Tuesday, 12 February 2013

NEDA: defining a cure

#MSBlog: Defining an MS cure.

"I have been having several recent discussions with colleagues about whether or not we can cure MS. I think we can, but we need to know what a cure means to do this. We used the opportunity in a recent Editorial to define a cure. Do you think it is a reasonable starting point?"



Banwell et al. Editors' welcome and a working definition for a multiple sclerosis cure. Multiple Sclerosis and Related Disorders. 2013; 2(2):65-67.


.... Defining a cure in MS is a difficult task. How long should we wait before declaring a victory; 15, 20 or 25 years? Oncologists have back-tracked on this issue and instead of a cure they now prefer to use the term NEDD, or no evidence of detectable disease, at a specific time-point knowing full well that a limited number of subjects will relapse and present with recurrent disease after this point. We propose using the term NEDA, or no evident disease-activity, at 15 years as a starting point for defining a cure. Why 15 years? This is the most commonly accepted time-point used for defining benign MS and therefore it is a usual end point. In addition, the median time to the onset of secondary progressive MS is ~10-11 years (Kremenchutzky, Rice et al. 2006) and is well within the 15 year time window of our proposed definition of a cure. At present NEDA is defined using a composite of a) no relapses, or b) no EDSS progression, or c) no MRI activity (new or enlarging T2 lesions or no Gd-enhancing lesions) (Havrdova, Galetta et al. 2009; Giovannoni, Cook et al. 2011). This description is currently based on data that is routinely collected in contemporary clinical trials (Havrdova, Galetta et al. 2009; Giovannoni, Cook et al. 2011). The definition of NEDA will evolve with technological innovations and clinical practice, and in the future it will almost certainly include MSer-related outcomes, grey matter disease activity, an index of brain atrophy and hopefully a CSF biomarker profile.....


References:

Giovannoni, G., S. Cook, et al. (2011). "Sustained disease-activity-free status in patients with relapsing-remitting multiple sclerosis treated with cladribine tablets in the CLARITY study: a post-hoc and subgroup analysis." Lancet Neurol 10(4): 329-337.

Havrdova, E., S. Galetta, et al. (2009). "Effect of natalizumab on clinical and radiological disease activity in multiple sclerosis: a retrospective analysis of the Natalizumab Safety and Efficacy in Relapsing-Remitting Multiple Sclerosis (AFFIRM) study." Lancet Neurol 8(3): 254-260

Kremenchutzky, M., G. P. Rice, et al. (2006). "The natural history of multiple sclerosis: a geographically based study 9: observations on the progressive phase of the disease." Brain 129(Pt 3): 584-594.

CoI: I am co-chief editor of MSARDs the journal in which this definition was published

Other posts of interest on this blog in relation to the term cure:


20 Nov 2012
Research: Antigen-coated beads the New (Old) Cure of the Week. Daniel R Getts, Aaron J Martin, Derrick P McCarthy, Rachael L Terry, Zoe N Hunter, Woon Teck Yap, Meghann Teague Getts, Michael Pleiss, Xunrong Luo, ...
12 Oct 2012
OK sit in your seats because I seldom enthuse, but if this study works to the author's plan it is a CURE to autoimmunity and could be the end to relapsing MS. If you stop relapsing MS you could stop MS, if you start early ...
01 Feb 2012
Last weekend at the Research Day Prof Gold (Prof G Down Under) from Team G aired his new vision for the treatment of MS, but you will have to wait for the video evidence to appear. As many do not view the blog but get their ...
02 Jun 2011
In MS we will not know if we have a cure until we have followed up a patient after a particular treatment for 15 to 20 years. This is the duration of follow-up required for us to be confident that the disease won't return in its ...

06 Apr 2012
This is an updated post from the 7th March 2010. I was at a meeting on optic neuritis in central London yesterday (5th April 2012) and we got onto the usual discussion/debate about early aggressive treatment vs. watchful ...

1 comment:

  1. As a working definition, NEDA seems more than reasonable. The best of all cures would be reversal of past damage along with NEDA. The ability to prevent MS would be a cure even if it did nothing for those of us who already have MS.

    ReplyDelete

Please note that all comments are moderated and any personal or marketing-related submissions will not be shown.