Tysabry® Demonstrate Sifnificant Health-Related Quality-Of Life Improvements For Multiple Sclerosis Patients In Study Published In Annals Of Neurology
Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) announced today the publication of results demonstrating that patients treated with TYSABRI® (natalizumab) showed a significant improvement in health-related quality-of-life (HRQoL) measures when compared to placebo. These results are from the first Phase III multiple sclerosis (MS) studies that have demonstrated improvement on HRQoL measures in patients with relapsing forms of MS. The results have been published in today’s issue of Annals of Neurology.
“These data showed that patients treated with TYSABRI were more likely to experience statistically important improvement in the quality-of-life measures used to assess meaningful disease improvement or progression. These findings have not been previously observed in clinical studies involving MS patients,” said Richard Rudick, MD, Director of the Mellen Center for Multiple Sclerosis Treatment and Research at the Cleveland Clinic, the lead investigator of the study.
These two-year, randomized, double-blind, placebo-controlled, multicenter, Phase III clinical trials (AFFIRM and SENTINEL) were conducted in 2,113 patients with relapsing forms of MS. The objective was to assess the relationship between disease activity and HRQoL in relapsing forms of MS, and the impact of TYSABRI on these measures.
In the studies, HRQoL was assessed using two different measures at baseline and weeks 24, 52 and 104:
The Short Form-36 (SF-36), a standardized, well-validated survey that has been used extensively in many disease areas, including MS to review health status. The SF-36 is comprised of 36 questions designed to assess physical (Physical Component Summary or PCS) and mental (Mental Component Summary or MCS) well-being from the perspective of the patient.
The Visual Analogue Scale (VAS), a measure of well-being as assessed by the patient and marked on a scale of 0 to 100, with 0 indicating “poor” and 100 indicating “excellent.”
Results from the AFFIRM monotherapy trial include:
A statistically significant improvement in SF-36 PCS beginning at week 24 and all subsequent time points compared with a decline in the placebo-treated group.
A statistically significant improvement in SF-36 MCS at week 104 compared with a decline in the placebo-treated group.
Statistically significant benefits using the VAS when compared with placebo at week 52 and at week 104.
Patients showed sustained improvement from baseline quality-of-life measures, not just a slowing down of quality-of-life deterioration.
HRQoL measures correlated with common measures of MS severity, including EDSS, sustained disability progression, relapse number, MSFC and volume of T2-hyperintense and T1-hypointense lesions.
Improvements on quality-of-life measures were also observed in the SENTINEL study, in which TYSABRI was added to AVONEX® (Interferon beta-1a). This publication is in addition to a presentation of preliminary results from the same study presented at the 2006 American Academy of Neurology Annual Meeting.
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