Q1 What is SKYRIZI (risankizumab-rzaa) approved for in pediatric patients?
SKYRIZI is approved for the treatment of moderate-to-severe plaque psoriasis in pediatric patients 6 years of age and older who are candidates for systemic therapy or phototherapy, and for active psoriatic arthritis in pediatric patients 6 years of age and older, per the FDA prescribing information. The labeling update reflecting pediatric indications is recorded in FDA documents revised in 6/2026 and in the FDA supplemental approval record dated 2026-06-26.
Q2 How does risankizumab (SKYRIZI) work?
Risankizumab-rzaa is a humanized IgG1 monoclonal antibody that selectively binds the p19 subunit of the human interleukin-23 (IL-23) cytokine and inhibits its interaction with the IL-23 receptor, inhibiting release of pro-inflammatory cytokines and chemokines. The mechanism is described in the FDA prescribing information.
Q3 What is the recommended pediatric dosing of SKYRIZI for psoriasis and psoriatic arthritis?
For pediatric patients 6 years of age and older the recommended dosing is weight based: patients weighing less than 40 kg receive 55 mg administered by subcutaneous injection at Week 0, Week 4, and every 12 weeks thereafter; patients weighing 40 kg or greater receive 150 mg administered by subcutaneous injection at Week 0, Week 4, and every 12 weeks thereafter, as stated in the FDA labeling. Clinicians should consult current prescribing information for complete dosing guidance.
Q4 What are the side effects to monitor in pediatric patients receiving SKYRIZI?
The FDA prescribing information lists the most common adverse reactions for plaque psoriasis and psoriatic arthritis (≥ 1%) as upper respiratory infections, headache, fatigue, injection site reactions, and tinea infections. Warnings and precautions specifically include hypersensitivity reactions (including anaphylaxis), increased risk of infection, evaluation for tuberculosis prior to initiation, and avoidance of live vaccines. Hepatotoxicity monitoring recommendations are included in the labeling for inflammatory bowel disease indications and are noted in warnings sections.