FDA Approves Risankizumab for Pediatric Plaque Psoriasis, Psoriatic Arthritis

The FDA has approved risankizumab-rzaa (Skyrizi; AbbVie) for children aged 6 and older with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, as well as for pediatric patients 6 years and older with active psoriatic arthritis. The approval includes a new 55 mg pre-filled syringe to support weight-based dosing for patients weighing less than 40 kg, and risankizumab becomes the first and only IL-23 inhibitor approved in the US for pediatric patients aged 6 and older weighing less than 40 kg with plaque psoriasis or psoriatic arthritis.¹

A Treatment Gap in Younger Patients

Approximately 30% of people who develop psoriasis experience symptoms before age 18, and each year roughly 20,000 children under 10 are diagnosed with psoriasis in the US, while an estimated 14,000 children are affected by psoriatic arthritis. Symptoms in children can interfere with mobility and daily activities and add burden for caregivers. For families navigating these chronic conditions, expanding access to treatments with proven efficacy supports improved disease management and extends established standards of care to younger patients.^1,2

Trial Data Behind the Expanded Indication

The pediatric psoriasis approval is supported by data from the phase 3 OptIMMize psoriasis clinical trial program (NCT04435600; NCT04862286), which included 2 lead-in pharmacokinetic cohorts, a randomized, efficacy assessor-blinded, active-controlled cohort of patients aged 12 to younger than 18 years, and a single-arm, open-label cohort of patients aged 6 to younger than 12 years.^1-6

In the adolescent cohort, patients were randomized 2:1 to risankizumab or ustekinumab for 16 weeks; 85.2% of risankizumab-treated patients achieved a 75% or greater improvement in Psoriasis Area and Severity Index (PASI75) at week 16, compared with 85.7% of ustekinumab (Stelara; Johnson & Johnson)-treated patients, while complete skin clearance (PASI100) was achieved in 40.7% of risankizumab-treated patients versus 17.9% of ustekinumab-treated patients.³

Longer-term follow-up data found that risankizumab demonstrated efficacy and safety over 52 weeks in pediatric patients with moderate to severe psoriasis, improving pruritus, skin clearance, and quality of life. The pediatric psoriatic arthritis approval, by contrast, is supported by the OptIMMize psoriasis program together with population pharmacokinetic modeling and simulation based on well-controlled adult psoriatic arthritis studies, rather than a dedicated randomized pediatric efficacy trial.¹

Mechanism of Action

Risankizumab is a humanized IgG1 monoclonal antibody that binds to the p19 subunit of IL-23 and inhibits IL-23 from interacting with the IL-23 receptor and downstream signaling, a pathway implicated in plaque psoriasis and psoriatic arthritis. Its pharmacokinetics are linear and time-independent across approved indications, and the drug has shown positive exposure-response relationships for efficacy without apparent exposure-dependent worsening in safety.^1,4

The newly approved 55 mg prefilled syringe supports weight-based dosing for patients weighing less than 40 kg, while the existing 150 mg prefilled syringe and pen remain approved for patients weighing 40 kg or more. The safety profile observed in pediatric plaque psoriasis patients treated with risankizumab was consistent with the established safety profile of risankizumab in adults. Common adverse reactions in patients with psoriatic disease include upper respiratory infections, headache, fatigue, injection site reactions, and fungal skin infections.¹

Access Considerations

AbbVie offers a patient support program and co-pay card that may reduce out-of-pocket costs to as little as $0 per month for eligible, commercially insured patients, along with the myAbbVie Assist program for those with limited or no insurance. Pharmacists counseling families of pediatric patients with psoriatic disease should be prepared to discuss weight-based product selection, infection screening prior to initiation, and the financial assistance programs available through the manufacturer.¹

REFERENCES

1. SKYRIZI® (risankizumab-rzaa) now FDA approved for pediatric use in psoriatic disease. News Release. AbbVie. Released June 26, 2026. Accessed June 30, 2026. https://news.abbvie.com/2026-06-26-SKYRIZI-R-risankizumab-rzaa-Now-FDA-Approved-for-Pediatric-Use-in-Psoriatic-Disease

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

3. Magnolo N, Lee LW, Reich A, et al. Efficacy and safety of risankizumab in pediatric patients with psoriasis: results from the OptIMMize-1 phase 3 study. J Invest Dermatol. 2026;146(3):S19. doi:10.1016/s0022-202x(26)00610-x

4. Pang Y, D'Cunha R, Winzenborg I, Veldman G, Pivorunas V, Wallace K. Risankizumab: Mechanism of action, clinical and translational science. Clin Transl Sci. 2024;17(1):e13706. doi:10.1111/cts.13706

5. A study of subcutaneous risankizumab injection for pediatric participants with moderate to severe plaque psoriasis to assess changes in disease symptoms (OptIMMize-1). ClinicalTrials.gov Identifier: NCT04435600. Last Updated May 20, 2025. Accessed June 30, 2026. https://clinicaltrials.gov/study/NCT04435600

6. Study to evaluate adverse events and change in disease activity in participants between 6 and 17 years with moderate to severe plaque psoriasis treated with subcutaneous (SC) injection of Risankizumab who have completed participation in study M19-977. ClinicalTrials.gov Identifier: NCT04862286. Last Updated August 12, 2025. Accessed June 30, 2026. https://clinicaltrials.gov/study/NCT04862286