AbbVie said Thursday its investigational drug for plaque psoriasis outperformed its blockbuster drug Humira (ingredient: adalimumab) and Johnson & Johnson’s Stelara (ingredient: ustekinumab) in three phase 3 trials.
Risankizumab (ABBV-066) is an anti-interleukin-23 (IL-23) antibody in development to treat multiple inflammatory diseases, including psoriasis, Chron’s disease, and psoriatic arthritis. Moderate-to-severe psoriasis is characterized by red, scaly plaques that are itchy. The plaques may cover some, or all, of the body.
All three trials met the co-primary endpoints of at least a 90 percent improvement in the Psoriasis Area and Severity Index (PASI 90) after 16 weeks of treatment and a score of "clear or almost clear" on the static Physician Global Assessment (sPGA) scale, the company said. Safety and efficacy profiles have not yet been established.
When compared to J&J’s Stelara, 75 percent of patients in the risankizumab arm had a PASI 90 score compared to the 5 percent who achieved the score in the placebo arm after 16 weeks of treatment. The trial also showed double the number of patients achieving completely clear skin (PASI 100) with AbbVie’s drug at week 16 and one year.
When compared to Humira, risankizumab demonstrated significantly higher response rates, the company said, with 72 percent of patients taking risankizumab achieving PASI 90 versus 47 percent in the Humira arm. 40 percent in the risankizumab arm also achieved PASI 100 whereas 23 percent did so in the Humira arm at week 16.
"We are encouraged by these positive results. What is particularly exciting is the number of patients who achieved high rates of skin clearance in these three head-to-head clinical trials. Risankizumab has the potential to provide a meaningful new treatment option for people living with psoriasis," said Michael Severino, executive vice president, R&D, and chief scientific officer at AbbVie.
The news comes as more competitors are entering the psoriasis treatment market. Some significant contenders are Eli Lilly’s Taltz, Valeant’s Siliq, Novartis’ Cosentyx, and Johnson & Johnson’s investigational drug guselkumab. Each has been rolling out data on next-generation psoriasis drugs with Novartis recently presenting impressive five-year data on Cosentyx, the first-in-class drug.
AbbVie continues to push ahead into an increasingly competitive market. "AbbVie is committed to advancing care for patients with immune-mediated diseases,” Severino said. “We are building on our two decades of expertise as a leader in immunology to develop a robust portfolio of innovative therapies addressing continued unmet needs.”
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