- Novartis' inflammation drug Cosentyx failed to beat AbbVie's Humira in a head-to-head Phase 3b trial of patients with active psoriatic arthritis, handing the Swiss pharma a setback in its ambitions to grow market share among rival blockbuster biologics.
- The study randomly split more than 800 patients who were naive to biologic therapies to take either Cosentyx or Humira for one year. The primary endpoint was ACR20, a standard composite measure named after the American College of Rheumatology.
- While Novartis did not release specific clinical results in a Friday release, the company stated the study "narrowly missed statistical significance for superiority." Psoriatic arthritis is one of three U.S.-approved indications for Cosentyx, along with plaque psoriasis and ankylosing spondylitis.
The trial disclosure coincided with AbbVie releasing its third quarter results Friday morning, which showed Humira (adalimumab) steadily growing in the U.S. market while falling off internationally due to the entry of biosimilar competition.
Humira brought in $4.9 billion in total sales for the three months of July, August and September, with the U.S sales growing 10% and international sales falling 31% from the same period a year ago. Through the first nine months of 2019, Humira has brought in $14.4 billion for AbbVie, nearly 60% of the big biotech's total revenue.
First approved in 2002, Humira has kept its sales dominance, aided by a growing list of indications and aggressive defense of its patents. It's done so even as a flurry of biologics entered the auto-immune market, including Cosentyx, Eli Lilly's Taltz (ixekizumab), Johnson & Johnson's Stelara (ustekinumab) and J&J's Tremfya (guselkumab).
Head-to-head studies can be a compelling way to differentiate one's product. Cosentyx, for instance, was bested by Tremfya in a head-to-head plaque psoriasis study released last December.
Even with the Humira head-to-head falling short of statistical significance, Novartis still figures to use the data to position the biologic as a first-line choice for psoriatic arthritis (PsA). The study did not test for non-inferiority, a Novartis spokesperson told BioPharma Dive.
"Statistically significant advantages of Cosentyx versus Humira in PsA-specific endpoints were observed in a pre-specified sensitivity analysis," the company said in a Nov. 1 statement.
Even with intense competition, Cosentyx has been a key growth driver for the Swiss pharma and is on pace to become Novartis' best-selling drug in 2019.
For the first nine months of the year, Cosentyx has brought in $2.6 billion, an increase of about 27% from a year ago. Last year, it was Novartis's second best-seller behind the multiple sclerosis treatment Gilenya (fingolimod).