Biogen Idec, Elan find quality of life benefits in phase 3 trial of Tysabri for MS

New York, April 6 - Biogen Idec and Elan Corp. plc announced results from phase 3 studies of Tysabri (natalizumab) for multiple sclerosis that show significant effects on pre-specified health-related quality of life measures.

The improvements are in addition to those previously reported on disability progression, relapse rate and MRI.

"MS is a debilitating disease that significantly reduces the quality of patients' lives by causing symptoms like fatigue, pain, and diminished emotional well-being," said Richard Rudick, director of the Mellen Center for Multiple Sclerosis Treatment and Research at the Cleveland Clinic, in a news release.

Rudick presented the quality of life findings at the American Academy of Neurology annual meeting in San Diego.

"We have never before observed positive findings on our quality of life measures in a phase 3 MS study.

"The Tysabri study data show not only significant reductions in relapses and disability, but also suggest improved quality of life. This is very encouraging."

In the two phase 3 clinical trials, Affirm and Sentinel, quality of life was assessed using three different measures, the Multiple Sclerosis Quality of Life Inventory, the Short Form-36 Health Survey, which is a component of the quality of life inventory, and a Visual Analogue Scale.

The quality of life inventory is a battery of 10 scales that measure disease impact including fatigue, pain, sexual function, bowel and bladder function, visual impairment, mental health and need for social support. The survey is comprised of 36 questions designed to assess patients' physical and mental well-being.

In the Affirm monotherapy study, patients in the Tysabri-treated group realized a significant improvement in physical measures on the survey compared with a decline in the placebo-treated group.

A significant improvement was also seen in the mental component of the survey in patients treated with Tysabri compared with a decline in the placebo-group.

Significant benefits were also seen using the visual analogue scale.

Improvements on quality of life measures were also observed in the Sentinel study, in which Tysabri was added to Avonex (Interferon beta-1a).

In another analysis of the Affirm and Sentinel data, patients treated with Tysabri had a reduction in the risk of visual decline as measured by contrast testing compared to control. Loss of visual function is one of the most common causes of disability and lower quality of life in MS patients. Low contrast letter acuity was a pre-specified endpoint in both studies. Recent studies have demonstrated that low contrast letter acuity (perception of light gray letters of progressively smaller size on a white background) is a more sensitive measure of visual dysfunction in MS than traditional measures.

The primary efficacy endpoint of Affirm and Sentinel at two years was the rate of disability progression sustained for three months as measured by the Expanded Disability Status Scale.

Additional measures of disability included the Multiple Sclerosis Functional Composite, which consists of three tests that evaluate ambulation, upper extremity dexterity and cognitive function.

In Affirm, treatment with Tysabri led to a 42% reduction in the risk of disability progression compared to the placebo. Tysabri was also associated with significant delay in progressing to disability status scale of 4.0 (ambulatory with moderate disability) and 6.0 (requiring a cane, crutch or brace).

Tysabri treatment also had a significant impact on all subscales of the functional composite.

Biogen is based in Cambridge, Mass., Elan in Dublin, Ireland.

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