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| |  Alemtuzumab Improves Disability in Patients With Relapsing-Remitting MS Independent of Relapse History: Presented at ECTRIMS By Chris Berrie DÜSSELDORF, Germany -- September 12, 2009 -- Improvements in disability observed with alemtuzumab treatment in patients with relapsing-remitting multiple sclerosis (RRMS) does not depend on recent relapse status, according to an analysis presented here at the 25th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). The results of the Campath in Multiple Sclerosis (CAMMS223) study showed that compared with interferon (IFN) beta-1a, treatment with alemtuzumab reduced the risk of relapse by 74% and the risk for sustained accumulation of disability by 71% in patients with RRMS. In addition, alemtuzumab improved the Expanded Disability Status Scale (EDSS) score of most patients, while it was worsened in patients treated with IFN beta-1a. “The hypothesis is that the reason alemtuzumab is effective in reducing disability is that the patients who we were treating were having relapses, and what alemtuzumab was doing was part of the natural recovery of that relapse,” said principal investigator Alasdair Coles, MD, Addenbrookes Hospital, Cambridge, United Kingdom, on September 10. The objective of the analysis was to examine the influence of relapses on the improvement in disability seen with alemtuzumab therapy in the CAMMS223 trial. Assessments were made according to patient pretreatment attack history recorded at trial entry. These were defined as “recent” (attacks occurring within 3 months prior to first study treatment) and “early” attacks (attacks occurring within 6 months following first study treatment). According to pretreatment relapse status, at month 6 the alemtuzumab-treated patients had comparable significant mean EDSS improvements from baseline for both recent and no recent pretreatment relapse (-0.44 vs -0.37, respectively). Significant mean EDSS improvements were also seen for alemtuzumab versus IFN beta-1a throughout the study, and were independent of pretreatment relapse history. For patients without early on-study relapse, significant EDSS improvements were seen for the alemtuzumab-treated patients both from baseline to 6 months and between the treatment groups throughout the study. In contrast, IFN beta-1a-treated patients without early on-study relapse did not experience any improvements in EDSS. “We conclude from this that the hypothesis is not correct, and there is actually an alternative mechanism whereby patients have alemtuzumab and have their disability improved,” said Dr. Coles. “We speculate that alemtuzumab is positively promoting brain repair, or at least allowing the endogenous mechanisms for brain repair,” he added, noting also that the magnetic resonance imaging data on these improved patients showed an increase in brain volume, indeed indicating tissue restoration and hence some brain repair. Funding for this study was provided by Genzyme. [Presentation title: Alemtuzumab Reverses Pre-Existing Disability in Relapsing-Remitting Multiple Sclerosis Patients Independent of Relapse History. Abstract P465]
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