Novartis Cosentyx receives EU approval for first-line systemic treatment in pediatric psoriasis - Seite 2

Children with psoriasis have a poorer quality of life than their peers due to symptoms such as itching and fatigue, in addition to feelings of stigmatization. These in turn may affect their emotional wellbeing and performance at school⁸.

“Children with psoriasis are susceptible to bullying, name-calling and shaming at school, leading to higher rates of depression and anxiety than their peers,” said Jan Koren, President of the European patient group EUROPSO. “We welcome this approval, as there is a need for additional treatment options that can help give children the freedom to enjoy full and active lives by improving psoriasis symptoms and thus overall quality of life.”

Novartis is working closely with all stakeholders to ensure that eligible European pediatric patients can start benefitting from Cosentyx as quickly as possible. Novartis will also be seeking approval for Cosentyx for the treatment of moderate-to-severe plaque psoriasis in children and adolescents aged 6 to <18 years in a number of other countries including Australia, Canada, Japan and the US.

About psoriasis
Psoriasis is a life-long debilitating systemic inflammatory disease that significantly impacts patients’ quality of life, both physically and emotionally⁹. One-third of psoriasis cases begin in childhood and of these the onset is most common during adolescence¹⁰. Moderate-to-severe psoriasis affects more than 350,000 children worldwide and may impact children “deeper than the skin”, with the physical and psychological burden of psoriasis disrupting important formative years². The incidence of pediatric psoriasis has more than doubled between 1970 and 2000 in the US and an upward trend in incidence of psoriasis has been observed in several countries^9,10. There are only a few approved treatment options available and the unmet medical need remains high³.

About the study data
The two Phase III international studies in children and adolescents aged 6 to <18 years consisted of one open‑label, two-arm, parallel‑group, multicentre study in children with moderate-to-severe plaque psoriasis and one randomized, double-blind, placebo and etanercept-controlled study in children with severe plaque psoriasis. Dosing regimens of Cosentyx were stratified by weight.

In children with moderate-to-severe plaque psoriasis, the low dose of Cosentyx provided fast and strong skin clearance, with 93% achieving Psoriasis Area Severity Index (PASI) 75 as early as Week 12, 69% achieving PASI 90 at Week 12 and 88% at Week 24, 59.5% achieving completely clear skin (PASI 100) by Week 12 and 67% by Week 24. In patients with severe psoriasis, the low dose of Cosentyx ensured sustained skin clearance through Week 52, with PASI 90 achieved in 75% of patients¹. Differences in PASI 75 in patients with severe psoriasis treated with Cosentyx were seen as early as Week 4 and in patients with moderate-to-severe psoriasis as early as Week 2.