Novartis cues up Cosentyx as disease-modifying treatment for psoriasis

Novartis says Cosentyx could be used as an early intervention in psoriasis after new data suggests it is the first drug of its kind to modify the course of the disease.

The Swiss big pharma company is one of a group of companies vying for supremacy in the multi-billion dollar psoriasis drug market, aiming to take over from current top-seller Humira.

Most next-generation treatments are aiming to be second or third line treatments for when Johnson & Johnson’s Stelara (ustekinumab) fails – but emboldened by strong data, Novartis believes its drug can be a frontline treatment.

A newly released extension study shows that around a fifth of patients treated with Cosentyx can achieve long-term, treatment-free skin clearance.

Now the company is starting a study to see if early intervention can also stop the disease progressing.

An injected drug, Cosentyx became a blockbuster last year with sales of $1.1 billion, and Novartis is looking for ways to gain an advantage over Eli Lilly’s rival IL-17A inhibitor, Taltz (ixekizumab).

Novartis say Cosentyx is the first and only IL-17A inhibitor to report disease modifying potential, based on findings of the A2302E1 extension study, and will begin the STEPIn study exploring the drug’s potential as an early intervention.

A2302E1 is an extension of pivotal phase 3 studies ERASURE and FIXTURE made up of a double-blind, placebo-controlled study of 120 psoriasis patients.

After one year of Cosentyx treatment, patients who achieved a PASI 75 (75% skin clearance) response were randomised to receive either Cosentyx 300mg or placebo.

Patients treated with Cosentyx maintained their high level of response – but among those on placebo, 21% of psoriasis patients maintained skin clearance for up to one year without treatment and 10% maintained skin clearance after two years without treatment.

STEPIn will be a year-long randomised, multicentre trial in patients suffering from new-onset moderate-to-severe plaque psoriasis as early intervention compared to standard of care treatment with narrow-band UVB.

Vas Narasimhan

Vas Narasimhan

Novartis’ chief medical officer, Vas Narasimhan, said: “These results suggest that Cosentyx may go beyond simply treating symptoms and could actually modify the course of psoriasis, and highlights the need for further investigation into early intervention.”

“Being able to change the course of disease is the ultimate goal of treatment, which is why we are investing in the STEPIn trial to further understand the disease modifying ability of Cosentyx in psoriasis.”

Meanwhile, Johnson & Johnson’s Stelara is becoming an increasingly popular choice, generating sales around $2.3 billion last year in psoriasis and Crohn’s disease. But it has a different mechanism of action, inhibiting IL-12 and IL-23.

Also making inroads into the market is Celgene, with its less effective but more patient-friendly pill Otezla (apremilast).

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