📌 The essentials On June 26, 2026, the FDA expanded the approval of Skyrizi (risankizumab-rzaa, AbbVie) to include two pediatric indications: moderate-to-severe plaque psoriasis in children aged 6 years and older who are candidates for systemic therapy or phototherapy, and active psoriatic arthritis in children aged 6 years and older. Both approvals cover pediatric patients regardless of body weight. A new 55 mg pre-filled syringe has been simultaneously approved to support weight-based dosing for patients weighing less than 40 kg. The existing 150 mg pre-filled syringe and pen remain approved for patients weighing 40 kg or more. This makes Skyrizi the first and only IL-23 inhibitor approved in the United States for pediatric patients aged 6 years and older who weigh less than 40 kg with plaque psoriasis or psoriatic arthritis. The European Commission approved risankizumab for pediatric plaque psoriasis in the same age group on June 23, 2026, three days before the U.S. action. The clinical basis for the plaque psoriasis approval: Phase 3 OptIMMize-1 (NCT04435600) and OptIMMize-2 (NCT04862286). Adolescents aged 12 to younger than 18 years (n=82, randomized 2:1 risankizumab versus ustekinumab): at week 16, PASI75 achieved in 85.2% (risankizumab) versus 85.7% (ustekinumab); PASI90 64.8% versus 60.7%; PASI100 40.7% versus 17.9%; sPGA0/1 79.6% versus 75.0%. Responses maintained or improved at week 52; sPGA0/1 achieved in approximately 95% of risankizumab responders who continued to week 52. Children aged 6 to younger than 12 years (n=30, open-label, single-arm): at week 16, PASI75 86.7%; PASI90 76.7%; PASI100 43.3%; sPGA0/1 90.0%. Responses maintained or improved through week 52. The psoriatic arthritis approval was supported by the OptIMMize program data plus population pharmacokinetic modeling and simulation extrapolated from well-controlled adult PsA studies. No dedicated randomized pediatric PsA efficacy trial was conducted. Safety profile in pediatric patients was consistent with the established adult safety profile. Skyrizi was originally approved in April 2019 for adults with moderate-to-severe plaque psoriasis and subsequently approved for adults with active psoriatic arthritis (2022), Crohn’s disease (2022), and ulcerative colitis (2024).

Psoriasis in children is not the same clinical experience as psoriasis in adults. The visible, chronic, and often unpredictable nature of the disease shapes childhood in ways that extend well beyond the skin. School-age children with moderate-to-severe plaque psoriasis deal with itching, pain, and lesions during the years when peer relationships form and self-image develops. Adolescents navigate a disease that can appear on exposed skin just as social self-consciousness peaks. Parents manage the daily treatment burden alongside their own anxiety about long-term treatment options for a child whose body and immune system are still developing.

The treatment toolkit for moderate-to-severe pediatric psoriasis has been narrower than most clinicians and families would like. Methotrexate, cyclosporine, and acitretin are systemic options that carry meaningful toxicity concerns in children. Etanercept, a TNF inhibitor, has been approved for pediatric psoriasis for many years. Secukinumab and ixekizumab, IL-17 inhibitors, expanded the pediatric biologic options. But the IL-23 inhibitor class, which in adults has produced some of the most durable and complete skin clearance rates seen in dermatology, has until now been unavailable to children.

Skyrizi (risankizumab-rzaa, AbbVie) changed that on June 26, 2026. The approval covers children as young as six years old, extends to patients weighing less than 40 kg through a new weight-based formulation, and includes both plaque psoriasis and psoriatic arthritis. It is the first time any IL-23 inhibitor has received FDA approval for pediatric psoriatic disease, and it is supported by Phase 3 data showing complete skin clearance in more than 40% of treated children at 16 weeks, with responses maintained through a year of treatment.

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What Pediatric Psoriasis and Psoriatic Arthritis Are

Plaque psoriasis in children

Plaque psoriasis is a chronic immune-mediated skin disease characterized by well-demarcated, raised, erythematous plaques covered by silvery-white scale. It results from dysregulated immune activation that accelerates the normal skin cell lifecycle from 28 to 30 days down to 3 to 5 days, causing immature keratinocytes to accumulate on the skin surface in the characteristic plaques. The scalp, elbows, knees, and trunk are the most commonly affected areas, though involvement can occur anywhere on the body including the face, nails, and flexural areas.

Pediatric psoriasis affects approximately 1% of children globally and accounts for roughly 30% of all psoriasis cases when considered across lifetime onset. Onset most commonly occurs in the first two decades of life, with two peaks: one in early childhood and one in adolescence. The disease presentation in children can differ from adults, with facial involvement, scalp disease, and guttate morphology (small, drop-like lesions often triggered by streptococcal infection) being more common in younger patients.

Moderate-to-severe disease, the population covered by this approval, is defined by a Psoriasis Area and Severity Index (PASI) above 10 or body surface area involvement above 10%, or disease affecting critical areas including the face, palms, soles, or genitalia regardless of BSA. Patients with moderate-to-severe disease are candidates for systemic therapy or phototherapy, the threshold specified in the approval.

The psychosocial burden of pediatric psoriasis is substantial and often underappreciated in clinical settings. Studies consistently show that children with psoriasis have higher rates of depression, anxiety, social withdrawal, and reduced health-related quality of life compared to peers without skin disease. Adolescents are particularly affected. These psychological consequences are among the reasons that achieving complete or near-complete skin clearance, rather than merely reducing plaque severity, has become the goal of modern biologic therapy.

Psoriatic arthritis in children

Psoriatic arthritis in children, sometimes referred to as juvenile psoriatic arthritis within the broader category of juvenile idiopathic arthritis, involves inflammation of the joints that occurs in the setting of psoriatic disease. It presents with swollen, tender joints, morning stiffness, and in some children with characteristic features including dactylitis (sausage-shaped swelling of fingers or toes) and enthesitis (inflammation at tendon or ligament insertion sites). Without adequate treatment, pediatric psoriatic arthritis can cause permanent joint damage and growth abnormalities.

The psoriatic arthritis indication in this approval is meaningful because children with psoriasis are at elevated risk of developing arthritis, and early effective treatment of both the skin and joint manifestations can prevent structural damage. The evidentiary basis for the PsA approval in children rests on population pharmacokinetic modeling and simulation from adult PsA trials, along with the psoriasis data from OptIMMize, rather than a dedicated randomized pediatric PsA efficacy trial. This extrapolation approach is acceptable under FDA pediatric development frameworks when the disease mechanism and drug pharmacology are well-characterized in adults and PK data support comparable drug exposure in children. However, it is a meaningful limitation that clinicians and families should understand during shared decision-making, particularly for younger children.

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How Risankizumab Works: The IL-23 Mechanism

Risankizumab is a humanized IgG1 monoclonal antibody that selectively targets interleukin-23 (IL-23), specifically the p19 subunit of the IL-23 cytokine. IL-23 is a key regulatory cytokine produced by antigen-presenting cells (dendritic cells and macrophages) in response to immune stimulation. Its primary function is to promote the differentiation, expansion, and survival of Th17 cells, the T helper cell population that drives much of the inflammatory activity in psoriatic disease.

By blocking IL-23 at its p19 subunit, risankizumab interrupts this cascade before it begins. With less IL-23 available, Th17 cell populations cannot expand normally. As a result, the downstream cytokines that drive psoriatic inflammation, principally IL-17A, IL-17F, and IL-22, are produced in lower quantities. The result is a reduction in keratinocyte hyperproliferation, dermal inflammation, and the immune-mediated joint damage that characterizes psoriatic arthritis.

The IL-23 p19 targeting approach distinguishes risankizumab and the other IL-23 inhibitors (guselkumab, tildrakizumab) from IL-12/23 dual inhibitors like ustekinumab, which block the shared p40 subunit of both IL-12 and IL-23. By specifically targeting IL-23 and sparing IL-12, risankizumab does not interfere with IL-12-dependent immune responses that are important for host defense against certain infections, a theoretical advantage over dual inhibition that is reflected in the clinical safety profile.

The practical consequence of this mechanism for patients is that risankizumab produces deep and durable skin clearance by addressing the upstream cytokine driver of psoriatic disease rather than its downstream effects. In adult trials, risankizumab has produced PASI90 and PASI100 rates that are among the highest reported for any psoriasis biologic, and these effects are sustained over years of treatment.

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The OptIMMize Program: What the Pediatric Data Shows

The FDA approval for pediatric plaque psoriasis rests on data from Phase 3 OptIMMize-1 (NCT04435600) and its open-label extension OptIMMize-2 (NCT04862286). The program included four components: two lead-in pharmacokinetic cohorts that established age- and weight-appropriate dosing, a randomized active-controlled cohort in adolescents aged 12 to younger than 18, and a single-arm open-label cohort in children aged 6 to younger than 12.

Adolescents aged 12 to younger than 18 years: randomized cohort

In the randomized cohort, 82 adolescents were randomized 2:1 to risankizumab (n=54) or ustekinumab (n=28) for 16 weeks. Ustekinumab was chosen as the active comparator because it was, at the time the trial was designed, one of the few biologics with established pediatric psoriasis data and approval. Both drugs were dosed according to weight-based protocols consistent with their respective approved adult dosing frameworks.

Endpoint at week 16	Risankizumab (n=54)	Ustekinumab (n=28)
PASI75 (at least 75% improvement in PASI)	85.2%	85.7%
PASI90 (at least 90% improvement in PASI)	64.8%	60.7%
PASI100 (complete skin clearance)	40.7%	17.9%
sPGA0/1 (clear or almost clear)	79.6%	75.0%
sPGA0/1 with at least 2-grade improvement	68.5%	67.9%

Source: 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. NCT04435600.

The PASI75 results were comparable between risankizumab and ustekinumab at week 16, meaning both drugs achieved substantial disease control at a similar rate in this population. The more clinically meaningful differentiator was the PASI100 rate: complete skin clearance in 40.7% of risankizumab-treated adolescents versus 17.9% of ustekinumab-treated adolescents. In practical terms, more than twice as many adolescents treated with risankizumab achieved completely clear skin at 16 weeks compared to those on ustekinumab.

Durability through week 52 was maintained and in many cases improved. Among adolescents who responded to risankizumab and continued treatment through week 52, sPGA0/1 (clear or almost clear skin) was achieved in approximately 95% of patients. This long-term durability is consistent with what has been observed in adult risankizumab trials, where sustained responses without tachyphylaxis have been a characteristic feature of the drug.

Children aged 6 to younger than 12 years: open-label cohort

The younger cohort (n=30) was evaluated in a single-arm, open-label design, which is appropriate for this age group given the practical and ethical challenges of conducting blinded, placebo-controlled trials in young children with moderate-to-severe skin disease. These children received the 55 mg dose (for those under 40 kg) or the standard adult dose (for those at or above 40 kg) and were evaluated at week 16 and through week 52.

Endpoint at week 16	Risankizumab (n=30)
PASI75	86.7%
PASI90	76.7%
PASI100 (complete skin clearance)	43.3%
sPGA0/1 (clear or almost clear)	90.0%
sPGA0/1 with at least 2-grade improvement	83.3%

Source: OptIMMize-1/2 open-label cohort, ages 6 to younger than 12. NCT04435600/NCT04862286.

These response rates are high across all measures. A 90% rate of clear or almost clear skin at 16 weeks, alongside a 43.3% rate of complete skin clearance, represents an efficacy signal in children aged 6 to 11 that is consistent with and in some measures exceeds what has been observed in adult trials with risankizumab. Responses in this younger cohort were maintained or improved through week 52, confirming sustained disease control over a year of treatment.

An important interpretive note: the open-label, single-arm design of the younger cohort means there is no placebo or active comparator for this group’s results. Response rates in open-label trials are generally higher than in blinded, placebo-controlled trials because of patient and investigator expectancy effects and the known PASI improvement that occurs in some patients over time even without active treatment (regression to the mean). This is a recognized limitation of pediatric trial design in diseases where withholding treatment from children with moderate-to-severe psoriasis for the duration of a placebo-controlled study raises ethical concerns. The FDA’s approval for this age group reflects a judgmental weighing of the unmet medical need, the consistency of the results with the mechanistic and adult evidence base, and the favorable safety profile.

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The New 55 mg Formulation: Why Weight-Based Dosing Matters for Children

The simultaneous approval of a 55 mg pre-filled syringe specifically for patients weighing less than 40 kg is a clinically important element of this approval that could easily be overlooked in headlines focused on the age extension.

Children under 40 kg receiving the standard adult 150 mg dose would receive a substantially higher mg/kg dose than intended, with potential implications for both safety and long-term tolerability. The 55 mg dose was developed through the pharmacokinetic lead-in cohorts of OptIMMize, which characterized risankizumab exposure across the pediatric weight and age range and identified the dose that achieves drug exposure comparable to the adult 150 mg dose on a per-kilogram basis.

This weight-based dosing approach is what allows the approval to extend meaningfully to children aged 6 to 11, many of whom will weigh less than 40 kg. Without a lower-dose formulation, the approval would carry a practical limitation that undermined its clinical utility in younger and smaller children. With it, clinicians have a dosing framework that is pharmacokinetically grounded rather than extrapolated downward from adult dosing.

Patient weight	Risankizumab dose	Formulation
Less than 40 kg	55 mg subcutaneous injection	New 55 mg pre-filled syringe
40 kg or more	150 mg subcutaneous injection	Existing 150 mg pre-filled syringe or pen

Dosing schedule mirrors the adult schedule: subcutaneous injection at weeks 0 and 4, then every 12 weeks for maintenance. This 12-weekly maintenance schedule is one of the most infrequent in the biologic psoriasis class and is a meaningful practical advantage for families managing a child’s long-term treatment. Fewer injections per year reduces the physical and psychological burden on both the child and the caregivers who administer the medication.

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The Psoriatic Arthritis Approval: What the Evidence Does and Does Not Cover

The psoriatic arthritis approval for children aged 6 and older is supported by two distinct evidentiary streams: the OptIMMize psoriasis data (establishing the drug’s safety and efficacy in the same age group for the related psoriatic condition) and population pharmacokinetic modeling and simulation extrapolated from well-controlled adult PsA trials, including the KEEPsAKE-1 and KEEPsAKE-2 trials that supported the 2022 adult PsA approval.

The modeling demonstrates that the weight-based risankizumab dosing approved for pediatric psoriasis achieves drug exposures in children similar to those produced by the 150 mg adult dose that was shown to be effective in adult PsA trials. The FDA considered this extrapolation appropriate given the shared pathophysiology between adult and pediatric psoriatic arthritis, the well-established adult efficacy database, and the pharmacokinetic consistency across weight groups.

What the approval does not include is a dedicated randomized, controlled efficacy trial specifically in children with psoriatic arthritis. This is the most important limitation for clinicians managing pediatric PsA patients considering risankizumab. The drug is approved and the pharmacokinetic rationale is sound, but clinicians and families should understand that the PsA efficacy evidence is extrapolated rather than directly demonstrated in this age group. For children with active joint disease alongside psoriasis, this distinction should be part of the treatment discussion.

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Safety: Consistent with the Established Adult Profile

The safety profile observed in pediatric plaque psoriasis patients treated with Skyrizi was consistent with the established safety profile in adult patients with plaque psoriasis. This is a reassuring finding given that the IL-23 inhibitor class has accumulated a substantial real-world safety dataset across several years of adult use since risankizumab’s original 2019 approval. Patient Care Online

The key safety considerations from the adult label and their pediatric relevance:

Serious infections: IL-23 inhibition reduces the Th17-mediated immune response, which plays a role in mucosal defense against certain fungal pathogens including Candida species. Fungal skin infections are among the more common adverse events reported with risankizumab. Serious infections including those requiring hospitalization have been reported in adults, though at low absolute rates. Clinicians treating children should assess for active infection before initiating and monitor for infection signs during treatment.

Prior to initiating, tuberculosis testing is required. Risankizumab has not been studied in patients with active TB, and the prescribing information requires evaluation for latent TB before treatment. Patients with latent TB should be treated with standard anti-tuberculosis therapy before starting risankizumab.

Hypersensitivity reactions: Serious hypersensitivity reactions, including anaphylaxis, have been reported. Patients and caregivers should be educated about signs of hypersensitivity and instructed to seek immediate medical attention if they occur.

Live vaccines: Do not administer live vaccines during risankizumab treatment. This is particularly important in the pediatric setting, where the standard childhood immunization schedule includes live vaccines. The timing of immunizations should be discussed with the prescribing physician before initiating risankizumab. All required vaccinations should be completed before starting treatment wherever possible.

Common adverse reactions reported in the pediatric trial, consistent with the adult profile, include upper respiratory tract infections, headache, fatigue, injection site reactions, and fungal skin infections.

Inflammatory bowel disease: In adult trials, rare cases of new or worsening inflammatory bowel disease have been reported with IL-17 inhibitors. While the IBD signal with IL-23 inhibitors is less pronounced and risankizumab is actually approved for Crohn’s disease and ulcerative colitis in adults, clinicians should monitor for GI symptoms in all patients.

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Skyrizi’s Complete Pediatric and Adult Indication Picture After June 2026

Indication	Approved population	Approval date
Moderate-to-severe plaque psoriasis	Adults	April 23, 2019
Active psoriatic arthritis	Adults	January 21, 2022
Moderate-to-severe Crohn’s disease	Adults	June 20, 2022
Moderate-to-severe ulcerative colitis	Adults	June 9, 2024
Moderate-to-severe plaque psoriasis	Children aged 6 and older	June 26, 2026
Active psoriatic arthritis	Children aged 6 and older	June 26, 2026

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What This Means for Pediatric Dermatologists, Rheumatologists, and Families

For clinicians

This approval gives pediatric dermatologists and rheumatologists their first IL-23 inhibitor option for children, the drug class that has produced the most durable complete clearance rates in adult psoriasis. For adolescents aged 12 and older who have failed or are intolerant to methotrexate or a TNF inhibitor and are candidates for an IL-23 inhibitor, the OptIMMize data now provides direct randomized evidence in their age group comparing risankizumab favorably to ustekinumab, particularly on the metric of complete skin clearance.

For children aged 6 to 11, the open-label data and the weight-based dosing framework are now available, though the single-arm design means clinicians should interpret the efficacy data with appropriate awareness of its limitations.

For the psoriatic arthritis indication in children: the extrapolation-based approval is appropriate for use in clinical practice but should be accompanied by discussion with the family of the evidentiary basis, so that treatment expectations and monitoring plans reflect what is and is not directly demonstrated in children.

The 12-weekly maintenance dosing schedule is a meaningful practical advantage for pediatric patients. Fewer clinic visits and fewer injections per year reduce treatment burden on children and families and may improve long-term adherence.

For families

If your child has been diagnosed with moderate-to-severe plaque psoriasis or psoriatic arthritis and is at least 6 years old, risankizumab is now an FDA-approved option that your child’s pediatric dermatologist or rheumatologist can prescribe. The drug is given as a subcutaneous injection (under the skin, typically in the thigh or abdomen) at weeks 0 and 4, and then every 12 weeks. For children under 40 kg, the new 55 mg dose is specifically designed for their weight range.

Because Skyrizi is a specialty biologic medication, insurance coverage and prior authorization requirements vary by plan. AbbVie operates a patient support program called myAbbVie Assist for eligible patients who need help with access or cost. A specialty pharmacy familiar with AbbVie biologics can help navigate the prior authorization process and assist with co-pay or patient assistance programs.

Before starting risankizumab, your child’s doctor will need to: rule out active or latent tuberculosis, review your child’s current vaccination status and complete any needed live vaccines before treatment begins, and review any current or planned medications including other immunosuppressants.

For related HED coverage on AbbVie’s dermatology and immunology portfolio, see our earlier post on Skyrizi’s approval for ulcerative colitis in 2024 and our coverage of the TrenibotE CRL from AbbVie’s neurotoxin program. For broader context on pediatric biologic approvals, see our post on KRESLADI, the first gene therapy for severe LAD-I in pediatric patients.

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Sources

AbbVie FDA approval press release: SKYRIZI (risankizumab-rzaa) Now FDA Approved for Pediatric Use in Psoriatic Disease. AbbVie. PRNewswire. June 26, 2026.

AbbVie newsroom announcement: SKYRIZI Now FDA Approved for Pediatric Use in Psoriatic Disease. news.abbvie.com. June 26, 2026.

Drugs.com approval news: Skyrizi (risankizumab-rzaa) Now FDA Approved for Pediatric Use in Psoriatic Disease. drugs.com. June 26, 2026.

AJMC full data summary: FDA Expands Risankizumab Approval to Pediatric Plaque Psoriasis, Active PsA. ajmc.com. June 2026.

Drug Topics (full endpoint table): FDA Approves Skyrizi for Pediatric Plaque Psoriasis, Psoriatic Arthritis. drugtopics.com. June 2026.

Pharmacy Times clinical review: FDA Approves Risankizumab for Pediatric Plaque Psoriasis, Psoriatic Arthritis. pharmacytimes.com. June 2026.

Practical Dermatology coverage: FDA Grants SKYRIZI Approval to Children With Plaque Psoriasis and PsA. practicaldermatology.com. June 2026.

Contemporary Pediatrics (PsA limitation noted): FDA approves risankizumab for pediatric plaque psoriasis and psoriatic arthritis. contemporarypediatrics.com. June 2026.

HCPLive clinical detail: FDA Approves Risankizumab for Pediatric Plaque Psoriasis, Psoriatic Arthritis. hcplive.com. June 2026.

Patient Care Online (evidentiary limitation note): FDA Approves Risankizumab for Pediatric Psoriasis, Psoriatic Arthritis. patientcareonline.com. June 2026.

Dermatology Advisor: Skyrizi Earns FDA Pediatric Approval for Psoriatic Disease in Patients Aged 6+. dermatologyadvisor.com. June 2026.

The Dermatology Digest: US FDA Approves Risankizumab for Pediatric Psoriatic Disease. thedermdigest.com. June 2026.

Psoriasis Hub: FDA approves risankizumab for pediatric patients with plaque psoriasis or active PsA. psoriasis-hub.com. June 2026.

OptIMMize-1 primary publication: 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.

OptIMMize-1 trial registration: NCT04435600. ClinicalTrials.gov.

OptIMMize-2 trial registration: NCT04862286. ClinicalTrials.gov.

Adult PsA approval (KEEPsAKE basis): FDA approves risankizumab-rzaa for active psoriatic arthritis. FDA.gov. January 2022.

IL-23 mechanism and psoriasis biology: IL-23 in Psoriasis. PMC8289557.

Plaque psoriasis overview: Psoriasis. StatPearls. NCBI.

Psoriatic arthritis overview: Psoriatic Arthritis. StatPearls. NCBI.

Skyrizi prescribing information: SKYRIZI (risankizumab-rzaa) Prescribing Information. AbbVie. 2026.

Skyrizi approval history: Skyrizi FDA Approval History. drugs.com.

AbbVie myAbbVie Assist patient support: myAbbVie Assist. abbvie.com.

Patient resources: National Psoriasis Foundation: 1-800-723-9166 | Arthritis Foundation | Psoriasis and Psoriatic Arthritis Alliance | AbbVie Skyrizi patient support

Disclaimer: Health Evidence Digest provides general information about FDA approvals and health research for educational purposes. This content is not a substitute for professional medical advice. The psoriatic arthritis indication for children aged 6 and older was supported by pharmacokinetic extrapolation from adult studies rather than a dedicated pediatric randomized controlled trial; clinicians should discuss this evidentiary basis with families during treatment decision-making. Risankizumab requires pre-treatment tuberculosis screening and review of vaccination status. All treatment decisions for pediatric psoriasis and psoriatic arthritis should be made in consultation with a board-certified pediatric dermatologist or rheumatologist.