers as opposed to "actual" numbers when it comes to publishing trial data.After two years, 17% of Tysabri patients had seen their MS progress, compared to 29% of placebo patients.
That pretty much supports the info that the patients in this trial mostly had mild cases of MS and weren't likely to have a lot of disease progression. But like many of us have stated, we won't know the real effect on patients until the end of the year.I understand that to say as well that almost 3/4ths of the people on placebo did not have any disability progression in two years. To be exact, 71% of the people on placebo did not have disability progression in two years; 83% of the people on Tysabri did not have disability progression.
Not sure I like the amount of "unknowns" by Biogen in this letter when it comes to PML.Just to try and keep everyone up to speed, here's a link to the letter Biogen sent to the docs today.