Abstracts

Rationale: Rash has been associated with the use of several antiepileptic drugs (AED). To gain a thorough understanding of the risk of rash in association with the use of eslicarbazepine acetate (ESL), the incidence of rash and pruritus was analyzed in subjects taking ESL compared with placebo as adjunct therapy in the pooled population of Phase III studies. Methods: ESL was tested in the 3 pivotal placebo-controlled Phase III studies as adjunctive treatment in 1049 adults with partial-onset epilepsy treated with 1 to 3 AEDs. The population was randomized to treatment with once-daily ESL 400 mg, 800 mg, 1200 mg or placebo for 12 weeks. The incidence of rash or pruritus Treatment Emergent Adverse Events (TEAEs) was summarized by treatment group. Results: A summary of all pruritus and rash TEAEs is provided in Table I. A total of 22 subjects reported pruritus and/or rash (including rash pruritic, rash vesicular or rash papular). The combined incidence of rash and pruritus with ESL treatment was low. Four subjects (2.0%) in the 400 mg ESL group, 4 (1.4%) in the 800 mg ESL group, and 10 (3.6%) in the 1200 mg ESL group reported rash or pruritus as a TEAE, compared to 4 subjects (1.3%) in the placebo group. Of these cases in the ESL groups, 3 (1.5%) in the 400 mg group, 1 (0.4%) in the 800 mg group, and 7 (2.5%) in the 1200 mg group were considered possibly, probably, or definitely related to study medication by the investigator. One subject in the 400 mg ESL group reported severe pruritus and one subject in the 1200 mg ESL group reported severe rash; both subjects discontinued the study. Three additional subjects in the 1200 mg ESL group and another in the placebo group were discontinued from the study due to mild or moderate rash. All TEAEs of rash or pruritus resolved without sequelae. Conclusions: The risk of developing dermatological reactions in association with ESL is low. Most observed events were mild or moderate in severity and all events resolved without sequelae. Supported by BIAL- Portela & Co, SA