Tysabri info
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HarryZ
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Amelia,
The problem is they can't prove nor disprove the third case, other than the person was on Tysabri. Was it the Tysabri, a combination of Tysabri and the other drugs or the other drugs only? But because the person was part of a Tysabri clinical trial, they have to do a lot of investigating now.
Harry
One case was from the San Franciso area and I forget where the second person was from. Not sure where the Crohn's patient lived.amelia wrote:Has there been any cases reported in the UK or Ireland? Or is anybody saying where the cases have come from? I really don't think you can pin the third case on Tysabri, if it is the one with Crohns. Remember that one of the medicines they had been on causes PML all by itself.
The problem is they can't prove nor disprove the third case, other than the person was on Tysabri. Was it the Tysabri, a combination of Tysabri and the other drugs or the other drugs only? But because the person was part of a Tysabri clinical trial, they have to do a lot of investigating now.
Harry
Harry
One way of looking at the pharmaceutical industry is to say that by definition pharma cos make money out of other peoples suffering. When I think that way I just get angry.
_________________
John
I am what I am
PS Harry - I enjoy immensely reading your submissions. Please keep it up.
One way of looking at the pharmaceutical industry is to say that by definition pharma cos make money out of other peoples suffering. When I think that way I just get angry.
This is not the place for extensive socio-political debate but I am sure that although it maybe a "fact of life" at the moment it wont be forever.HarryZ wrote:... it is a fact of life.
_________________
John
I am what I am
PS Harry - I enjoy immensely reading your submissions. Please keep it up.
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HarryZ
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John,
Harry
I become angry, not at the fact that they are in the business that they are but because of the way many pharmas deceive the public when it comes the drugs they produce. One only has to look at the past year to see this (ie Vioxx, Neurontin).One way of looking at the pharmaceutical industry is to say that by definition pharma cos make money out of other peoples suffering. When I think that way I just get angry.
Harry
Once again...........modestly effective treatments...........significant profits.
I've mentioned many times, in many threads, drug companies won't discover nutritional factors or cures. Drug companies won't discover treatments based on 20 year old antibiotics.
Universities or independent research facilities will. Throw in a little financial support from some large corps. and then where does that leave us?
Treez
I've mentioned many times, in many threads, drug companies won't discover nutritional factors or cures. Drug companies won't discover treatments based on 20 year old antibiotics.
Universities or independent research facilities will. Throw in a little financial support from some large corps. and then where does that leave us?
Treez
In the world today, not with just Pharma cos, but just about everything, you can get where you want to be with the right connections, the right amount of money, and sometimes giving the right amount of money to the right person under the table. With gov and companies everywhere, there are many that will jepordize our health for the bottom line of money. I am sure the FDA probably falls in this catagory as well. Just my thought.
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better2gether
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This is getting personal
Opinion from an neurologist
"This is getting personal
Today my second former Tysabri patient (2 doses total) had a relapse. She had decided not to take any medicine despite my advice. Double vision and a numb hand. Severe enough to treat. Now she'll consider restarting a medication. What about the other 4999 patients?
Exactly 1/10th of a year has passed since the Feb 28 decision. What has this meant to MS patients. 5000 patients were on Tysabri and 10000 were waiting approval.
Lets follow this group for 36 days. 15000 patients on less effective therapy (90%) or on no therapy (10%). 1500 x 0.74 relapses/year off therapy = 110 relapses in 36 days. 13500 patients x 0.5 relapses/year on other therapy = 625 relapses in 36 days, Total = 735 exacerbations.
Lets look at this same group if they were on Tysabri. 15000 x 0.25 relapses/yr = 375 exacerbations in 36 days.
In only 36 days, this group could have had 360 more exacerbations than the same group on Tysabri.
Of these AVOIDABLE exacerbations 1/3 were moderate or severe and require 5 days or so IV steroids. Half of these 120 exacerbations will not completely recover. Some of these exacerbations were at the top of the cervical spine. Five of these patients can not walk now, three will never walk independently again.
Tick Tock Tick Tock
May June July Enough time for reviews. Enough times for decisions. 1000 more avoidable exacerbations. One dozen more people in wheelchairs. Does anyone care?
Tick Tock Tick Tock
More expert panels, more reviews?
August, Sept, Oct, Nov, Dec, Jan... A new year. A total of 3600 avoidable exacerbations. Thirty people permanently in wheelchairs, Thirty patients legally blind, 30 patients now incontinent, 30 patients with significantly lower IQs.
MS is impatient, it will not wait for the FDA. "
.
"This is getting personal
Today my second former Tysabri patient (2 doses total) had a relapse. She had decided not to take any medicine despite my advice. Double vision and a numb hand. Severe enough to treat. Now she'll consider restarting a medication. What about the other 4999 patients?
Exactly 1/10th of a year has passed since the Feb 28 decision. What has this meant to MS patients. 5000 patients were on Tysabri and 10000 were waiting approval.
Lets follow this group for 36 days. 15000 patients on less effective therapy (90%) or on no therapy (10%). 1500 x 0.74 relapses/year off therapy = 110 relapses in 36 days. 13500 patients x 0.5 relapses/year on other therapy = 625 relapses in 36 days, Total = 735 exacerbations.
Lets look at this same group if they were on Tysabri. 15000 x 0.25 relapses/yr = 375 exacerbations in 36 days.
In only 36 days, this group could have had 360 more exacerbations than the same group on Tysabri.
Of these AVOIDABLE exacerbations 1/3 were moderate or severe and require 5 days or so IV steroids. Half of these 120 exacerbations will not completely recover. Some of these exacerbations were at the top of the cervical spine. Five of these patients can not walk now, three will never walk independently again.
Tick Tock Tick Tock
May June July Enough time for reviews. Enough times for decisions. 1000 more avoidable exacerbations. One dozen more people in wheelchairs. Does anyone care?
Tick Tock Tick Tock
More expert panels, more reviews?
August, Sept, Oct, Nov, Dec, Jan... A new year. A total of 3600 avoidable exacerbations. Thirty people permanently in wheelchairs, Thirty patients legally blind, 30 patients now incontinent, 30 patients with significantly lower IQs.
MS is impatient, it will not wait for the FDA. "
.
Amen to that!! Gary, my husband, is one of those waiting to be permantly in a wheel chair, is already legally blind, and I catherize him daily. He is 46 yer old. Gary has always been as active a possible. Even now, he does more than any DR wants and anyone would believe. I let him go. He pushes to go because the other side of that is going down farther with MS and the TV stations. What quality of life is this to him. It is none of my business that he would risk life to have life. I can't make that call, only him. And he wants the Tysabri. If he died because of it, I would be happy knowing he died TRYING to get better. I want him around as long as possible, but not if he is so depressed and miserable because he can't do ANYTHING for himself and there was some hope he could have had.
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HarryZ
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Re: This is getting personal
Better.
What was that someone said about statistics....you can use them to prove or disapprove almost anything!!!
Perhaps the researchers at Biogen should have thought about more about rushing the approval of this drug!!
Harry
What was that someone said about statistics....you can use them to prove or disapprove almost anything!!!
Perhaps the researchers at Biogen should have thought about more about rushing the approval of this drug!!
Harry
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better2gether
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POSITIVE ONE-YEAR DATA FROM SENTINEL TRIAL
POSITIVE ONE-YEAR DATA FROM SENTINEL TRIAL EVALUATING ADDITION OF TYSABRI® TO AVONEX® PRESENTED AT AMERICAN ACADEMY OF NEUROLOGY MEETING
Data from GLANCE Safety Study Also Presented
Cambridge, MA and Dublin, Ireland - April 13, 2005 - One-year data from the Phase III SENTINEL trial, presented at the 57th annual American Academy of Neurology (AAN) meeting in Miami Beach, FL, demonstrated that when TYSABRI® (natalizumab) was added to AVONEX® (Interferon beta-1a) in patients with relapsing forms of multiple sclerosis (MS), the annualized clinical relapse rate was reduced by 54 percent over the effect of AVONEX alone (p<0.001). In addition, these data, presented for the first time at a major medical meeting, demonstrated that the addition of TYSABRI to AVONEX resulted in significantly fewer new or newly enlarging T2 hyperintense lesions and gadolinium-enhancing lesions than AVONEX alone, and that the proportion of TYSABRI/AVONEX patients who remained relapse-free was significantly higher than in the AVONEX group.
On February 28, 2005, Biogen Idec and Elan Corporation, plc announced that they voluntarily suspended TYSABRI from the U.S. market and all ongoing clinical trials. This decision was based on reports of progressive multifocal leukoencephalopathy (PML), a rare and frequently fatal, demyelinating disease of the central nervous system. Biogen Idec and Elan's comprehensive safety evaluation concerning TYSABRI and any possible link to PML is ongoing. The results of this safety evaluation will be discussed with regulatory agencies to determine possible re-initiation of dosing in clinical trials and future commercial availability.
"SENTINEL is a large, well-designed clinical trial that for the first time evaluated the efficacy of add-on therapy for MS patients who continued to experience disease activity despite interferon therapy," said Richard Rudick, MD, lead investigator of the SENTINEL trial and director of the Mellen Center for MS Treatment and Research at Cleveland Clinic Foundation. "We look forward to learning more from the ongoing evaluation of TYSABRI."
SENTINEL One-Year Results
SENTINEL is a two-year, randomized, multi-center, placebo-controlled, double-blind study of 1,171 AVONEX-treated patients in 123 clinical trial sites worldwide. AVONEX-treated patients who continued to experience disease activity were randomized to add TYSABRI (n=589) or placebo (n=582) to their standard regimen.
The primary endpoint at one-year was the reduction in the rate of clinical relapses. The addition of TYSABRI to AVONEX resulted in a 54 percent reduction in the rate of clinical relapses over the effect of AVONEX alone (p<0.001). The annualized relapse rate was 0.36 for patients receiving TYSABRI when added to AVONEX versus 0.78 with AVONEX plus placebo.
Analysis of annualized relapse rate by pre-specified subgroups of disease severity, including baseline Expanded Disability Status Scale (EDSS) (measured on a scale 0-10) or relapse history, supported the primary endpoint finding. In patients with an EDSS greater than or equal to 4.0, TYSABRI reduced the relapse rate by 51 percent, while in patients with an EDSS less than 4.0, it reduced the relapse rate by 53 percent. Additionally, in patients with more than two relapses in the year prior to study entry, TYSABRI reduced the annualized relapse rate by 55 percent, while in patients with one relapse, TYSABRI reduced the annualized relapse rate by 53 percent.
SENTINEL also met all secondary endpoints, including MRI measures. In the group treated with TYSABRI plus AVONEX, 67 percent of patients developed no new or newly enlarging T2-hyperintense lesions compared to 40 percent in the AVONEX plus placebo group (p<0.001). On the one-year MRI scan, 96 percent of TYSABRI plus AVONEX-treated patients had no gadolinium-enhancing lesions compared to 76 percent of AVONEX plus placebo-treated patients (p<0.001). The proportion of patients who remained relapse-free was 67 percent in the TYSABRI plus AVONEX-treated group compared to 46 percent in the AVONEX plus placebo-treated group (p<0.001).
TYSABRI One-year Safety
The adverse event profile in SENTINEL and AFFIRM were similar at one year. Common adverse events included headache, fatigue, urinary tract infection, depression, lower respiratory tract infection, joint pain and abdominal discomfort. The rate of infection was approximately one per patient-year in both TYSABRI-treated patients and placebo-treated patients. Serious infections occurred in 1.3 percent of placebo treated patients and 2.1 percent of TYSABRI-treated patients. TYSABRI has been associated with hypersensitivity reactions, including serious systemic reactions, which occurred at an incidence of less than 1 percent of patients.
The two PML cases reported in MS were in patients treated with more than two years of AVONEX plus TYSABRI.
TYSABRI Immunogenicity
All biologics have the potential to induce antibody formation. Analysis of the one-year results indicated a low level of immunogenicity associated with TYSABRI. Patients were tested for antibodies every 12 weeks in the AFFIRM and SENTINEL trials. Antibodies were detected in approximately 10 percent of patients at least once during treatment, with 6 percent of patients remaining persistently positive. Persistently positive antibodies were associated with a substantial decrease in efficacy and an increase in certain infusion-related adverse events. Almost all patients who tested positive for antibodies did so within the first 12 weeks of treatment.
"The one-year results from SENTINEL add to the compelling data set for TYSABRI. At the conclusion of our extensive safety evaluation, we hope to have a clearer understanding of the product's efficacy and safety profile and the prudent next steps," said Burt Adelman, MD, executive vice president, Development, Biogen Idec.
"Patient safety remains our first priority in all matters and these data will be considered within the context of our ongoing safety evaluation to determine the most appropriate future course," said Lars Ekman, MD, PhD, executive vice president and president, Research and Development, Elan.
GLANCE Results
Results from GLANCE, a Phase II study evaluating the safety and pharmacokinetics of TYSABRI when added to Copaxone® (glatiramer acetate), were also presented today at the AAN meeting. GLANCE is a 24-week study which enrolled 110 MS patients who were relapsing on Copaxone. When TYSABRI was added to Copaxone, there was no increase in the rate of new active MRI lesion formation, a safety measure and the primary endpoint of the study. Because of the short duration of this study, further study would be necessary to evaluate the safety and efficacy of TYSABRI
http://www.biogenidec.com/news/BiogenIDECPR_076.htm
Data from GLANCE Safety Study Also Presented
Cambridge, MA and Dublin, Ireland - April 13, 2005 - One-year data from the Phase III SENTINEL trial, presented at the 57th annual American Academy of Neurology (AAN) meeting in Miami Beach, FL, demonstrated that when TYSABRI® (natalizumab) was added to AVONEX® (Interferon beta-1a) in patients with relapsing forms of multiple sclerosis (MS), the annualized clinical relapse rate was reduced by 54 percent over the effect of AVONEX alone (p<0.001). In addition, these data, presented for the first time at a major medical meeting, demonstrated that the addition of TYSABRI to AVONEX resulted in significantly fewer new or newly enlarging T2 hyperintense lesions and gadolinium-enhancing lesions than AVONEX alone, and that the proportion of TYSABRI/AVONEX patients who remained relapse-free was significantly higher than in the AVONEX group.
On February 28, 2005, Biogen Idec and Elan Corporation, plc announced that they voluntarily suspended TYSABRI from the U.S. market and all ongoing clinical trials. This decision was based on reports of progressive multifocal leukoencephalopathy (PML), a rare and frequently fatal, demyelinating disease of the central nervous system. Biogen Idec and Elan's comprehensive safety evaluation concerning TYSABRI and any possible link to PML is ongoing. The results of this safety evaluation will be discussed with regulatory agencies to determine possible re-initiation of dosing in clinical trials and future commercial availability.
"SENTINEL is a large, well-designed clinical trial that for the first time evaluated the efficacy of add-on therapy for MS patients who continued to experience disease activity despite interferon therapy," said Richard Rudick, MD, lead investigator of the SENTINEL trial and director of the Mellen Center for MS Treatment and Research at Cleveland Clinic Foundation. "We look forward to learning more from the ongoing evaluation of TYSABRI."
SENTINEL One-Year Results
SENTINEL is a two-year, randomized, multi-center, placebo-controlled, double-blind study of 1,171 AVONEX-treated patients in 123 clinical trial sites worldwide. AVONEX-treated patients who continued to experience disease activity were randomized to add TYSABRI (n=589) or placebo (n=582) to their standard regimen.
The primary endpoint at one-year was the reduction in the rate of clinical relapses. The addition of TYSABRI to AVONEX resulted in a 54 percent reduction in the rate of clinical relapses over the effect of AVONEX alone (p<0.001). The annualized relapse rate was 0.36 for patients receiving TYSABRI when added to AVONEX versus 0.78 with AVONEX plus placebo.
Analysis of annualized relapse rate by pre-specified subgroups of disease severity, including baseline Expanded Disability Status Scale (EDSS) (measured on a scale 0-10) or relapse history, supported the primary endpoint finding. In patients with an EDSS greater than or equal to 4.0, TYSABRI reduced the relapse rate by 51 percent, while in patients with an EDSS less than 4.0, it reduced the relapse rate by 53 percent. Additionally, in patients with more than two relapses in the year prior to study entry, TYSABRI reduced the annualized relapse rate by 55 percent, while in patients with one relapse, TYSABRI reduced the annualized relapse rate by 53 percent.
SENTINEL also met all secondary endpoints, including MRI measures. In the group treated with TYSABRI plus AVONEX, 67 percent of patients developed no new or newly enlarging T2-hyperintense lesions compared to 40 percent in the AVONEX plus placebo group (p<0.001). On the one-year MRI scan, 96 percent of TYSABRI plus AVONEX-treated patients had no gadolinium-enhancing lesions compared to 76 percent of AVONEX plus placebo-treated patients (p<0.001). The proportion of patients who remained relapse-free was 67 percent in the TYSABRI plus AVONEX-treated group compared to 46 percent in the AVONEX plus placebo-treated group (p<0.001).
TYSABRI One-year Safety
The adverse event profile in SENTINEL and AFFIRM were similar at one year. Common adverse events included headache, fatigue, urinary tract infection, depression, lower respiratory tract infection, joint pain and abdominal discomfort. The rate of infection was approximately one per patient-year in both TYSABRI-treated patients and placebo-treated patients. Serious infections occurred in 1.3 percent of placebo treated patients and 2.1 percent of TYSABRI-treated patients. TYSABRI has been associated with hypersensitivity reactions, including serious systemic reactions, which occurred at an incidence of less than 1 percent of patients.
The two PML cases reported in MS were in patients treated with more than two years of AVONEX plus TYSABRI.
TYSABRI Immunogenicity
All biologics have the potential to induce antibody formation. Analysis of the one-year results indicated a low level of immunogenicity associated with TYSABRI. Patients were tested for antibodies every 12 weeks in the AFFIRM and SENTINEL trials. Antibodies were detected in approximately 10 percent of patients at least once during treatment, with 6 percent of patients remaining persistently positive. Persistently positive antibodies were associated with a substantial decrease in efficacy and an increase in certain infusion-related adverse events. Almost all patients who tested positive for antibodies did so within the first 12 weeks of treatment.
"The one-year results from SENTINEL add to the compelling data set for TYSABRI. At the conclusion of our extensive safety evaluation, we hope to have a clearer understanding of the product's efficacy and safety profile and the prudent next steps," said Burt Adelman, MD, executive vice president, Development, Biogen Idec.
"Patient safety remains our first priority in all matters and these data will be considered within the context of our ongoing safety evaluation to determine the most appropriate future course," said Lars Ekman, MD, PhD, executive vice president and president, Research and Development, Elan.
GLANCE Results
Results from GLANCE, a Phase II study evaluating the safety and pharmacokinetics of TYSABRI when added to Copaxone® (glatiramer acetate), were also presented today at the AAN meeting. GLANCE is a 24-week study which enrolled 110 MS patients who were relapsing on Copaxone. When TYSABRI was added to Copaxone, there was no increase in the rate of new active MRI lesion formation, a safety measure and the primary endpoint of the study. Because of the short duration of this study, further study would be necessary to evaluate the safety and efficacy of TYSABRI
http://www.biogenidec.com/news/BiogenIDECPR_076.htm
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HarryZ
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Re: POSITIVE ONE-YEAR DATA FROM SENTINEL TRIAL
Better.
Interesting stats....now that's all they have to figure out is how to prevent the patients from possibly getting PML when using this combination therapy.
Harry
Interesting stats....now that's all they have to figure out is how to prevent the patients from possibly getting PML when using this combination therapy.
Harry
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better2gether
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Tysabri is put back on the Forbes Watch List.
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Tysabri is put back on the Forbes Watch List!
Sales Potential: $ = up to $500 million in annual sales
Novelty: +++ = new class of medicines, or dramatic improvement
This multiple sclerosis medicine, formerly called Antegren, was approved on Nov. 23, 2004. Now it is the first approved drug to be put back on our watch list. Biogen Idec and Elan pulled the drug after some patients developed progressive multifocal leukoencephalopathy (PML), a condition caused when the immune system is suppressed and a dormant virus damages the brain.
It's not entirely clear what role Tysabri played in the PML cases; other drugs also may have been involved. Now, for the treatment to return to the market for even a small group of patients, the risk has to be better characterized and understood.
http://www.forbes.com/sciencesandmedici ... sheet.html
.
Tysabri is put back on the Forbes Watch List!
Sales Potential: $ = up to $500 million in annual sales
Novelty: +++ = new class of medicines, or dramatic improvement
This multiple sclerosis medicine, formerly called Antegren, was approved on Nov. 23, 2004. Now it is the first approved drug to be put back on our watch list. Biogen Idec and Elan pulled the drug after some patients developed progressive multifocal leukoencephalopathy (PML), a condition caused when the immune system is suppressed and a dormant virus damages the brain.
It's not entirely clear what role Tysabri played in the PML cases; other drugs also may have been involved. Now, for the treatment to return to the market for even a small group of patients, the risk has to be better characterized and understood.
http://www.forbes.com/sciencesandmedici ... sheet.html
.
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HarryZ
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Re: Tysabri is put back on the Forbes Watch List.
Anyone who ever thought that drug companies were interested in people's health should now be convinced otherwise. It always has been and will continue to be "about the money"!better2gether wrote:.
Tysabri is put back on the Forbes Watch List!
Harry
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better2gether
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Tysabri might make a comeback.
.
Tysabri might make a comeback.
In a morning interview on CNBC, Biogen CEO James Mullen said the companies hoped a safety review would conclude Tysabri could be prescribed to certain patients, especially if they are monitored. Mullen said the Tysabri safety review should be concluded by late summer and that company officials would be meeting with regulators over the coming months.
Tysabri, which was approved by the Food and Drug Administration in November 2004, had been hailed as a breakthrough in the treatment of MS. Because of this, some patients and healthcare advocates have requested that the drug to be put back on the market, at least for certain patients.
<shortened url>
Tysabri might make a comeback.
In a morning interview on CNBC, Biogen CEO James Mullen said the companies hoped a safety review would conclude Tysabri could be prescribed to certain patients, especially if they are monitored. Mullen said the Tysabri safety review should be concluded by late summer and that company officials would be meeting with regulators over the coming months.
Tysabri, which was approved by the Food and Drug Administration in November 2004, had been hailed as a breakthrough in the treatment of MS. Because of this, some patients and healthcare advocates have requested that the drug to be put back on the market, at least for certain patients.
<shortened url>