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New Clinical Data on Tysabri (Natalizumab) Presented at MS Conference

Drug reduced relapse rates over 4 years (Oct. 11)
The company’s announcement included key data from Tysabri presentations, as described below.

The Tysabri Observational Program (TOP) evaluated long-term safety, efficacy, associations between baseline treatment history and the post-baseline annualized relapse rate (ARR), and overall 2-year clinical disease activity-free (DAF) status in 4,434 patients with relapsing-remitting multiple sclerosis (RRMS ) treated with Tysabri.

Results from TOP demonstrate that, in the post-marketing setting, Tysabri treatment had an effect on the ARR, which was also accompanied by a stable Expanded Disability Status Scale (EDSS), over 4 years. ARRs were lower in treatment-naïve patients than in previously treated patients, and lower in patients with an EDSS score of less than 3.0 at baseline. The incidence of serious adverse events, including infections, reported in TOP was consistent with the known safety profile of Tysabri.

Another study — the nonrandomized, open-label, prospective, observational TYNERGY trial — evaluated whether an improvement in MS-related fatigue during Tysabri treatment is associated with a significant improvement in health-related quality of life (HRQoL) in patients with RRMS who were Tysabri treatment-naïve at baseline.

After 12 months of therapy with Tysabri, a significant reduction in fatigue was associated with improvements in mental and physical components of HRQoL. Reduced cognitive fatigue was associated with improved mental components of HRQoL, while reduced motor fatigue was associated with improved physical components of HRQoL.

A post hoc analysis was conducted to determine the relationship between changes in visual function and DAF status among patients with RRMS in the AFFIRM trial. Low-contrast letter acuity is a visual function measure that captures treatment effects as well as overall disability in MS.

In the AFFIRM study, 37% of Tysabri-treated patients were free of clinical and radiological disease activity over the 2-year study period. Patients with lower relapse rates, fewer lesions on magnetic resonance imaging (MRI), and better EDSS scores at treatment initiation were more likely to achieve DAF status.

Among all 942 patients in the AFFIRM trial, mean changes from baseline in the visual function test (VFT) were greater and trended toward increased (better) scores over time in the DAF group compared with the non-DAF group. Sustained VFT worsening was less likely in the group that remained free of disease activity than in the group that had disease activity. In the post hoc analysis, a relationship between visual function and clinical or radiological disease activity was also observed.

Tysabri (natalizumab) is approved in the U.S. as monotherapy for relapsing forms of MS, generally for patients who have had an inadequate response to, or are unable to tolerate, an alternative MS therapy.

For more information, visit the Biogen Idec Web site.

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