Abstract Details

Title Understanding Burden and Health Outcomes Based on Number of Adverse Events in Patients with Lennox-Gastaut Syndrome in Real-world Clinical Practice Settings

Topic Epilepsy/Clinical Neurophysiology (EEG)

Presentation(s) P10 - Poster Session 10 (11:45 AM-12:45 PM)

Poster/Presentation
Number 1-010

Objective To quantify the incremental treatment burden of adverse events (AEs) among patients with Lennox-Gastaut syndrome (LGS) receiving antiseizure medication (ASM).

Background LGS is a severe form of treatment-resistant childhood-onset epilepsy. Use of multiple ASMs frequently results in AEs and drug–drug interactions.

Design/Methods Data for this retrospective cross-sectional analysis were derived from the real-world Adelphi LGS Disease Specific Programme (DSP^TM). Neurologists/pediatric neurologists provided information on treatment patterns, AEs (from a pre-specified list) per treatment regimen, non-seizure symptoms, and resource use. Data were stratified by number of AEs (0–1; 2; 3+) irrespective of number of ASMs prescribed and compared using bivariate testing.

Results Of 803 patients (mean age 14.7 years), 117 (15%) experienced 2 AEs and 139 (17%) 3+ AEs. Mean number of current ASMs per patient was similar across groups (0–1 AEs, 2.5; 2 AEs, 2.4; 3+ AEs, 2.6). Mean number of seizure-related injuries experienced (last 6 months) was significantly higher among patients with 3+ AEs (overall, 7.0; head injuries, 1.5) than with 0–1 (1.3 and 0.3, respectively) or 2 AEs (2.3 and 0.6) (p<0.0001). Non-seizure burden (last 4 weeks) was also higher among patients with 3+ AEs versus 0–1 or 2 AEs, especially the proportions of patients having difficulty with gait, dysphasia, and cognitive impairment (all p<0.05). The proportions of patients with ≥1 hospitalization event, ≥1 ER visits, and ≥1 outpatient visits over the last 12 months were highest among those with 3+ AEs (all p<0.0001). Proportions with very poor to somewhat poor quality of life (p=0.0006) were also highest among those with 3+ AEs.

Conclusions Despite similar ASM use across groups, patients with more AEs (versus fewer) experienced a substantial clinical burden and greater healthcare resource use suggesting a potentially more vulnerable population. There is a clear need for new LGS treatments with a better tolerability profile.

Authors/Disclosures
Arturo I. Benitez, MD (Takeda) PRESENTER	Dr. Benitez has received personal compensation for serving as an employee of Takeda.
Drishti Shah, PhD (Takeda)	Dr. Shah has received personal compensation for serving as an employee of Takeda.
Jeffrey Andrews (Takeda Pharmaceuticals)	No disclosure on file
Jonathan de Courcy	No disclosure on file
Yasmin Taylor	Yasmin Taylor has received personal compensation for serving as an employee of Adelphi Real World.
Hannah Connolly (Adelphi Real World)	Hannah Connolly has nothing to disclose.
Sophie Lai (Adelphi Real World)	No disclosure on file
Vicente Villanueva	Vicente Villanueva has received personal compensation in the range of $500-$4,999 for serving as a Consultant for UCB. Vicente Villanueva has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Angelini. Vicente Villanueva has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Xenon. Vicente Villanueva has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Rapport. Vicente Villanueva has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for UCB. Vicente Villanueva has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Angelini. Vicente Villanueva has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for EISAI. Vicente Villanueva has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Paladin. Vicente Villanueva has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Jazz pharmaceutical.

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