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Saturday, May 19, 2012

While U.S. Patients Report High Levels of Satisfaction with Current DMAs, Switching Interest is Highest among Patients for Sanofi / Genzyme’s Teriflunomide and Biogen Idec’s BG-12, According to a Recent BioTrends Report



EXTON, Penn.--()--BioTrends Research Group, one of the world’s leading research and advisory firms for specialized biopharmaceutical issues, finds that patients diagnosed with multiple sclerosis (MS) view themselves as key decision-makers in the management and treatment of MS in equal partnership with their neurologist. According to the recently published PatientTrends®: Multiple Sclerosis (U.S.), patients’ perceptions of their influence are supported by the high percentage (71 percent to 100 percent) of disease-modifying agent (DMA) brand requests which were recalled to have been honored by their neurologists. And, perhaps as a result of being highly involved in brand decisions, MS patients tend to give uniformly high ratings for current DMA brand satisfaction, advocacy, and loyalty. In fact, MS patients rate their current DMAs higher compared to neurologists as seen when patient–reported data are compared with physician-reported data from the recently published TreatmentTrends®: Multiple Sclerosis Q1 2012 (U.S.). The satisfaction gaps between the two groups are greatest for Biogen Idec’s Avonex and Novartis’s Gilenya suggesting that patient satisfaction can be a major influence on persistency for these brands.
Similar to physician-reported perceptions in TreatmentTrends: Multiple Sclerosis, the 299 surveyed MS patients rate efficacy attributes as most important in the brand decision process. However, depending upon their current DMA, patients do differ significantly on how important attributes related to safety, drug cost, patient assistance, and dosing frequency are to them. As an example, patients currently treated with Bayer’s Betaseron rate drug cost as significantly more important compared to all other patients. Finally, two-thirds of patients report being aware of the anti-JC virus antibody assay and, among the few patients currently treated with Biogen Idec’s Tysabri who are known to be seronegative, confidence is high in the PML risk stratification algorithm.
The PatientTrends: Multiple Sclerosis (U.S.) report also finds that the MS patient journey frequently began with patients experiencing symptoms — often abnormal sensory perceptions — and making an appointment with the doctor within one month of symptom onset. Only one out of ten patients are diagnosed at this initial visit perhaps due to the high percentage of patients who first turn to their PCP for medical care. Once diagnosed, most patients start their first-line DMA within six months of diagnosis. Interestingly, patients currently on Betaseron or Pfizer / EMD Serono’s Rebif, both high dose, high frequency interferons, recall having waited significantly longer to start their first-line DMA compared to patients started on the low dose, low frequency interferon, Avonex. Since being diagnosed with MS, 82 percent of patients report having participated in some type of pharmaceutical company-sponsored program. Betaseron and Teva’s Copaxone receive especially high marks for their medical support and financial assistance programs, respectively.

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Could Your MS Diagnosis Be Wrong?



An alarming study finds that MS is often diagnosed in people who do not have it.

MAY 16, 2012









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Researchers surveyed 122 doctors who specialize in multiple sclerosis and found that more than 95% of them had seen at least one patient within the past year who had received a diagnosis of MS from another doctor, but whom the specialist "strongly felt did not in fact have MS." In all, the group had seen almost 600 MS patients within the past year who they strongly believed had been misdiagnosed. Many of those misdiagnosed patients had begun MS medications and treatments, which can have potentially serious side effects and can cost $40,000 per year.
Some of the conditions the doctors believed the misdiagnosed patients may have had instead of MS: small vessel ischemic disease (which is often related to hypertension), migraine, psychological disorders, neuromyelitis optica, and fibromyalgia. Many of the MS specialists said a significant percentage of these misdiagnosed patients had already begun disease-modifying therapy for MS, which carries potentially serious side effects and can be very expensive, often at least $40,000 per patient per year.
Now, if you or a relative has been diagnosed with MS, this study does not mean you should question it. "There are many cases of MS that are very typical and not challenging to diagnose, which means diagnostic criteria are validated by specific symptoms combined with particular MRI abnormalities," says study author Andrew Soloman, MD, who worked at Oregon Health and Sciences University and the Portland Veterans Affairs Medical Center when he conducted the study, and now is now an assistant professor at the University of Vermont College of Medicine and is a member of the University of Vermont Medical Group Neurology Service at Fletcher Allen Health Care. "But sometimes doctors see changes on an MRI that could be caused by something else, chronic hypertension or migraine for example, and even if the symptoms aren't quite right they might diagnose MS." In that case a better plan, he says, would be to monitor symptoms over time instead of making a diagnosis and starting therapy. "Our finding that misdiagnosis of MS was this common has significant consequences for patients and for our health care system," says Soloman.
Even more troubling, about one in seven of the MS specialists surveyed said that they had sometimes chosen not to inform the patients that their initial diagnosis was inaccurate. Some of the reasons given for not informing the patients: The doctors thought that telling the patients the truth could harm them psychologically and they worried that a change in diagnosis could result in the patient losing needed social support or disability benefits. Another factor could be simply the awkwardness of telling patients that they've been misdiagnosed: A majority of doctors surveyed said that informing a patient long thought to have MS that he or she was likely misdiagnosed was actually more difficult than giving a patient a new, accurate MS diagnosis.
This seems strange, because from the patient's perspective I would think being told that you do not, after all, have a degenerative neurological condition would be fantastic news and a huge relief. But keep in mind that these patients suffer from a  .... CLICK HERE to continue reading



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A Free MS Seminar in Spanish on SYMPTOM MANAGEMENT - May 23rd at 6pm



MS Views and News
Invites you to this Multiple Sclerosis Educational Program  


SYMPTOM MANAGEMENT   - MANEJO DE SINTOMAS   
 FUTURE MEDICATIONS 
- MEDICACIONES tratamiento en el futuro


This program will be in Spanish only

RSVP REQUIRED

Topic:
Su Vida Con Esclerosis M├║ltiple
Living with Multiple Sclerosis

Una Programa en Espa├▒ol solamente
This program will be in Spanish only

Presented by:
Carlos Ramirez-Calderon, MD -Neurology

Date:   Wednesday, May 23rd, 2012

6:00 pm – Registration
6:30 pm – Program
Complimentary Lite-Dinner

Location:
InterContinental Hotel en Doral
2505 NW 87th Ave. – Miami, Fl. 33172


To obtain a confirmation number
Respond via email to: info@msviewsandnews.org
RSVP BY MONDAY MAY 21st 2012




Program Sponsored with an Education Grant from:
 Teva Neuroscience

Display Tables provided by:
Questcor Pharmaceutical,
 Teva Neuroscience, 
Univ of Miami Genome Study,
Biogen and Acorda Therapeutics







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Friday, May 18, 2012

New Analysis of Risk Stratification for TYSABRI® Published in New England Journal of Medicine


18 May 2012
- Use of Biomarker has Potential to Advance Personalized Treatment for MS Patients -


WESTON, MA, USA & DUBLIN, Ireland I May 17, 2012 I Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) today announced that the New England Journal of Medicine published research from the companies’ global risk management program that updates the risk of TYSABRI® (natalizumab)-associated progressive multifocal leukoencephalopathy (PML), an infrequent but serious brain infection that usually leads to death or severe disability, in people with multiple sclerosis (MS). The analysis looked at three risk factors associated with a patient’s PML risk: anti-JC virus (JCV) antibody status, use of immunosuppressant (IS) therapy prior to TYSABRI initiation, and longer duration of treatment with TYSABRI.


Biogen Idec and Elan developed the quantitative risk stratification algorithm to help physicians and people with MS have more confidence in their treatment decisions when considering TYSABRI, a highly effective treatment for relapsing forms of MS.


“By identifying these risk factors and incorporating them into our risk stratification algorithm, we bring the advantages of personalized medicine to MS,” said Alfred Sandrock, M.D., Ph.D., senior vice president, development science and chief medical officer, Biogen Idec. “This approach to treatment is intended to help patients better understand their individual benefit-risk profiles when considering TYSABRI as a treatment option.”


About the Research
Researchers used data from clinical studies, post-marketing sources, and an independent Swedish registry to estimate the incidence of PML among TYSABRI-treated patients. Data as of Feb 29, 2012 from 212 confirmed cases of PML among 99,571 TYSABRI-treated patients were used to develop a risk stratification algorithm based on three established risk factors for PML: anti-JCV antibody status, prior use of IS therapy, and duration of treatment with TYSABRI (one to 24 months vs. 25 to 48 months). Based on the presence or absence of these risk factors, patients were divided into distinct subgroups at lower or higher risk for the development of PML.

The risk of PML increased with longer duration of TYSABRI treatment, with the greatest increase observed after two years of therapy. Data beyond four years of therapy were limited.




Blood samples from 5,896 MS patients who participated in three clinical studies - AFFIRM , STRATIFY-1, and the U.S. arm of the TYSABRI Global Observational Program in Safety [TYGRIS] study - as well as blood samples from patients included in the Swedish Multiple Sclerosis registry, were tested for anti-JCV antibodies.


In addition, data from 54 TYSABRI-treated patients who developed PML and had blood samples collected six to 187 months before they were diagnosed with PML were tested for anti-JCV antibodies; all samples tested positive for anti-JCV antibodies.


Data on prior IS use were not available for all patients taking TYSABRI. 


Therefore, the proportion of prior IS use within the global TYGRIS studies (U.S. and Rest of World) were used to estimate prior IS use in the overall TYSABRI-treated population.


Results
The risk of PML increased with longer duration of TYSABRI treatment, with the greatest increase observed after two years of therapy. Data beyond four years of therapy were limited.


Prior IS use was more common in patients who developed PML (34.5%) compared to patients in the global TYGRIS study (20.3%), indicating that prior IS use was associated with an increased risk of PML.



The prevalence of anti-JCV antibodies in the general MS population was 54.9 percent (95% confidence interval [CI], 53.7 – 56.2) and differed from the 100 percent anti-JCV antibody positivity observed in the 54 MS patients who developed PML and had known pre-PML anti-JCV antibody status. Because all 54 MS patients with known pre-PML anti-JCV antibody status tested positive, a sensitivity analysis assuming one hypothetical anti-JCV antibody negative PML patient was used to estimate the PML risk in antibody negative patients.
Anti-JCV antibody status, combined with prior IS use and TYSABRI treatment duration were used to stratify patients at lower or higher risk for the development of PML. There was an approximately 120-fold difference between patients in the lowest and highest risk groups. Patients who were anti-JCV antibody negative were at the lowest risk for PML with an estimated risk of 0.09 cases or fewer per 1,000 patients (95% CI, 0 to 0.48).

The highest risk of PML was found in patients who had received 25 to 48 months of TYSABRI treatment, had been treated with an IS therapy before TYSABRI treatment was initiated, and were positive for anti-JCV antibodies. The PML incidence in this group was estimated to be 11.1 cases per 1,000 patients (95% CI, 8.3 to 14.5).

The authors concluded that data from prospective studies are needed to further characterize these risks.

“Although TYSABRI has proven efficacy, the risk of PML has been a cause of concern for patients," said Ted Yednock, head of global research at Elan. "This analysis illustrates how the risk stratification model we have developed with Biogen Idec can help physicians and MS patients make more informed treatment decisions."

About the Risk Stratification
The TYSABRI U.S. label and EU Summary of Product Characteristics were updated to add anti-JCV antibody status as a risk factor for PML. In addition to prior IS therapy and duration of TYSABRI therapy, anti-JCV antibody status is the third factor in the risk stratification model developed by Biogen Idec and Elan that helps identify a patient’s risk for developing PML. Physicians can determine their MS patient’s anti-JCV antibody status by using the STRATIFY JCV assay, the first blood test to be market authorized for the qualitative detection of antibodies to the polyomavirus JC virus.


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MS in Northern Scotland More Prevalent than Anywhere else



Author: MS Trust
Newly published research shows that the prevalence of multiple sclerosis is particularly high in northern Scotland and that Orkney has the highest level of MS in the world.
Researchers at the University of Aberdeen searched medical records to identify people with MS living in Aberdeen, Shetland and Orkney. From this they calculated that the prevalence rates were 229 people per 100,000 in Aberdeen, 295 in Shetland and 402 in Orkney. The rate for the UK as a whole is thought to be about 160.
These rates all showed increases from similar studies 30 years ago, particularly in Orkney. Prevalence was higher in women than men (2.55:1) which means that about 1 in 170 women in Orkney have MS.
Researchers suggest that reasons for the increase could include the rising ratio of women with MS and factors linked to the interaction of genes and the environment.
Visser EM, et al.
A new prevalence study of multiple sclerosis in Orkney, Shetland and Aberdeen city.
Journal of Neurology, Neurosurgery and Psychiatry. 2012 May 10. [Epub ahead of print]
Abstract

Source: http://www.mstrust.org.uk/news/article.jsp?id=5388&dm_i=157R,T6YT,5SOYLQ,2DU6J,1

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Thursday, May 17, 2012

Comprehensive Longitudinal Investigations - An MS webcast



The National MS Society
and MS Learn Online invite you to view..   
   

This video provides an overview of the Comprehensive Longitudinal Investigations (CLIMB) at the Brigham Women's Hospital. The study follows 2,000 people with MS over a 10 year period and studies how MS changes over time. 



 Click here to view the webcast, or copy into your 
browser:



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Monday, May 14, 2012

Vascular Expert Supports FDA Warning about Experimental Therapy for MS Patients



MIAMI, May 11, 2012 (BUSINESS WIRE) -- An internationally acclaimed expert in endovascular treatments supports the Food and Drug Administration's warning about the dangers of an experimental therapy for multiple sclerosis and calls for FDA approved clinical trials to study the connection.
Barry Katzen, M.D., founder and medical director of Baptist Cardiac & Vascular Institute in Miami, advocates a controlled clinical trial to obtain credible evidence that the experimental procedure to treat chronic cerebrospinal venous insufficiency (CCSVI) is beneficial for MS. The FDA reported injuries and death related to the therapy.
"Any new treatment like this gives hope to people with multiple sclerosis. Because it is a high-risk procedure, we need new clinical trials to obtain evidence that confirms it is truly effective in treating multiple sclerosis," said Dr. Katzen, who has performed the procedure in other instances.
Some researchers believe that CCSVI, distinguished by a narrowing of veins in the neck and chest, either may cause or contribute to MS by blocking blood flow from the brain and upper spinal cord.
The FDA warned researchers who use balloon angioplasty devices and stents for widening the veins they must comply with FDA regulations for investigative trials. Clinical studies considered to be high risk require the necessary FDA approval, called an investigational device exemption.
SOURCE: Baptist Cardiac & Vascular Institute in Miami
        
        For Baptist Cardiac & Vascular Institute in Miami 
        Melissa Lichtenheld, 305-372-1234 
        mlichtenheld@wraggcasas.com

Article source, click here




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