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August 27, 2010 — Researchers from Biogen Idec Inc and Elan Corporation Inc say they have developed an enzyme-linked immunosorbent assay (ELISA) that can detect JC virus (JCV) antibodies in serum and plasma.
They hope that with further research the assay could be used to identify patients with multiple sclerosis (MS) at greatest risk of developing progressive multifocal leukoencephalopathy (PML) associated with natalizumab treatment (Tysabri) and help guide use of this immunosuppressive agent.
Data from preliminary analyses of the assay were released online August 24 in Annals of Neurology and will appear in the journal's September issue.
PML and Natalizumab
PML is a rare but serious and often fatal adverse effect of natalizumab, characterized by progressive damage or inflammation of the white matter of the brain at multiple locations. Infection with JCV is a prerequisite for PML development.
Natalizumab was temporarily pulled from the market in 2005 after being linked to PML but was reintroduced in 2006 with stricter safety warnings. To date, there are 63 confirmed cases of natalizumab-associated PML, including 12 deaths, according to a statement issued Tuesday by Elan Corp. "The global PML rate is still within the 1 in 1,000 rate previously seen in clinical trials," the statement reads. Some 52,700 patients continue to take the drug around the world, according to the company.
In the new report, Leonid Gorelik, PhD, from Biogen Idec Inc, and colleagues developed and analytically validated a "sensitive and specific" 2-step ELISA for anti-JCV antibodies. (Development and testing of the assay was funded jointly by Biogen Idec Inc and Elan Corporation Inc.)
Using ELISA in a large, geographically diverse sample of 831 MS natalizumab-treated MS patients, the researchers found that 53.6% tested positive for anti-JCV antibodies (95% confidence interval, 49.9% – 57.3%). "The false-negative rate of the ELISA was calculated to be approximately 2.5%, with an upper 1-sided confidence limit of 4.4%," they report.
This assay "suggests that only 53% of the population has been exposed to the JC virus as opposed to earlier studies, which suggest that close to 80% of the population had been exposed," Lily Jung Henson, MD, director of the neurology clinic at the Swedish Neuroscience Institute/Swedish Physicians Division, Seattle, Washington, and member of the American Academy of Neurology, noted in an email to Medscape Medical News.
"This is obviously good news in terms of the risks of developing PML being less in the general population than originally thought," said Dr. Jung Henson, who was not involved in the research.
"Notably," Dr. Gorelik and colleagues say, all 17 (100%) of the pre-PML samples available from natalizumab-treated patients who were eventually diagnosed as having PML were seropositive for anti-JCV antibodies.
"If these numbers can be confirmed," Dr. Jung Henson said, "it means we can identify which patients have not been previously exposed to the JC virus and therefore can be treated with natalizumab without fear of developing PML. Those who are positive will make a more informed decision about the risks they face in taking natalizumab."
Dr. Gorelik and colleagues say further clinical studies are under way to confirm their results "and to determine whether our assay may be a useful tool for stratifying natalizumab-treated MS patients for higher and lower risk of PML."
Looking for JCV in Blood, Urine Not Useful
In a companion paper in Annals of Neurology, Richard A. Rudick, MD, from the Cleveland Clinic Mellen Center for Multiple Sclerosis in Ohio, and colleagues from Biogen Idec and elsewhere report that measuring JCV DNA in blood or urine using currently available methods is "unlikely to be useful at predicting PML risk in natalizumab-treated MS patients."
Their findings are based on a total of 12,850 blood and urine samples from nearly 1400 MS patients from natalizumab clinical trials.
Using the ViraCor quantitative polymerase chain reaction (PCR) assay, they detected JCV DNA in 4 of 1397 patients (0.3%) from the Dose Suspension Safety Assessment study. A more sensitive quantitative PCR from the National Institutes of Health confirmed these positive samples and detected JCV DNA in an additional 2 of 205 patients (1%) who tested negative with the ViraCor assay, they say.
None of these 6 JCV DNA–positive, natalizumab-treated patients developed PML, the investigators report.
In the Safety of Tysabri Redosing and Treatment, or STRATA, study, JCV DNA was detected in plasma of 6 of 1094 patients (0.3%), none of whom developed PML. Urine was assessed at baseline and week 48 of natalizumab treatment in 224 of these patients, yielding positive results in 58 (26%) at baseline and 55 (25%) at week 48. JCV DNA was not found in any peripheral blood mononuclear cells (PBMCs) from any of the 1094 patients before or after natalizumab treatment.
"In 5 patients who developed PML," the researchers report, "JCV DNA was not detected in blood at any time point before symptoms first occurred.
"The commercial test used to test the presence of JC virus DNA in blood and urine was not useful in identifying patients who developed PML and showed presence of JC virus in those who did not go on to develop PML," Dr. Jung Henson noted.
Dr. Rudick and colleagues point out that the rates of JCV DNA in blood and urine of natalizumab-treated patients in their analyses are consistent with several other reports from smaller numbers of patients that found increased JCV DNA in plasma, PBMCs, or urine after 15 to 30 months of treatment.
They are inconsistent, however, with 2 recent reports, in which JCV DNA was detected in urine from 64% of 19 patients treated with natalizumab for 1 year and in plasma and PBMCs after treatment for 18 months (N Engl J Med. 2009;361:1067-1074 and J Neurol.2010;257:264-272).
Possible explanations for the discrepant findings include "differences in assay methodologies, sample handling (particularly in samples with low DNA copy number), and chance occurrence in a small cohort," Dr. Rudick and colleagues speculate.
The first study was jointly funded by Biogen Idec Inc and Elan Corporation. All of the study authors of the first paper are employees of these companies. The data for the second report were derived from the National Institutes of Health Laboratory of Molecular Medicine and Neuroscience and were shared with Biogen Idec under a collaborative agreement. Dr. Rudick and 3 coauthors on the second study have received consulting fees from Biogen Idec. The other coauthors are employees of Biogen Idec. Dr. Jung-Henson has disclosed no relevant financial relationships.
First, let it be said that what I write here on this blog posting is just my opinion.
For many it will be seen and understood as either a positive or a negative and as I explained to someone yesterday who is fed-up with many things being told to the ms community, there are positives and negatives to everything in life.
That for every positive, there is a negative,,,
Almost everyday, I am asked my opinion on drugs (medications) in circulation or of those being studied. And so, here is what I see/think with medications soon on the horizon and for some already on the market.
Like Tysabri, during clinical trials there was no problem with PML and like many of these other meds in final studies or getting ready for approval, there also are not many problems to keep it from being launched. It's not until thousands begin using the medications that problems are then discovered, that were not known to happen during the trials... Are the negatives being held back so that the drug is launched? This I can not answer. There are risks and potential side effects to everything you use or do, in life. It's what risks you want to take to enjoy the life you have.... Some sky dive or go bungee jumping. These are things I would not choose to do and instead I find joy and happiness in other things, like providing "you" with information" and doing other forms of entertainment. Yet getting back to those that Sky dive, many of you will say hey that is way too risky for me to do..
And then there are those that know that taking certain medications may be more risky than others, but have found that without taking that particular medication, that their level of "QOL" (quality of life) did not measure-up, prior to that medication.
So, in essence, taking a specific path or using a certain medication may be the same for those, that Skydiving or bungee jumping, may be for others...... Get my drift?
I hope to see your comments. Here at this blog posting or on my facebook page, where this article will feed-to, as soon as it gets published.....
Have a great day everybody... Regards, Stuart Schlossman
Cherie Binns commented on your note "Cladribine and Natalizumab can adversely interact".
"I'd like to clear some confusion. As far as I know, there IS NO DRUG in oral form that will do what Tysabri does. I think this is a mistaken impression placed on our minds by a NARCOMS Cleveland Clinic questionnaire which went out recently looking at people's methods of making decisions regarding their therapy. They had one series of questions talking about the effectiveness of Tysabri and said "if a pill that did the same thing were to exist and you had a 1:1000 chance of dying in your sleep the next night, would you take that chance?" There is no pill that does that! It was a confusing questionnaire and , for some, maybe even damaging by the ideas it placed in thought."
In 2010, when someone receives bad news from their doctor, their first stop is often their home computer. This trend is a double edged sword according to many physicians. Their patients are both more knowledgeable about their diagnosis and treatment options, and more likely to run across erroneous information presented as fact. One thing is certain, the days of patients saying, "Whatever you think best, Doctor” are fading away as more people take responsibility for their health care and demand more of their physicians.
The Internet has certainly changed the isolation that many people felt in the past. Someone diagnosed with the rarest of conditions, can, within minutes on the Internet, connect with someone else with the same condition. And sometimes, knowing that you're not alone is medicine in itself.
That kind of reaching out and connecting helped Ann Cherry, 56, to find information and resources which led her to an alternative treatment for her Multiple Sclerosis (MS) three years ago.
Ann was diagnosed with MS in 1998 at the age of 44. Her physician started her on an interferon drug, one that had been available only since 1995. Current cost is about $2500/month. After 8 years of use, both she and her physician agreed that the interferon drug was not helping and she stopped using it. Her physician wanted to try a new, yet more expensive ($7600/month) drug with some scary potential side effects and Ann declined. At about that time, she heard about a drug that was the subject of much talk on an Internet MS discussion group. And that's when it got interesting.
A primer on MS: MS is a chronic, progressive disease that attacks the Central Nervous System (CNS) which includes the brain, spinal cord and optic nerves. In MS, the body's own defense (immune) system attacks the myelin or protective cover over the CNS nerves. When this cover is damaged, the nerve impulses traveling to and from the brain and spinal cord are distorted or blocked. There are several types of MS. The progress, severity and symptoms of MS are unpredictable and vary from one person to another. Most people are diagnosed between age 20-50, but MS is also seen in teens and young children as well as older adults. Women are more likely to have MS than men. There are 400,000 people in the US with MS, 2.1 Million world-wide.
REGINA — An upcoming meeting of the country's health ministers should help shed light on which provinces might be willing to fund clinical trials of an unproven treatment for multiple sclerosis, says Saskatchewan Health Minister Don McMorris.
"I think there will be some clarity. Whether we'll all be on the same page may be a different story," said McMorris, who will go to St. John's, N.L., for the gathering next month.
After initially standing mostly alone in its pledge to finance trials of the so-called liberation procedure, the Saskatchewan Party government is now seeing interest from other provinces.
The latest is Newfoundland and Labrador, which this week indicated it would consider putting funds into a clinical trial to test the procedure — a turnabout from earlier this month when, at a meeting of the country's premiers, Saskatchewan Premier Brad Wall was offered only moral support.
BRITAIN: Justin Gover does not look like a drug dealer. But he is, albeit a legal one. Neither does he look much like a hero. But he could well become one to the 100,000 people who suffer from multiple sclerosis in Britain after producing a medicine that has been shown to relieve the pain associated with the disease.
The discovery may also put an end to MS sufferers' widespread dependence on cannabis which many have used for decades to alleviate symptoms of the disorder.
In June, GW Pharmaceuticals, at which Gover is managing director, launched Sativex in the UK.
It was a world first - the only cannabis-based treatment to get a green light from medical authorities for use as a prescription drug.
Scientists have found that vitamin D influences more than 200 genes, including ones related to cancer and autoimmune diseases like multiple sclerosis -- a discovery that shows how serious vitamin D deficiency can be.
Worldwide, an estimated one billion people are deficient in vitamin D, and a team of scientists from Britain and Canada said health authorities should consider recommending supplements for those at most risk.
"Our study shows quite dramatically the wide-ranging influence that vitamin D exerts over our health," said Andreas Heger of the Functional Genomics Unit at Britain's Oxford University, who led the study. Vitamin D effects our DNA through something called the vitamin D receptor (VDR), which binds to specific locations of the human genome.
Heger's team mapped out these points and identified more than 200 genes that it directly influences. Vitamin D deficiency is a well-known risk factor for rickets, and some evidence suggests it may increase susceptibility to autoimmune diseases such as multiple sclerosis (MS), rheumatoid arthritis and type 1 diabetes, as well as certain cancers and even dementia. With this is mind, the group looked at disease-associated regions of the gene map to see if they had higher levels of VDR binding. They found VDR binding was “significantly enriched" in regions linked to several common autoimmune diseases, such as MS, type 1 diabetes and Crohn's disease, as well as in regions associated with cancers such as leukaemia and colorectal cancer.
Sreeram Ramagopalan, of the Wellcome Trust Centre for Human Genetics at Oxford University, said the results, published on Monday in the journal Genome Research, showed "just how important vitamin D is to humans, and the wide variety of biological pathways that vitamin D plays a role in."
Most Vitamin D is made by the body as a natural by-product of the skin's exposure to sunlight. It can also be found in fish liver oil, eggs and fatty fish such as salmon, herring and mackerel, or taken as a supplement. Some experts say that up to half the world's population has lower than optimal levels of vitamin D, and that about one billion people are actually vitamin D deficient. The problem is getting worse as people spend more time indoors.
A study published in March found that vitamin D is vital for activating the immune system's killer cells, known as T cells, which remain dormant and unaware of threats from infections if vitamin D is lacking in the blood. Ramagopalan said the latest study suggested vitamin D played a role "in susceptibility to a host of diseases" and that health authorities should consider giving supplements to pregnant women and young children as a preventative measure.
"Vitamin D supplements during pregnancy and the early years could have a beneficial effect on a child's health in later life," he wrote. "Some countries such as France have instituted this as a routine public health measure." There are no definitive studies on the optimal daily dose of vitamin D but some experts recommend 25 to 50 micrograms.