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

Nina Magnolo, Külli Kingo, Vivian Laquer, John Browning, Adam Reich, Jacek C. Szepietowski, Deborah Keefe, Rafal Mazur, Prayashi Ghelani, Pascal Forrer, Linda Ann Wraith, Manmath Patekar

Research output: Contribution to journalArticlepeer-review

7 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)122-130
Number of pages9
JournalJournal of the American Academy of Dermatology
Volume86
Issue number1
DOIs
StatePublished - Jan 2022

Keywords

  • moderate to severe plaque psoriasis
  • pediatric psoriasis
  • secukinumab

ASJC Scopus subject areas

  • Dermatology

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