Novartis’ Cosentyx (secukinumab) has been granted approval by the European Commission as a treatment for moderate-to-severe plaque psoriasis in children and adolescents aged six to <18 years.
The approval is based on two phase 3 studies in children and adolescents aged six to <18 years. In both studies, low-dose (75–150 mg) and high-dose (75–300 mg) Cosentyx was effective in rapidly improving skin symptoms and quality of life.
The low-dose of Cosentyx provided fast skin clearance, with 93% of children achieving Psoriasis Area Severity Index (PASI) 75 as early as week 12, and 69% achieving PASI 90 at week 12 and 88% at week 24. Furthermore, 59.5% achieved completely clear skin (PASI 100) by week 12 and 67% by week 24.
In patients with severe psoriasis, the low-dose of Consentyx helped to sustain skin clearance through week 52, with a PASI 90 score achieved in 75% of patients and 44.7% reporting complete relief by week 12.
In addition, half of children with moderate-to-severe plaque psoriasis who were treated with low-dose Cosentyx reported complete relief from symptom burden of psoriasis on their quality of life as early as week 24.
“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 paediatric population and so it is important to broaden the adult therapeutic options out to children when possible,” said 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.”
Novartis is also seeking approval for Cosentyx for the treatment of moderate-to-severe plaque psoriasis in children and adolescent in a number of countries, including Australia, Canada, Japan and the US.