FDA Expands Risankizumab Approval to Pediatric Plaque Psoriasis, Active PsA

On Friday, June 26, the FDA 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 those with active psoriatic arthritis (PsA).¹

The currently available 150 mg pre-filled syringe (PFS) and pen are approved for patients weighing 40 kg or more, and a new 55 mg PFS has been approved for those weighing less than 40 kg.

Expanded Approval Addresses Unmet Pediatric Need

Risankizumab is an interleukin (IL)-23 inhibitor, blocking it by selectively binding to its p19 subunit. IL-23 is a cytokine involved in inflammatory processes that is thought to be linked to several chronic immune-mediated diseases.

Risankizumab was previously approved in 2019 to treat moderate to severe plaque psoriasis in adults and in 2022 to treat adults with active PsA. It was also approved in 2022 to treat adults with moderate to severe active Crohn disease and in 2024 for adults with moderate to severe active ulcerative colitis.

This most recent approval helps the approximately 20,000 children under 10 years old diagnosed with psoriasis in the US annually and the estimated 14,000 children impacted by PsA. Symptoms of these diseases can interfere with children’s mobility and daily activities, putting additional burden on caregivers.

"We are proud that SKYRIZI is now the first and only IL-23 inhibitor approved in the US for pediatric patients 6 years of age and older weighing less than 40 kg with plaque psoriasis or PsA,” 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."

OptiMMize Clinical Program Supports Pediatric Use

The decision was supported by data from the phase 3 OptiMMize psoriasis clinical trial program (NCT04435600; NCT04862286), which included data from 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 those aged 6 to younger than 12 years.

In the phase 3 OptIMMize-1 trial, in particular, adolescents aged 12 to younger than 18 years were randomized 2:1 to risankizumab (n = 54) or ustekinumab (n = 28) for 16 weeks.²

At week 16, response rates were similar between arms for a Psoriasis Area and Severity Index of 75% or greater improvement (PASI75); it was achieved in 85.2% of patients treated with risankizumab vs 85.7% of those treated with ustekinumab. Meanwhile, PASI90 was achieved in 64.8% with risankizumab vs 60.7% with ustekinumab, and complete skin clearance, or PASI100, was achieved in 40.7% vs 17.9%, respectively.

In addition, a static Physician's Global Assessment score of clear or almost clear (sPGA0/1) was achieved in 79.6% vs 75.0% of the cohorts, respectively, whereas an sPGA 0/1 with at least a 2-grade improvement was achieved in 68.5% vs 67.9%, respectively.

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, 76.7% for PASI90, and 43.3% for PASI100. Additionally, 90.0% achieved sPGA0/1, and 83.3% had sPGA0/1 with at least a 2-grade improvement. Investigators noted that responses were maintained or improved at week 52.

"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 PsA,” Amy S. Paller, MD, OptiMMIze program investigator and chair of dermatology and professor of pediatrics at Northwestern University Feinberg School of Medicine, said in a news release.¹

References

1. 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, 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