Analysis of cutaneous allergic reactions in clinical trials of eslicarbazepine acetate

Data de publicação: Data Ahead of Print:

Autores da FMUP

  • Patrício Manuel Vieira Araújo Soares Da Silva

    Autor

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

Acta Neurologica Scandinavica  Wiley-Blackwell Publishing Ltd

Tipo:
Article
Páginas:
397-404
Link para outro recurso:
www.scopus.com

Citações Recebidas na Web of Science: 8

Citações Recebidas na Scopus: 10

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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

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