FDA Approves Guselkumab for Pediatric Plaque Psoriasis and Active Psoriatic Arthritis

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The US FDA has approved 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), Johnson & Johnson announced September 29, 2025. The decision makes guselkumab 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.

According to Johnson & Johnson, approximately 20 000 children in the US are diagnosed with plaque PsO annually, and an estimated 14 000 children are affected by PsA. PsO beginning in childhood may cause itching, pain, and psychosocial burden, while pediatric PsA accounts for about 5% of the juvenile idiopathic arthritis population and can impair joint function and overall wellbeing.

For pediatric PsO and PsA, guselkumab is administered as a subcutaneous injection at weeks 0 and 4, followed by every 8 weeks thereafter, with a recommended dosage of 100 mg.

Guselkumab is also approved in adults for PsO, PsA, ulcerative colitis, and Crohn disease.^2,3

References:

1. US FDA approves Tremfya (guselkumab) for the treatment of pediatric plaque psoriasis and active psoriatic arthritis, marking a first and only approval for an IL-23 inhibitor. Johnson & Johnson. News release. Published September 29, 2025. Accessed September 29, 2025. https://www.jnj.com/media-center/press-releases/u-s-fda-approves-tremfya-guselkumab-for-the-treatment-of-pediatric-plaque-psoriasis-and-active-psoriatic-arthritis-marking-a-first-and-only-approval-for-an-il-23-inhibitor

2. Jennings S. FDA Approves Guselkumab as First IL-23 Inhibitor With Fully Subcutaneous Induction Regimen for Ulcerative Colitis. Patient Care®. September 22, 2025. Accessed September 30, 2025. https://www.patientcareonline.com/view/fda-approves-guselkumab-as-first-il-23-inhibitor-with-fully-subcutaneous-regimen-for-ulcerative-colitis

3. Halsey G. Guselkumab (Tremfya) Wins Approval for Crohn Disease, Fourth Indication for Immune-Mediated Diseases. Patient Care®. March 21, 2025. Accessed September 30, 2025. https://www.patientcareonline.com/view/guselkumab-tremfya-wins-approval-for-crohn-disease-fourth-indication-for-immune-mediated-diseases