The results from EXCEED demonstrated a consistent and favourable safety profile for Cosentyx and no new safety signals were detected
Image: EXCEED trial compares efficacy of Cosentyx with Humira. Photo: Courtesy of Novartis AG.
Switzerland-based pharmaceutical firm Novartis has unveiled results from the EXCEED head-to-head trial intended to compare Cosentyx (secukinumab) with Humira (adalimumab) in patients with active psoriatic arthritis (PsA).
EXCEED is a 52-week, multi-centre, randomised, double-blind, active control, Phase IIIb trial, involving more than 800 biologic-naïve patients, to evaluate the efficacy of Cosentyx compared with Humira in patients with active PsA who are naïve to biologic therapy.
Cosentyx has demonstrated better results than Humira, but closely missed the superiority in ACR 20, the primary endpoint of the EXCEED trial.
Novartis immunology, hepatology & dermatology global development unit head Eric Hughes said: “EXCEED is the first ever monotherapy head-to-head trial with a primary endpoint in psoriatic arthritis specific to joints.
“Novartis continues to reimagine care for patients and advance science in rheumatology. We will assess the EXCEED data in their totality and we view the results as confirming our vision of Cosentyx becoming standard of care in psoriatic arthritis.”
PsA is part of inflammatory diseases that affect the joints and associated with psoriasis
PsA is a complex disease characterised with multiple manifestations driving patient symptoms and is estimated to affect up to 50 million people across the globe.
According to the company, Cosentyx is the only biologic with proven efficacy in all key manifestations of psoriatic arthritis and is backed by five-year sustained efficacy and consistent safety data across psoriatic arthritis, ankylosing spondylitis and psoriasis.
The study results have demonstrated a consistent and favourable safety profile for Cosentyx similar to the previous clinical trials, and no new safety signals were detected.
Novartis said that EXCEED is the first double-blinded monotherapy head-to-head trial with a primary endpoint specific to joints in PsA. The company intends to present the study results at a future scientific congress.
University of Glasgow rheumatology professor Iain McInnes said: “These data will be welcomed by patients and clinicians to guide clinical decision making and highlight secukinumab as a viable option as a first-line biologic for the treatment of psoriatic arthritis.”