Redefining Acute Relapses in Multiple Sclerosis: Implications for Phase 3 Clinical Trials and Treatment Algorithms

Conclusion A better definition of what constitutes a relapse in MS is urgently needed. From a treatment perspective, the management of relapses, particularly in the emergency department (ED), is highly variable. In general, it is possible that patients are treated with steroids based on symptomatology and an ED physician’s evaluation. It is often difficult in the ED to ascertain baseline status or a deviation from it, and an MRI may or may not be performed in the ED owing to cost and availability. However, if objective MRI data are not the singular surrogate biomarker to validate BBB breach, false-positive cases are probably subjected to unneccessary treatment in clinical practice, and false-positive cases may inaccurately “improve” a drug’s efficacy in clinical research. As MRI techniques improve, it is only a matter of time before a gold standard based on imaging will emerge. Clinical skills and evaluations, meanwhile, are probably stagnant, at best. It is time to ditch the current definition of an MS relapse. Routine MRIs should be performed on all patients with MS. If the BBB is intact, then the patient should not be diagnosed as having an acute relapse. References Schumacker GA, Beebe G, Kibler RF, et al. Problems of experimental trials of therapy in multiple sclerosis: Report by the panel on the evaluation of experimental trials of therapy in multiple sclerosis. Ann N Y Acad Sci. 1965;122:552–568. Guthrie TC, Nelson, DA. Influence of temperature changes on mu...
Source: Innovations in Clinical Neuroscience - Category: Neuroscience Authors: Tags: Commentary Current Issue Devices Evaluations Multiple Sclerosis Neurology Technology acute relapse big data blood brain barrier imaging magnetic resonance imaging MRI MS Source Type: research