Mazen Dimachkie, M.D., was among the authors of a New England Journal of Medicine nonfiction outlining the affirmative results of the archetypal large-scale, randomized controlled objective proceedings investigating the effectiveness of a cause to dainty dermatomyositis. | Photo credit: Microphotograph provided by Mazen M. Dimachkie, M.D.
Mazen Dimachkie, M.D., prof of neurology astatine the University of Kansas Medical Center, was among the authors of recent probe published successful the New England Journal of Medicine reporting affirmative results of the archetypal large-scale, randomized controlled objective proceedings demonstrating the effectiveness of a cause to dainty a uncommon disease, dermatomyositis (DM).
Published successful the Oct. 6 variation of the journal, the Progress successful Dermatomyositis (ProDERM) survey investigating the effectiveness of intravenous immune globulin (IVIG) successful treating DM was the catalyst for the caller U.S. Food and Drug Administration support of IVIG arsenic a attraction for the condition.
DM is simply a uncommon systemic autoimmune illness that causes progressive musculus weakness and tegument rashes. Previously, DM has been treated utilizing steroids and different immunosuppressive agents that improved the information but were being utilized off-label and came with important broadside effects.
In the 16-week ProDERM trial, researchers from 36 European and North American sites enrolled 95 participants with DM who were assigned randomly to either the IVIG radical oregon the placebo group. By the extremity of the 16 weeks, the probe squad recovered that the proportionality of participants successful the IVIG radical who showed astatine slightest minimal betterment without confirmed deterioration of illness (79%) was greater successful examination to that observed successful the placebo radical (44%). The quality betwixt the 2 groups was statistically significantly.
“Prior to the ProDERM trial, the fewer large-scale controlled studies successful myositis had failed to amusement a quality betwixt the involution radical and the power group. ProDERM is the archetypal large-scale randomized controlled survey to show a affirmative result successful DM,” Dimachkie said. “This occurrence provides a roadworthy representation for the plan of aboriginal myositis objective trials, and successful peculiar DM.” (Myositis is immoderate information causing inflammation of the muscles, including dermatomyositis.)
The ProDERM survey besides utilized the Total Improvement Score (TIS) arsenic a superior result measure. The TIS is simply a weighted composite people including six components related to myositis activity.
“The palmy implementation of this caller result measurement volition interaction aboriginal probe studies. The connection moving guardant is that DM studies should powerfully see utilizing the TIS arsenic a superior result measure,” Dimachkie said. “Its eventual validation arsenic demonstrated by the TIS palmy implementation successful the ProDERM survey volition stimulate researchers from academia and manufacture to motorboat much studies to analyse therapies to payment radical surviving with myositis.”
Dimachkie directs the KU neurology department’s neuromuscular part and oversees 1 of the largest neuromuscular probe objective proceedings units successful North America. A often invited planetary presenter connected neuromuscular conditions, helium besides is 1 of 4 elected coordinators for the International Myositis Assessment and Clinical Studies Group (IMACS), a consortium of 600 wellness attraction professionals focused connected improving the lives of radical with myositis done research.