The US FDA has approved guselkumab for the treatment of moderate-to-severe plaque psoriasis and active psoriatic arthritis (PsA) in children aged 6 years or older who weigh at least 40 kg, according to a press release from the manufacturer.

Guselkumab (Tremfya), an interleukin (IL)-23 inhibitor, is the first IL-23 inhibitor to be approved for these indications in children, according to the manufacturer, Johnson & Johnson. It was approved for adults with moderate-to-severe plaque psoriasis in 2017 and for adults with active PsA in 2020.

The approval for children with psoriasis was based on data from PROTOSTAR, a phase 3 study of children aged 6-17 years with moderate-to-severe plaque psoriasis, and supportive data from the phase 3 VOYAGE 1 and 2 studies of guselkumab in adults with moderate-to-severe psoriasis, according to the company.

In the PROTOSTAR study, 56% of children treated with guselkumab met one of the primary endpoints, ie, Psoriasis Area Severity Index score of 90, at week 16 compared with 16% of those on placebo (P < .01). In addition, 66% of those on guselkumab met the other primary endpoint, an Investigator’s Global Assessment (IGA) score of 0/1, at week 16 compared with 16% of patients on placebo (P < .001).

Additionally, nearly 40% of children treated with guselkumab achieved complete clearance, an IGA score of 0, at 16 weeks compared with 4% of those on placebo (P < .01). Adverse events were similar between treatment and placebo groups, and the most common were nasopharyngitis, upper respiratory tract infections, and COVID. No serious or opportunistic infections were reported.

The additional indication for active PsA was based on extrapolated data from PROTOSTAR and studies of guselkumab for PsA in adults.

Approximately one third of psoriasis cases begin in childhood, but treatment options for young patients are limited, according to the manufacturer.

For pediatric patients, guselkumab is administered subcutaneously at baseline and after 4 weeks, followed by injections every 8 weeks. The currently indicated dose is 100 mg, administered via a 1-mL prefilled syringe. Full prescribing information is available here.

The manufacturer also is seeking approval of guselkumab to inhibit the progression of structural damage in adults with PsA.

The guselkemab studies were funded by Johnson & Johnson.