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Randomized Controlled Trial
. 2022 Jan;86(1):122-130.
doi: 10.1016/j.jaad.2021.08.066. Epub 2021 Sep 30.

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  1 , Külli Kingo  2 , Vivian Laquer  3 , John Browning  4 , Adam Reich  5 , Jacek C Szepietowski  6 , Deborah Keefe  7 , Rafal Mazur  8 , Prayashi Ghelani  9 , Pascal Forrer  8 , LindaAnn Wraith  7 , Manmath Patekar  8
Affiliations
Randomized Controlled Trial

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 et al. J Am Acad Dermatol. 2022 Jan.

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.

Keywords: moderate to severe plaque psoriasis; pediatric psoriasis; secukinumab.

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Conflict of interest statement

Conflicts of interest Dr Magnolo has been a principal investigator in studies performed by AbbVie, Asana, Boehringer Ingelheim, Celgene, Dr Reddy's Laboratories, Eli Lilly, Galderma, Genentech, Incyte, Janssen, Kyowa Kirin, LEO Pharma, Novartis, MSD, Pfizer, Regeneron, Sun Pharma, and UCB and is a consultant or speaker for AbbVie, LEO Pharma, and UCB. Dr Kingo has received fees for serving as an investigator in studies sponsored by Celgene, Merck, Mitsubishi Tanabe Pharma, Novartis, Regeneron Pharmaceuticals, and Sandoz. Dr Laquer is an investigator for AbbVie, Amgen, Biofrontera, Cara Therapeutics, Celgene, ChemoCentryx, Dermavant, Dermira, Eli Lilly, Galderma, Incyte, Kiniksa, LEO Pharma, Novartis, Pfizer, Regeneron, Sun Pharma, and UCB. Dr Browning is an investigator for Amryt, Brickell Biotech, Celgene, ChemoCentryx, Eli Lilly, Incyte, Lenus, LEO Pharma, Mayne, Novartis, Pfizer, Regeneron, and Valeant; a consultant for Dermavant and LEO Pharma; and a speaker for Dermira, Regeneron, and Pfizer. Dr Reich is a principal investigator or sub investigator in clinical trials sponsored by AbbVie, Drug Delivery Solutions Ltd, Galderma, Genentech, Janssen, Kymab Ltd, LEO Pharma, Menlo Therapeutics, MetrioPharm AG, MSD, Novartis, Pfizer, and Trevi Therapeutics and a consultant or speaker for AbbVie, Bioderma, Celgene, Chema-Elektromet, Eli Lilly, Galderma, Janssen, LEO Pharma, Medac, Menlo Therapeutics, Novartis, Pierre Fabre, Sandoz, and Trevi Therapeutics. Dr Szepietowski is an advisory board member of AbbVie, LEO Pharma, Novartis, Pierre Fabre, Menlo Therapeutics, Sienna Biopharmaceuticals, Trevi; principal investigator for AbbVie, Novartis, Menlo Therapeutics, Trevi, Janssen, Merck, Regeneron, Amgen, Boehringer Ingelheim, Galapagos, Galderma, InflaRX, Kymab Ltd., Pfizer, UCB, Helm, and Incyte; and a speaker for AbbVie, Novartis, Janssen, Eli Lilly, Sanofi-Genzyme, Sunfarm, and Berlin-Chemie Mennarini. Dr Keefe and author Wraith are employees of Novartis Pharmaceuticals Corporation. Author Ghelani is an employee of 264957 Ontario Limited and serves as an independent contractor for Novartis. Drs Mazur, Forrer, and Patekar are employees of Novartis Pharma AG.

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