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Novartis’ Cosentyx misses the mark in Humira head-to-head

Narrowly missed statistical significance for superiority

Novartis

Novartis’ Cosentyx (secukinumab) failed to show significant superiority over AbbVie’s Humira (adalimumab) in a head-to-head trial in psoriatic arthritis (PsA).

Although Cosentyx showed numerically higher results compared to Humira, it narrowly missed statistical significance for superiority in ACR 20, the primary endpoint of the EXCEED trial.

The study is a 52-week phase 3b investigation of Cosentyx versus Humira in patients with active PsA who are naive to biologic therapy, and involves over 800 participants.

At the pre-specified sensitivity analysis, Cosentyx demonstrated statistically significant advantages over Humira in PsA-specific endpoints. The trial also showed a consistent and favourable safety profile for Consentyx – in line with previous clinical trials.

“EXCEED is the first ever monotherapy head-to-head trial with a primary endpoint in psoriatic arthritis specific to joints,” said Eric Hughes, global development unit head, immunology, hepatology & dermatology, Novartis.

“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,” he added.

These results are a blow for Novartis, especially after the resounding positive results it unveiled at the beginning of the month for Cosentyx in non-radiographic axial spondyloarthritis (nr-axSpA).

In that trial, Cosentyx met its primary endpoint of patients achieving an ASAS40 response, which is characterised by at least 40% improvement in patient global assessment, pain, function and inflammation.

The interleukin-17 inhibitor is already approved for another form of the disease, ankylosing spondylitis. It is also approved for psoriatic arthritis and plaque psoriasis.

The Swiss pharma giant posted a 27% increase in Cosentyx sales in its recent third quarter earnings, with the drug bringing in $937m.

The drug has been outpacing expectations since its launch, and the Swiss pharma is looking to expand its use into additional indications to help it continue on the blockbuster trajectory.

However, the inflammatory and immunology field is becoming increasingly competitive thanks to a new class of biologic therapies that are competing for market share.

This includes Johnson & Johnson’s Tremfya (guselkumab), AbbVie’s Skyrizi (risankizumab), Eli Lilly’s Taltz (ixekizumab) and Pfizer’s Xeljanz (tofacitinib citrate).

AbbVie has also just posted positive results for its competitor Rinvoq (upadacitinib), which met all primary and secondary endpoints in a phase 3 study in PsA.

The primary endpoint of ACR20 response at week 12 versus placebo was met in patients with active PsA who have responded inadequately to one or more biologic modifying anti-rheumatic drugs.

Novartis plans to present the detailed data from the EXCEED trial at a future scientific congress.

Article by
Lucy Parsons

1st November 2019

From: Research

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