Study shows Tysabri may aid in quality of life
By Stephen Heuser, Globe Staff | April 8, 2006
Patients taking the multiple sclerosis drug Tysabri showed improvement in several important quality-of-life measurements, according to the results of studies presented at a medical conference this week.
The findings, from two studies sponsored by the drug's makers, Biogen Idec Inc. of Cambridge and Elan Corp. of Ireland, provide new evidence of the effectiveness of a treatment that was pulled off the market last year after two patients taking it died of a rare brain infection.
The Food and Drug Administration is considering whether to allow Tysabri sales to resume.
The new report analyzed data from earlier Tysabri studies to see whether the drug could improve patients' lives and alleviate MS symptoms. It measured such factors as energy level, vision, bowel and bladder function, and mental health. It was presented on Thursday at the American Academy of Neurology meeting in San Diego by Richard Rudick of the Cleveland Clinic, the lead investigator of one of the studies.
In a statement, Rudick called the findings ''very encouraging."
According to a summary issued by the companies, patients using Tysabri showed ''a significant improvement" in standard measurements of both mental and physical health in one of the studies. Patients treated with a placebo, meanwhile, showed a decline.
In the second study, patients taking Tysabri in combination with Avonex, Biogen Idec's current MS drug, experienced physical improvements. Patients using Avonex alone did not see a significant change in their condition.
''I'm always glad to see a major clinical trial looking at quality of life, because that's very important," said Nicholas LaRocca, an executive of the National Multiple Sclerosis Society who has helped develop quality-of-life measurements for multiple sclerosis patients.
''I don't know if it's a huge difference or a modest difference, but even a modest difference is better than no difference," he said.
Multiple sclerosis is an incurable disease in which the body's own immune system attacks the tissue that surrounds and insulates nerves, causing tremors, vision problems, weakness, and progressively worsening disability.
Tysabri was approved by the FDA in November 2004 based on one year's data, rather than the customary two, after results showed it reduced flare-ups of MS symptoms twice as effectively as current treatments.
It was voluntarily pulled from the market by Biogen Idec and Elan in February 2005 after they learned of two cases of a rare brain disease in patients taking the drug. A third case was later confirmed, and two of the patients died. An extensive safety review by the companies did not uncover additional cases of the disease, called progressive multifocal leukoencephalopathy.
In February, the FDA allowed Biogen to continue giving the drug in a clinical trial, and last month an advisory panel recommended Tysabri return to market. The FDA is now reviewing the companies' plan to monitor patient safety and is expected to make a decision by June 28.
Stephen Heuser can be reached at sheuser@globe.com.
http://www.boston.com/business/healthcare/articles/2006/04/08/study_shows_tysabri_may_aid_in_quality_of_life/
Patients taking the multiple sclerosis drug Tysabri showed improvement in several important quality-of-life measurements, according to the results of studies presented at a medical conference this week.
The findings, from two studies sponsored by the drug's makers, Biogen Idec Inc. of Cambridge and Elan Corp. of Ireland, provide new evidence of the effectiveness of a treatment that was pulled off the market last year after two patients taking it died of a rare brain infection.
The Food and Drug Administration is considering whether to allow Tysabri sales to resume.
The new report analyzed data from earlier Tysabri studies to see whether the drug could improve patients' lives and alleviate MS symptoms. It measured such factors as energy level, vision, bowel and bladder function, and mental health. It was presented on Thursday at the American Academy of Neurology meeting in San Diego by Richard Rudick of the Cleveland Clinic, the lead investigator of one of the studies.
In a statement, Rudick called the findings ''very encouraging."
According to a summary issued by the companies, patients using Tysabri showed ''a significant improvement" in standard measurements of both mental and physical health in one of the studies. Patients treated with a placebo, meanwhile, showed a decline.
In the second study, patients taking Tysabri in combination with Avonex, Biogen Idec's current MS drug, experienced physical improvements. Patients using Avonex alone did not see a significant change in their condition.
''I'm always glad to see a major clinical trial looking at quality of life, because that's very important," said Nicholas LaRocca, an executive of the National Multiple Sclerosis Society who has helped develop quality-of-life measurements for multiple sclerosis patients.
''I don't know if it's a huge difference or a modest difference, but even a modest difference is better than no difference," he said.
Multiple sclerosis is an incurable disease in which the body's own immune system attacks the tissue that surrounds and insulates nerves, causing tremors, vision problems, weakness, and progressively worsening disability.
Tysabri was approved by the FDA in November 2004 based on one year's data, rather than the customary two, after results showed it reduced flare-ups of MS symptoms twice as effectively as current treatments.
It was voluntarily pulled from the market by Biogen Idec and Elan in February 2005 after they learned of two cases of a rare brain disease in patients taking the drug. A third case was later confirmed, and two of the patients died. An extensive safety review by the companies did not uncover additional cases of the disease, called progressive multifocal leukoencephalopathy.
In February, the FDA allowed Biogen to continue giving the drug in a clinical trial, and last month an advisory panel recommended Tysabri return to market. The FDA is now reviewing the companies' plan to monitor patient safety and is expected to make a decision by June 28.
Stephen Heuser can be reached at sheuser@globe.com.
http://www.boston.com/business/healthcare/articles/2006/04/08/study_shows_tysabri_may_aid_in_quality_of_life/
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