Sustainable Risk Management
The title of the article by Havla et al. (1) raised expectations of sustainable risk management as an integral component of an evidence-based therapeutic approach for multiple sclerosis (MS), not merely a sort of early warning and control system for adverse effects. Genuine risk management means that when defining indications, these need to be adapted to the disease risk, which in MS is extremely variable. Unfortunately, in the specialty of neurology, instead of evidence-based considerations of risks and benefits, we have only expert opinion at our disposal—for example, the stepwise therapeutic scheme of the MS guideline and the “no evidence of disease activity” (NEDA) concept. It is problematic that according to NEDA, even the mere development of new lesions on MRI in clinically stable patients is categorized as therapeutic failure and an indication for second-line therapy, without any scientifically confirmed causal association between subclinical MRI activity and long-term results.
As the second consequence for affected patients, MS immunotherapy has to be conducted as continuous therapy from disease onset, in order to achieve the therapeutic objective of NEDA. The NEDA concept is neither evidence-based nor individually tailored. It leads to consecutive trials of licensed immunotherapies without taking into account potential cumulative risks and late sequelae. Furthermore, if one considers extending the diagnosis to mild clinical courses as a result of the McDonald criteria introduced in 2001, MS patients are currently running the risk of contracting greater harm from adverse effects than they would have had to expect from MS alone.
In order to prevent worse outcomes, one might look to, for example, successful oncology research and treatment networks (German Hodgkin Study Group [www.ghsg.org], or the German Childhood Cancer Foundation’s treatment network HIT [www.kinderkrebsstiftung.de]), which use studies of treatment optimization that are systematically building on one another and—actually in the form of interdisciplinary collaboration—have created the underlying data for risk stratification and risk group–adapted therapy of numerous cancers.
Dr. med. Jutta Scheiderbauer
Trierer Aktionsgruppe Multiple Sklerose
Conflict of interest statement
The author declares that no conflict of interest exists.
|1.||Havla J, Warnke C, Derfuss T, Kappos L, Hartung HP, Hohlfeld R: Interdisciplinary risk management in the treatment of multiple sclerosis. Dtsch Arztebl Int 2016; 113: 879–86 VOLLTEXT|