Novartis has reported positive data from the Phase III JUNIPERA clinical trial of Cosentyx (secukinumab) in adolescents and children with enthesitis-related arthritis (ERA) and juvenile psoriatic arthritis (JPsA).
ERA and JPsA are two types of juvenile idiopathic arthritis (JIA).
A fully human biologic, Cosentyx hinders the activity of interleukin-17A (IL-17A).
The double-blind, randomised-withdrawal, placebo-controlled, two-year, three-part trial had a total of 86 children and adolescents aged between two and 17 years with JPsA or ERA.
The time to flare during 12 to 104 weeks was the trial’s primary goal.
Assessment of JIA ACR 30/50/70/90/100 responses, as well as each JIA ACR core component, were some of the secondary goals of the trial until week 12.
The secondary goals also included total enthesitis and dactylitis count, as well as variation in the juvenile arthritis disease activity score (JADAS) from baseline.
Two-year data showed that Cosentyx treatment offered an increased time to flare, demonstrating a 72% flare risk reduction against placebo.
More than 30% of subjects had experienced improvement on receiving Cosentyx while approximately 90% had JIA ACR 30 response by 12 weeks.
Furthermore, during the same time period, approximately 35% of the subjects attained inactive disease status on JIA ACR.
Improvements in disease activity assessed by the mean JADAS 27 were reported at week one with disease activity hitting a low from week 12 to 104.
The safety profile of the treatment in this trial was in line with those observed in adults with plaque psoriasis, non-radiographic axial spondyloarthritis, ankylosing spondylitis and psoriatic arthritis.
Novartis Medical Affairs Immunology, Hepatology and Dermatology global head Todd Fox said: “With more than 500,000 patients treated worldwide since launch, these JUNIPERA data further reinforce the known efficacy and safety of Cosentyx for children and adults living with rheumatologic and dermatologic conditions.
“We are committed to bringing Cosentyx to young people living with inflammatory rheumatic diseases as quickly as possible, as part of our ambition to expand Cosentyx to ten indications.”
The company has already sought regulatory approvals for Cosentyx in ERA and JPsA indications from the regulatory agencies in Europe and the US.
In a separate development, Novartis reported that its drug, Aimovig (erenumab) demonstrated a superior tolerability profile against topiramate in Phase IV HER-MES trial in people with episodic and chronic migraine.
Last month, Novartis announced that its antibody canakinumab plus pembrolizumab and platinum-based doublet chemotherapy failed to achieve primary endpoints in the Phase III CANOPY-1 trial in people with non-small cell lung cancer.