James Song, MD

Dermatology Education Foundation (DERM) 2025 NP/PA CME Conference

, Eingun James Song, MD, highlighted some of the biggest takeaways from his team’s phase 4 research in the UnlIMMited study.

Song, who serves as director of clinical research at Frontier Dermatology, spoke in a 

 about his team’s efficacy findings on risankizumab for genital and scalp psoriasis.

 Here, he was asked about some of the secondary endpoints and the implications of all of the study’s findings on risankizumab.

New Findings on Risankizumab for Genital and Scalp Psoriasis, with Eingun James Song, MD

“In addition to the ‘clear or almost clear’ [findings], there were various secondary endpoints that we were looking at, and these ranged from skin clearance metrics like the Psoriasis Scalp Severity Index, which is like a PASI score for the scalp, and a lot of patient-reported outcome data as well. This is so important for high-impact areas, because the whole idea here is that these are [patients with] lower body surface area involvement, but high impact on quality of life. So we wanted to show that the quality of life also mirrored the skin clearance.”

For example, Song pointed out that when looking at the genital psoriasis patient population, 60% of these patients reported that their quality of life improved to the point where their psoriasis had little or no impact on their overall quality of life. Later, he also highlighted impacts on patients’ sexual health.

“One of the real interesting questions that we are looking at in the genital population was the impact on sexual frequency,” Song said. “We know that if you have psoriasis that affects your genital skin, it's most likely going to affect how often you're going to engage in sexual activity. We did see that on average, most of these patients say that their psoriasis, at least sometimes, will affect their sexual frequency. That was actually one of the secondary endpoints in this study. At the 16-week endpoint, we saw that over seven out of 10 patients said that, once they started risankizumab, 70%-plus of the patients said that their psoriasis now had no or very little impact on the amount of sexual activity that they were having.”

Song lastly discussed patients with scalp psoriasis in the study who were treated with risankizumab.

“When it comes to scalp, one of the key secondary endpoints was itch reduction,” Song explained. “For whatever reason, scalp psoriasis tends to be even itchier than other areas, and as a result, when we scratch the scalp, it Koebnerizes and makes it even harder to treat. But we did see high levels of itch reduction in the scalp population. Some people even got to the point where their itching, burning, redness, and pain went completely to zero, which wasn't statistically significant when he compared it to the placebo group. But still, we saw a very, very positive trend in favor of using risankizumab.”

To find out more, view Song’s full interview segment posted in the video above. For more research covered at the DERM 2025 conference, view our 

The quotes implemented in this summary were edited for the purposes of clarity.

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.

Song E. Discussing Risankizumab Efficacy in Genital and Scalp Psoriasis, with Eingun James Song, MD. HCPLive. July 24, 2025. 

https://www.hcplive.com/view/discussing-risankizumab-efficacy-genital-scalp-psoriasis-eingun-james-song-md

Videos

This interview segment highlights additional information on the 16-week risankizumab data from the phase 4 UnlIMMited study.

, Eingun James Song, MD, spoke about 16-week findings from the phase 4 UnlIMMited study and the efficacy and safety of risankizumab for genital and scalp 

Song—who is known for his role as the director of clinical research at Frontier Dermatology in Mills Creek, Washington—spoke about some of the most notable elements of the study’s design and about some of the biggest takeaways regarding risankizumab’s use in genital and scalp psoriasis. Though the study is ongoing, these 16-week data demonstrated several unique findings Song wished to highlight.

Discussing Risankizumab Efficacy in Genital and Scalp Psoriasis, with Eingun James Song, MD

“The reason we did the unlimited study was that psoriasis that affects what we call high-impact or special side areas, specifically the scalp and genital skin tends to be misdiagnosed or under-diagnosed and under-treated,” Song explained. “These patients are often just using topical therapies, or they're using the wrong treatment altogether because they think they have something completely different. These patients are underrepresented in our typical phase 3 studies for psoriasis, because you typically need 10% BSA and PASI-12 to get into these studies. So this has been a large unmet area for us as far as research.”

Song highlighted that even among clinicians treating psoriasis who feel comfortable using medications such as risankizumab in patients with limited body surface area (BSA) and have disease in high impact areas, did not have a large dedicated study to demonstrate a safe and effective use of this medicine in such a population.

UnlIMMited was broken up into 2 sub-studies by disease location, with participants with moderate to severe genital psoriasis in one and those with moderate to severe scalp psoriasis in another. Those taking part received subcutaneous risankizumab injections over a 52-week treatment period, or a placebo during the 16 week treatment period followed by risankizumab in the 36-week treatment period.

“The way the study was designed is very straightforward,” Song said. “You either got a placebo or you got risankizumab at the label dose of 100 to 50 milligrams, at Week 0, at Week 4, and then 16 weeks was the primary endpoint. That's the data that we're going to be talking about today, although there is some additional data that'll be coming in the future, looking at the 52 week data. To qualify for this study…you just had to have moderate to severe genital or scalp psoriasis, based on IGA specifically.”

Song highlighted the high levels of response observed by his team in both the genital and scalp cohorts.

“If you look at the genital population specifically, close to 7 out of 10 patients on risankizumab at the label dose got completely clear or almost clear," Song said. "That's at 16 weeks. So very high efficacy for the scalp. It was about 60% of the patients got to clear or almost clear. In my personal experience, generally, the scalp takes longer to clear than other parts of the body. So if I were to guess, these numbers could potentially get even better in the future when we show you that 52-week data.”

For any additional information, view Song’s full interview segment posted in the video above. To find out more covered during the DERM 2025 conference, view our 

The quotes used in this summary were edited for clarity.

This interview with Song at DERM2025 highlights recent phase 3 data on risankizumab for genital and scalp psoriasis.

Future Directions for Psoriasis Treatment

Video content above is prompted by the following:

Panelists discuss how the future of psoriasis treatment is evolving toward more personalized approaches with earlier biologic intervention for patients with high-impact disease regardless of body surface area, improved assessment tools that better capture disease burden, greater consideration of comorbidities and quality-of-life impacts, increased diversity in clinical trials, expanded patient education, innovative delivery systems, combination therapies, and targeted treatments for specific psoriasis phenotypes—all aimed at addressing current treatment gaps and moving closer to disease modification rather than merely symptom management.

Dosing Interval Differences in Psoriasis and Psoriatic Arthritis Treatment

SPECTREM was the first randomized controlled trial to evaluate biologics in this patient population. What other clinical trial data are there on the use of biologics for difficult-to-treat areas?

Panelists discuss how although SPECTREM was groundbreaking as the first randomized controlled trial specifically targeting moderate psoriasis in high-impact areas, other valuable evidence exists including subgroup analyses from pivotal trials of interleukin-17 inhibitors (secukinumab, ixekizumab, brodalumab) showing efficacy for scalp and nail psoriasis, dedicated studies like GESTURE (secukinumab for palmoplantar psoriasis), IXORA-Q (ixekizumab for genital psoriasis), data on TNF inhibitors for inverse/intertriginous disease, and observational real-world evidence supporting various biologics for difficult-to-treat locations—though most preceding studies were limited by focusing on patients with higher overall body surface area rather than the clinically important population with limited but high-impact disease that SPECTREM specifically addressed.

James Song, MD

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