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09-12-2007, 07:17 PM | #1 | ||
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Newswise — People with multiple sclerosis who stop taking the drug natalizumab may experience a rebound increase in disease activity, according to a study published September 12, 2007, in the online edition of Neurology, the medical journal of the American Academy of Neurology.
The study involved 21 people who had MRI scans of their brains taken before taking natalizumab and again an average of 15 months after receiving the last infusion of the drug. The drug is given by IV infusion once a month. The participants were divided into two groups: one group took the drug for an average of three years, and the other group took the drug for an average of two months. The participants developed more than three times as many brain lesions, or areas of damage in the brain that are a marker of MS disease activity, in the 15-month period after discontinuing the drug than they had developed before they started taking the drug. The results were most pronounced for those who took the drug for only a short time; they developed five times as many brain lesions after stopping the drug than they did before they started taking it. More research needs to be done with larger numbers of patients before any recommendations can be made about use of the drug, according to study author Machteld Vellinga, MD, of VU University Medical Center in Amsterdam, the Netherlands. “For now the recommendations remain the same—patients and their doctors should choose the most applicable treatment for them,” she said. Vellinga said it’s not clear why discontinuing the drug would lead to increased disease activity, although an earlier animal study showed a similar result when rats with an animal model of multiple sclerosis were given a drug that suppresses the immune system. The study came about because use of natalizumab was suspended in 2005 after three people participating in clinical trials for the drug developed a rare, often fatal brain disease called progressive multifocal leukoencephalopathy. “All of our patients had an MRI shortly after the drug was suspended, and our neuroradiologist noticed that in some patients a considerable number of new lesions developed on their MRIs in the following year,” said Vellinga. “We decided to do a formal analysis to see if this was actually the case.” Vellinga noted that the results need to be confirmed in independent groups of patients. The drug was reintroduced in 2006 with specific guidelines for its use and to monitor patients for signs of progressive multifocal leukoencephalopathy. The American Academy of Neurology, an association of more than 20,000 neurologists and neuroscience professionals, is dedicated to improving patient care through education and research. A neurologist is a doctor with specialized training in diagnosing, treating and managing disorders of the brain and nervous system such as epilepsy, dystonia, migraine, Huntington’s disease, and dementia. For more information about the American Academy of Neurology, visit http://www.aan.com. http://www.newswise.com/articles/view/533267/?sc=rsmn |
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09-12-2007, 09:14 PM | #2 | |||
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Grand Magnate
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Yuck!
Well I guess the drug hasn't been out long enough to determine any real patterns yet, but this makes me wonder if Tysabri is just temporarily "holding back" the disease process. I suppose it doesn't matter much if a person stays on the drug forever, but last I heard, some people were advised to take breaks at some point in time. Anyone know if that is still "the plan" for some? Cherie
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09-12-2007, 10:12 PM | #3 | |||
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In Remembrance
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Hi Pantos, how are you doing? We haven't heard from you in awhile.
I had heard that about Tysabri before...sheesh, it's like pick your poison and take your chances.. I also heard that if you had been on TY for a short time, then got off of it, then restarted it, that it didn't work as well??? Thanks for posting.
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~Love, Sally . "The best way out is always through". Robert Frost ~If The World Didn't Suck, We Would All Fall Off~ |
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09-14-2007, 07:22 AM | #4 | |||
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Magnate
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If you look hard enough at small groups of patients, you can come up with a group to fit your needs.
I take issue with this "study". Does it tell us what treatment these patients received after they went off Tysabri? Were they left untreated for 15 months? Did they have any steroids, CRABs, Cellcept, Imuran,Novantrone? Isn't going off a drug an obvious restart to disease activity? MS is CHRONIC. It will reappear and worsen if treatment is stopped. That would be ANY treatment. This issue has been studied in REAL studies. How about this one? http://www.emea.europa.eu/humandocs/PDFs/EPAR/tysabri/H-603-en6.pdf "The study met its primary endpoint in the number of new Gd-enhancing lesions from baseline to month 6 for both dosage groups in favour of natalizumab (p<0.001). After cessation of treatment, i.e. in the 6-month follow-up period (months 7-12), no further treatment effect was observed. Also, the number of new Gd-enhancing lesions did not exceed that of the placebo group, i.e. no rebound effect was observed concerning the number of lesions." Elan and Biogen also addressed this in Phase 2. No rebound effect was observed. Sorry if anyone disagrees. Too much has gone on with published reports funded by competing drug companies. 21 people does NOT make a study. Where's the rest of the people who were on Tysabri?
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I know the sound the river makes, by dawn, by night, by day. But can it stay me through tomorrows that find me far away? . I have this mental picture in my mind of you all, shaking bones and bells and charms, muttering prayers and voodoo curses, dancing around in a circle of salt, with leetle glasses and tiny bottles of cheer in the middle...myyyyyy friends! diagnosed 09/03/2004 scheduled to start Tysabri 03/05 Tysabri withdrawn from market 02/28/05 Copaxone 05/05-12/06 Tysabri returned to market 06/05/06 Found a new neuro 04/07 Tysabri 05/25/07-present Medical Marijuana legally 12/03/09 . Negative for JC virus antibodies! . I'm doing alright and making good grades, The future's so bright, I gotta wear shades! . |
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09-14-2007, 08:21 AM | #5 | |||
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Junior Member
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River...or anyone....
I am having a hard time following what this really means. In the pdf article you linked there seems to be a contridiction, or am I reading this wrong? You quoted supportive phase II study Study MS 231 Quote:
• Rebound after discontinuation Data from the phase II study MS 231, where patients received 6 months of active treatment and a follow-up of additional 6 months after treatment discontinuation, suggested that there might be the danger of a subclinical rebound of MRI lesions, exceeding those in the placebo group. Now I am really confused.
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09-14-2007, 04:30 PM | #6 | |||
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Grand Magnate
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Quote:
- the follow-up period was very short; 6 months - that study focused on gadolinium enhancement (which is said to be a transient phenomenon of MRI disease activity) - this most recent study focused on the cumulative burden of disease (T2 lesions) Cherie
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I am not a Neurologist, Physician, Nurse, or Hairdresser ... but I have learned that it is not such a great idea to give oneself a haircut after three margaritas
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09-14-2007, 07:42 PM | #7 | ||
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This "study" really doesn't say too much other than these patients ended up with a lot more brain lesions...which means just what in MS?!
Lesions come and go in MS patients and there is little if any correlation between lesions and symptoms. It's not the number of lesions, it's the location of them that is important. The study fails to mention if these patients encountered an increase in symptoms and that I find a bit irresponsible. Prior to Tysabri being approved the first time around, there were rumours of this rebound effect with some patients who had to stop the drug for various reasons. In the Affirm and Sentinel trials, it was determined that 6% of the patients ended up with constant, high level antibodies and they had to stop treatment. I've never heard if these patients ended up getting an increase in lesions. I'd also be interested in hearing if potential Tysabri patients are advised of this possibility if they have to stop taking the drug. I'm afraid there is still a lot unknown about this drug and now that thousands of patients have used it for 6 months, we are likely going to start seeing some complications. Let's hope that the MS patients who are using it don't run into any major problem. Harry |
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09-14-2007, 09:38 PM | #8 | |||
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In Remembrance
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Amen Harry....I worry too!
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~Love, Sally . "The best way out is always through". Robert Frost ~If The World Didn't Suck, We Would All Fall Off~ |
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09-17-2007, 04:44 PM | #9 | |||
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Grand Magnate
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Quote:
http://www.nationalmssociety.org/sit...rch_2007sept14 Cherie
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I am not a Neurologist, Physician, Nurse, or Hairdresser ... but I have learned that it is not such a great idea to give oneself a haircut after three margaritas
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09-22-2007, 08:21 PM | #10 | ||
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Hi Cherie,
Just to let you know that Marg is in the hospital with Pancreatitis and is quite sick. She had been feeling lousy for several weeks and was seeing a specialist when it got worse quite quickly. She'll likely be there for 7-10 days or longer. Harry |
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