AAN 2024 | Distinguishing true relapses from pseudo-relapses in MS: the impact on clinical trial readouts

Stephen Krieger, MD, FAAN, Icahn School of Medicine at Mount Sinai, New York, NY, and, Enrique Alvarez, MD, PhD, University of Colorado Anschutz Medical Center, University of Colorado, Aurora, CO, discuss their work aiming to define clinical criteria to distinguish true relapse from pseudo-relapses in multiple sclerosis (MS). A pseudo-relapse is a clinical event during which patients will experience symptoms as a result of a trigger (infection, overheating, stress, poor sleep, etc.), but with no associated changes observed using MRI. Dr Krieger and Dr Alvarez utilized data from the ULTIMATE I and ULTIMATE II trials (NCT03277261 and NCT03277248, respectively) to investigate the discrepancy between the reduction in new enhancing legions and relapse rates in patients receiving ublituximab for their MS. When identifying relapses which met MRI criteria for relapse, a lower rate of relapse was observed than reported in the trial, suggesting that pseudo-relapses contribute a significant proportion of the relapses reported and mask the efficacy of the agent. When employing more stringest clinical defintions of relapse, the relapse rate was lower than originally reported, but continued to be higher than the relapse rate determined using MRI criteria. This indicates that, at present, MRI is essential to ensure that an accurate relapse rate is captured in trials and that a true assessment of the efficacy of disease-modifying therapies is made. This interview took place at the American Academy of Neurology (AAN) Annual Meeting 2024 in Denver, CO.

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