Wednesday, 20 August 2014

Back to the Stone Age

Lublin FD, Reingold SC, Cohen JA, Cutter GR, Sørensen PS, Thompson AJ, Wolinsky JS, Balcer LJ, Banwell B, Barkhof F, Bebo B Jr, Calabresi PA, Clanet M, Comi G, Fox RJ, Freedman MS, Goodman AD, Inglese M, Kappos L, Kieseier BC, Lincoln JA, Lubetzki C, Miller AE, Montalban X, O'Connor PW, Petkau J, Pozzilli C, Rudick RA, Sormani MP, Stüve O, Waubant E, Polman CH.Defining the clinical course of multiple sclerosis: The 2013 revisions. Neurology. 2014. pii: 10.1212/WNL.0000000000000560. [Epub ahead of print] 

Accurate clinical course descriptions (phenotypes) of multiple sclerosis (MS) are important for communication, prognostication, design and recruitment of clinical trials, and treatment decision-making. Standardized descriptions published in 1996 based on a survey of international MS experts provided purely clinical phenotypes based on data and consensus at that time, but imaging and biological correlates were lacking. Increased understanding of MS and its pathology, coupled with general concern that the original descriptors may not adequately reflect more recently identified clinical aspects of the disease, prompted a re-examination of MS disease phenotypes by the International Advisory Committee on Clinical Trials of MS. While imaging and biological markers that might provide objective criteria for separating clinical phenotypes are lacking, we propose refined descriptors that include consideration of disease activity (based on clinical relapse rate and imaging findings) and disease progression.

The original MS clinical descriptions were published in 1996, and provided the 4 MS clinical courses which we currently use -
  • Relapsing- remitting (RRMS)
  • Secondary progressive (SPMS)
  • Primary progressive (PPMS)
  • Progressive relapsing (PRMS)
The new recommendations now suggest that modify this to active or not active based on MRI disease activity -
  • Clinically isolated syndrome - Active/Not active
  • RRMS - Active/Not active
  • Progressive disease - Active and with progression/Active but without progression/Not active but with progression/Not active and without progression

Not only is this a mouthful - consultations littered with active but lets see if it's progressive...reading the recommendations was somewhat of an anti-climax (imagine yourself going to the Miss World contest but discovering at the last minute that its the Miss Essex contest!). 

In the words of the authors: "When proposed [back in 1996], it was noted that these clinical course descriptors were based on subjective views of MS experts and lacked objective biological support... [But] We recognise that there (may) be other markers of disease activity, but there is insufficient evidence for including them at this time". 

If truth be known, we now know so much about MS that it's the clinical descriptors that are superfluous! MS is an autoimmune disease affecting the nervous system - there I've said it.

Proponents who lost out in this revision were:
  • MRI (atrophy, MTR, DTI etc)
  • All body fluid biomarkers
  • Optical coherence tomography (OCT)
  • Patient-reported outcomes
Imagine what precedent would be set if these had been included ???

Although, in a bizarre way there may be light at the end of the tunnel/loophole, which is by deciding to use disease activity as a descriptor more patients maybe eligible for treatment! - take that NICE!!

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