An international committee of multiple sclerosis (MS) experts further clarified how guidelines, updated in 2013, should be used to classify this disease’s different states, and stressed the importance of measuring these states in a timely and consistent manner.
The group’s statement, “The 2013 clinical course descriptors for multiple sclerosis: A clarification,” was issued by the International Advisory Committee on Clinical Trials in Multiple Sclerosis and published in the journal Neurology.
Jointly supported by the U.S. National MS Society and the European Committee for Treatment and Research in MS, the committee (comprised of 25 MS experts) provides perspective and guidance for the planning of clinical trials of investigational MS therapies.
“With this published statement, we’re encouraging the healthcare and regulatory community to use the terms as described for the different subtypes of MS and for describing disease activity,” Fred Lublin, MD, the first author of this statement and of two previous committee-sponsored studies defining MS subtypes, said in a National MS Society news story.
“It’s critical not just for improving patient care, but also for selecting participants for clinical trials, so you are comparing apples to apples,” Lublin added. He is director of the Corinne Goldsmith Dickinson Center for Multiple Sclerosis at Mount Sinai’s Icahn School of Medicine in New York.
In a 2013 committee-sponsored study, MS specialists established four subtypes of MS, and recommended the addition of terms to describe a patient’s current disease state, such as “activity” and “progression,” and that the disease state be framed in time.
“Inclusion of a time frame is critical for effective clinical decision making,” the committee wrote in their statement. While the time period was not specified in the 2013 study, it was recommended that disease assessment be performed at least annually.
However, these terms have been inconsistently used and without reference to a time frame. In particular, regulatory authorities in Europe and the U.S. have used different definitions of disease activity in recent MS therapy approvals, including those given to Ocrevus (by Genentech), Mayzent (by Novartis), and Mavenclad (by EMD Serono; Merck KGaA outside North America).
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