Q&A: How Is Risankizumab’s FDA Approval Changing the Psoriatic Disease Landscape?

Following the June 29 approval by the US Food and Drug Administration (FDA) of risankizumab-rzaa (Skyrizi) for pediatric patients aged 6 years and older with moderate to severe plaque psoriasis and active psoriatic arthritis (PsA), an interview was conducted by the HCPLive editorial team.^1,2

The interview, conducted with Amy Paller, MD, highlighted various elements regarding risankizumab in this new age range, including the weight-based prefilled syringe dosing system for children weighing less than 40 kg. Paller, a professor and chair of the Department of Dermatology at Northwestern University’s Feinberg School of Medicine, spoke about the recent decision by FDA officials and the clinical significance of the expanded indication for dermatology clinicians treating children living with inflammatory skin disease.

In this Q&A interview with HCPLive, Paller’s responses to inquiries by the editorial team touch on several key points regarding the significance of the FDA approval of risankizumab for psoriasis and PsA in this young patient population:

HCPLive: What makes the FDA approval of risankizumab for children aged 6 years or older with moderate to severe psoriasis who are candidates for systemic therapy or phototherapy, as well as for those ged 6 years or older with active psoriatic arthritis significant for clinicians?

Paller: We're very excited because of the fact that this is one of the best medicines out there for treating psoriasis, based on what we've seen in adults. It also has an every 12-week administration, which is the favored frequency of administration by pediatric dermatologists, and one of the reasons we've used so much ustekinumab.

HCPLive: How do you see this expanded indication changing your approach to selecting biologic therapy for children with moderate to severe psoriasis?

Paller: We do have many biologics now for treating psoriasis, which is very fortunate because it gives us options. However, we also have the pleasure of having medicines like risankizumab that put most kids in the range of PASI 90 or 100. And that's really where we want to be. A study in adolescence showed that there is a statistically significant difference in quality of life between reaching PASI 75 versus getting to PASI 90 or better. That's now our new goal. We also like the ability to only have to give it every 12 weeks. The fact that it's approved for psoriatic arthritis as well means the lower risk for our patients of moving in that direction, or the ability to cover both for the few that do.

HCPLive: What should dermatology clinicians know about the new weight-based dosing option, and how might it benefit younger patients?

Paller: Now we don't have to have the pharmacist or someone else try to make sure that it's on a weight-based dose. We have available the 55 milligram prefilled syringe, and that's great for those younger children. I will also note that a syringe is more comfortable in general for children, and has been the preferred way that we've delivered for most of our patients on biologics who are in those younger age ranges. It works well.

HCPLive: When considering risankizumab for a pediatric patient, what efficacy and safety considerations are most important to discuss with families?

Paller: Well, efficacy we want as high as possible, and to be able to talk with them about the majority of individuals, even over a relatively short period of time, reaching 90 to 100 percent reduction in their psoriasis is pretty impressive and a wonderful thing to have to discuss. In addition, the fact that we don't really need to be tracking laboratory tests or otherwise worrying about side effect profiles is also reassuring for parents.

HCPLive: Looking ahead, what additional data or research would you like to see to further inform the use of risankizumab in pediatric psoriasis and psoriatic arthritis?

Paller: The fact that IL-23 is so central to the development of psoriasis, and that we have an agent here that targets IL-23 specifically, is also special and part of the conversation with parents. Looking to the future, we really want to understand better whether there are any long-term risks of using a pediatric population. In addition, we have questions like: Will this possibly prevent the development of other comorbidities that can occur over time in children with psoriasis?

Whether it’s arthritis or inflammatory bowel disease, or whether we're talking about the cardiovascular comorbidities of the disease, [these are] not easy to study and will take long-term observation. But I think it is important because we have growing evidence in the adult community that these biologics that are targeted anti-inflammatory agents can reduce the risk of developing them; one would think that in the pediatric population, that risk would be even more important to have early intervention that is highly effective.

Disclosures for Paller include the following: AbbVie, AnaptysBio, Eli Lilly, Galderma, Incyte, Janssen, LEO Pharma, Novartis, Regeneron Pharmaceuticals, Inc., Sanofi – investigator; AbbVie, Amgen, Asana, Dermavant, Dermira, Eli Lilly, Forte, Galderma, LEO Pharma, Matrisys Bioscience, Menlo Therapeutics, MorphoSys/Galapagos, Novartis, Pfizer, Regeneron Pharmaceuticals. Inc., Sanofi – consultant.

References

1. Johnson V. FDA Approves Risankizumab for Pediatric Plaque Psoriasis, Psoriatic Arthritis. HCPLive. June 29, 2026. Accessed July 21, 2026. https://www.hcplive.com/view/fda-approves-risankizumab-pediatric-plaque-psoriasis-psoriatic-arthritis.

2. AbbVie. SKYRIZI® (risankizumab-rzaa) now FDA approved for pediatric use in psoriatic disease. PRNewswire. Published June 26, 2026. Accessed July 21, 2026. https://www.prnewswire.com/news-releases/skyrizi-risankizumab-rzaa-now-fda-approved-for-pediatric-use-in-psoriatic-disease-302812335.html.