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Multiple Sclerosis
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my personal edition > multiple sclerosis > news
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DGNews
New Data on Natalizumab Demonstrate Significant Improvement in Cognitive Function in Patients With Multiple Sclerosis
ZUG, SWITZERLAND and DUBLIN, IRELAND -- September 28, 2006 -- Biogen Idec and Elan Corporation, plc announced today that data from the phase 3 AFFIRM monotherapy study demonstrated that treatment with TysabriŽ (natalizumab) significantly reduced the proportion of multiple sclerosis (MS) patients with worsening cognitive function as measured by the 3-second Paced Auditory Serial Addition Test (PASAT 3).
These data, presented at the 22nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Madrid, Spain, contribute to existing data which demonstrate the overall therapeutic benefits of Tysabri, including its significant impact on relapse reduction, disability progression and MRI measures.
Tysabri has demonstrated a 68% relative reduction in the annualized relapse rate compared to placebo and a 42% reduction in the relative risk of disability progression, as published in the New England Journal of Medicine.
Cognitive deficits are under-recognized and often misdiagnosed as depression, stress or other personality disorders. Studies have shown that approximately 43% to 65% of MS patients show measurable cognitive impairment in formal testing. Cognitive dysfunction can occur early in MS and in patients with relatively mild physical disability. These deficits have a substantial effect on the daily functioning of patients. Areas impacted by cognitive dysfunction include memory, ability to process information and learning. 1,2
The AFFIRM study was a two-year, randomized, multi-center, placebo-controlled, double-blind study of 942 patients conducted in 99 sites worldwide, evaluating the effect of Tysabri on the progression of disability and the rate of clinical relapses. Evaluating the effect of Tysabri on cognitive function was a pre-specified endpoint of the AFFIRM study. Cognitive function was assessed using the 3-second Paced Auditory Serial Addition Test (PASAT 3), a test of auditory information processing. The study showed that treatment with Tysabri reduced the risk of sustained cognitive worsening by 43% (P =.013) when compared to placebo.
These cognitive function data complement the previously presented results of the AFFIRM study, which demonstrated a significant effect of Tysabri on two-widely accepted health-related quality of life measures, the Short Form-36 Health Survey and the Visual Analogue Scale.
"Neuropsychological dysfunction significantly diminishes quality of life in many patients with multiple sclerosis, impacting everything from employment to social interaction. It is responsible for much hardship experienced by MS patients. The important positive effects of Tysabri on cognitive functioning and quality of life add to the important benefits already reported on progression of disability and relapses. This provides strong evidence that observed neurologic benefits translate into important improvements as perceived by the patients," said Richard Rudick, MD, Director of the Mellen Center for Multiple Sclerosis Treatment and Research at the Cleveland Clinic.
About Tysabri
In the US, Tysabri is approved as a monotherapy treatment for relapsing forms of MS. Tysabri increases the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain that usually leads to death or severe disability.
Patients should be monitored at regular intervals for any new or worsening signs or symptoms suggestive of PML. Because of the increased risk of PML, Tysabri is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, alternate MS therapies. It is available in the US only through a restricted distribution program called the TOUCH Prescribing Program.
According to product labeling, after two years, Tysabri treatment led to a 67% relative reduction (P >.001) in the annualized relapse rate compared to placebo and reduced the relative risk of disability progression by 42% (P >.001). Tysabri treatment also resulted in sustained and statistically significant reductions in brain lesion activity as measured by MRI. Changes in MRI findings often do not correlate with changes in the clinical status of patients (e.g., disability progression). The prognostic significance of the MRI findings in these studies has not been evaluated.
In the European Union, Tysabri is indicated as a single disease-modifying therapy in highly active relapsing-remitting MS patients. Because of the increased risk of PML, it is for patients with high disease activity despite treatment with a beta-interferon or in patients with rapidly evolving severe relapsing-remitting MS. According to product labeling in the EU, after two years, Tysabri treatment led to a 68% relative reduction (P >.001) in the annualized relapse rate compared to placebo and reduced the relative risk of disability progression by 42-54% (P >.001).
Serious adverse events that occurred in Tysabri-treated patients included hypersensitivity reactions (e.g., anaphylaxis), infections, depression and gallstones. In MS trials, the incidence and rate of other serious and common adverse events, including the overall incidence and rate of infections, were balanced between treatment groups. Herpes infections were slightly more common in patients treated with Tysabri. Serious opportunistic and other atypical infections have been observed in Tysabri-treated patients, some of whom were receiving concurrent immunosuppressants. Common adverse events reported in Tysabri-treated patients include headache, fatigue, infusion reactions, urinary tract infections, joint and limb pain, lower respiratory infections, rash, gastroenteritis, abdominal discomfort, vaginitis, and diarrhea.
SOURCE: Biogen Idec
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