FDA Approves Skyrizi for Pediatric Plaque Psoriasis, Psoriatic Arthritis

The FDA approved Skyrizi (risankizumab-rzaa) for the treatment of children 6 years and older with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy and for active psoriatic arthritis in the same age group.¹

The approval makes risankizumab the first and only IL-23 inhibitor approved in the US for pediatric patients 6 years and older who weigh less than 40 kg with either condition. A new 55 mg prefilled syringe (PFS) was simultaneously approved to support weight-based dosing for that lower-weight population.

Addressing a High-Burden Childhood Disease

Approximately 30% of people who develop psoriasis experience symptoms before age 18. Each year, an estimated 20,000 children under 10 years old are diagnosed with psoriasis in the US, and approximately 14,000 children are affected by psoriatic arthritis. Beyond the physical manifestations, psoriasis and psoriatic arthritis can interfere with mobility, daily activities, and quality of life—burdens that extend to caregivers as well.¹

"Plaque psoriasis and psoriatic arthritis can affect much more than skin and joints—these conditions can shape daily life and disrupt important childhood experiences," Roopal Thakkar, MD, executive vice president of research and development and chief scientific officer at AbbVie, said in a news release. "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."

Phase 3 Data: OptIMMize Program

The pediatric plaque 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 for patients aged 12 to younger than 18 years, and a single-arm open-label cohort for patients aged 6 to younger than 12 years.¹

In the OptIMMize-1 phase 3 study, adolescents aged 12 to younger than 18 years were randomized 2:1 to risankizumab (n = 54) or ustekinumab (UST; n = 28) for 16 weeks. At week 16, primary end point response rates were similar between arms for Psoriasis Area and Severity Index of 75% or greater improvement (PASI75), which was achieved in 85.2% of risankizumab-treated patients versus 85.7% of ustekinumab-treated patients. The other end point included a static Physician's Global Assessment score of clear or almost clear (sPGA0/1), which was achieved in 79.6% versus 75.0%, respectively. sPGA0/1 with at least a 2-grade improvement was achieved in 68.5% versus 67.9%.²

For deeper responses, PASI90 was achieved in 64.8% with risankizumab versus 60.7% with ustekinumab, and complete skin clearance (PASI100) was achieved in 40.7% versus 17.9%, respectively.²

In the open-label cohort of children aged 6 to younger than 12 years (n = 30), week 16 response rates were 86.7% for PASI75, 90.0% for sPGA0/1, 83.3% for sPGA0/1 with at least a 2-grade improvement, 76.7% for PASI90, and 43.3% for PASI100. Responses were maintained or improved at Week 52.²

"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," Amy S. Paller, MD, chair of dermatology and professor of pediatrics at Northwestern University Feinberg School of Medicine and a study investigator, said in a news release.¹ "These clinical responses, combined with weight-based dosing for younger patients, may help physicians better support a broad range of children living with plaque psoriasis or psoriatic arthritis."

The pediatric psoriatic arthritis approval is supported by the OptIMMize psoriasis clinical trial program data combined with population pharmacokinetic modeling and simulation based on well-controlled adult psoriatic arthritis studies.

Safety Profile and Dosing

The safety profile observed in pediatric patients with plaque psoriasis treated with risankizumab was consistent with the established safety profile in adults. Serious adverse events of note include risk of serious infections—including tuberculosis—and serious allergic reactions. The most common adverse effects in patients treated for plaque psoriasis and psoriatic arthritis include upper respiratory infections, headache, fatigue, injection site reactions, and fungal skin infections.¹

With the new approval, risankizumab is now available in the following formulations: a 55 mg/0.37 mL PFS for patients weighing less than 40 kg, a 150 mg/mL PFS and pen for patients weighing 40 kg or greater, a 600 mg/10 mL vial for intravenous infusion, and a 180 mg/1.2 mL or 360 mg/2.4 mL single-dose prefilled cartridge with on-body injector. Pharmacists dispensing risankizumab for pediatric patients should be aware of the weight-based dosing distinction and confirm the correct formulation is prescribed and dispensed.

REFERENCES

1. AbbVie. Skyrizi (risankizumab-rzaa) now FDA approved for pediatric use in psoriatic disease. News release. AbbVie. June 26, 2026. Accessed June 29, 2026. https://news.abbvie.com/2026-06-26-SKYRIZI-R-risankizumab-rzaa-Now-FDA-Approved-for-Pediatric-Use-in-Psoriatic-Disease

2. Magnolo N, Wine Lee L, Reich A, et al. Efficacy and safety of risankizumab in pediatric patients with psoriasis: results from the OptIMMize-1 Phase 3 Study. Abstract presented at: PeDRA Annual Conference. 2025. Accessed June 29, 2026. https://www.jidonline.org/article/S0022-202X(26)00610-X/pdf