FDA Approves Risankizumab for Pediatric Plaque Psoriasis, Psoriatic Arthritis

The US Food and Drug Administration (FDA) has approved risankizumab-rzaa (SKYRIZI) for children aged 6 years or older with moderate to severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy, as well as for pediatric patients aged 6 years or older with active psoriatic arthritis (PsA), according to a June 26, 2026, announcement from AbbVie.1

The approval also adds a 55-mg prefilled syringe intended to support weight-based dosing for children weighing less than 40 kg; the 150-mg prefilled syringe and pen remain approved for patients weighing 40 kg or more.

“At Week 16 in part 2 of the OptIMMize psoriasis clinical trial program, risankizumab demonstrated clinically meaningful improvements in sPGA and PASI responses, with responses maintained long-term with continued treatment,” said Amy S. Paller, MD.

Expanding Pediatric Use of Risankizumab in Psoriatic Disease

Risankizumab is now the first IL-23 inhibitor approved in the United States for pediatric patients aged 6 years or older weighing less than 40 kg with plaque PsO or PsA. The announcement did not include the FDA approval letter or a revised prescribing information document beyond the safety and use information summarized in the release.

Risankizumab is a humanized immunoglobulin G1 monoclonal antibody targeting interleukin-23 through selective binding to the p19 subunit.1 IL-23 is involved in inflammatory pathways relevant to several immune-mediated diseases. The drug is already approved by the FDA and European Medicines Agency for adult plaque PsO, PsA, Crohn disease, and ulcerative colitis, according to the company announcement.1

Pediatric PsO is a clinically distinct treatment setting because long-term disease control, growth, administration burden, and caregiver involvement can influence treatment selection. Joint American Academy of Dermatology–National Psoriasis Foundation guidance notes pediatric PsO can require topical therapy, phototherapy, systemic nonbiologic therapy, or biologic therapy depending on severity and treatment response.2 Juvenile PsA remains less common than adult PsA, with heterogeneity in presentation and overlap with juvenile idiopathic arthritis categories.3

What the OptIMMize Pediatric Psoriasis Program Reported

The pediatric plaque PsO approval was supported by the phase 3 OptIMMize PsO clinical trial program (NCT04435600 and NCT04862286).1 AbbVie described the program as including 2 lead-in pharmacokinetic cohorts, a randomized efficacy assessor-blinded active-controlled cohort enrolling patients aged 12 to younger than 18 years, and a single-arm open-label cohort enrolling patients aged 6 to younger than 12 years.

The company reported risankizumab was associated with improvements in static Physician Global Assessment and Psoriasis Area and Severity Index responses at week 16 in part 2 of OptIMMize, with responses maintained longer term during continued treatment.1 Numeric response rates, confidence intervals, comparator results, and detailed durability data were not included in the June 26 announcement. The absence of those data limits independent assessment of effect size from the press release alone.

For pediatric PsA, the approval was supported by the OptIMMize psoriasis program plus population pharmacokinetic modeling and simulation based on well-controlled adult psoriatic arthritis studies, according to AbbVie.1 This approach indicates the pediatric PsA indication was not described in the announcement as being supported by a dedicated randomized pediatric psoriatic arthritis efficacy trial.

Approximately 30% of individuals who develop PsO have symptoms before age 18 years, according to the pediatric psoriasis guideline cited in the company announcement.2 Pediatric psoriatic disease can affect skin, joints, function, and quality of life, although the magnitude and domains of burden vary by age, disease phenotype, and severity.2,3

Safety Findings and Remaining Data Questions for Pediatric Clinicians

AbbVie reported the safety profile observed among pediatric patients with plaque PsO treated with risankizumab was consistent with the established adult plaque PsO safety profile.1 The announcement did not provide pediatric adverse event rates, serious adverse event rates, discontinuation rates, or laboratory abnormality data from OptIMMize.

The safety information included in the announcement lists serious allergic reactions and infections among important risks.1 The company states clinicians should evaluate patients for infections and tuberculosis before treatment and monitor for tuberculosis during and after therapy. The most common adverse events (AEs) listed for plaque psoriasis and psoriatic arthritis include upper respiratory infections, headache, fatigue, injection-site reactions, and fungal skin infections.1 The announcement also notes liver problems have occurred in treatment for Crohn disease or ulcerative colitis, including a case involving liver test abnormalities with rash requiring hospitalization after intravenous treatment in a person with Crohn disease.1

Unanswered questions include the numerical efficacy and safety results from each pediatric cohort, comparative performance against active control, and long-term safety outcomes in younger children receiving weight-based dosing. Peer-reviewed publication of the OptIMMize pediatric data and updated FDA labeling would provide additional detail for assessing the risk-benefit profile in pediatric psoriatic disease.

References

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

2. Menter A, Cordoro KM, Davis DMR, et al. Joint American Academy of Dermatology–National Psoriasis Foundation guidelines of care for the management and treatment of psoriasis in pediatric patients. J Am Acad Dermatol. 2020;82(1):161-201. doi:10.1016/j.jaad.2019.08.049

3. Brunello F, Tirelli F, Pegoraro L, et al. New insights on juvenile psoriatic arthritis. Front Pediatr. 2022;10:884727. doi:10.3389/fped.2022.884727