Analysis of cutaneous allergic reactions in clinical trials of eslicarbazepine acetate

Autor: Trevor Resnick, Joanne Rogin, Silvia Kochen, Yan Li, David Blum, Elinor Ben-Menachem, Patrício Soares-da-Silva, Laura Strom, Helena Gama, Todd Grinnell
Rok vydání: 2020
Předmět:
Zdroj: CONICET Digital (CONICET)
Consejo Nacional de Investigaciones Científicas y Técnicas
instacron:CONICET
ISSN: 1600-0404
0001-6314
DOI: 10.1111/ane.13218
Popis: Objectives: To evaluate cutaneous allergic reactions in clinical trials of adjunctive eslicarbazepine acetate (ESL) for focal seizures. Materials and methods: Data were analyzed from three phase III randomized, double-blind, placebo-controlled studies of adjunctive ESL in adults (placebo, n = 426; ESL, n = 1021) and two randomized, double-blind, placebo-controlled studies (and open-label extensions [OLEs]) of adjunctive ESL in children aged 4-17 years (placebo, n = 160; ESL, n = 202; OLE, n = 337). Results: Adult studies: Rash (ESL 1.9%, placebo 0.9%) and pruritus (ESL 1.2%, placebo 0.9%) were the most frequent rash-related treatment-emergent adverse events (TEAEs). Most rash-related TEAEs were mild or moderate in severity. Incidence of rash increased with increasing ESL dose, but was not higher for patients who initiated treatment with higher ESL doses. Pediatric studies: Allergic dermatitis (ESL 3.0%, placebo 0) and rash (controlled studies: ESL 1.0%, placebo 1.3%; OLE periods: ESL ≤1.2%) were the most frequent rash-related TEAEs. There was one case of DRESS in the ESL group. Most rash-related TEAEs were mild or moderate in severity and judged as not related to treatment with ESL. Conclusions: Serious skin rashes were rare during adult and pediatric clinical trials of ESL. Although the incidence of rash with ESL was low, it is important for patients/caregivers to be made aware of the potential signs and symptoms associated with serious skin rashes. Fil: Rogin, Joanne. Minneapolis Clinic of Neurology. Midwest Center for Seizure Disorders; Estados Unidos Fil: Resnick, Trevor. Florida International University; Estados Unidos Fil: Strom, Laura. University of Colorado Denver Health Sciences. Department of Neurology; Estados Unidos Fil: Ben Menachem, Elinor. Sahlgrenska Academy Institute of Neuroscience and Physiology; Suecia Fil: Kochen, Sara Silvia. Universidad Nacional Arturo Jauretche. Unidad Ejecutora de Estudios en Neurociencias y Sistemas Complejos. Provincia de Buenos Aires. Ministerio de Salud. Hospital Alta Complejidad en Red El Cruce Dr. Néstor Carlos Kirchner Samic. Unidad Ejecutora de Estudios en Neurociencias y Sistemas Complejos. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - La Plata. Unidad Ejecutora de Estudios en Neurociencias y Sistemas Complejos; Argentina Fil: Blum, David. Sunovion Pharmaceuticals Inc; Estados Unidos Fil: Gama, Helena. São Mamede de Coronado. BIAL - Portela & Ca, S.A.; Portugal Fil: Soares da Silva, Patrício. São Mamede de Coronado. BIAL - Portela & Ca, S.A.; Portugal. Universidad de Porto; Portugal Fil: Li, Yan. Sunovion Pharmaceuticals Inc; Estados Unidos Fil: Grinnell, Todd. Sunovion Pharmaceuticals Inc; Estados Unidos
Databáze: OpenAIRE
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