SKYRIZI® Gains FDA Approval for Use in Children with Psoriatic Disease
AbbVie has announced that the U.S. Food and Drug Administration (FDA) has approved SKYRIZI® (risankizumab-rzaa) for the treatment of children aged six years and older with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy, as well as for active psoriatic arthritis. The approval expands the use of SKYRIZI into the pediatric population, offering a new treatment option for children living with chronic immune-mediated diseases that can significantly affect both physical health and quality of life.
In addition to the expanded indication, the FDA also approved a new 55 mg pre-filled syringe (PFS) to enable weight-based dosing for pediatric patients weighing less than 40 kilograms. Children weighing 40 kilograms or more will continue to receive treatment using the already available 150 mg pre-filled syringe and pre-filled pen formulations.
The approval marks another important milestone for AbbVie’s immunology portfolio and establishes SKYRIZI as the first and only interleukin-23 (IL-23) inhibitor approved in the United States for children six years of age and older weighing less than 40 kilograms who are living with plaque psoriasis or psoriatic arthritis.
Expanding Treatment Options for Young Patients
Plaque psoriasis and psoriatic arthritis are chronic inflammatory diseases that often begin during childhood or adolescence. While psoriasis primarily affects the skin, causing red, inflamed, and scaly plaques, psoriatic arthritis also involves painful inflammation of the joints, which can interfere with mobility, physical activity, and overall development.
Children diagnosed with these conditions frequently experience symptoms during formative years, when participation in school, sports, social activities, and other aspects of childhood is especially important.
Without effective treatment, the diseases can have lasting physical, emotional, and psychological consequences, affecting both patients and their families.
The FDA approval of SKYRIZI provides physicians with an additional biologic therapy specifically approved to address both skin and joint manifestations in eligible pediatric patients.
AbbVie Highlights Importance of Pediatric Approval
Roopal Thakkar, M.D., Executive Vice President of Research and Development and Chief Scientific Officer at AbbVie, emphasized the significance of extending SKYRIZI to younger patients.
According to Thakkar, plaque psoriasis and psoriatic arthritis impact far more than the skin and joints. The chronic nature of these diseases can influence nearly every aspect of a child’s daily life, including education, social interactions, physical activities, and emotional well-being.
He noted that SKYRIZI has become the first and only IL-23 inhibitor approved in the United States for pediatric patients aged six years and older weighing less than 40 kilograms with plaque psoriasis or psoriatic arthritis.
Thakkar said the expanded approval provides families with access to a therapy supported by proven clinical efficacy while extending established standards of care to younger individuals living with chronic inflammatory diseases.
Childhood Psoriasis Remains a Significant Burden
Psoriasis is not exclusively an adult disease. Approximately 30 percent of individuals who develop psoriasis begin experiencing symptoms before the age of 18.
In the United States, an estimated 20,000 children younger than ten years of age receive a psoriasis diagnosis every year.
In addition, approximately 14,000 children are affected by psoriatic arthritis, highlighting the need for effective therapies capable of addressing both skin and joint disease during childhood.
Beyond the visible symptoms, pediatric psoriasis and psoriatic arthritis can have widespread effects on physical functioning.
Joint pain, stiffness, and swelling may limit participation in sports, recreational activities, and even routine daily tasks.
The burden also extends to caregivers, who often coordinate medical appointments, treatment administration, and long-term disease management while supporting the emotional needs of affected children.
Patient Advocacy Community Welcomes New Option
Leah M. Howard, President and Chief Executive Officer of the National Psoriasis Foundation, welcomed the approval as an important advancement for children and families affected by chronic immune-mediated diseases.
She noted that many children living with psoriasis or psoriatic arthritis spend much of their childhood attending medical appointments while coping with uncertainty surrounding disease progression and long-term treatment.
Howard emphasized that having an approved therapy capable of treating both skin and joint disease provides families with another valuable treatment option while offering renewed hope as they navigate the challenges associated with these lifelong conditions.
Clinical Trial Program Supports Approval
The FDA’s decision was supported by findings from AbbVie’s comprehensive Phase 3 OptIMMize pediatric psoriasis clinical development program.
The program included multiple clinical studies evaluating the safety, pharmacokinetics, and efficacy of risankizumab in children and adolescents living with plaque psoriasis.
Researchers enrolled pediatric patients across several age groups, including children aged 6 to under 12 years and adolescents aged 12 to under 18 years.
The development program incorporated:
- Two lead-in pharmacokinetic studies.
- A randomized, efficacy assessor-blinded active-controlled cohort involving adolescents.
- A single-arm, open-label study involving younger children.
Together, these studies generated the evidence necessary to evaluate appropriate dosing strategies and clinical outcomes across a broad pediatric population.
Support for Pediatric Psoriatic Arthritis Approval
The approval for active pediatric psoriatic arthritis was supported through a combination of evidence.
In addition to the OptIMMize pediatric psoriasis clinical program, researchers incorporated population pharmacokinetic modeling and simulation based on previously completed, well-controlled adult clinical trials in psoriatic arthritis.
This integrated approach allowed investigators to establish dosing regimens expected to provide therapeutic drug exposure in pediatric patients comparable to that demonstrated effective in adults.
The strategy is commonly used when conducting pediatric drug development for diseases that share similar biological mechanisms across age groups.
Meaningful Clinical Improvements Demonstrated
According to Amy S. Paller, M.D., Chair of Dermatology and Professor of Pediatrics at Northwestern University Feinberg School of Medicine and an investigator in the OptIMMize program, SKYRIZI demonstrated clinically meaningful improvements during the clinical studies.
At Week 16 of the efficacy evaluation, treatment with risankizumab resulted in significant improvements across multiple disease activity measures.
Patients achieved favorable responses on both the:
- Static Physician Global Assessment (sPGA), which measures overall skin clearance.
- Psoriasis Area and Severity Index (PASI), which evaluates both the severity and extent of psoriasis.
Importantly, these improvements were maintained during long-term treatment, suggesting sustained disease control with continued therapy.
Paller noted that the combination of durable clinical responses and weight-based dosing flexibility may help physicians effectively treat a wide range of pediatric patients living with plaque psoriasis or psoriatic arthritis.
Favorable Safety Profile Consistent with Adults
Safety findings from the pediatric clinical development program were consistent with the established safety profile previously observed in adults treated with SKYRIZI for plaque psoriasis.
No new safety concerns were identified during the pediatric studies.
Maintaining a consistent safety profile across age groups is an important consideration when introducing biologic therapies into younger patient populations, where long-term disease management often begins early in life.
The favorable safety findings provide additional confidence for physicians considering SKYRIZI as a treatment option for eligible pediatric patients.
New Weight-Based Dosing Option
An important component of the FDA approval is the introduction of a new 55 mg pre-filled syringe specifically designed for children weighing less than 40 kilograms.
Weight-based dosing helps ensure that younger patients receive appropriate therapeutic exposure while accounting for differences in body size and development.
Children weighing 40 kilograms or more will continue receiving the existing 150 mg pre-filled syringe or pre-filled pen formulations.
The addition of the lower-dose presentation expands treatment flexibility and supports individualized care across a broader pediatric population.
Supporting Patient Access
AbbVie stated that it remains committed to helping eligible patients gain access to SKYRIZI through various patient assistance initiatives.
For commercially insured patients who qualify, the company offers a co-pay assistance program that may reduce monthly out-of-pocket costs to as little as zero dollars.
AbbVie also operates myAbbVie Assist, a patient assistance program designed to provide SKYRIZI at no cost to eligible individuals who have limited or no health insurance coverage.
These support programs aim to reduce financial barriers and improve access to treatment for families managing chronic inflammatory diseases.
Growing Role of IL-23 Inhibition
SKYRIZI targets the interleukin-23 (IL-23) pathway, a key driver of inflammation involved in psoriasis and psoriatic arthritis.
By selectively inhibiting IL-23, the therapy helps reduce inflammatory activity responsible for both skin lesions and joint symptoms while supporting long-term disease control.
The FDA approval further expands the role of IL-23 inhibition in pediatric immunology and reflects increasing confidence in targeted biologic therapies for managing chronic inflammatory diseases in children.
The FDA approval of SKYRIZI for children aged six years and older with moderate-to-severe plaque psoriasis or active psoriatic arthritis represents a significant advancement in pediatric dermatology and rheumatology. Supported by data from the Phase 3 OptIMMize clinical program, the approval introduces the first and only IL-23 inhibitor authorized in the United States for younger patients weighing less than 40 kilograms with these conditions.
With the addition of a new weight-based 55 mg pre-filled syringe, physicians now have greater flexibility to tailor treatment according to patient size while maintaining consistent therapeutic exposure. Combined with durable efficacy, a well-established safety profile, and expanded patient support programs, the approval offers new hope for children and families seeking improved long-term management of chronic immune-mediated diseases that affect both skin and joints during critical years of growth and development.
About SKYRIZI® (risankizumab-rzaa)
SKYRIZI is an interleukin-23 (IL-23) inhibitor that blocks IL-23 by selectively binding to its p19 subunit. IL-23, a cytokine involved in inflammatory processes, is thought to be linked to a number of chronic immune-mediated diseases. SKYRIZI is approved by the U.S. Food and Drug Administration and the European Medicines Agency for the treatment of plaque psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis.
