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.
ultIMMa studies
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.