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| |  Temsirolimus Reduces Rate of Brain Atrophy in Patients With Relapsing-Remitting MS: Presented at ECTRIMS By Chris Berrie DÜSSELDORF, Germany -- September 14, 2009 -- Temsirolimus significantly reduces the rate of brain atrophy compared with placebo in patients with relapsing-remitting multiple sclerosis (RRMS), according to 2 independent magnetic resonance imaging (MRI)-based methods, researchers noted here at the 25th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). In this phase 2 study, 297 patients with RRMS were randomised to receive either placebo or temsirolimus 2, 4, and 8 mg per day for 9 months. Two MRI protocols were followed with 3-mm slices: conventional T1-weighted images, and dual-echo T2-weighted, 2-dimensional spin-echo images. Results were presented here on September 10 by coinvestigator Robert Allen, MD, Clinical Research and Development Department, Wyeth Research, Philadelphia, Pennsylvania. "We showed effects on both Gd [gadolinium] lesions and relapse rate," Dr. Allen noted, "but more significantly and of interest, was the effect using the SIENA [Structural Image Evaluation, Using Normalisation, of Atrophy] method, which showed that there seemed to be a dose response in brain volumes." Indeed, the percentage brain-volume changes from baseline were calculated successfully in 262 patients according to the registration-based SIENA method, using the conventional T1-weighted MRI images. During treatment, the placebo group experienced a change in brain volume of -0.37%. This brain-volume decrease was reduced under temsirolimus treatment, with the highest temsirolimus dose promoting a minor, but significant, increase in brain volume from baseline (+0.14%; P = .0063). To confirm the secondary outcome measure from this trial, Dr Allen said, "We repeated the analysis using the BPF [Brain Parenchymal Fraction] method, and as far as we know, this is the first time where both methods have been applied to the same dataset." This measure was based on the dual-echo T2-weighted, 2-dimensional spin-echo MRI images. Successful analyses were performed in 274 patients for the segmentation-based BPF method during treatment, and the placebo group again saw a change in brain volume, this time of -0.32%. At the highest concentration of temsirolimus (8 mg/day), there was complete brain-volume stabilisation with this BPF analysis (+0.02; P = .0015). Thus, as well as its anti-inflammatory activity on MRI lesion development and relapses, temsirolimus provides beneficial effects for brain-volume changes, as assessed by these 2 independent methods. The ability of temsirolimus to minimise, and even enhance, these brain-volume changes, concluded Dr. Allen, suggests that it can also have neuroprotective effects on the brain. Funding for this study was provided by Wyeth Research. [Presentation title: The Effect of Oral Temsirolimus on Brain Atrophy. Abstract P481]
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