Johnson & Johnson is chasing giants in immunology with a plaque psoriasis nod from the FDA––and fast-growing sales––to show for it so far. Not content with that, though, Tremfya is pushing toward psoriatic arthritis, and it might now have the data to get it there.
In two trials presented Monday at the American College of Rheumatology meeting in Atlanta, Tremfya topped placebo in the percentage of psoriatic arthritis patients who showed 20% improvement in disease symptoms at the 24-week mark.
In two different dosing regimens, 59% of patients treated with Tremfya every four weeks and 52% of those treated at weeks zero, four and every eight weeks thereafter achieved a 20% improvement on their symptoms. Only 22% of placebo patients hit the same mark.
Among patients with 3% or more of body surface area affected by psoriasis, 75% and 57% of patients, respectively, achieved clear or minimally affected skin compared to 15% for placebo patients, J&J said.
"These results from the Discover program represent a major step in the development of Tremfya as a treatment for psoriatic arthritis," said Alyssa Johnsen, J&J's Janssen unit's vice president and rheumatology disease area leader.
The Discover-1 and Discover-2 data were the basis for a supplemental Biologics License Application in September to the FDA seeking a psoriatic arthritis approval, J&J said. The drugmaker also based its European Medicines Agency application in October on the data.
Pushing into psoriatic arthritis could help Tremfya make the leap to blockbuster status as it faces tough rivals such as AbbVie's Humira, Novartis' Cosentyx and Eli Lilly's fast-growing Taltz.
In the third quarter, Tremfya hit $290 million in global sales––a 69% increase from the same time period last year. The drug was approved in late 2017 to treat plaque psoriasis.
All three of those competitors are already in blockbuster territory, and Tremfya will be entering an increasingly competitive field if it nabs the FDA approval it is looking for.
In June, Lilly released 24-week data showing Taltz bested Humira in terms of clearing patients' skin and improving joint function. Those data could help Taltz continue to grow its market share in new patients and chip away at Humira's megablockbuster sales.
Of course, Tremfya is very familiar with Taltz: In October, Lilly released phase 4 data showing its drug beat out Tremfya in completely clearing 41.3% of moderate to severe plaque psoriasis patients’ skin at 12 weeks compared with 24.9% for the latter.
Not only did Taltz best its rival at the 12-week primary endpoint, the drug also topped Tremyfa in completely and partially clearing skin at a range of weekly markers, Lilly said. The study is ongoing, with a final marker at 24 weeks.