The FDA has expanded the approved indications for risankizumab (Skyrizi) to include children aged 6 years and older with moderate-to-severe plaque psoriasis and active psoriatic arthritis, according to manufacturer AbbVie.
An interleukin (IL)-23 antagonist, risankizumab is indicated for pediatric patients with plaque psoriasis who are candidates for systemic therapy or phototherapy, as well as those with active psoriatic arthritis. The approval marks the first IL-23 inhibitor available for children weighing less than 40 kg (88 lbs), supported by a new 55-mg pre-filled syringe designed for weight-based dosing in this population.
Efficacy data supporting the expanded approval came from two Phase 3 trials, OptIMMize-1 and OptIMMize-2. At week 16, 69% of risankizumab-treated patients achieved a static Physician Global Assessment of Psoriasis (sPGA) score of 0 or 1 (clear or almost clear) with at least a two-point improvement from baseline, while 85% achieved a 75% or greater reduction in Psoriasis Area and Severity Index (PASI) scores.
“Risankizumab demonstrated clinically meaningful improvements in sPGA and PASI responses, with responses maintained long-term with continued treatment,” said investigator Amy Paller, MD, of Northwestern University Feinberg School of Medicine in Chicago.
“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,” Paller added.
The psoriatic arthritis indication in children was supported by the OptIMMize studies alongside population pharmacokinetic modeling and simulation based on controlled adult psoriatic arthritis studies, AbbVie noted.
According to the prescribing information, common adverse events observed in psoriatic disease trials included upper respiratory and tinea infections, headache, fatigue, and injection site reactions. Warnings and precautions highlight the risk of hypersensitivity reactions and infections, the requirement for tuberculosis screening prior to initiation, reports of drug-induced liver injury in inflammatory bowel disease patients, and the avoidance of live vaccines during treatment.
The IL-23 antagonist is also approved for the treatment of Crohn’s disease and ulcerative colitis in adults.
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