The US Food and Drug Administration has approved risankizumab (Skyrizi) for pediatric patients aged 6 years and older with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy and for pediatric patients with active psoriatic arthritis, according to a press release from AbbVie. The approval also includes a 55-mg prefilled syringe for weight-based dosing in patients weighing less than 40 kg.

According to AbbVie, risankizumab is the first interleukin-23 inhibitor approved in the US for pediatric patients aged 6 years and older weighing less than 40 kg with plaque psoriasis or psoriatic arthritis. The existing 150-mg prefilled syringe and pen remain approved for patients weighing 40 kg or greater.

AbbVie stated that approximately 30% of patients who develop psoriasis first experience symptoms before age 18. The company also cited estimates that approximately 20,000 children younger than 10 years are diagnosed with psoriasis each year in the US and approximately 14,000 children are affected by psoriatic arthritis.

The pediatric plaque psoriasis indication is supported by the phase 3 OptIMMize clinical trial program, which included 2 pharmacokinetic lead-in cohorts, a randomized, efficacy assessor-blinded active-controlled cohort of patients aged 12 years to younger than 18 years, and an open-label cohort of patients aged 6 years to younger than 12 years. The pediatric psoriatic arthritis indication is supported by data from the OptIMMize psoriasis program together with population pharmacokinetic modeling and simulation based on well-controlled adult psoriatic arthritis studies. AbbVie stated that the safety profile observed in pediatric patients with plaque psoriasis was consistent with the established safety profile in adults.

Amy S. Paller, MD, chair of dermatology and professor of pediatrics at Northwestern University Feinberg School of Medicine and a study investigator in the OptIMMize program, said, “At Week 16 in part 2 of the OptIMMize psoriasis clinical trial program, risankizumab demonstrated clinically meaningful improvements in [static Physician’s Global Assessment] and [Psoriasis Area and Severity Index] responses, with responses maintained long-term with continued treatment.”

According to AbbVie’s Important Safety Information, risankizumab may cause serious allergic reactions and infections, and health care providers should check patients for infections and tuberculosis before treatment. The safety information also states that patients should avoid receiving live vaccines right before, during, or right after treatment.

Source: AbbVie