Poza kontrolą napadów: Wyniki niezwiązane z napadami padaczki ogniskowej leczonej cenobamatem. Trzecie wyniki przejściowe z badania BLESS

OBJECTIVE: Cenobamate is approved for treatment of focal seizures in adults, but evidence on non-seizure outcomes remains limited. This interim statistical analysis of the cenoBamate in aduLts with focal-onsEt SeizureS (BLESS) study evaluated patient- and clinician-reported outcomes for up to 52 weeks of cenobamate treatment. METHODS: BLESS is an observational, retrospective and prospective cohort study designed to assess the real-world effectiveness and safety of adjunctive cenobamate in adults with uncontrolled focal epilepsy. Outcomes included patient-reported health-related quality of life, sleepiness, anxiety, mood, and global functioning assessed by the 31-item Quality of Life in Epilepsy Inventory (QOLIE-31), the Epworth Sleepiness Scale (ESS), the Hospital Anxiety and Depression Scale (HADS), and the Clinical Global Impression (CGI) scales. RESULTS: A total of 377 participants were included. Among subjects with an available score at 12 (n = 197), 24 (n = 363), and 52 (n = 197) weeks, the QOLIE-31 overall score remained stable. Subjects with sustained seizure freedom at 24 weeks showed a significantly higher QOLIE-31 overall score (p = 0.041) and cognitive functioning scores (p = 0.019) compared with those who did not reach sustained seizure freedom. More than 68% of participants had normal daytime sleepiness (total ESS score 0-10) and did not report anxiety or depression according to the HADS-A and HADS-D subscales at each assessment up to 52 weeks. Clinicians rated 91.3% (n/N = 179/196), 85.7% (n/N = 300/350), and 87.4% (n/N = 167/191) of subjects as improved for their overall condition from the initiation of treatment according to the CGI-Improvement or change (CGI-I) scale, at 12, 24, and 52 weeks. SIGNIFICANCE: This interim analysis provides preliminary descriptive evidence on non-seizure outcomes in subjects treated with adjunctive cenobamate. Patient-reported outcome scores remained stable from 12 weeks and up to 52 weeks, consistent with preserved overall well-being. Better quality of life and cognitive functioning emerged in sustained vs non-sustained seizure-free participants. Based on clinicians' judgment, there was signal of improvement in overall condition compared to baseline in most treated subjects throughout the observation period. STUDY REGISTRATION: NCT05859854.