Skyrizi: FDA Approves Pediatric Expansion of IL‑23 Inhibitor for Moderate-to-Severe Plaque Psoriasis and Active Psoriatic Arthritis

What Is Skyrizi, and Why Does It Matter?

Skyrizi (risankizumab-rzaa) is a prescription biologic used to treat certain immune-mediated inflammatory conditions. It is now approved by the FDA for children aged 6 years or older with moderate-to-severe plaque psoriasis or active psoriatic arthritis. For children with plaque psoriasis, the medicine can be used when you may benefit from topical treatments, such as prescription injections, pills, or light therapy (phototherapy). Skyrizi attaches to the p19 subunit of interleukin-23 (IL-23), a protein that drives inflammation, helping calm your immune system. About 3 in 10 people with psoriasis develop symptoms before they turn 18. In the U.S., around 20,000 children under 10 years of age are diagnosed with psoriasis each year, and about 14,000 children have psoriatic arthritis. These conditions can make it harder for children to move around, take part in everyday activities, and enjoy childhood while also placing extra demands on parents and caregivers. This approval is important as Skyrizi is the first IL-23 blocker in the U.S. available for kids aged 6 years or older who weigh under 40 kilograms and have plaque psoriasis or psoriatic arthritis. A new 55-milligram prefilled syringe supports dosing for those under 40 kilograms, and a 150-milligram syringe or pen is used for those weighing 40 kilograms or more. Because many U.S. children are affected by psoriatic disease each year, having additional therapeutic options matters. In adults, Skyrizi is used to treat moderate-to-severe plaque psoriasis, active psoriatic arthritis, moderate-to-severe Crohn’s disease, and moderate-to-severe ulcerative colitis.

Why Was It Approved?

This pediatric expansion is backed by data from studies in children with psoriasis and from analyses that linked pediatric dosing to data for adults with psoriatic arthritis. For pediatric psoriasis, the main goals at week 16 were two standard measures: to achieve a reduction in skin symptoms (clear or almost clear skin) and achieve a reduction in symptom severity (at least a 75% reduction in symptom severity). In one group, 69% met the first measure, and 85% met the second. At week 52, the response was maintained in 95% of early responders who continued using Skyrizi compared with 39% who stopped using it. Safety through 52 weeks in children was similar to that seen in adults. Common side effects included upper respiratory infections, headache, fatigue, injection site reactions, and tinea (fungal) infections. Serious allergic reactions can occur with Skyrizi, and the medicine may raise your risk for infection.

What Do I Need to Know?

If your child is 6 years or older and has plaque psoriasis or psoriatic arthritis, Skyrizi shots are given using either a prefilled syringe or a prefilled pen at weeks 0 and 4 and then every 12 weeks. The dose depends on your child's weight: 55 milligrams if under 40 kilograms and 150 milligrams if 40 kilograms or more. You and a caregiver should receive training before giving injections under the skin. In children aged 6 to less than 10 years, Skyrizi should be given by an adult. For children 10 or older, an adult should give or supervise each dose. Do not use Skyrizi if you are allergic to risankizumab-rzaa, as serious allergic reactions can occur. Skyrizi may lower your body’s ability to fight infections. Your health care provider will check for infections, including tuberculosis, before you start treatment and may test during and after treatment. Avoid live vaccines right before, during, or right after using Skyrizi. It is not known whether Skyrizi can harm a fetus or pass into breast milk. Talk to your health care provider if you are pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed.