Novartis’ Cosentyx (secukinumab) has failed to show any benefit in the Phase III study in adults with newly diagnosed or relapsing giant cell arteritis (GCA).
In the GCAptAIN trial (NCT04930094), Cosentyx was evaluated in combination with a 26-week steroid taper and compared to a placebo plus a 52-week steroid taper.
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Cosentyx did not demonstrate a statistically significant improvement in sustained remission at week 52 compared to placebo, the study’s primary endpoint.
There was also no statistical improvement in secondary endpoints, but Novartis did state that patients treated with Cosentyx showed numerically better outcomes compared to placebo for cumulative steroid dose and steroid-related toxicity.
Safety remained consistent with previous studies and real-world data of Cosentyx patients. The randomised, double-blind, placebo-controlled study enrolled 354 patients from 27 countries.
Novartis’ chief medical officer Dr Shreeram Aradhye, said: “While the Phase III results of GCAptAIN did not replicate the positive outcomes observed in the Phase II trial, we remain committed to continuing to drive scientific progress and deepening the understanding of immune-mediated diseases.”
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By GlobalDataNovartis will complete a full evaluation of the GCAptAIN data, with the findings shared at a future date.
Currently, treatment includes corticosteroids, usually prednisone, as a first-line treatment. Patients may also be treated with Actemra (tocilizumab), an IL-6 receptor antagonist. There are a number of candidates in mid-stage and late-stage studies, including BMS’ Orencia (abatacept), which is in a Phase III trial in GCA.
Cosentyx is one of Novartis’ flagship drugs
Novartis’ Cosentyx is a fully human biologic that directly inhibits interleukin-17A. It acts by neutralising IL-17A, which reduces inflammation associated with autoimmune and inflammatory conditions.
It was first approved by the US Food and Drug Administration (FDA) in January 2015 for the treatment of moderate-to-severe plaque psoriasis in adults. It has since been approved for use in children aged six years and over with plaque psoriasis, adults with hidradenitis suppurativa (HS), and adults with active psoriatic arthritis (PsA), among others.
GlobalData analysis suggests Cosentyx will make peak annual sales of $8.2bn in 2028 before sales start to drop. This will be largely related to the US drug expiry for Cosentyx in January 2029, allowing generic versions of the therapy to enter the market.
GlobalData is the parent company of Clinical Trials Arena.
