As the immunology biologics market gets even more crowded, drugmakers are eyeing new indications to expand their reach. Now, Novartis’ Cosentyx and Eli Lilly’s IL-17A rival med Taltz have rolled out detailed data in non-radiographic axial spondyloarthritis.
In an analysis required by European regulators, Cosentyx helped significantly reduce disease activity in 42.2% of patients at week 16, versus 29.2% for placebo, according to data presented at the American College of Rheumatology annual meeting. This primary endpoint is measured by ASAS40, which is a common scoring system that entails an improvement of at least 40% on several aspects of the disease.
As for Taltz, Lilly showed as many as 40% of Taltz patients achieved ASAS40 response, compared to 19% with placebo. And by the 52-week mark, the number was 31% for Taltz.
Novartis has already submitted the data to the EMA for approval in non-radiographic axial spondyloarthritis, also known as nr-axSpA. As for the FDA, the U.S. agency requires 52-week data, which the company has previously said are also positive for a filing by year-end.
“The Prevent study showed clinically significant outcomes as early as week three, and these were maintained up to one year for patients treated with Cosentyx,” Atul Deodhar, lead author for both Cosentyx’s Prevent trial and Taltz’s Coast-X study, said in a statement on Tuesday.
Novartis has yet to release its one-year data, but Eric Hughes, global development unit head of immunology, hepatology and dermatology at Novartis, told FiercePharma that it’s expecting the drug’s level of efficacy to sustain into 52 weeks.
“We’ve seen across all our studies a very robust maintenance of response,” he said. “We have data out to five years in AS, in PsA and psoriasis.” Given Cosentyx’s response is maintained in all those disease areas, Hughes said Novartis expects to show exactly how nr-axSpA is the same in details in future presentations.
After its initial FDA nod in plaque psoriasis, Cosentyx has since added ankylosing spondylitis (AS) and psoriatic arthritis (PsA) to its label. And Taltz matched up all those indications with a green light in AS in August. If approved, nr-axSpA could be both drugs’ fourth indication, with Taltz now slightly ahead in the U.S. regulatory process. The disease is generally considered as an early stage of AS. It’s called non-radiographic because unlike AS, its inflammatory damage isn’t visible on x-rays.
Currently, nonsteroidal anti-inflammatory drugs (NSAIDs) are widely used for nr-axSpA. Patients in both the Prevent and Coast-X trials had previously had inadequate responses to at least two different NSAIDs and they were also on background NSAIDs during the trial.
In March, UCB’s anti-TNF antibody Cimzia became the first drug FDA specifically approved for nr-axSpA. But that drug carries a boxed warning about the increased risk of serious infections.
Hughes touted Prevent as the largest study of a biologic in nr-axSpA. Cimzia’s approval came from a trial of 317 patients, Taltz’s Coast-X involved 303 patients, while Cosentyx’s Prevent enrolled 555.
“We believe the durability of Cosentyx’s response is very strong,” Hughes said. “Not only have we had a good response […] we anticipate that there will be a long-lasting treatment response.” Novartis intends to prove its case as the Prevent trial is entering a two-year extension phase.
Cosentyx and Taltz have been battling it out in psoriasis, psoriatic arthritis and ankylosing spondylitis. Both are growing sales at double digits. Cosentyx, boasting a head start in all three indications, racked up $2.59 billion in the first nine months, up 30% year over year. Meanwhile, sales of Taltz jumped 50% during the same period and reached $946 million. But more biologics are entering the space, such as AbbVie’s recently approved Skyrizi.