Natalizumab 5 years on

Zivadinov R, Hojnacki D, Bergsland N, Kennedy C, Hagemeier J, Melia R, Ramasamy DP, Durfee J, Carl E, Dwyer MG, Weinstock-Guttman B. Effect of natalizumab on brain atrophy and disability progression in multiple sclerosis patients over 5 years.Eur J Neurol. 2016. doi: 10.1111/ene.12992. [Epub ahead of print]

BACKGROUND AND PURPOSE: The long-term benefit of natalizumab on brain atrophy progression in multiple sclerosis (MS) patients is unknown. Our aim was to investigate its effect over 5 years.
METHODS: This prospective study included 60 relapsing MS patients who started natalizumab treatment in years 2006-2007.
RESULTS: At the 5-year follow-up, 20 patients discontinued natalizumab after an average of 29.5 cycles, 27 continued natalizumab treatment with some periods of honeymoon (average of 38.4 infusions) and 13 never stopped natalizumab (average of 60.6 infusions). The number of natalizumab infusions was associated with decrease of relapse rate (P = 0.037), but no association was found with the progression of disability, accumulation of lesion burden or brain volume loss. However, only one (8%) patient in the continuous monthly group experienced disability progression compared to 10 (37%) in the non-continuous and seven (35%) in the discontinuation natalizumab groups. At the follow-up, two patients had died [one from a fatal case of progressive multifocal leukoencephalopathy (PML) and one from a car accident] and 15 patients were lost to follow-up. There was another case of non-fatal PML over the follow-up.
CONCLUSIONS: In line with previous reports, MS patients with longer and continuous use of natalizumab had fewer relapses and remained stable in their disability status. No difference in lesion burden accumulation or brain atrophy development was found in relation to the duration of natalizumab use. PML occurred in 2.5% of patients in this small sample cohort. Given the increased risk of PML and uncertain benefit of prolonged natalizumab use on clinical and MRI outcomes of disease progression found in this study, a careful risk-benefit therapeutic assessment is mandatory.

This is a thing you all want to know, which is what are the long term consequences of the different treatments and notably what is the prognosis, will getting relapses in check stop your disease.   I hope so, but does the data really support this. It is often hard to tell, especially in the age of softly, softly where we don’t do antthing until things are going wrong and then we get the big guns out, rather comming out blasting right from the get go. in the adsence of real advice  based on follow-up of large number of people, centred report on small studies based on their experiences. 

Natalizumab is believed to be one of the more effective DMT when it comes to stopping relapses but what happens with longt-term use.
There was bad news for 3% as they got PML, which is twice the Biogen rate, but closer to others predicted and as 33% of this cohort stopped  natalizumab after about 2-3 years this means that PML risk was actually higher. However in the 20% of users would took the PML risk and stayed on drug and took it as prescribed then 12/13 (92%) did not progress clinically compared to 65% who discontinued but they could not find an assossication of treatment and  disability however if you start with a small sample and loose track of 20% of the population it is going to be difficult to get this information. Surely the pharma companies could give us this information based on the thousands of people treated with natalizumab.   So more good reason to sign up to an MS registry so some one other than pharma can have large numbers and do these types of follow-ups that may not give us the answer that pharma would like to hear .

So if you live in the UK why not sign up to the MS register


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  • What a grim report, can you compare this to alemtuzumab 5 years report from ectrims 2015? Maybe this cohord is too small but… what bad results, bad adherence, fatal AEs, disability progresion, no report of patients improving disability…

  • "..and 13 never stopped natalizumab (average of 60.6 infusions)."

    "At the follow-up, two patients had died [one from a fatal case of progressive multifocal leukoencephalopathy (PML)"

    So 1 out of 13 patients on continuous therapy (7.5%) died of PML.

    Since there was no statistical difference in brain atrophy and progression between those on continuous therapy and those whose stopped it does not seem that impressive given the risk of getting PML.

  • The MS Register: I filled in some questionnaires and revisited the site over a year after. I noticed some of my answers are not correct. I don't know if this a fault with the register or I was not giving it my full attention at the time. I was able to correct these over a year later. I.e It said I still smoked but I do not smoke. So anyone looking at this register would have had incorrect information.

    The list of meditations I was unable to change these. There are mistakes in this too. I emailed the team but was told to put any information like this in the experiences box on the questionnaire.
    Anyone analysing this would get incorrect medication information.

  • This data is almost useless and scary for those of us on Tysabri long term. I am at over 10 years and counting with no missed doses. I think the bigger take away from this discussion is that Biogen has tons of data from the Touch program that they will not share. Risk is hard enough to understand.

  • I've had 98 infusions of tysabri I'm 8 and a half years on tysabri I've never had a relapse in all that time in less than a year on tysabri I was well enough to get out of my wheelchair and learn to walk again my mri's all showed improvements and for the last 4 years they showed my ms is now stable.
    For me the benefits far out weigh the risks.

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