Abstracts

Rationale: Epidiolex^®, a plant-derived, highly purified pharmaceutical formulation of CBD is approved for the treatment of seizures associated with Dravet syndrome (DS), Lennox-Gastaut syndrome (LGS), and tuberous sclerosis complex (TSC); nonseizure benefits of CBD have also been reported. Caregiver Analysis of Real-world Epidiolex^® in Epilepsy Context (CARE-EpiC) was a cross-sectional caregiver survey evaluating the real-world effects of CBD treatment.


Methods: Caregivers (aged ≥ 18 years) of dependents taking CBD (Epidiolex^®; 100 mg/mL oral solution) for treatment of seizures completed a one-time cross-sectional survey. Caregiver burden was measured using the Burden Scale for Family Caregivers (BSFC; maximum score, 30; higher scores representing greater burden). Wearable data to assess caregiver activity level were collected for 1 year, retrospectively. Outcomes were evaluated overall and for the following subgroups: race/ethnic communities (underrepresented vs non-underrepresented), sex (female vs male), and caregiver responsibility (shared vs sole).


Results: Overall, 204 respondents completed the survey. Mean (SD) age of caregivers was 38 years (11); 38% were from underrepresented communities, 54% were female, and 78% shared caregiver responsibilities. Most dependents (56%) were adults and taking concomitant medications for seizures (86%). LGS, DS, or TSC was diagnosed in 52% of dependents; 45% were experiencing < 1 seizure/week. Most dependents had co-occurring conditions (Table 1). Mean (SD) overall BSFC score was 14.1 (6.8) and was higher for caregivers in underrepresented vs non-underrepresented communities and for male vs female caregivers (Table 2). Overall, caregivers (81%) reported emotional and behavioral care activities as most burdensome. Daily care activities had a greater negative impact on caregivers from underrepresented (reported by 83% of caregivers) vs non-underrepresented communities (71%). Wearable data (Table 2) showed differences among the subgroups. Caregivers in underrepresented communities and female caregivers had lower step count and active minutes and higher resting heart rate than those in non-underrepresented communities and male caregivers, respectively. Sole caregivers had lower step count and higher resting heart rate than those who shared responsibilities. Seizure frequency reduction (46%) was the most common reason for starting CBD; 69% reported their dependents had been taking CBD for > 6 months. Most caregivers reported reduction in the average seizure duration (64%) and improvements in their dependent’s condition (78%) and their own experience (78%) after CBD initiation.


Conclusions: Our results show that caregivers experience a high burden of caregiving and negative impact on their activity level, emphasizing the need for additional support, especially for those from underrepresented communities and sole caregivers, for their dependents’ physical, emotional, and behavioral care. CBD initiation was associated with positive changes in dependents’ well-being and caregivers’ experiences.


Funding: Jazz Pharmaceuticals, Inc.