Efficacy and safety of natalizumab in multiple sclerosis: interim observational programme results.
Bottom Line: Follow-up for at least 4 years from natalizumab commencement in 468 patients and at least 2 years in 2496 patients revealed no new safety signals.Interim TOP data confirm natalizumab's overall safety profile and the low relapse rate and stabilised disability levels in natalizumab-treated patients with RRMS in clinical practice.NCT00493298.
Affiliation: Department of Medicine, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Melbourne, Victoria, Australia Department of Neurology, Box Hill Hospital, Monash University, Victoria, Victoria, Australia.Show MeSH
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Mentions: Significant associations between baseline disease characteristics and annualised relapse rates on natalizumab therapy were observed (figure 2). Lower mean on-therapy annualised relapse rates were associated with lower baseline EDSS scores, fewer relapses in the prior year and fewer DMTs used prior to natalizumab (figure 2A). When therapy history and baseline relapse status were analysed together, the lowest on-therapy annualised relapse rates were seen in patients with a history of only one relapse in the prior 12 months who were either therapy naïve or had received only one DMT prior to natalizumab; those with greater numbers of relapses and/or DMTs had higher rates (0.16 to 0.18 vs 0.23 to 0.40; p<0.0001) (figure 2B). While patients treated with natalizumab had significant reductions in annualised relapse rate regardless of treatment history, annualised relapse rates were lowest in patients who were therapy naïve at baseline and highest in those patients with prior IS use (figure 2C). In pairwise comparisons, annualised relapse rates were significantly different for the therapy-naïve group versus each of the other groups and for any of the comparisons of GA and/or IFN use groups versus the prior IS use group (p<0.05).
Affiliation: Department of Medicine, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Melbourne, Victoria, Australia Department of Neurology, Box Hill Hospital, Monash University, Victoria, Victoria, Australia.