Novartis has reported that data from two pivotal Phase III trials of Cosentyx (secukinumab) demonstrated fast and strong skin clearance and significant improvement in quality of life in patients aged between six and 18 years with moderate-to-severe plaque psoriasis.
Cosentyx is a fully human biologic that directly blocks interleukin-17A (IL-17A).
IL-17A is a cytokine involved in the inflammation and development of plaque psoriasis, psoriatic arthritis (PsA), ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA).
An open‑label, two-arm, parallel‑group, multi-centre study was conducted on children with moderate-to-severe plaque psoriasis, while a separate randomised, double-blind, placebo and etanercept-controlled study treated children with severe plaque psoriasis.
Results from the trial involving children with moderate-to-severe plaque psoriasis showed the low dose of Cosentyx provided fast and strong skin clearance, with 93% achieving Psoriasis Area Severity Index (PASI) 75 by week 12.
In patients with severe psoriasis, PASI 90 was achieved in 75% of patients who were given a low dose of Cosentyx and showed sustained skin clearance by week 52.
Half of the children with moderate-to-severe plaque psoriasis reported complete relief from symptom burden of psoriasis on their quality of life by week 12.
In the severe plaque psoriasis arm, 44.7% of children reported complete relief by week 12 and 60.6% by week 52.
Novartis Medical Affairs for Immunology, Hepatology and Dermatology global head said Todd Fox said: “These new data add to the wealth of evidence Cosentyx has across four indications.
“Cosentyx is already approved as a first-line systemic treatment for children in Europe and next year we are expecting a response on our recently accepted submission to the US Food and Drug Administration.”
In March this year, Novartis received positive opinion from the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) for Cosentyx in non-radiographic axial spondyloarthritis (nr-axSpA).