Risankizumab superior to other biologics for psoriasis in three trials

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.

IMMvent trial

The phase 3 IMMvent study is also a randomized, double-blind, double-dummy, active-controlled analysis. In this study, patients were assigned risankizumab 150 mg, administered at baseline, 4 weeks and every 12 weeks after, or Humira (adalimumab, AbbVie) at 80 mg initially, and then 40 mg every other week. There were 301 patients in the risankizumab arm and 304 in the adalimumab arm. Per study protocols, patients assigned adalimumab who failed to reach PASI 50 by week 16 were switched to risankizumab, while those with PASI 90 continued adalimumab therapy; those between PASI 50 and PASI 90 were randomly assigned again to risankizumab or adalimumab.

PASI 90 rates at 16 weeks in this study were 72% for risankizumab and 47% for adalimumab, while PASI 100 rates were 40% for risankizumab and 23% for the adalimumab. Similarly, 84% of patients treated with risankizumab and 60% of those treated with adalimumab reached sPGA 0/1 at 16 weeks.

During the switch period between week 16 and week 44, 66% of patients who switched to risankizumab reached PASI 90, vs. 21% of those who continued with adalimumab.

Week 44 findings indicated a 40% rate of PASI 100 for risankizumab, compared with 7% in the adalimumab arm.

Findings in this study were also all statistically significant.

“In this trial, four out of five patients achieved clear or almost clear skin with risankizumab at week 16,” Kristian Reich, MD, professor of dermatology, Dermatologikum Hamburg and SCIderm Research Institute, Hamburg, Germany, and the principal investigator on the IMMvent study, said in a press release. “High levels of skin clearance, PASI 90, were also seen at week 44 for patients who received risankizumab, with a 12-week dosing regimen. These data support previous results showing the potential of risankizumab to address unmet needs for patients suffering from psoriasis.” – by Rob Volansky

Disclosure: Healio Dermatology was unable to confirm relevant financial disclosures at the time of publication.