Antiseizure Medication Treatment Patterns, Reasons for Disruption, and Side Effects for Patients with Dravet Syndrome or Lennox-Gastaut Syndrome: A Retrospective Analysis of US Physician Notes

Abstract number : 2.286
Submission category : 7. Anti-seizure Medications / 7D. Drug Side Effects
Year : 2023
Submission ID : 893
Source : www.aesnet.org
Presentation date : 12/3/2023 12:00:00 AM
Published date :

Authors :
Presenting Author: Mei Lu, MD, MS – Takeda Pharmaceuticals USA, Inc.

Dave Iwanyckyj, N/A – Amplity; Sally Wade, N/A – Wade Outcomes Research and Consulting; Pablo Racana, N/A – Amplity; Fernando Otalora, N/A – Amplity; Satish Rao, MD, MS – Takeda Pharmaceuticals USA, Inc.

Rationale: Patients (pts) with Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS) are refractory to treatment and experience inadequate seizure control and safety issues resulting from polypharmacy of antiseizure medications (ASMs). Our study describes real-world treatment patterns for these pts, to better characterize the unmet need and complex treatment paradigms that they face.

Methods: Natural language processing (NLP) was used to analyze the Amplity Insights’ database, which contains transcriptions of narrative medical records from pt interactions with clinicians across the US. NLP identified pts with a diagnosis of DS or LGS and ≥1 ASM. Descriptive pt-level characteristics, ASM use, treatment disruptions, side effects, safety monitoring, and non-ASM therapies were described.

Results: NLP identified 166 pts with DS and 1063 pts with LGS between January 2010 and January 2022. Pts with available data were predominantly White (DS: 95%; LGS: 90%). At the recorded visit, the majority of pts were aged < 18 y (pediatric) in the DS group (84%) and ≥ 18 y (adult) in the LGS group (58%). Pts with DS had a younger mean age at diagnosis (1.1 y) vs pts with LGS (2.1 y). Combination ASM therapy was used by 67% of pts with DS and 58% of pts with LGS. ASMs clobazam (DS: 54%; LGS: 49%) and levetiracetam (DS: 53%; LGS: 47%) were used by nearly half of the pts in both groups. Divalproex/valproic acid was used by 58% of pts in the DS group and 40% of pts in the LGS group. Up to 58% of pts with DS and 51% of pts with LGS received rescue ASMs. One or more ASM treatment disruptions were experienced by 39% of pts with DS and 28% of pts with LGS, most frequently caused by switching (DS: 57%; LGS: 45%), discontinuation (DS: 48%; LGS: 55%), and dose decreases (DS: 28%; LGS: 38%) (Figure 1). Reasons for treatment disruption included side effects/adverse events/tolerability (DS: 57%; LGS: 53%), unspecified failure (DS: 26%; LGS: 22%), and insufficient efficacy (DS: 26%; LGS: 30%). For both groups, 23% of pts reported ASM side effects; the top 2 were drowsiness/somnolence/sedation (DS: 21%; LGS: 32%) and any mood side effects (DS: 21%; LGS: 26%) (Figure 2). Approximately 40% of pts in the DS and LGS groups had blood-based laboratory testing. ASM drug-level checks were mentioned for 17% of pts with DS and 13% of pts with LGS. Many pts used non-ASM therapies, such as antipsychotics, antidepressants, or anxiolytics (DS: 10%; LGS: 17%). Other non-ASM interventions included dietary therapy (DS: 23%; LGS: 16%), therapy for developmental delay (DS: 16%; LGS: 14%), and surgery (DS: 1%; LGS: 8%).

Conclusions: DS and LGS are refractory epilepsy conditions treated with available ASMs, which provide inadequate seizure control and are limited by tolerability and safety issues. Using NLP, this real-world study suggests that pts may benefit from more effective and tolerable ASMs.

Funding: Takeda Pharmaceuticals USA, Inc. funded this study and writing support.

Anti-seizure Medications