The U.S. Food and Drug Administration (FDA) expanded the approved uses for risankizumab (Skyrizi) to include children aged 6 years and older with plaque psoriasis and psoriatic arthritis. This approval marks the first interleukin (IL)-23 inhibitor for children weighing less than 40 kg (88 lb).

Risankizumab is an IL-23 antagonist. It is indicated for patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. The drug is also indicated for patients with active psoriatic arthritis and is delivered subcutaneously or intravenously. A 55-mg pre-filled syringe is now available to facilitate weight-based dosing for children weighing less than 40 kg.

The expanded approvals were supported by data from the OptIMMize-1 and OptIMMize-2 phase III studies for plaque psoriasis. Week-16 results from these studies showed that 69% of patients treated with risankizumab achieved a static Physician Global Assessment of Psoriasis (sPGA) score of 0 or 1, along with at least a 2-point improvement from baseline. Additionally, 85% of patients demonstrated a 75% or greater reduction in their Psoriasis Area and Severity Index (PASI) score at week 16.

"Risankizumab demonstrated clinically meaningful improvements in sPGA and PASI responses, with responses maintained long-term with continued treatment," said Amy Paller, an investigator at Northwestern University Feinberg School of Medicine. "These clinical responses, combined with weight-based dosing for younger patients, may help physicians better support a broad range of children living with plaque psoriasis or psoriatic arthritis."

The psoriatic arthritis indication in children was supported by the OptIMMize studies, as well as population pharmacokinetic modeling and simulation based on well-controlled adult psoriatic arthritis studies. Common adverse events observed in trials included upper respiratory and tinea infections, headache, fatigue, and injection site reactions. The prescribing information includes warnings and precautions regarding potential hypersensitivity reactions and infections.

The labeling also notes the need to check for tuberculosis before starting risankizumab and advises avoiding live vaccines during treatment. Drug-induced liver injury has been reported in inflammatory bowel disease patients. Risankizumab is also approved for treating Crohn's disease and ulcerative colitis in adults.