A phase 3 open-label, randomized multicenter study to evaluate efficacy and safety of secukinumab in pediatric patients with moderate to severe plaque psoriasis: 24-week results.
J Am Acad Dermatol
; 86(1): 122-130, 2022 01.
Article
em En
| MEDLINE
| ID: mdl-34555481
ABSTRACT
BACKGROUND:
Psoriasis affects 0.13%-2.1% of children and adolescents. Despite a high unmet need, the current treatment options approved for pediatric psoriasis are limited.OBJECTIVE:
To evaluate the efficacy and safety of 2 secukinumab dosage regimens (low dose 75/75/150 mg; high dose 75/150/300 mg) stratified and randomized by weight (<25 kg, 25 to <50 kg, ≥50 kg) and disease severity (moderate, severe) in pediatric patients aged 6-<18 years with moderate to severe plaque psoriasis.METHODS:
This is a phase 3, open-label, randomized, multicenter study (NCT03668613).RESULTS:
Both secukinumab doses were superior to historical placebo with respect to psoriasis area and severity index (PASI)-75/90 and investigator global assessment 0/1 responses at week 12. The estimated probability of a positive treatment effect (ie, log odds ratio > 0) for low- or high-dose secukinumab compared to historical placebo is 1 (ie, 100%). For the low and high doses at week 12, the investigator global assessment 0/1 response rates were 78.6% and 83.3%, respectively, and the PASI-90 response rates were 69% and 76.2%, respectively. The PASI-75 response rate was 92.9% for both the doses.LIMITATIONS:
This is an open-label study design without a control arm.CONCLUSION:
Secukinumab dosing regimens were efficacious and well tolerated in pediatric patients with moderate to severe plaque psoriasis.Palavras-chave
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Base de dados:
MEDLINE
Assunto principal:
Psoríase
/
Anticorpos Monoclonais
Idioma:
En
Ano de publicação:
2022
Tipo de documento:
Article