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

Magnolo, Nina; Kingo, Külli; Laquer, Vivian; Browning, John; Reich, Adam; Szepietowski, Jacek; Keefe, Deborah L.; Mazur, Rafał; Ghelani, Prayashi; Forrer, P; Wraith, LindaAnn; Patekar, Manmath

doi:10.1016/j.jaad.2021.08.066

Cited by 31 publications

(46 citation statements)

References 36 publications

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“…The efficacy of secukinumab for the treatment of pediatric plaque psoriasis was evaluated in two phase III trials: a randomized, double-blind, multicentre, placebo-and active comparator-controlled trial in patients with severe plaque psoriasis [15] and an open-label, multicentre trial in patients with moderate to severe plaque psoriasis [16].…”

Section: Therapeutic Efficacy Of Secukinumabmentioning

confidence: 99%

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Secukinumab: A Review in Moderate to Severe Pediatric Plaque Psoriasis

Blair

2021

Pediatr Drugs

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Subcutaneous secukinumab (Cosentyx ® ) is a recombinant, fully human, immunoglobulin (Ig) G1κ monoclonal antibody targeted against interleukin (IL)-17A, a proinflammatory cytokine involved in the pathogenesis of psoriasis. Secukinumab is approved in the EU and the USA for the treatment of moderate to severe plaque psoriasis in pediatric patients aged ≥ 6 years. In pivotal phase III trials in pediatric patients aged 6 to < 18 years, both low (75-150 mg) and high (75-300 mg) doses of secukinumab were significantly better than placebo and numerically better than etanercept at week 12 in terms of the proportion of patients achieving ≥ 75% improvement from baseline in Psoriasis Area and Severity Index and significantly better than placebo and etanercept in terms of the proportion of patients achieving an Investigator's Global Assessment score of 0 or 1. The clinical efficacy of secukinumab observed during the first 12 weeks of treatment was maintained over the longer term. Treatment with secukinumab improved health-related quality of life and was generally well tolerated. In conclusion, secukinumab represents a valuable new addition to the limited treatment options available for children and adolescents with moderate to severe plaque psoriasis. Plain Language SummaryPlaque psoriasis is a chronic, inflammatory skin condition that can have a negative impact on the quality of life of affected children and their families. Compared with the expanding treatment options for adults with plaque psoriasis, the number of approved medications for pediatric plaque psoriasis is relatively low. Subcutaneous secukinumab (Cosentyx ® ) is one of several targeted biologic agents that have recently been approved for treating plaque psoriasis in pediatric patients. Secukinumab binds to IL-17A and inhibits the release of proinflammatory cytokines and chemokines. Treatment with secukinumab provided fast and durable skin clearance and continuous improvements in health-related quality of life in children and adolescents aged 6 to < 18 years with moderate to severe plaque psoriasis. The benefits of secukinumab were maintained over the longer term and the drug was generally well tolerated. With a convenient 4-weekly maintenance dosing regimen and the option of caregiver administration, secukinumab is a valuable option for the treatment of moderate to severe pediatric plaque psoriasis.

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Section: Therapeutic Efficacy Of Secukinumabmentioning

confidence: 99%

“…The second trial enrolled patients aged 6 to < 18 years with moderate to severe plaque psoriasis for ≥ 3 months who were eligible for systemic therapy [16]. They had a PASI score of > 12, an IGA score of > 3, and BSA involvement of > 10%.…”

Section: Moderate To Severe Plaque Psoriasismentioning

confidence: 99%

Secukinumab: A Review in Moderate to Severe Pediatric Plaque Psoriasis

Blair

2021

Pediatr Drugs

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“…СЕКУКИНУМАБ В ЛЕЧЕНИИ ДЕТЕЙ С ПСОРИАЗОМ В 2021 г. секукинумаб зарегистрирован в России для лечения детей в возрасте старше 6 лет со среднетяжелым и тяжелым бляшечным псориазом при наличии показаний для системной терапии [24]. Регистрации препарата предшествовала публикация результатов открытого рандомизированного клинического исследования фазы III по оценке безопасности, переносимости и эффективности секукинумаба в низкой и высокой дозах у детей со среднетяжелым и тяжелым бляшечным псориазом [25].…”

Section: патогенез псориаза новые возможности таргетного воздействияunclassified

“…Согласно дизайну, доза секукинумаба для инъекций рассчитывалась по массе тела: < 25 кг -низкая и высокая дозы (по 75 мг); от 25 В результате через 16 нед терапии секукинумабом индекс PASI 75 (уменьшение тяжести и распространенности псориаза на 75%) был достигнут у 93% пациентов, получавших низкие дозы, и у 91% -высокие дозы препарата; индекс PASI 90 -у 83 и 79%; индекс PASI 100 (абсолютно чистая кожа) -у 62 и 55%; индекс глобальной оценки псориаза IGA mod 2011 0/1 (чистая или почти чистая кожа) -у 88 и 86% детей соответственно. Оценка качества жизни детей, выполненная на 24-й нед исследования, не выявила влияния псориаза на качество жизни (значения 0/1 согласно опроснику CDLQI) 61% детей, получавших низкие дозы, и 67% -высокие дозы секукинумаба.…”

Section: патогенез псориаза новые возможности таргетного воздействияunclassified

“…назофарингиты -в 10 (12%), инфекции верхних дыхательных путей -в 3 (4%), кандидозный вульвовагинит -в 1 (1%); нейтропения обнаружена у 3 (4%) больных. При этом профиль безопасности секукинумаба совпадал с аналогичным показателем в исследованиях с участием взрослых [25]. У 1 пациента, получавшего высокие дозы секукинумаба, наблюдалась диарея геморрагического характера, позднее был установлен диагноз «синдром раздраженного кишечника».…”

Section: патогенез псориаза новые возможности таргетного воздействияunclassified

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Management of Moderate and Severe Forms of Psoriasis in Children: New Opportunities of Genetically Engineered Biologic Drugs

Namazova-Baranova

Бакулев

Murachkin

et al. 2021

Vopr. sovr. pediatr.

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The article shows the key role of IL-17 in the psoriasis pathogenesis and the opportunities of its management via monoclonal antibodies product secukinumab. The review of international randomized trials on clinical efficacy and safety of genetically engineered biologic drug secukinumab in children and adolescents with psoriasis is presented. During treatment periods of 12 to 52 weeks, secukinumab has shown high therapeutic efficacy for psoriasis severity and skin lesion areas and has improved quality of life of children and adolescents according to dynamic assessments of PASI, IGA 0/1 mod 2011 indices, CDLQI questionnaire. The safety profile of secukinumab in children is estimated as favorable and comparable to using it in adults.

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Innovative Pediatric Development for Secukinumab in Psoriasis: Faster Patient Access, Reduction of Patients on Control

You

Weber

Bieth

et al. 2022

Clin Pharma and Therapeutics

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This paper describes the innovative pediatric development strategy of secukinumab in psoriasis. Initially, this pediatric development had been planned early during the adult development program. This is common for most development programs as it is required by law in major regions worldwide. At that time, only limited experience with secukinumab’s mechanism of action was available, especially in the pediatric population for which no data had been collected yet. Pediatric extrapolation frameworks were not in use. As a result, a standard pediatric program had initially been proposed requiring two relatively large placebo‐controlled pivotal trials. However, as experience with the use of secukinumab grew, so did experience with—and regulatory openness to—innovative quantitative approaches, such as extrapolation. It became clear that the pediatric development of secukinumab could be substantially accelerated by these novel ideas. Here, we report how these concepts were implemented in the pediatric development program of secukinumab in psoriasis, using a wide range of innovative quantitative techniques. This strategy led to the removal of the placebo arm from one trial, a substantial reduction of the overall sample size in this program, and a significantly faster approval of secukinumab for the pediatric psoriasis population.

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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

Cited by 31 publications

References 36 publications

Secukinumab: A Review in Moderate to Severe Pediatric Plaque Psoriasis

Secukinumab: A Review in Moderate to Severe Pediatric Plaque Psoriasis

Management of Moderate and Severe Forms of Psoriasis in Children: New Opportunities of Genetically Engineered Biologic Drugs

Innovative Pediatric Development for Secukinumab in Psoriasis: Faster Patient Access, Reduction of Patients on Control

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