“I have been discussing the TOP results for several years; they show that MSers derive the most benefit from natalizumab when it is started early and as a first-line therapy. In addition the lower the disability at baseline the greater your chances of improving or recovering; low disability implies reserve capacity to allow recovery. It will be interesting to see if the EMA are swayed by this data and allow MSers who are JCV-ve access to this drug as a first-line therapy. At present it is mainly used as a second-line drug in those with highly-active or severe rapidly-evolving MS.
Epub: Butzkueven et al. Efficacy and safety of natalizumab in multiple sclerosis: interim observational programme results. J Neurol Neurosurg Psychiatry. 2014 Feb
BACKGROUND: Clinical trials established the efficacy and safety of natalizumab. Data are needed over longer periods of time and in the clinical practice setting.
OBJECTIVE: To evaluate long-term safety of natalizumab and its impact on annualised relapse rate and Expanded Disability Status Scale (EDSS) progression in RRMSers.
RESULTS: In this 5-year interim analysis, 4821 RRMSers were enrolled. Follow-up for at least 4 years from natalizumab commencement in 468 MSers and at least 2 years in 2496 MSers revealed no new safety signals. There were 18 cases of progressive multifocal leucoencephalopathy reported, following 11-44 natalizumab infusions. Mean annualised relapse rate decreased from 1.99 in the 12 months prior to baseline to 0.31 on natalizumab therapy (p<0.0001), remaining low at 5 years. Lower annualised relapse rates were observed in MSers who used natalizumab as first MS therapy, in MSers with lower baseline EDSS scores, and in MSers with lower pre-natalizumab relapse rates. Mean EDSS scores remained unchanged up to 5 years.
CONCLUSIONS: Interim TOP data confirm natalizumab’s overall safety profile and the low relapse rate and stabilised disability levels in natalizumab-treated MSers with RRMS in clinical practice.