FDA approves Skyrizi for pediatric psoriatic disease

FDA approved Skyrizi (risankizumab-rzaa) for children aged 6 years and older with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy, or with active psoriatic arthritis.

AbbVie said Skyrizi is now the first IL-23 inhibitor approved in the US for children aged 6 years and older weighing less than 40 kg with either condition. Skyrizi selectively binds the p19 subunit of IL-23, a cytokine involved in inflammatory pathways, and was already approved for several adult immune-mediated diseases, including plaque psoriasis, psoriatic arthritis, Crohn disease, and ulcerative colitis.

A new 55 mg prefilled syringe was approved to support weight-based dosing for patients weighing less than 40 kg. The currently available 150 mg prefilled syringe and pen are approved for pediatric patients weighing 40 kg or more.

Pediatric psoriatic disease can affect more than skin and joints. Plaque psoriasis and psoriatic arthritis can interfere with mobility, daily activities, school, social development, and family routines. AbbVie noted that about 30% of people who develop psoriasis have symptoms before age 18, and approximately 20,000 children younger than 10 years are diagnosed with psoriasis each year in the US.

The pediatric plaque psoriasis approval was supported by the phase 3 OptIMMize psoriasis clinical trial program, which included adolescents aged 12 to younger than 18 years and children aged 6 to younger than 12 years. The pediatric psoriatic arthritis approval was supported by the same program, along with population pharmacokinetic modeling and simulation based on adult psoriatic arthritis studies.

The company reported that pediatric patients with plaque psoriasis treated with Skyrizi had a safety profile consistent with the established adult plaque psoriasis safety profile.

Safety considerations include the known risks of IL-23 inhibition. Skyrizi may increase infection risk, and patients should be evaluated for infection and tuberculosis before treatment. Live vaccines should be avoided before, during, or shortly after therapy. Serious allergic reactions have been reported. For plaque psoriasis and psoriatic arthritis, common adverse reactions include upper respiratory infections, headache, fatigue, injection-site reactions, and fungal skin infections.

The approval adds another systemic option for children whose plaque psoriasis requires more than topical therapy or phototherapy, and for pediatric patients with active psoriatic arthritis. The new weight-based syringe may also make treatment more practical for smaller children.

“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, chair of dermatology and professor of pediatrics at Northwestern University Feinberg School of Medicine and study investigator in the OptIMMize program. “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.”

Source: AbbVie. 2026 June 26. [Press release]. Skyrizi (risankizumab-rzaa) now FDA approved for pediatric use in psoriatic disease