ECTRIMS 2023 | Baseline characteristics in the HERCULES trial: tolebrutinib in non-relapsing SPMS

Erik Wallstroem, MD, PhD, Global Head of Development, Neurology and Opthalmology, Sanofi, and Tom Snow, VP, Global Franchise Head, Neurology and Rare Blood Disorders, Sanofi, explore the intricacies of HERCULES trial (NCT04411641) focusing on patients with non-relapsing secondary progressive multiple sclerosis (SPMS). In the study, patients had no recorded relapses for two years prior to entry, with an average age just below 50 and 33% showing active lesions at baseline. This demographic illustrates a significant unmet need in MS treatment. Feedback from neurologists emphasized the authenticity of the trial population, reflecting real-life SPMS patients without recent relapses. They also highlight the challenges in assessing and comparing relapse data across different phases of clinical trials due to varying methodologies. Emphasis is placed on the importance of consistent relapse adjudication and the potential pitfalls of comparing data from different trial designs. This interview took place at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) Congress 2023 in Milan, Italy.

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