FDA Approves Guselkumab for Pediatric Plaque Psoriasis, Active Psoriatic Arthritis: Daily Dose

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On September 30, 2025, we reported on the FDA approval of guselkumab for the treatment of children aged 6 years and older, weighing at least 40 kg, with moderate to severe plaque psoriasis (PsO) or active psoriatic arthritis (PsA).

The approval

Guselkumab is the first and only interleukin (IL)-23 inhibitor approved for pediatric indications in PsO and PsA. The approval for pediatric plaque PsO was supported by results from the phase 3 PROTOSTAR study. In this trial, patients treated with guselkumab achieved significantly greater rates of skin clearance compared with placebo. At week 16, 56% of patients receiving guselkumab achieved Psoriasis Area Severity Index 90 compared with 16% on placebo (P < .01). High levels of skin clearance, defined as an Investigator’s Global Assessment score of 0 or 1, were achieved in 66% of patients in the guselkumab group compared with 16% in the placebo group (P < .001). Complete clearance was reported in nearly 40% of treated patients versus 4% of placebo recipients (P < .01).

The indication for active PsA was supported by pharmacokinetic extrapolation analyses using data from pediatric and adult PsO and PsA studies, including PROTOSTAR, VOYAGE 1 and 2, and DISCOVER 1 and 2. These analyses demonstrated consistency in efficacy and safety across pediatric and adult populations.

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