Portal de investigação
Analysis of cutaneous allergic reactions in clinical trials of eslicarbazepine acetate
Data de publicação:
Data Ahead of Print:
Autores da FMUP
Participantes de fora da FMUP
- Rogin, J
- Resnick, T
- Strom, L
- Ben-Menachem, E
- Kochen, S
- Blum, D
- Gama, H
- Li, Y
- Grinnell, T
Unidades de investigação
Abstract
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.
© 2020 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.
Dados da publicação
- ISSN/ISSNe:
- 1600-0404, 0001-6314
- Tipo:
- Article
- Páginas:
- 397-404
- DOI:
- 10.1111/ane.13218
- Link para outro recurso:
- www.scopus.com
Acta Neurologica Scandinavica Wiley-Blackwell Publishing Ltd
Citações Recebidas na Web of Science: 8
Citações Recebidas na Scopus: 10
Documentos
- Não há documentos
Filiações
Keywords
- adjunctive; allergic reactions; epilepsy; eslicarbazepine acetate; focal seizures; pediatric; rash; safety
Financiamento
Proyectos asociados
Inervação simpática e mecanismos adrenérgicos locais na regulação funcional da córnea
Investigador Principal: Patrício Manuel Vieira Araújo Soares da Silva
Estudo Clínico Académico . 2019
Citar a publicação
Rogin J,Resnick T,Strom L,Ben E,Kochen S,Blum D,Gama H,Soares P,Li Y,Grinnell T. Analysis of cutaneous allergic reactions in clinical trials of eslicarbazepine acetate. Acta Neurol. Scand. 2020. 141. (5):p. 397-404. IF:3,209. (3).
