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How Does the FDA Approval of Risankizumab Impact Pediatric Psoriasis and PsA? With Amy Paller, MD

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Amy Paller, MD, highlights takeaways from the recent FDA approval of risankizumab-rzaa (Skyrizi) for children with psoriasis and PsA.

In June 2026, the US Food and Drug Administration (FDA) approval of risankizumab-rzaa (Skyrizi) was announced for pediatric patients aged 6 years and older with moderate to severe plaque psoriasis and active psoriatic arthritis (PsA).1,2

In an interview with the HCPLive team, Amy Paller, MD, professor and chair of the Department of Dermatology at Northwestern University Feinberg School of Medicine, discussed the recent decision and the clinical significance of the expanded indication for dermatology clinicians treating children with inflammatory skin disease. Speaking with HCPLive, Paller described the approval as an important addition to the pediatric psoriasis medication landscape, citing the drug’s impressive efficacy noted among adult populations and its practical advantages for improving long-term disease management.

What Does Risankizumab’s New Age Indication Add to the Psoriasis Landscape?

“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, and 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,” Paller expressed.

Paller pointed to 1 of risankizumab's distinguishing characteristics as being its every-12-week maintenance dosing schedule. According to Paller, the interval is among the most desirable administration frequencies of treatment for pediatric dermatologists as it diminishes the number of injections needed by young patients throughout the year while maintaining their disease control. Such an approach, she noted, may help lessen treatment burden for patients and caregivers as opposed to drugs requiring more frequent administration.

How Are Psoriatic Disease Goals Shifting as New Options Emerge?

The expanded approval, she stated, also adds another highly effective biologic agent to an increasingly robust therapeutic armamentarium for pediatric psoriasis. While clinicians now have multiple biologic options available, Paller described treatment goals as having evolved beyond attaining partial disease improvement. She pointed to data demonstrating children who attain Psoriasis Area and Severity Index (PASI) 90 or PASI 100 responses experience greater improvements in quality of life than those achieving PASI 75, reinforcing the importance of pursuing near-complete or complete skin clearance whenever possible. Risankizumab, she noted, has demonstrated the ability to help many children attain those higher response thresholds.

Later in her discussion, Paller highlighted the value of risankizumab’s new weight-based dosing option for children. The availability of a 55-mg prefilled syringe for children weighing less than 40 kg simplifies the dosing schedule by eliminating the need for individualized dose preparation. She also described prefilled syringes as generally preferred for younger pediatric patients.

Beyond plaque psoriasis, Paller noted that the expanded indication for pediatric PsA also strengthens risankizumab's role in clinical practice. The expansion may allow clinicians to select a single biologic capable of treating both skin and joint manifestations when appropriate. As expectations for treatment continue to evolve, she described this combination of efficacy, convenience, and broad disease coverage as positioning risankizumab as an important new option.

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.

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