Dive Brief:
- The International Advisory Committee on Clinical Trials has redefined MS and published their recommendations and research in the most recent issue of Neurology.
- The last time the committee addressed MS was in 1996 when they defined the four courses of the disease
- The committee recommended re-categorizing progressive, relapsing MS and also categorizing a person's disease as either 'active' or 'not active', as well as 'progressive' or 'not progressive.'
Dive Insight:
Almost 20 years ago, the current paradigm for MS was outlined. Based on that paradigm, the four courses of the disease are relapsing/remitting (RRMS)--the most common; secondary progressive (SPMS)--most people with RRMS progress to SPMS; primary progressive (PPMS) and progressive relapsing (PRMS). These categories have been useful for making treatment decisions, but the medical literature reflects how much the understanding of MS has increased since the mid-90's.
The committee convened an international workshop funded by the National MS Society and other groups to explore new data on MS and redefine the disease in order to make clinical trials more effective and improve clinical decision-making. They aggregated their finding and made recommendations as follows:
-- Retain the major courses of MS, with the exception of PRMS. PRMS, which according to the 'four courses' paradigm only affects 5% of patients should be categorized as part of PPMS, whichis MS that progresses steadily starting with diagnosis, without periods of remission.
-- MS should be categorized as either 'active' or 'inactive' based on relapses and MRI scans.
-- MS should be categorized as either 'progressing' or 'not progressing' based on changes in disability.
Refining the understanding of MS could very well change the way clinical trials are designed and the way clinical decisions are made. All told, the new paradigm is more straightforward---which bodes well for the 2.5 million people worldwide who have MS, including the 400,000 patients in the U.S.