AbbVie has posted positive phase 3 psoriasis data on potential blockbuster risankizumab. The IL-23 antibody easily outperformed Johnson & Johnson’s Stelara and AbbVie’s own Humira, setting it up to go before regulators next year.
Risankizumab aced all the primary and ranked secondary endpoints across three clinical trials, two identical studies comparing it to Stelara and a third that pitted it against Humira. Regardless of the comparator, risankizumab posted statistically better PASI 90 rates—the proportion of participants whose lesions improved by 90%—and responses against harder-to-hit complete clearance goals.
The 16-week PASI 90 rates across the three trials ranged from 72% to 75%. None of the active comparators got within 20 percentage points of the bottom end of the risankizumab range. The difference in the proportion of patients achieving clear or nearly clear skin was similarly large.
AbbVie’s data go some way to showing why it was willing to pay Boehringer Ingelheim $595 million upfront last year to gain the rights to risankizumab.
Risankizumab delivered the results without setting off any safety alarms. In the first 16 weeks of the Stelara studies, 2% of patients on risankizumab experienced a serious adverse event. That rate is lower than that achieved by the Stelara cohorts and in the same ballpark as those seen in trials of the other drugs risankizumab will compete against if it comes to market.
Risankizumab's performance against Humira and Stelara suggests it is efficacious. But to win a big piece of the psoriasis market, AbbVie will need to persuade people that risankizumab is also more than a match for more recently approved drugs. The data suggest that is achievable.
“While noting the usual caveats with cross-trial comparisons, we believe the efficacy of risankizumab looks as good as J&J's Tremfya, which is the only approved IL-23,” Jefferies analyst Jeffrey Holford, Ph.D., wrote in a note to investors. “Further, risankizumab has a less frequent dosing regimen at an injection every 12 weeks after the two initial doses, compared to an injection every 8 weeks after the two initial doses for Tremfya.”
Tremfya, also known as guselkumab, won FDA approval earlier this year on the strength of phase 3 data linking it to 16-week PASI 90 responses ranging from 64% to 73%. Eli Lilly’s Taltz, an IL-17 drug also trying to carve out a piece of the psoriasis market, delivered PASI 90 response rates within the same range on its path to approval.
Risankizumab also matches up in terms of the durability of response, a key failing of older drugs. Tremfya’s two-year PASI 90 and PASI 100 response rates came in at 82% and 49%, respectively. Risankizumab’s one-year PASI 90 and PASI 100 response rates were around 82% and 56% to 60%, respectively. Both risankizumab response rates are higher than those achieved after 16 weeks.
When combined with a less onerous dosing schedule, Jefferies thinks the efficacy will see AbbVie’s drug go on to rack up $1.5 billion in peak psoriasis sales. AbbVie expects the first of those sales to start trickling in in 2019.
Between now and then, AbbVie plans to move risankizumab into phase 3 trials in Crohn’s disease, ulcerative colitis and psoriatic arthritis, giving it the makings of a franchise that can go some way to offsetting the long-feared loss of Humira sales.