Spotlighting New Data on Risankizumab for Scalp and Genital Psoriasis, With Eingun James Song, MD

In an interview at the 2025 European Academy of Dermatology and Venereology (EADV) Congress, Eingun James Song, MD, director of clinical research at Frontier Dermatology, spoke with HCPLive about his team’s recent phase 4 findings on risankizumab for patients with moderate to severe scalp and genital psoriasis.1

The UnlIMMited study was a phase 4, multicenter, randomized, double-blind, placebo-controlled study assessing risankizumab in individuals with moderate-to-severe scalp and/or genital psoriasis. The trial was created to address a historically underrepresented patient population in clinical trials: those with limited body surface area (BSA) involvement but with disease in “high-impact areas” such as the scalp and genitals, known to disproportionately impact quality of life.

“You could have one or two patches of psoriasis affecting these areas, and it can affect your quality of life as much as someone who has 25% body surface area,” Song explained. “What this study was trying to do was look at a population that was historically underrepresented or just flat out excluded from clinical trials to see [if] this medicine works in this population, and is it safe?”

Traditional psoriasis trials have required ≥10% BSA and a Psoriasis Area and Severity Index (PASI) score ≥12, but in this study, participants with <10% BSA were included if they had significant scalp or genital involvement. The study randomized patients 1:1 to receive either risankizumab 150 mg or placebo, administered at the 0 and 4-week mark, with the primary endpoint assessed at Week 16.

Song highlighted that the team’s findings demonstrated that nearly 70% of those treated with risankizumab attained clear or almost clear skin in the genital region, and that approximately 60% attained such an outcome in the scalp. Patient-reported outcomes (PROs) also improved significantly, including noted reductions in patients’ reports of itch, redness, burning, and scaling.

In addition, those taking part were shown to have improvements in sexual health, with decreased disease-related impact on sexual frequency following risankizumab treatment. Safety findings also aligned with prior data.

“One can make a very compelling argument that a medicine like risankizumab may very well be your first-line option for a patient who has a scalp or genital psoriasis that does not adequately respond to a topical therapy,” Song said. “That would very much be in line with the International Psoriasis Council recommendations, which state that we should not just refer or use a mild, moderate, or severe category anymore, but we should simply state a patient is a topical or systemic candidate. And if they have a higher impact area and they don't respond to a topical, that makes them eligible for a systemic therapy.”

Song has been a consultant, speaker or investigator for the following companies: AbbVie, Janssen, Amgen, Lilly, SUN, UCB, Incyte, Novartis, Sanofi & Regeneron, Castle Biosciences, and Pfizer.

References

1. Song J, et al. Safety and Efficacy of Risankizumab in Genital and Scalp Psoriasis in the UnlIMMited Phase 4 Randomized Clinical Trial at Week 16. Presented at the 2025 European Academy of Dermatology and Venereology (EADV) Congress, Sept 17-20, 2025.