Switzerland-based Novartis has revealed mixed results in the EXCEED phase 3b trial that has been assessing Cosentyx (secukinumab) in active psoriatic arthritis in comparison to Abbvie's Humira (adalimumab), it was reported yesterday.
The product is an inhibitor of interleukin-17A (IL-17A). It could not show statistical significance for superiority in ACR 20 over the AbbVie drug in the head-to-head late-stage trial. Due to this the product fell short of meeting the primary endpoint for ACR20 response rates at Week 52. The company stated that its IL-17A inhibitor indicated numerically higher results compared to Humira. It also showed statistically significant advantages over Humira in PsA-specific endpoints in a pre-specified sensitivity analysis, according to the company. According to Novartis, Cosentyx maintained a consistent and favourable safety profile, which was similar to what was observed in previous clinical trials.
The EXCEED trial included more than 800 biologic-naive patients with PsA and is a 52-week, multi-centre, randomised, double-blind, active control study.
The US Food and Drug Administration (FDA) has already approved Cosentyx for the treatment of psoriasis, PsA and ankylosing spondylitis.
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