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The European Commission has approved secukinumab (Cosentyx, Novartis) for treatment of moderate-to-severe plaque psoriasis in pediatric patients 6<18 years in the European Union.
Secukinumab (Cosentyx, Novartis) has been approved by the European Commission for the treatment of moderate-to-severe plaque psoriasis in children and adolescents ages 6 to <18 years.
Secukinumab is a fully human biologic designed to target inhibition of interleukin-17A (IL-17A), a cytokine associated with systemic inflammation in diseases such as plaque psoriasis and psoriatic arthritis.
“Psoriasis is a life-long debilitating disease that significantly impacts children’s quality of life, both physically and emotionally. There are only a few approved treatment options available for the pediatric population, and so it is important to broaden the adult therapeutic options out to children when possible,” says Professor Christine Bodemer, head of the department of dermatology, Necker–Enfants Malades Hospital, Paris. “This approval means Cosentyx is now available in Europe for children and adolescents and will provide an additional option to quickly gain relief from their symptom burden and to significantly improve their quality of life.”
The approval is backed by positive data from two phase 3 international studies that showed both the low dose (75–150 mg) and high dose (75–300 mg) of secukinumab were highly effective at improving skin symptoms and quality of life and demonstrated a favorable safety profile up to 52 weeks.
The studies consisted of one open-label, two-arm, multicenter, parallel-group study in children with moderate-to-severe plaque psoriasis and one double-blind, randomized, placebo and etanercept-controlled study in children with severe plaque psoriasis.
In the study evaluating secukinumab in children with moderate-to-severe plaque psoriasis, 93% of patients who received the low dose achieved Psoriasis Area Severity Index (PASI) 75 as early as week 12. PASI 90 was achieved by 69% of patients in week 12 and 88% in week 24. PASI 100 was reached by 59.5% of patients in week 12 and 67% by week 24.1
Meanwhile, in the study investigating secukinumab in children with severe plaque psoriasis, 75% of patients who were treated with the low dose achieved PASI 90 and demonstrated sustained skin clearance through week 52. 1
Quality of life was measured according to the Children's Dermatology Life Quality Index (CDLQI) 0/1. Responses showed by 50% patients with with moderate-to-severe plaque psoriasis receiving the low dose and 44.7% of patients with severe disease reported complete relief from symptom burden as early as week 12, and 60.6% of patients with severe psoriasis reported complete relief by week 52.1
The safety profile for both the low and high dose of secukinumab was consistent with previous trial results for adult patients with psoriasis, with no newly discovered safety signals being detected in children.1
“This is the second European approval this year for Cosentyx, which also has approvals across four adult indications, reinforcing our commitment to reimagine medicine for both pediatric and adult patients,” says Todd Fox, global head of medical affairs immunology, hepatology and dermatology at Novartis.
Novartis plans on pursuing approval of secukinumab for the treatment of moderate-to-severe plaque psoriasis in pediatric patients in other countries including the United States, Canada, Japan and Australia.
The recommended dose of secukinumab for children up to 50 kg is 75 mg and 150 mg for those 50 kg or more (150 mg starting dose, which can be increased to 300 mg, if needed).
1. Novartis Cosentyx® receives EU approval for first-line systemic treatment in pediatric psoriasis. https://www.novartis.com/news/media-releases/novartis-cosentyx-receives-eu-approval-first-line-systemic-treatment-pediatric-psoriasis. Published August 3, 2020. Accessed August 4, 2020.