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| |  Natalizumab Therapy Significantly Improves Quality of Life in Patients With Highly Active Relapsing MS: Presented at ENS By Judith Moser, MD MILAN, Italy -- June 24, 2009 -- According to a post hoc analysis presented here at the 19th Meeting of the European Neurological Society (ENS), patients with highly active multiple sclerosis (MS) have significant improvement in their physical and mental quality of life (QOL) after 2 years of treatment with natalizumab. In the phase 3 Natalizumab Safety and Efficacy in Relapsing Remitting Multiple Sclerosis (AFFIRM) study and the Safety and Efficacy of Natalizumab in Combination With Interferon Beta-1a in Patients With Relapsing Remitting Multiple Sclerosis (SENTINEL) study, natalizumab significantly improved QOL as measured by the Medical Outcomes Study Short Form-36 (SF-36) and a visual analogue scale (VAS) of well-being in patients with relapsing MS. In AFFIRM, patients received natalizumab or placebo for up to 116 weeks. In SENTINEL, treatment consisted of natalizumab added to interferon (IFN) beta-1a or placebo plus IFN beta-1a for up to 116 weeks. “We performed a post hoc analysis to assess QOL in the subgroup of patients with highly active disease,” explained Robert Hyde, PhD, Biogen Idec, Inc., Cambridge, Massachusetts, on June 22. The researchers pooled data from AFFIRM and SENTINEL to evaluate the effects of natalizumab on QOL at 2 years in this patient group (n = 378). At baseline, patients with highly active disease had worse QOL than the general United States population. Their mean physical component summary (PCS) score was 43.2, and their mean mental component summary (MCS) score was 45.8, according to SF-36. “This is quite a poor QOL compared with heart disease and oncology indications,” Dr. Hyde pointed out.
In AFFIRM, natalizumab significantly improved the mean QOL from baseline to 2 years compared with placebo. The mean score change with natalizumab and placebo, respectively, was 1.6 vs -2.2 for PCS (P = .019), 3.4 vs -1.3 for MCS (P = .030), and 3.7 vs -7.6 for VAS (P = .013). In SENTINEL, treatment with natalizumab plus IFN beta-1a significantly improved mean changes in PCS scores (0.7 vs -0.9 with IFN beta-1a alone; P = .032) and VAS scores (1.0 vs -3.5 with IFN beta-1a alone; P = .044) at 2 years. Dr. Hyde indicated that the distribution of patients who experienced a clinically important change in MCS scores in AFFIRM was significantly more favourable with natalizumab treatment than with placebo (P = .018). More patients on treatment experienced improvement or no change compared with the placebo group, in which a greater percentage of patients was subject to worsening. “Even in this small group of patients, natalizumab improved the QOL on the physical and mental level, whereas the placebo group experienced a deterioration,” Dr. Hyde summarised. Funding for this study was provided by Biogen Idec, Inc., and Elan Pharmaceuticals, Inc. [Presentation title: Natalizumab Improves Quality-of-Life Outcomes in Patients With Highly Active Multiple Sclerosis. Abstract P351]
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