|
||
| The Copaxone News Channel |  |
|
|
|||||
|
|||||
|
|||||
| MS NEWS ARCHIVES: by week | |||||
| March 2005 | |||||
| June 2005 | |||||
| July 2005 | |||||
| August 2005 | |||||
| October 2005 | |||||
| November 2005 | |||||
| December 2005 | |||||
| January 2006 | |||||
| February 2006 | |||||
| May 2006 | |||||
| June 2006 | |||||
| August 2006 | |||||
| October 2006 | |||||
| November 2006 | |||||
| December 2008 | |||||
| January 2013 | |||||
| May 2013 | |||||
| June 2013 | |||||
| July 2013 | |||||
| September 2013 | |||||
| October 2013 | |||||
| November 2013 | |||||
| November 2014 | |||||
| December 2014 | |||||
| January 2015 | |||||
| March 2015 | |||||
| April 2015 | |||||
| May 2015 | |||||
| July 2015 | |||||
| February 2016 | |||||
 |
|||||
 |
|||||
 |
|||||
 |
|||||
 |
|||||
 |
|||||
| HERE'S A FEW OF OUR 6000+ Facebook & MySpace FRIENDS | |||||
 |
|||||
| |||||
| |||||
 Click to view 1280 MS Walk photos! | |||||
|
|||||
|
|||||
|
|||||
Sunday
15 STUDIES IN FRIDAY'S NEWS
PLUS: 1590 new Studies we posted from 11/1 to Thursday 2/12 Start at the Bottom!
The NBSS, developed specifically to assess the symptoms and consequences associated with neurogenic bladder dysfunction, has appropriate psychometric properties. Depending on the measurement need, individual domains may be selected, or it can be used as a comprehensive score.
The fraction of intrathecally-produced VZV-specific IgG of the total intrathecally produced IgG discriminates between patients with VZV reactivation and MS. Our results provide further evidence that intrathecally-produced VZV antibodies are part of the polyspecific immune response in patients with MS.
In addition to autoantigens implicated in thyroid autoimmunity, fibrocytes and derivative fibroblasts express multiple autoantigens associated with T1DM. This expression results from active gene promoters and abundant steady-state mRNA encoding ICA69 and IA-2. These latest findings demonstrate that fibrocytes express antigens relevant to multiple forms of endocrine autoimmunity. They suggest the potential for these cells playing a direct role in immune reactivity directed at the thyroid and pancreatic islets.
MMPs can also enhance the cleavage of myelin basic protein (MBP) and the demyelination process. Regarding the growing data on the roles of MMPs and their tissue inhibitors (TIMPs) in the pathogenesis of MS, this review discusses the role of different types of MMPs, including MMP-2, -3, -7, -9, -12 and -25, in the immunopathogenesis and treatment of MS.
In a real-world setting, patients with MS who switched from IFNs to fingolimod were significantly less likely to experience relapses than those who switched to GA.
Read Study Pubmed.gov
Labels: 500 BEST PML STORIES & STUDIES, Aubagio, Avonex, Betaseron, Copaxone, Extavia, Gilenya, Novantrone, PML (Progressive Multifocal Leukoencephalopathy), Rebif, sativex, TECFIDERA, Tysabri
15 STUDIES IN THURSDAY'S NEWS
PLUS: 1575 new Studies we posted from 11/1 to Wednesday 2/12 Start at the Bottom!
In patients with SSc, serum levels of ICAM-1 and P-selectin may serve as prognostic indicators of respiratory dysfunction and physical disability, respectively. Further longitudinal studies of larger populations are needed to confirm these findings.
Seizures can occur at any stage during the course of MS, but it is more common during the early stages.
In a real-world setting, patients with MS who switched from IFNs to fingolimod were significantly less likely to experience relapses than those who switched to GA.
In the NARCOMS cohort, functional health literacy is high. However, lower levels of health literacy are associated with adverse health behaviors and greater health care utilization.
Read Study at Pubmed.gov
In the pathogenesis of MS, this review discusses the role of different types of MMPs, including MMP-2, -3, -7, -9, -12 and -25, in the immunopathogenesis and treatment of MS.
Read Study at Pubmed.gov
Read more »
Labels: 500 BEST PML STORIES & STUDIES, Aubagio, Avonex, Betaseron, Copaxone, Extavia, Gilenya, Novantrone, PML (Progressive Multifocal Leukoencephalopathy), Rebif, sativex, TECFIDERA, Tysabri
Friday's News for Neurologists: Here's 276 New Studies from 10/1 to Friday 11/1
Labels: 500 BEST PML STORIES & STUDIES, Ampyra, For Doctors, PML (Progressive Multifocal Leukoencephalopathy), sativex, Study, Tysabri
Thursday's News for Neurologists: Here's 266 New Studies from 10/1 to Thursday 10/31
Labels: 500 BEST PML STORIES & STUDIES, Ampyra, Gilenya, PML (Progressive Multifocal Leukoencephalopathy), sativex, Tysabri
Tuesday's News for Neurologists: Here's 256 New Studies from 10/1 to Tuesday 10/29:
Neuropsychological, balance and mobility risk factors for falls in people with multiple sclerosis: a prospective cohort study.
Menopause in multiple sclerosis: therapeutic considerations.
Dalfampridine improves walking speed, walking endurance, and community participation in veterans with multiple sclerosis: a longitudinal cohort study.
Neuropsychological, balance and mobility risk factors for falls in people with multiple sclerosis: a prospective cohort study.
Aerobic exercise increases hippocampal volume and improves memory in multiple sclerosis: Preliminary findings.
Oligoclonal bands and age at onset correlate with genetic risk score in multiple sclerosis.
MOST NEUROLOGISTS IN SCOTLAND DO NOT USE THE MCDONALD 2010 CRITERIA TO DIAGNOSE MULTIPLE SCLEROSIS.
Labels: 500 BEST PML STORIES & STUDIES, Ampyra, Gilenya, PML (Progressive Multifocal Leukoencephalopathy), sativex, Tysabri
Monday's News for Neurologists: Here's 246 New Studies from 10/1 to Monday 10/28:
AUDIT ON INTRAVENOUS IMMUNOGLOBULIN (IVIG) USE IN ABERDEEN ROYAL INFIRMARY NEUROLOGY DEPARTMENT ACCORDING TO 2005 ASSOCIATION OF BRITISH NEUROLOGISTS (ABN) GUIDELINES.
Labels: 500 BEST PML STORIES & STUDIES, Gilenya, PML (Progressive Multifocal Leukoencephalopathy), sativex, Tysabri
Friday
ECTRIMS Congress 2013: TYSABRI: Fast MS Comeback May Ruin Drug 'Holiday'
ECTRIMS Congress 2013: AMSTERDAM -- Stopping natalizumab (Tysabri) to reduce the risk of a rare, life-threatening side effect in patients with multiple sclerosis (MS) carries a steep cost -- the substantial likelihood of renewed disease activity within six months, a researcher said here.
More than half of patients in the randomized, controlled RESTORE trial who switched to methylprednisolone or glatiramer acetate (Copaxone) for six months relapsed or developed new gadolinium-enhancing lesions on brain MRI scans said Robert Fox, MD, of the Cleveland Clinic.
Read more »
Labels: 500 BEST PML STORIES & STUDIES, PML (Progressive Multifocal Leukoencephalopathy), Tysabri
Monday
Natalizumab an Alternative for Those in Whom Other MS Treatments Have Failed
(Posted By: Josi Creek)
A new study suggests that patients with relapsing-remitting multiple sclerosis (RRMS) in whom previous treatment regimens have failed remain stable or show improvement when switched to treatment with natalizumab (Tysabri, Novartis).
Read more »
A new study suggests that patients with relapsing-remitting multiple sclerosis (RRMS) in whom previous treatment regimens have failed remain stable or show improvement when switched to treatment with natalizumab (Tysabri, Novartis).
Read more »
Labels: 500 BEST PML STORIES & STUDIES, Avonex, Betaseron, PML (Progressive Multifocal Leukoencephalopathy), Rebif, Tysabri
Biogen added 1500 new Tysabri patients in the 1st quarter compared to 2,600 patients in the 4th quarter last year-This is the 3rd quarter in a row of declining patient growth
Tysabri's label was recently changed to indicate that the longer patients remain on the drug, the greater their risk of a potentially deadly brain infection called progressive multifocal leukoencephalopathy (PML). Even though Tysabri is a more effective drug, patients are comfortable with inferior but safer options such as Teva Pharmaceutical's Copaxone, Novartis' Extavia, and Rebif from Pfizer.
Read more »
Read more »
Labels: 500 BEST PML STORIES & STUDIES, Extavia, PML (Progressive Multifocal Leukoencephalopathy), Rebif, Tysabri
More Tysabri Problems; Time for a Biogen-Idec Credibility Check
Unsubstantiated whisperings about Biogen Idec and its controversial multiple sclerosis drug took an ugly turn to the truth on Thursday when Europeon regulators disclosed another new case of progressive multifocal leukoencephalopathy, a serious brain infection known as PML, in a relapsed MS patient receiving Tysabri (natalizumab) infusions. With 11 new cases in two months, Biogen is going to face some awkward questions that will challenge the credibility of the company — and its promising MS franchise:
What did they know?
How long have they known it (more PML cases)?
And, how safe are other drugs in the MS pipeline?
In response to an email I wrote to the FDA inquiring as to how many confirmed cases of PML were on file — and were more reports to be expected — spokeswoman Sandra Walsh would only say:
"Yes, there are 24 confirmed cases of PML (since Tysabri re-marketing in 2006). The FDA is still receiving and reviewing follow-up information on cases of PML so we cannot yet comment further.
We’ll keep you posted as we learn more."
The global press will likely scapegoat Biogen management, accusing officials of withholding clinical data on side effects culled from Tysabri-treated patients. Before criticizing chief executive Jim Mullen & Co., however, the American public needs to remember that all current and emerging biological therapies for immune-mediated diseases, such as rheumatoid arthritis, Crohn’s disease, and MS, are imperfectly understood at best. The actual mechanism by which most of these drugs work is often murky, and they can cause unknown side effects as well:
Increasing numbers of invasiv e fungal infections are being reported in patients who have autoimmune inflammatory diseases and are being treated with newer immunosuppressive drugs, such as the well-known tumor necrosis factor (TNF)-alpha antagonist Enbrel (Etanercept), the anti-CD52 antibody Campath (alemtuzumab), or the interleukin-2 receptor antibody Simulect (basiliximab). [Current Infectious Disease Reports, 2009 Nov; 11(6): 435-8]
Or, as Ralf Gold, a well-respected neurologist in residence at Ruhr-University, located in Bochum, Germany, pointed out in a paper published in the New England Journal of Medicine:
“new MS drugs unfortunately have new side effects that can sometimes be fatal. Currently Natalizumab is the focal point of interest throughout the world, but [that] other new drugs, such as Alemtuzumab or anti-CD20 antibodies may soon follow.”
Still, all stakeholders, especially MS patients, have the right to feel both betrayed and angry, as Biogen management appeared to be both evasive and equivocal when answering queries from biotech analysts on the October 20 third-quarter earnings call. For example, as up to 17 worldwide cases of PML had been reported prior to third-quarter end, Eun Yang, biotech analyst at Jeffries & Co, asked management about emerging data suggesting there was a link between duration of Tysabri therapy and increased risk of developing PML.
“When you look at the patients who have been on the treatment for 24-months or longer, PML rate runs around 1 in 800, which is higher than what is in the [prescribing] label,” said Yang. “So, my question to you is what do you think would be the critical threshold of a PML rate where physicians or regulatory agencies would become more cautious on Tysabri?”
“I don’t want to speculate what makes regulators want to do things,” responded chief operating officer Bob Hamm, “but I can assure you that our current thinking is that the risk of PML even in that third year beyond 24-months is within the currently implied risk in the label.”
The current rate of PML in patients who had received at least 24 infusions ranges from 0.4 to 1.3 per 1,000 - patients, according to an FDA Safety Alert Update posted on September 16.
Management also downplayed any safety advantage to “drug holidays” for long-term Tysabri users. Specifically, when asked to comment on the proportion of patients in Biogen’s database where providers implemented drug holidays, senior researcher Al Sandrock tersely replied: “From the data we have — we are seeing very, very isolated cases of that.”
Management also downplayed any safety advantage to “drug holidays” for long-term Tysabri users. Specifically, when asked to comment on the proportion of patients in Biogen’s database where providers implemented drug holidays, senior researcher Al Sandrock tersely replied: “From the data we have — we are seeing very, very isolated cases of that.”
As I referenced in an earlier BNET Pharma posting, about 13,400 patients receiving monthly infusions (or approximately 29 percent of all patients taking the drug) had been on Tysabri therapy for more than two years — paying, on average, $28,500 per year for 13 infusions. It’s easy to do the math, subtract number of infusions and units sold decline.
Short-term, in my opinion, physician and patient distrust could lead to Tysabri (once again) losing market share to Teva Pharmaceutical’s (non-interferon) immunomodulator Copaxone (glatiramer acetate), with harmless injection-site reactions the most annoying of reported adverse events. Data from a 15-year ongoing Copaxone prospective study demonstrating patients treated for 10 and 15 years with the drug had significant reduction in disease severity should stimulate growth in sales, too.
“To stumble twice against the same stone is a proverbial disgrace, ” said the great Roman statesman Marcus Cicero. Not that Jim Mullens need give a Richard Nixon-like Checkers speech: “My fellow Americans.” The goal of Biogen management, nonetheless, is the same as Nixon’s was 50 years ago — damage control with humility. Admit (without admitting liability) that PML is more prevalent than original surveillance data suggested and move forward, working with MS interest groups and the FDA and European regulators to strengthen distribution and monitoring programs at Tysabri infusion centers worldwide. Also, Mullens should remind providers that the drug’s demonstrated 67 percent reduction in the relapse rate tips the risk-benefit scale in Tysabri’s continued favor.
The importance to Biogen of retaining credibility cannot be understated, as the company is racing against European drugmakers Merck KGaA (cladribine) and Novartis AG (fingolimod) to introduce the first oral pill for MS to market. Biogen agreed back in July to pay up to $510 million to market Fampridine SR (sustained-release), an oral tablet owned by Acorda Therapeutics, outside the United States.
The FDA’s Peripheral and Central Nervous System Drugs (PCNSD) Advisory Committee voted 12 to 1 that clinical data on Fampridine-SR 10 mg twice daily, which will sold under the brand name Amaya, has demonstrated substantial evidence of effectiveness as a treatment to improve walking in MS patients. Most experts agree that the drug could likely be on pharmacy shelves in the U.S. by the second quarter of 2010.
Biogen Idec expects to file for approval by the European Medicines Agency (EMEA) in early 2010. However, an unknown here and abroad is whether the therapy will receive a boxed warning for seizure risk (side effect looks to be dose-related). Consequently, the key issue to early adoption by physicians of Fampridine SR will likely, once again, turn on credibility — do neurologists trust Biogen Idec?
Story in BNET
Labels: 500 BEST PML STORIES & STUDIES, PML (Progressive Multifocal Leukoencephalopathy), Tysabri
Sunday
TYSABRI: "Biologic treatment for MS offers hope"
TYSABRI: "Biologic treatment for MS offers hope": Daytona Beach News-Journal
December 18, 2006
Biologic treatment for MS offers hope
By DR. YONG H. TSAI
Susan awoke one day with blurred, obstructed vision along with dizziness and numbness in her legs. A trip to her doctor's office triggered an order for blood tests and an MRI. She was diagnosed with multiple sclerosis (MS), an autoimmune disease involving the central nervous system.
Our brain and spinal cord, that house the main pathway of our body's nerve signals, offer a layer of insulation, called myelin, that surrounds and protects these nerve cells.
Like a plastic cover that surrounds the many wires of an electric cable, myelin covers nerve fibers to ensure that the nerve signals have safe, uninterrupted passage.
With MS, myelin sheaths break down (demyelination), due to inflammation caused by the autoimmune process. Damaged tissue eventually turns into scar tissue (sclerosis), meaning "multiple sclerosis."
Classic symptoms of MS include numbness, visual disturbance, abnormal gait, imbalance, muscle weakness or spasm, urinary incontinence, vertigo, slurred speech and even pain.
There are several forms of MS. Relapsing-remitting MS (RRMS) occurs about 25 percent of the time with intermittent relapses, including worsening of existing symptoms or the development of new ones.
Over the course of 10 to 15 years, more than 50 percent of RRMS will evolve into progressive MS, known for more frequent relapses, incomplete remission bouts and general overall deterioration.
During the past few years, beta interferons such as Avonex, Rebif, Betaseron and Copaxone, by modifying the inflammatory process, have been used to treat MS.
However, all still have side effects and some have poor results. In November 2005, Natalizumab (Tysabri), a biologic agent, was proven to block the function of key molecules. The process could transport immune cells crossing the brain and blood barrier (BBB), and prevent against an attack on one's central nervous system.
Clinical trials have shown Tysabri, administered by monthly intravenous infusion, is a very effective therapy in reducing relapses and decreasing new brain lesions.
However, the shocking news surfaced Feb. 28 that Tysabri was suspended temporarily from commercial distribution due to three serious, adverse events. Multifocal leukoencephalopathy (PML) occurred in clinical trial patients treated with Tysabri plus Avonex.
However, there have been no reports of PML in patients treated with either Tysabri or Avonex alone.
More recently, Tysabri has been permitted for MS treatment. Tysabri is only indicated as a single-agent treatment instead of in combined therapy with Avonex or other agents. It's for patients with the relapsing form of MS and poor response to traditional treatments.
Though there is some concern with rare side effects of Tysabri, this new biologic agent offers new hope.
December 18, 2006
Biologic treatment for MS offers hope
By DR. YONG H. TSAI
Susan awoke one day with blurred, obstructed vision along with dizziness and numbness in her legs. A trip to her doctor's office triggered an order for blood tests and an MRI. She was diagnosed with multiple sclerosis (MS), an autoimmune disease involving the central nervous system.
Our brain and spinal cord, that house the main pathway of our body's nerve signals, offer a layer of insulation, called myelin, that surrounds and protects these nerve cells.
Like a plastic cover that surrounds the many wires of an electric cable, myelin covers nerve fibers to ensure that the nerve signals have safe, uninterrupted passage.
With MS, myelin sheaths break down (demyelination), due to inflammation caused by the autoimmune process. Damaged tissue eventually turns into scar tissue (sclerosis), meaning "multiple sclerosis."
Classic symptoms of MS include numbness, visual disturbance, abnormal gait, imbalance, muscle weakness or spasm, urinary incontinence, vertigo, slurred speech and even pain.
There are several forms of MS. Relapsing-remitting MS (RRMS) occurs about 25 percent of the time with intermittent relapses, including worsening of existing symptoms or the development of new ones.
Over the course of 10 to 15 years, more than 50 percent of RRMS will evolve into progressive MS, known for more frequent relapses, incomplete remission bouts and general overall deterioration.
During the past few years, beta interferons such as Avonex, Rebif, Betaseron and Copaxone, by modifying the inflammatory process, have been used to treat MS.
However, all still have side effects and some have poor results. In November 2005, Natalizumab (Tysabri), a biologic agent, was proven to block the function of key molecules. The process could transport immune cells crossing the brain and blood barrier (BBB), and prevent against an attack on one's central nervous system.
Clinical trials have shown Tysabri, administered by monthly intravenous infusion, is a very effective therapy in reducing relapses and decreasing new brain lesions.
However, the shocking news surfaced Feb. 28 that Tysabri was suspended temporarily from commercial distribution due to three serious, adverse events. Multifocal leukoencephalopathy (PML) occurred in clinical trial patients treated with Tysabri plus Avonex.
However, there have been no reports of PML in patients treated with either Tysabri or Avonex alone.
More recently, Tysabri has been permitted for MS treatment. Tysabri is only indicated as a single-agent treatment instead of in combined therapy with Avonex or other agents. It's for patients with the relapsing form of MS and poor response to traditional treatments.
Though there is some concern with rare side effects of Tysabri, this new biologic agent offers new hope.
Labels: 500 BEST PML STORIES & STUDIES, Avonex, Betaseron, PML (Progressive Multifocal Leukoencephalopathy), Rebif, Tysabri