Source: Epilepsy Curr  |  Posted 5 years ago

By Claire Sowerbutt

SAN DIEGO, C.A. -- April 6, 2006 -- Results from a phase 3 study of the novel monoclonal antibody, natalizumab, show significant efficacy in reducing progression of disability and suppressing disease-related changes in patients with multiple sclerosis (MS).

Treatment with natalizumab resulted in a 42% reduction in disability progression over 2 years compared with placebo (P =.0002), according to results from the Natalizumab Safety and Efficacy in Relapsing Remitting Multiple Sclerosis (AFFIRM) study.

J. Theodore Phillips, MD, PhD, director, Multiple Sclerosis Center at Texas Neurology, clinical associate professor of neurology, University of Texas Southwestern Medical Center at Dallas, and attending neurologist, Baylor University Medical Center, Dallas, Texas, United States, reported the results here on April 4[^]th[] at the 58[^]th[] Annual Meeting of the American Academy of Neurology (AAN).

In the double-blind, placebo-controlled trial, Dr. Phillips and colleagues randomised 627 patients to natalizumab 300 mg and 315 to placebo administered as an intravenous infusion every 4 weeks for 116 weeks.

The primary efficacy endpoint, measured at 2 years postrandomisation, was the rate of sustained disability progression as per the Expanded Disability Status Scale (EDSS). At 2 years, the investigators also measured disability progression using the Multiple Sclerosis Functional Composite (MSFC), T2-hyperintense lesion volume, the number of new T1-hypointense lesions. They also measured the percentage of patients reaching an EDSS of >/=4.0 (in patients with an EDSS /=6.0 (in patients with an EDSS "There were significant delays in time to EDSS of greater than 4.0, and 6.0, representing 67% to 70% risk reduction in the same. Natalizumab also significantly reduced disease progression," Dr. Phillips said.

Further, there were significant reductions in the number of new T1-hypointense lesions and in T2 lesion volume (P <.0001 for both).

"The differences between natalizumab and placebo in MFSC were statistically significant at all times [P <.003]" Dr. Phillips said. Lesion volume over 2 years decreased by a mean of 906 in the natalizumab group and increased by a mean of 2891 in the placebo group (P <.001).

These data suggest that natalizumab may provide an efficacious therapeutic option for patients with MS, Dr. Phillips said.

This study was supported by Biogen Idec and Elan Pharmaceuticals.

[Presentation title: The Effects of Natalizumab Monotherapy on Multiple Measures of Disability Progression in MS Patients. Abstract S02.005]