AbbVie Gets European Commission Approval for Skyrizi in Children With Plaque Psoriasis: A New Treatment Option for Young Patients

For many children living with plaque psoriasis, the condition is not limited to skin symptoms.

It can affect school attendance, confidence, sleep, friendships, daily routines, and emotional well-being.

Visible lesions on the face, scalp, hands, or other exposed areas can make children feel different at an age when social confidence is still developing. Families may also face the challenge of managing a chronic immune-mediated disease while trying to find treatments that are both effective and practical.

AbbVie has announced that the European Commission has approved Skyrizi (risankizumab) for children and adolescents aged six years and older with moderate to severe plaque psoriasis who are candidates for systemic therapy.

The approval also includes a new 55 mg pre-filled syringe designed to support weight-based dosing for pediatric patients weighing less than 40 kg.

This is an important regulatory milestone because it expands access to an IL-23 inhibitor for younger patients with moderate to severe plaque psoriasis, a group that has historically had fewer advanced treatment options.

AbbVie Skyrizi Pediatric Psoriasis Approval: Key Facts

What Is Plaque Psoriasis?

Plaque psoriasis is a chronic immune-mediated inflammatory disease that causes raised, red, scaly skin patches known as plaques.

These plaques may appear on different parts of the body, including:

• Scalp

• Face

• Elbows

• Knees

• Hands

• Feet

• Back

• Skin folds

In children, psoriasis can be especially challenging because symptoms may appear in highly visible areas. This can increase emotional stress and affect self-esteem.

Plaque psoriasis is not contagious. However, it can have a serious impact on quality of life, particularly when symptoms are persistent, uncomfortable, or difficult to control.

Why Pediatric Plaque Psoriasis Needs More Attention

Psoriasis is often seen as an adult condition, but many patients develop symptoms early in life.

According to AbbVie, nearly one-third of people living with psoriasis experience symptoms before the age of 18.

Early-onset psoriasis can bring several challenges:

• Itching and skin discomfort

• Visible lesions and social stigma

• Sleep disruption

• School absenteeism

• Emotional stress

• Reduced confidence

• Long-term disease management burden

• Risk of other inflammatory or metabolic comorbidities

Despite this burden, many pediatric patients continue to rely only on topical therapies.

Topical creams and ointments can be helpful for mild disease. However, children with moderate to severe plaque psoriasis may need systemic therapy when topical treatment is not enough to control symptoms.

The European Commission approval of Skyrizi gives physicians another treatment option for this patient group.

What Is Skyrizi?

Skyrizi is the brand name for risankizumab, a biologic medicine developed by AbbVie.

It is an interleukin-23 inhibitor, often called an IL-23 inhibitor.

Skyrizi works by selectively blocking IL-23 through binding to its p19 subunit.

IL-23 is a cytokine involved in inflammatory processes and is linked to several chronic immune-mediated diseases.

By targeting IL-23, Skyrizi is designed to reduce the immune activity that contributes to psoriasis symptoms.

Skyrizi is already approved in adult patients for several conditions, including:

• Plaque psoriasis

• Psoriatic arthritis

• Crohn’s disease

• Ulcerative colitis

The new European Commission decision expands its use into pediatric plaque psoriasis for eligible children and adolescents.

What Does the European Commission Approval Mean?

The European Commission approval means that Skyrizi can now be used in eligible children and adolescents aged six years and above with moderate to severe plaque psoriasis across European Union member states, subject to local implementation and prescribing requirements.

The approval applies to patients who are candidates for systemic therapy.

Systemic therapy refers to treatment that works throughout the body, rather than only on the skin surface.

For children with more severe disease, systemic options may be considered when:

• Topical treatments do not provide adequate control

• The disease affects a large body surface area

• Symptoms significantly affect quality of life

• Lesions are present in difficult-to-treat or highly visible areas

• The patient has frequent flares or persistent disease activity

The approval also includes a new 55 mg pre-filled syringe for children weighing less than 40 kg, supporting a more tailored, weight-based dosing approach.

The Clinical Evidence Behind the Approval

The European Commission decision was supported by clinical data from AbbVie’s Phase 3 pediatric psoriasis development program.

This program included:

• OptIMMize-1

• OptIMMize-2

OptIMMize-1 Study

OptIMMize-1 included two lead-in pharmacokinetic cohorts:

1. A randomized, efficacy assessor-blinded, active-controlled cohort in adolescents aged 12 to under 18 years

2. A single-arm, open-label cohort in children aged 6 to under 12 years

The study evaluated how risankizumab performed in younger patients, including dosing, clinical response, and safety.

OptIMMize-2 Study

OptIMMize-2 was an open-label extension study designed to collect longer-term information.

Extension studies are important in chronic conditions because psoriasis often requires ongoing management over many years.

Safety Findings

AbbVie reported that the safety profile of Skyrizi in pediatric patients was consistent with what has already been observed in adults with moderate to severe plaque psoriasis.

The pediatric safety population included 137 patients.

No new safety signals were observed.

While this is encouraging, treatment decisions for children should always be made by qualified healthcare professionals who can assess the individual patient’s disease severity, medical history, treatment needs, and monitoring requirements.

Why Weight-Based Dosing Matters for Children

Children are not simply smaller adults.

Their bodies change rapidly as they grow, and medicine dosing often needs to account for body weight, age, metabolism, and developmental stage.

The new 55 mg pre-filled syringe is intended to support weight-based dosing for children weighing less than 40 kg.

This is important because it may help physicians provide a more appropriate treatment regimen for younger and lighter patients.

In pediatric care, flexible dosing options can improve treatment precision and help ensure that medicines are used according to approved recommendations.

How Skyrizi Fits Into the Changing Psoriasis Treatment Landscape

The treatment of psoriasis has changed significantly over the past two decades.

Earlier approaches often focused mainly on topical therapies, phototherapy, and traditional systemic medicines.

Today, biologic therapies are playing a larger role in managing moderate to severe disease.

Biologics are designed to target specific immune pathways involved in inflammation.

Different biologic classes used in psoriasis may target:

• TNF-alpha

• IL-17

• IL-12/23

• IL-23

IL-23 inhibitors, including risankizumab, are part of a growing treatment category focused on more precise immune modulation.

The availability of advanced therapies for pediatric patients reflects a broader shift toward earlier, more individualized management of chronic inflammatory diseases.

What This Means for Families Living With Pediatric Psoriasis

For families, new treatment approvals can bring hope—but they can also create questions.

Parents may want to know:

• Is my child eligible for systemic therapy?

• What are the expected benefits?

• How often will treatment be given?

• What safety monitoring is required?

• How does this option compare with other treatments?

• Is the treatment available and reimbursed in my country?

The answer will vary based on the child’s condition, age, weight, previous treatments, and local healthcare access.

The key message is that pediatric psoriasis care is becoming more personalized.

Instead of relying on a single treatment pathway, dermatologists now have more options to match treatment intensity with disease severity and patient needs.

The Wider Importance of Pediatric Immunology Research

The Skyrizi approval is also important beyond psoriasis.

It reflects a growing commitment across the pharmaceutical industry to study advanced therapies in children rather than relying only on adult data.

Pediatric clinical research is essential because children can have different disease patterns, treatment responses, and safety considerations.

Developing medicines for children requires:

• Age-appropriate trial design

• Ethical research practices

• Weight-based dosing strategies

• Long-term safety monitoring

• Family and caregiver engagement

• Specialized pediatric clinical expertise

As more companies invest in pediatric immunology, dermatology, and rare disease research, young patients may gain access to more evidence-based treatment options.

Career Opportunities in Dermatology and Immunology

Major regulatory approvals in dermatology and immunology also create long-term career opportunities across the life-sciences ecosystem.

Professionals may find growing demand in areas such as:

• Clinical Research

• Pediatric Clinical Operations

• Medical Affairs

• Regulatory Affairs

• Pharmacovigilance

• Medical Writing

• Clinical Data Management

• Biostatistics

• Biologics Manufacturing

• Quality Assurance

• Market Access

• Dermatology Sales and Marketing

• Patient Support Programs

For pharma candidates in India, global approvals often create downstream opportunities through clinical research organizations, global capability centers, pharmacovigilance teams, medical information services, regulatory support teams, and scientific communication roles.

What Happens Next?

Following European Commission approval, the focus will shift toward local implementation across European markets.

This may include:

• Country-level reimbursement discussions

• Local prescribing guidance

• Healthcare provider education

• Patient access planning

• Post-marketing safety monitoring

• Real-world evidence generation

AbbVie will also continue to study Skyrizi across its approved and investigational uses.

As pediatric dermatology treatment evolves, long-term real-world data will remain important for understanding how therapies perform outside clinical trials.

Key Takeaways

• AbbVie has received European Commission approval for Skyrizi in children and adolescents aged six years and older with moderate to severe plaque psoriasis.

• The approval is for patients who are candidates for systemic therapy.

• A new 55 mg pre-filled syringe supports weight-based dosing for patients weighing less than 40 kg.

• The decision was supported by Phase 3 OptIMMize-1 and OptIMMize-2 pediatric psoriasis studies.

• The pediatric safety profile was consistent with adult findings, with no new safety signals reported in 137 treated patients.

• The approval expands advanced treatment options for younger patients living with chronic plaque psoriasis.

• The update highlights continued growth in pediatric immunology and dermatology research.

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