Novartis’ EXCEED phase 3b trial, which has been evaluating Cosentyx (secukinumab) in active psoriatic arthritis (PsA) in comparison to Humira (adalimumab), has yielded mixed results.
Cosentyx, which is an inhibitor of interleukin-17A (IL-17A), could not show statistical significance for superiority in ACR 20 over the AbbVie drug in the head-to-head late-stage trial. As a result, the Novartis drug fell short of meeting the primary endpoint for ACR20 response rates at Week 52.
However, Novartis said that its IL-17A inhibitor showed numerically higher results compared to Humira. It also showed statistically significant advantages over Humira in PsA-specific endpoints in a pre-specified sensitivity analysis, said the Swiss drugmaker.
The EXCEED trial, which has involved more than 800 biologic-naïve patients with PsA, is a 52-week, multi-centre, randomised, double-blind, active control study.
University of Glasgow Rheumatology professor and an investigator in the secukinumab clinical trial program 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.”
According to Novartis, the EXCEED trial saw Cosentyx maintain a consistent and favourable safety profile, which was similar to what was observed in previous clinical trials. No new safety signals were observed following the treatment with the IL-17A inhibitor in the phase 3b trial, said the Swiss pharma company.
Novartis immunology, hepatology and 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.”
In September this year, the IL-17A inhibitor met the primary endpoint at Week 16 in the phase 3 PREVENT trial in patients with non-radiographic axial spondyloarthritis (nr-axSpA). Prior to that, in June 2019, the Novartis drug met the primary and key secondary endpoints in the phase 3 Maximise trial in psoriatic arthritis.
Cosentyx has approvals from the US Food and Drug Administration (FDA) for the treatment of psoriasis, PsA and ankylosing spondylitis.