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Analysis of cutaneous allergic reactions in clinical trials of eslicarbazepine acetate
Author(s) -
Rogin Joanne,
Resnick Trevor,
Strom Laura,
BenMenachem Elinor,
Kochen Silvia,
Blum David,
Gama Helena,
SoaresdaSilva Patrício,
Li Yan,
Grinnell Todd
Publication year - 2020
Publication title -
acta neurologica scandinavica
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.967
H-Index - 95
eISSN - 1600-0404
pISSN - 0001-6314
DOI - 10.1111/ane.13218
Subject(s) - rash , placebo , medicine , adverse effect , incidence (geometry) , dermatology , clinical trial , randomized controlled trial , pathology , physics , alternative medicine , optics
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.