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MS Study Confirms Benefits of High-dose, High-frequency Beta Interferon Regimen

Turin, Italy, April 2/PRNewswire/ -- New findings presented at today's American Academy of Neurology Annual Meeting reveal clinically relevant differences in disease activity after increasing the dose and frequency of beta interferon therapy in relapsing-remitting multiple sclerosis (MS) patients following treatment with an established lower-dose, lower-frequency regimen. Likewise, the results showed that reducing the dose and frequency of beta interferon is associated with increased disease activity.

Professor Luca Durelli, Chief, MS Centre of University Department of Neurosciences, Turin, Italy, and principle investigator of the study, said, "These data confirm the benefits of high-dose, high-frequency beta interferon and demonstrate the risks of changing to a lower-dose regimen even in the absence of clinical or MRI disease activity. These findings will help guide prescribing choices for MS patients."

The study is a continuation of research that began four years earlier. Thirteen patients who had received interferon beta-1b 250 mcg (Betaferon(r)/Betaseron(r) for SC Injection) for three years, and were consistently free of clinical and MRI disease activity, changed to once-weekly interferon beta-1a (Avonex(r)) 30 mcg for one year. During this time, disease activity resumed in most patients. Consequently, all of the patients changed back to a high-dose, high-frequency beta interferon regimen. Seven received interferon beta-1b 250 mcg every other day, four received interferon beta-1a (Rebif(r)) 44 mcg three times weekly, and two received interferon beta-1a (Rebif(r)) 22 mcg three times weekly.

The results showed that during the year on the high-dose, high-frequency regimens patients had significantly lower relapse rates compared to the preceding year on the lower, once-weekly dose (0.3 plus or minus 0.48 versus 0.9 plus or minus 0.6, p "Head-to-head studies such as INCOMIN have confirmed the superiority of high-dose, high-frequency beta interferon regimens versus lower-dose, lower-frequency regimens," added Prof. Durelli. "These new data add to our knowledge that the greatest treatment efficacy in MS is seen with high-dose, high-frequency beta interferon."

About the study:
The findings were presented at session MS: Clinical trials II on Tuesday, April 1st, 2003 of the American Academy of Neurology Annual Meeting, in Honolulu, Hawaii, USA. Clinical and laboratory assessments were performed every three months, and an MRI scan was performed after one year. Clinical evaluation was performed on an open-label manner, MRI scans were analysed by neuro-radiologists totally blinded to treatment and patient clinical characteristics.

Patients with clinical and MRI-confirmed stable disease activity on chronic 250 mcg every other day IFN beta-1b treatment for at least 3 years were randomised to reduce IFN beta dose and frequency of administration schedule being gradually switched to once weekly 30 mcg IFN beta-1a and followed up for one year, Then, due to resumption of disease activity, they were switched back to high dose / high frequency IFN beta and followed for a further year. Clinical activity significantly improved during the year after returning to high dose / frequency IFN beta, but MRI activity persisted in some patients, failing to return to the total absence of disease activity demonstrated after three years of chronic IFN beta-1b treatment prior to our decision to reduce the interferon beta dose. The resumption of disease activity and the increased disease duration may render patients less sensitive to IFN beta even if used again at high dose. The impaired MRI response was not associated with occurrence of neutralizing anti-IFN antibodies.

In conclusion, the reduction in IFN beta dose and frequency may be associated with increased signs of clinical and MRI disease activity. A return to the high dose IFNB may lead to only a partial improvement in signs of disease activity. Patients, even those with low levels of disease activity, should remain on IFNB with a high dose and frequency administration. Reduction in IFNB dose and frequency is not only not advisable but it may be dangerous.

The study was conducted independently from pharmaceutical industry.

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