The FDA has extended approval of risankizumab-rzaa to include treatment of children down to age 6 years with active psoriatic arthritis (PsA) or those with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy, according to a press release from the manufacturer.

Risankizumab (Skyrizi), an interleukin (IL)-23 inhibitor, was approved for treating moderate-to-severe plaque psoriasis in adults in 2019, and for active PsA in adults in 2022. It is approved for adults with moderate-to-severe active Crohn’s disease and for adults with moderate-to-severe active ulcerative colitis.

The biologic is the first and only IL-23 inhibitor approved in the US for the treatment of psoriatic disease in children aged 6 years or older weighing < 40 kg, according to AbbVie.

The approval was supported by data from the OptIMMize psoriasis clinical trial program, including a randomized, active controlled study of patients aged 6 years up to 18 years with psoriasis, and an extension study. Results included “clinically meaningful improvements” from baseline in Psoriasis Area and Severity Index and static Physician Global Assessment scores at week 16 among those treated with risankizumab, with maintenance of responses with continued treatment, according to the company.

Approval of the pediatric PsA indication “is supported by the OptIMMize psoriasis clinical trial program as well as population pharmacokinetic modeling and simulation based on well controlled adult psoriatic arthritis studies,” the company release said. 

For psoriasis and PsA, risankizumab is administered via subcutaneous injections, with starter doses at week 0 and week 4, followed by doses every 12 weeks. The approved doses are 55 mg for individuals aged 6 years or older weighing < 40 kg, and 150 mg for adults and children aged 6 years or older weighing ≥ 40 kg. The approval includes a 55-mg prefilled syringe to facilitate weight-based dosing. 

Safety profiles in pediatric patients were similar to those seen in adults, according to the company. Overall, the most common adverse reactions reported in studies of patients with psoriatic disease were upper respiratory tract infections, headache, fatigue, injection site reactions, and tinea infections.