James Song, MD

2025 European Academy of Dermatology and Venereology (EADV) Congress

 in Paris, Eingun James Song, MD, of Frontier Dermatology, touched on the topic of treatment sequencing, in light of his recent phase 4 data on risankizumab for those with moderate to severe scalp and genital 

Song’s team recently authored the UnlIMMited study, a multicenter, randomized, double-blind, placebo-controlled trial evaluating risankizumab. The team designed the study to address a historically underrepresented patient population in clinical research: patients with limited body surface area (BSA) involvement but with psoriasis affecting high-impact regions of the body such as the scalp and genitals.

Risankizumab and Treatment Sequencing in Scalp and Genital Psoriasis, With Eingun James Song, MD

“In the risankizumab studies, there were some patients who were on a prior systemic agent before,” Song explained. “So for the genital cohort, over 10% of these patients were on ixekizumab, an IL-17a inhibitor, with actually really good data for the genital scan, and then for the scalp group, we saw over 10% of these patients were either on adalimumab, a TNF alpha inhibitor, or apremilast, an oral PDE4 inhibitor. While we don't necessarily know how those patients responded to those prior therapies, what we can say is that people who've been exposed to those other biologics or DMARDs in the past, even if they didn't necessarily achieve a certain level of response, we are still seeing very high levels of response with risankizumab.”

Song noted that a caveat to his comments is that the numbers in this research are smaller and the data on these prior therapies are not known.

“My feelings on this, just based on my anecdotal experience, are that patients who don't do well with one particular agent, if they have very little response, we generally will switch out of the class,” Song said. “So if a patient was on an IL-17 or a TNF inhibitor before, and they had very little movement in their skin clearance, then we probably would move to an IL-23 inhibitor.”

In his discussion of treatment sequencing, Song highlighted the necessity of balancing risks and benefits.

“Purely from that standpoint, it is really hard to argue against the fact that an IL-23 inhibitor makes a very compelling case to be a first-line agent for patients if they've never been on anything before,” Song said. “Even for patients who've been on a systemic and maybe didn't get the result that they wanted…If there's maybe one thing I want you to take away from this study, it's that even in patients who have lower body surface areas, if they have a higher impact area that affects their quality of life [in a way that is] comparable to patients with much more extensive body surface area. So please don't under-treat these patients with just topicals. If they're not responding, at least consider escalating these patients to a systemic agent.”

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.

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.

Song J. Spotlighting New Data on Risankizumab for Scalp and Genital Psoriasis, With Eingun James Song, MD. HCPLive. September 17, 2025. 

https://www.hcplive.com/view/spotlighting-new-data-risankizumab-scalp-genital-psoriasis-eingun-james-song-md

Videos

This interview segment highlights Song’s risankizumab data covered during the 2025 EADV Congress in Paris.

, Eingun James Song, MD, director of clinical research at Frontier Dermatology, spoke with 

 about his team’s recent phase 4 findings on risankizumab for patients with moderate to severe scalp and genital psoriasis.

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.

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

“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.”

Eingun James Song, MD, highlights recent phase 4 data on risankizumab for patients with moderate to severe scalp and genital psoriasis.

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

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.

James Song, MD

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