Abstracts

Rationale: Data on the use of levetiracetam (LEV) in infants with epilepsy remain limited. Therefore, a post authorization safety study (PASS) was conducted to obtain further data on the safety of LEV among infants<12 months of age with different seizure types in routine clinical practice. Methods: This was a noninterventional sentinel sites PASS. Patients 1-11 months of age who were prescribed LEV oral solution, and whose parent(s)/legal representative provided consent, were included in the study. Of the 100 patients planned for inclusion at least 30 were to be aged 1-6 months at the time of enrollment. Patients were followed until the age of 13 months - if treatment ended before this, safety data were collected at the next scheduled visit. Given the observational nature of the study, patients' treatment plan was at the discretion of the treating physician. LEV doses were determined according to local prescribing information and the physician could add, withdraw, or change doses of different medications, including concomitant antiepileptic drugs (AEDs). The primary variable was treatment-emergent adverse events (TEAEs) as reported by parents/caregivers or observed by the physician. Physicians also rated patients' change in epilepsy severity from start to study end using a 7-point Global Evaluation Scale (1=marked worsening to 7=marked improvement). Results: Of 101 patients who started, 75 (74.3%) completed and 26 (25.7%) prematurely discontinued the study; 11.9% due to lack of efficacy, 6.9% due to AEs, 2.0% due to "other" (1 patient refused to swallow and another could not take glucose), 1.0% due to consent withdrawal, 1.0% experienced disease remission and 3.0% were lost to follow up. Mean age of infants was 6.0 months (53 were 1-6 months), 50 were male and the majority (68.3%) had focal epilepsy. Most patients (80%) took at least 1 concomitant AED, while 20% took only LEV. Overall, 54.5% of patients had at least 1 TEAE at any time during the study; the most common were bronchitis (9.9%), convulsion (9.9%) and pyrexia (7.9%). Most TEAEs were mild or moderate in intensity. Serious AEs were noted in 32 patients (31.7%), of which 2 (both convulsion) were considered to be drug-related by the Investigator. Six deaths were reported during the study; none were deemed to be related to the study drug by the Investigator. Seven patients (6.9%) had at least 1 TEAE leading to study discontinuation. The most common TEAEs leading to discontinuation were infantile spasms, respiratory disorder and respiratory distress (2 patients each); all other TEAEs were reported for 1 patient each. Of the 85 patients who had epilepsy severity evaluated at study end, 71.8% showed improvement, 18.8% remained stable and 9.4% showed worsening. Conclusions: No new safety concerns were identified in this PASS and the majority of patients showed improvement in epilepsy severity. Consequently, LEV is a suitable option for the treatment of infants with epilepsy. Sponsored by UCB