U.S. — The U.S. Food and Drug Administration (FDA) expanded the approved uses for risankizumab (Skyrizi) to include children aged 6 years and older for the treatment of plaque psoriasis and psoriatic arthritis. Manufacturer AbbVie announced the decision.

Risankizumab is an interleukin (IL)-23 antagonist 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 can be delivered subcutaneously or intravenously.

AbbVie stated that this approval represents the first IL-23 inhibitor specifically for children weighing less than 40 kg (88 lb). A 55-mg pre-filled syringe is now available to facilitate weight-based dosing for these children. The main efficacy support for the expanded approvals came from data derived from two phase III studies in plaque psoriasis, OptIMMize-1 and OptIMMize-2.

Study results at week 16 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. In addition, 85% of risankizumab-treated patients demonstrated a 75% or greater reduction in their Psoriasis Area and Severity Index (PASI) score by week 16.

Amy Paller, MD, an investigator at Northwestern University Feinberg School of Medicine, stated, "Risankizumab demonstrated clinically meaningful improvements in sPGA and PASI responses, with responses maintained long-term with continued treatment." Paller also noted, "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."

AbbVie indicated that the psoriatic arthritis indication for children was supported by the OptIMMize studies, as well as population pharmacokinetic modeling and simulation informed by well-controlled adult psoriatic arthritis studies. Common adverse events observed in trials for risankizumab in psoriatic disease included upper respiratory and tinea infections, headache, fatigue, and injection site reactions.

The labeling for risankizumab contains warnings and precautions regarding potential hypersensitivity reactions and infections. It also advises checking for tuberculosis before initiating treatment and notes reported instances of drug-induced liver injury in inflammatory bowel disease patients. Patients are advised to avoid live vaccines while taking risankizumab. Risankizumab is separately approved for the treatment of Crohn's disease and ulcerative colitis in adults.