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Tysabri updates

5th January, 2009

January 2009 - Tysabri patient update
MS Research Australia has been notified by Biogen Idec Medical Department that regrettably the third (of four) patients who have developed progressive multifocal leukoencephalopathy (PML) while on TYSABRI in this post marketing period, has recently died. This is a sombre message at this time of year but highlights the continuing need for close surveillance.

Early detection and a prompt response offer the most effective treatment for this depressing but rare complication. Changes in mental activity, personality or confusion and the sub acute onset of hemi motor or sensory symptoms all should alert the need for urgent neurological review.

Professor W M CARROLL
Chair MS Research Australia Research Management Council

December 2008 - Fourth PML case identified in a Tysabri patient

Statement from Professor Bill Carroll, MS Research Australia:

MS Australia and MS Research Australia have been advised by Biogen Idec Australia of another case of progressive multifocal leukoencephalopathy (PML) in an MS patient receiving this treatment. Briefly, the diagnosis was established after being suspected through the surveillance program established in the European Union (EU) and similar to that operating in Australia and elsewhere. The causative JC virus was detected in the Cerebral Spinal Fluid (CSF), and its Magnetic Resonance Image (MRI) findings were consistent with PML. The patient had received 26 months of Tysabri treatment and had previously received interferon beta therapy. Treatment of the case as with others before has been to stop Tysabri infusions and to clear it from the body.

This is the 4th case of PML since Tysabri treatment was recommenced 2 years ago. It has been available in Australia since July of this year. Worldwide more than 18,000 patients have received more than 12 months of this treatment. Although another case of PML is disconcerting, at present its rate of occurrence (number of cases of PML in relation to the total number of patients receiving Tysabri treatment) is not rising, but if anything is falling.

If you have any questions relating to this latest report you should contact your MS physician.

Statement from Biogen Idec Australia:

On Tuesday 17th December Biogen Idec Australia/New Zealand notified the Therapeutic Goods Administration (TGA) and Medsafe in New Zealand of a confirmed case of progressive multifocal leukoencephalopathy (PML) in a multiple sclerosis (MS) patient treated with TYSABRI in the commercial setting in the European Union. The diagnosis was made based upon the detection of JC Virus (JCV) DNA in the cerebrospinal fluid (CSF) in the setting of clinical signs, symptoms and magnetic resonance imaging (MRI) findings consistent with the diagnosis of PML. The patient has a history of MS and prior disease modifying therapies, including beta interferons. The patient had been treated with Tysabri monotherapy for approximately 26 months. As previously, clinical vigilance led to early identification of signs and symptoms of possible PML and clinical evaluation which included MRI scanning and CSF testing. Tysabri has been discontinued and the patient has undergone immunoadsorption. The patient is under the care of the treating physician and remains clinically stable.

In addition, an update was provided on the status of the three previously reported post-marketing cases of PML.

Patients 1 and 2 appear to have stabilised from the acute episode of PML, and that there is undetectable levels of JC virus in the CSF. They both continue in rehabilitation and are under medical care. Patient 3 is still in the acute phase of PML management.

These cases continue to underscore the importance of clinical vigilance in monitoring for PML and discontinuing TYSABRI in suspected cases.

As stated in the label, PML is a risk of TYSABRI therapy.This is articulated in the comprehensive risk management program and other communications around TYSABRI. There are now four confirmed cases in just over two years since TYSABRI was reintroduced in the United States and launched in Europe. As of the end September 2008, more than 35,500 patients worldwide are receiving Tysabri treatment, nearly 18000 have received at least 1 year of Tysabri and approximately 9500 patients have been on therapy for 18 months or longer.

TYSABRI remains an important therapeutic option for many patients. It has demonstrated a significant level of efficacy for patients with relapsing forms of multiple sclerosis and its risk-benefit profile continues to be favourable.

November 2008 - New Case of Brain Illness in Tysabri Patient

Another Tysabri patient has contracted progressive multifocal leukoencephalopathy, or PML, a recognised rare complication of Tysabri treatment.

Professor Bill Carroll, Chairman of MS Research Australia Research Management Council, reassures that “This is the third case since Tysabri was introduced in the US since 2006, and brings the total to five who have developed this complication with Tysabri in trials or open treatment of MS. Around the world over 36,000 people with MS are on the treatment and 18,000 are at 12 months or more. When Tysabri was introduced in Australia the risk of PML was approximately 1:1000 patients. Now it is about 1:3500, which puts this case into perspective.”

August - Tysabri Alert
This morning MSA was advised that two patients with MS, overseas, have been diagnosed with PML (progressive multifocal leucoencephalopathy) while on Tysabri (Natalizumab).

Details are not complete but one patient with aggressive MS developed the condition after 17 infusions having had no other treatment. The second had previously received Azathioprine and an immunomodulatory therapy.

Both were detected by the post marketing surveillance system set up for Europe and similar to the TAPP programme in Australia. With the cessation of Tysabri treatment and the use of plasma exchange the condition has been halted and the patients are now stable.

Biogen-Idec have advised the TGA (the Commonwealth Government authority) of the development and said that it highlights the need for continuing vigilance by MS practitioners and immunotherapy nurses. Further information will be posted as it becomes available.

Chair MS Research Australia Research Management Council