Navigation Links
Stopping Tysabri May Worsen MS

Small study finds increase in disease-linked brain lesions

THURSDAY, Sept. 13 (HealthDay News) -- People suffering from multiple sclerosis who stopped taking the controversial drug Tysabri experienced a resurgence of brain lesions associated with their disease, researchers report.

But experts countered that the study was a small one and needs further confirmation.

"It's a valid report, [but] the study only involved 21 people," noted Dr. Randall Light, clinical assistant professor of family and community medicine with the Texas A&M Health Science Center College of Medicine and a neurologist with the Texas Brain and Spine Institute. "It's a heads-up for other researchers to share information," said Light, who was not involved in the study.

"This is an observation that needs further investigation and confirmation," agreed another expert, Dr. John Richert, executive vice president of research and clinical programs at the National Multiple Sclerosis Society in New York City.

Patients currently taking the drug should not discontinue it without seeking advice, the experts stressed.

"People taking the drugs should talk to a neurologist before," Light continued. "For patients, it just means don't stop taking the drug without talking to your doctor."

The findings were published Sept. 12 in the online edition of Neurology.

Tysabri (natalizumab), a monoclonal antibody, has been placed under a cloud of controversy for some time. The drug works by attaching itself to white blood cells called lymphocytes and preventing them from entering the brain, where they do damage that causes the disabling symptoms of MS. Tysabri had also been used to treat Crohn's disease.

But the drug has a checkered past. It first received U.S. Food and Drug Administration approval in November 2004, only to be pulled from the market three months later after several patients in clinical trials developed a rare but deadly viral infection of the brain called progressive multifocal leukoencephalopathy.

In June 2006, the FDA allowed the drug to return to the market, but with strict conditions. According to the new guidelines, Tysabri can only be administered by approved doctors, at infusion sites and pharmacies that register and comply with a patient-safety program designed by Biogen-IDEC, the maker of Tysabri, and approved by the FDA.

According to the U.S. National Institutes of Health, multiple sclerosis is an unpredictable disease of the central nervous system that can range from relatively benign to somewhat disabling, to devastating, as communication between the brain and other parts of the body is disrupted.

Many researchers believe MS to be an autoimmune disease, one in which the body, through its immune system, launches a defensive attack against its own tissues. In the case of MS, it is nerve-insulating myelin tissue that is under assault.

This trial was initiated after a neuroradiologist noticed that some patients were developing new lesions (as evidenced on MRI) after their Tysabri was discontinued.

All participants in this trial had had MRIs of their brains taken before starting Tysabri. They then had another such scan taken an average of 15 months after receiving the last infusion of the drug.

Participants were divided into two groups -- one which had taken the drug for an average of three years and one which had taken Tysabri for an average of only two months.

MRI scans revealed that participants developed more than triple the number of brain lesions (damaged areas) in the 15-month period since stopping the drug than they had developed before starting it. Those who had taken the drug for the shorter interval showed the most disease activity.

"Virtually all of the high-rebound figure came from the group that had a mean duration of therapy of only two months. I think that's relatively reassuring for the drug," Richert said.

MS symptoms did not show any sign of relapse, the team added.

The findings are in conflict with a previous study which found that people who had come off Tysabri did not show any rebound, Richert added. But the studies were a little different.

"They varied enough that both might be right, but we just don't know that yet," Richert added. "Nevertheless, this is something that needs further study. I don't think that at this point it changes the way physicians and people with MS should be using the drug. We continue to need to be vigilant in the use of Tysabri."

More information

The National Multiple Sclerosis Society can tell you more about multiple sclerosis.

SOURCES: Randall Light, M.D., clinical assistant professor, family and community medicine, Texas A&M Health Science Center College of Medicine, and a neurologist, Texas Brain and Spine Institute; John Richert, M.D., executive vice president, research and clinical programs, National Multiple Sclerosis Society, New York City; Sept. 12, 2007, online edition, Neurology

Copyright©2007 ScoutNews,LLC.
All rights reserved

Related medicine news :

1. Therapy for stopping the spread of cancer cells
2. Stopping Prostate Cancer from Spreading
3. Stopping The Progression Of Parkinsons Disease
4. Stopping The Growth Of Viruses
5. Stopping The Growth Of Viruses
6. The Consequences Of Stopping Physical Activity
7. Study Finds Parkinson’s Cell Death Blocked by Stopping Inflammatory Facto
8. The Odds Of Stopping Smoking
9. Warning Issued by FDA on consumption of the drug Tysabri used to treat Multiple Sclerosis
10. FDA Issues Public Health Advisory on Tysabri, a New Drug for MS
11. Multiple Sclerosis drug, Tysabri banned due to neurological disorders
Post Your Comments:
(Date:10/13/2017)... ... 2017 , ... As health professionals work to improve their approach to healthcare, ... doing more than filling out a survey; in many cases health professionals and patients ... health care and research on the importance of active engagement with patients and members ...
(Date:10/13/2017)... ... October 13, 2017 , ... ... ‘17, and Jennifer Huggins, PharmD ’17, along with clinical associate professor Janice ... of cardiovascular diseases during the 15th Annual Women’s Health Conference. The SIU ...
(Date:10/13/2017)... ... October 13, 2017 , ... Ellevate Network, the leading network ... advocate for action towards gender equality at their inaugural Summit in New York City ... and reached a social audience of over 3 million. To watch the Mobilize Women ...
(Date:10/13/2017)... ... ... Journey: From the Mountains to the Mission Field”: the story of a missionary couple ... From the Mountains to the Mission Field” is the creation of published author, Carole ... and currently teaches a class of ladies at her church, which she has taught ...
(Date:10/12/2017)... ... October 12, 2017 , ... The company has developed ... consumer and regulatory authorities worldwide. From Children’s to Adults 50+, every formula has ... highest standard. , These products are also: Gluten Free, Non-GMO, Vegan, Soy ...
Breaking Medicine News(10 mins):
(Date:10/12/2017)... Pa. , Oct. 12, 2017 ... leader in innovative solutions for injectable drug administration, today ... before the market opens on Thursday, October 26, 2017, ... the results and business expectations at 9:00 a.m. Eastern ... (U.S.) or 253-336-8738 (International). The conference ID is 94093362. ...
(Date:10/10/2017)... , Oct. 10, 2017  NDS received FDA 510(k) clearance in ... medical-grade battery-powered display stand specifically designed for endoscopy environments. An innovative ... into a clinical solution to support the improvement of patient outcomes, ... Design ... Solution ...
(Date:10/4/2017)... 4, 2017  According to the Centers for Disease Control and Prevention ... . PhysicianOne Urgent Care is helping communities across Massachusetts ... , by offering no-cost* flu shots through the end of the month. ... health insurance regulations. ... to get a flu shot is by the end of October, according ...
Breaking Medicine Technology: