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
| Autor: | Pascal Forrer, Prayashi Ghelani, Rafal Mazur, Manmath Patekar, LindaAnn Wraith, Deborah L. Keefe, Vivian Laquer, Külli Kingo, John Browning, Jacek C Szepietowski, Nina Magnolo, Adam Reich |
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| Rok vydání: | 2020 |
| Předmět: |
medicine.medical_specialty
Adolescent business.industry MedDRA Antibodies Monoclonal Dermatology Odds ratio Placebo medicine.disease Antibodies Monoclonal Humanized Severity of Illness Index Treatment Outcome Double-Blind Method Psoriasis Area and Severity Index Internal medicine Psoriasis medicine Humans Secukinumab Dosing Adverse effect business Child |
| Zdroj: | Journal of the American Academy of Dermatology. 86(1) |
| ISSN: | 1097-6787 |
| Popis: | 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.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 to50 kg, ≥50 kg) and disease severity (moderate, severe) in pediatric patients aged 6-18 years with moderate to severe plaque psoriasis.This is a phase 3, open-label, randomized, multicenter study (NCT03668613).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 ratio0) 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.This is an open-label study design without a control arm.Secukinumab dosing regimens were efficacious and well tolerated in pediatric patients with moderate to severe plaque psoriasis. |
| Databáze: | OpenAIRE |
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