Tuesday, 19 March 2013

Predicting who will respond to natalizumab treatment

#MSBlog: Does early aggressive therapy prevent SPMS?

Epub: Sargento-Freitas et al. Clinical predictors of an optimal response to natalizumab in multiple sclerosis. J Clin Neurosci. 2013 Feb 25. doi:pii: S0967-5868(12)00501-2. 10.1016/j.jocn.2012.04.022.

Background: Despite the high level of effectiveness of natalizumab (NTZ) in the treatment of MS, concerns about its high direct cost and its safety have restricted its use. 

Aim: To identify and quantify the clinical factors that predict an optimal response to NTZ. 

Methods: MSers undergoing treatment with NTZ for at least 12 months were classified as optimal responders if, during treatment, they sustained a reduction in their Kurtzke Expanded Disability Status Scale (EDSS) score of 1 point or more or experienced a reduction in annualised relapse rate (ARR) of more than 1. The remaining MSers were classified as suboptimal responders and non-responders. 

Results: 48 MSers were studied. The variables associated with optimal response included: ARR in the previous year of at least 2, an age at first administration of 37.5 years or less, a baseline EDSS score of 4.5 points or less, a disease duration of 9.5 years or less and, in patients with secondary-progressive MS, a progressive-phase duration of 4.5 years or less. 

Conclusion: The characteristics of the disease at its onset did not affect responsiveness, indicating that MSers with highly active disease and low disability are the ideal candidates for NTZ treatment, regardless of previous clinical characteristics.


"This is a small study, but confirms what we know from the subgroup analyses of the original pivotal trial of natalizumab in MS; MSers that do well on natalizumab are those with highly active disease relatively early in the course of the disease. This seems to be a general rule in the treatment of MS; if you wait too long for damage to accumulate SPMS will have likely already started."

"Does early aggressive therapy prevent SPMS? What data will be required to prove to the sceptics that this is the right approach?"

CoI: multiple

4 comments:

  1. Preventing lymphocytes from crossing the blood brain barrier may prevent damage to the CNS, but what happens if you really have a problem such as encephalitis in which the immune system needs access to the CNS?

    To me, I would rather undergo the HSCT protocols such as that being performed by Dr. Richard Burt at Nortwestern Univerity. This seems like a more appropriate way of stopping MS rather than a work-around treatment.

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  2. The trial in Denmark where monthly pulses of Methylprednisolone 500mg over a three day period is a phase 2 trial,which is looking to see if progression can be slowed in SPMS and PPMS. What are your thoughts on this and are any figures/results available yet. I ask because I find Methylprednisolone helps me with problems such as joint pain/swelling, fatigue, circulation problems, but my Neurologist is reluctant to prescribe them despite an improvement in my quality of life. I have PPMS.

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    1. Steroids are not without side effects. For example avascular necrosis or AVN of the hip joint. This is why they are reluctant to prescribe the. I would also be. There are many other side effects of steroids that need to be considered.

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  3. You aren't going to get the data to prove to the sceptics that early aggressive treatment(eat) is the right course for another 10 years or so I would think, but maybe studies like this will persuade healthcare providers to consider eat as a first line treatment for those fitting the benefit criteria. Personally, I think alemtuzumab should be offered as an induction therapy to any new informed MSer who wants it.

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