Novartis' Cosentyx Fails to Outperform Humira in Head-to-Head Psoriatic Arthritis Trial

Compiled by Fan Dongdong

Novartis recently announced that Cosentyx failed to outperform AbbVie’s blockbuster drug Humira in the Phase 3b head-to-head clinical trial (Exceed) for psoriatic arthritis.

This is a 52-week, multicenter, randomized, double-blind, active-controlled study that enrolled more than 800 patients with active psoriatic arthritis who were previously untreated with biologic therapy. Patients were randomized to receive either Cosentyx or Humira for one year. The primary endpoint was ACR20 (one of the American College of Rheumatology response criteria).

Novartis stated that although a greater number of patients in the Cosentyx group achieved ACR20 responses, the results did not demonstrate statistically significant improvement. However, Cosentyx showed a clear statistical advantage in specific endpoints for active psoriatic arthritis observed in the trial. No new safety signals were identified in this study.

In fact, Cosentyx’s main competitor is Eli Lilly’s Taltz, with the two vying for leadership in the IL-17A inhibitor space. Late last year, Taltz demonstrated superior efficacy to Humira in the SPIRIT-H2H trial, a head-to-head Phase IIb/IV study in patients with psoriatic arthritis.

Nevertheless, Novartis has adopted a relatively open and optimistic stance on these trial results. Eric Hughes, Head of Global Development for Immunology, Hepatology, and Dermatology at Novartis, pointed out that the two drugs were evaluated using different trial designs, and that EXCEED is the first head-to-head trial of a monotherapy against primary endpoints in psoriatic arthritis. “The results of this trial reinforce our confidence in Cosentyx becoming the standard of care for psoriatic arthritis,” emphasized Hughes.

Novartis’ recently released third-quarter financial report shows that Cosentyx was the best-selling product this quarter, with sales reaching $937 million, a year-on-year increase of 27%.

Cosentyx is the first approved IL-17A inhibitor. Taltz received its initial US approval in March 2016, becoming the second IL-17A monoclonal antibody marketed in the United States after Cosentyx. IL-17A is a core pathogenic factor involved in inflammation and disease progression in psoriatic arthritis, ankylosing spondylitis, and psoriasis, playing a pivotal role in their pathogenesis. Currently, both agents are approved for the treatment of plaque psoriasis, psoriatic arthritis, and ankylosing spondylitis, and both are undergoing clinical trials for the treatment of other inflammatory diseases.

In mid-September 2019, Novartis announced that Cosentyx met the primary endpoint and all secondary endpoints in the Phase 3 PREVENT clinical trial for the treatment of non-radiographic axial spondyloarthritis. Novartis expects to submit a regulatory application to the U.S. Food and Drug Administration (FDA) later this year. If approved, this would mark the fourth indication for Cosentyx. Previously, Novartis had already submitted an application for this indication to the European Medicines Agency.

However, in the field of psoriatic arthritis, the two pharmaceutical companies have more competitors to worry about than just each other. Pfizer’s Xeljanz made progress in this area in late December 2018; on November 1, AbbVie’s JAK inhibitor Rinvoq met both the primary and key secondary endpoints in the Phase 3 SELECT-PsA 2 trial evaluating its efficacy in adult patients with active psoriatic arthritis.

Reference Source: Novartis' Cosentyx Can't Top AbbVie's Humira in Head-to-Head Psoriatic Arthritis Contest