UnlIMMited Data Demonstrate Risankizumab Efficacy in Genital and Scalp Psoriasis

Data presented at the DERM 2025 NP/PA Conference demonstrated that risankizumab (Skyrizi; AbbVie) significantly improved disease severity in patients with moderate to severe genital or scalp psoriasis.¹ The early findings from the phase 4 UnlIMMited trial (NCT05969223) provides evidence for these high impact areas and often underrecognized presentations of psoriasis.²

Participants in the double-blind, placebo-controlled multicenter trial were randomized to disease specific groups (ie, scalp psoriasis and genital psoriasis) to receive 150 mg of risankizumab or placebo at week 0 and week 4. At week 16, efficacy was assessed using the Physician’s Global Assessment for genital skin (sPGA-G) or the scalp Investigators Global Assessment (scalp IGA). Quality of life and safety endpoints were also assessed at that time.

At week 16, 69.1% of patients in the genital psoriasis group and 60.8% in the scalp psoriasis group achieved clear or almost clear skin with risankizumab as compared with 13.0% in both placebo groups (p<0.0001). In addition, patients reported positive outcomes: More than 70% of patients noting their genital psoriasis no longer affected the frequency of sexual activity and 60% said that their quality of life improved to the point where their psoriasis has little or no impact on their overall quality of life. In the scalp group, patients experienced substantial itch reduction.

“All this to say, we saw risankizumab works well in both of these areas, with high levels of clearance. But the patient reported outcomes, that is what I get really excited about because we saw that it did follow the skin clearance as well,” Song told Dermatology Times.

Because traditional psoriasis trials often require at least 10% body surface area (BSA) and a Psoriasis Area and Severity Index of at least 12, patients with scalp and genital psoriasis are underrepresented in phase 3 studies, Song said. The UnlIMMited study allowed enrollment based on localized disease severity using the static). Up to 40% of patients were permitted to have BSA <10%, broadening eligibility to better reflect the clinical population often seen in practice.

Scalp and genital psoriasis often go underreported and underrecognized, Song told Dermatology Times. As a result, patients “are often just using topical therapies or the wrong treatment altogether,” he added.

Song encouraged clinicians to ask about rashes and skin issues around the body to improve recognition.

“I think the reason that genital psoriasis is underdiagnosed is because we're not asking about it,” he explained. “And I understand sometimes we might not be comfortable asking them these types of questions, which could be a little bit more sensitive in nature. I just try to keep it very kind of matter of fact and normalize it.”

In initiating the discussion, Song tells patients that up to two-thirds of patients with psoriasis have involvement in the genital area, and then he asks if they have noticed anything. “And many times people don't even realize it's psoriasis in the area,” he said.

Song continues to keep it conversational: “Have you ever had a rash in your private areas that you weren't really sure what it was? And if so, would you want me to take a look? Because the good news is that we have so many great treatments now for genital psoriasis as well,” Song said.

Additional insights and 52 week data from theUnlIMMited trial is forthcoming early next year, Song said.

References

1. Song EJ, Ackerman L, Anschutz T, et al. Safety and Efficacy of Risankizumab in Genital and Scalp Psoriasis in the UnlIMMited Phase 4 Randomized Clinical Trial at Week 16. Poster presented at the DERM 2025 NP/PA CME Conference; July 23 - 26, 2025; Las Vegas, Nevada.
2. Study to Assess the Safety and Efficacy of Subcutaneously Injected Risankizumab in Adult Participants With Genital or Scalp Psoriasis (UnlIMMited). Updated February 26, 2025. Accessed July 23, 2025. https://clinicaltrials.gov/study/NCT05969223