Results of three phase 3 studies involving the IL-23 inhibitor risankizumab showed that the drug met Psoriasis Area and Severity Index endpoints and was superior to ustekinumab and adalimumab for moderate-to-severe plaque psoriasis.
The ultIMMa-1 and ultIMMa-2 phase 3 studies were randomized, double-blind, double-dummy, placebo- and active-controlled analyses in which patients were randomly assigned to receive a subcutaneous injection of risankizumab (AbbVie) 150 mg, ustekinumab (Janssen) 45 mg or 90 mg based on screening weight, or placebo, on weeks 0, 4, 16, 28 and 40.
In ultIMMa-1, 304 patients were assigned to risankizumab, 100 to ustekinumab and 102 to placebo. In ultIMMa-2, 294 patients were assigned risankizumab, 99 to ustekinumab and 98 to placebo.
Sixteen-week results from the ultIMMa data sets showed that 75% of patients assigned risankizumab reached PASI 90, compared with 5% for placebo and 42% for ustekinumab in ultiMMa-1, and 2% for placebo and 48% for ustekinumab in ultIMMa-2..
The researchers also assessed patients for static Physician Global Assessment (sPGA) score of 0/1. In ultIMMa-1, 88% of patients who received risankizumab reached this endpoint, vs. 8% for placebo and 63% for ustekinumab. In ultIMMa-2, 84% of patients in the risankizumab group reached this endpoint, compared with 5% in the placebo group and 62% in the ustekinumab group.
At week 16, in the ultIMMa-1 study, 36% of patients on risankizumab reached PASI 100, compared with 12% of patients on ustekinumab. In the ultIMMa-2 study, 51% of the risankizumab cohort and 24% of the ustekinumab cohort reached PASI 100.
By 1 year, PASI 100 was achieved by 56% of patients on risankizumab in ultIMMa-1 and 60% of those in ultIMMa-2, vs. 21% and 30% of patients treated with ustekinumab.
Other findings from 1 year showed that risankizumab yielded a PASI 90 result in 82% and 81% of patients in ultIMMa-1 and ultIMMa-2, respectively, while just 44% and 51% of patients treated with ustekinumab achieved this 1-year outcome.
All primary and secondary outcome measures for risankizumab were associated with statistically significant differences compared with placebo or ustekinumab, according to the findings.