Abstracts

Rationale: Eslicarbazepine acetate (ESL), is a third-generation antiseizure drug (ASD) approved for treatment of patients with focal seizures (FS) ≥ 4 years old. In patients 4 to 17 years of age, the recommended dose regimen is dependent upon body weight. The recommended initial dosage of ESL in adults is 400mg administered once daily with weekly increments of 400-600 mg based on clinical response and tolerability to a recommended maintenance dosage of 800-1600mg daily. However, there is lack of real-world evidence on titration practice for patients initiating ESL. Hence, the objective of this analysis was to determine the time required to reach maintenance dose in patients with FS initiating ESL, in a real-world setting.

Methods: A retrospective cohort study using the IQVIA PharMetrics^® Plus database (2016-2020) was conducted. The index date was defined as first observed initiation of ESL. Baseline and follow-up period were defined as 6 months pre and post index date. Key inclusion criteria were patients aged ≥4 years, having ≥1 diagnosis of FS in baseline, having ≥1 prescription of ESL, and no pregnancy during the study period. Titration period was defined as the time from ESL initiation on index date till the beginning of the maintenance dose. The variability of dosages during the titration period was calculated as daily dose. Daily dose was defined as product of units of drug dispensed and strength of drug dispensed, divided by number of days’ supply. Maintenance dose was defined as constant daily dosing of ESL for ≥60 days. Sensitivity analyses were conducted by varying the definition of constant dosing to 30 and 90 days. Demographic and clinical characteristics were studied during the baseline period. Time to reach maintenance dose was studied descriptively during the follow-up period. Additionally, the mean index and maintenance dose of ESL were also studied.

Results: 570 patients met study inclusion criteria. The mean [standard deviation (SD)] age of study cohort was 36(17.5) years and were 52.9% female. The top 5 comorbidities observed were: hypertension (14.1%), bipolar disorder (12.8%), major depressive disorder (9.3%), cerebrovascular disease (8.1%) and chronic pulmonary disease (7.2%). Patients used a mean of 2.5 ASDs in the baseline prior to initiating ESL. Most used ASDs in the baseline were: levetiracetam (32.3%), lamotrigine (19.3%), oxcarbazepine (16.5%) and lacosamide (14.1%). Under the base case scenario, the mean (SD) time to reach maintenance dose was 15.4(44.8) days with 67.8% of patients having zero days to reach maintenance dose, indicating they initiated treatment at their maintenance dose. The mean dose of ESL at index and maintenance period were 756.35mg and 839.9mg respectively. The mean (SD) time to reach maintenance dose based on definition of 30 and 90 days were 6.1(24.4) days and 25.2(55.1) days, respectively. 81.9% and 54.6% of the patients had zero days to reach maintenance dose based on definition of 30 and 90 days, respectively (Table 1).

Conclusions: This real-world study suggests patients with FS initiating ESL, took 15 days to reach maintenance dose, with >50% of the patients initiating at their maintenance dose.

Funding: Please list any funding that was received in support of this abstract.: Sunovion Pharmaceuticals Inc.