FDA Approves Guselkumab (Tremfya) for Pediatric Plaque Psoriasis, Psoriatic Arthritis

The US Food and Drug Administration has approved Johnson & Johnson’s guselkumab (Tremfya) for the treatment of children ≥ 6 years of age who also weigh ≥ 40 kg (88 lbs) with moderate to severe plaque psoriasis (PsO), who are candidates for systemic therapy or phototherapy, or active psoriatic arthritis (PsA).1

According to a September 29, 2025, press release from the Company, the decision makes guselkumab the first and only IL-23 inhibitor approved for these pediatric indications and builds on the initial FDA approvals in adults living with moderate to severe plaque PsO in 2017 and active PsA in 2020.1

"Despite advancements in the treatment of pediatric plaque psoriasis and active psoriatic arthritis, there continues to be a significant gap in available therapies for these debilitating immune-mediated diseases that impact a child's physical and emotional wellbeing during critical years," Vimal Hasmukh Prajapati, MD, Clinical Associate Professor, University of Calgary, Councilor for the International Psoriasis Council, as well as Co-Founder and Co-Director of the Skin Health & Wellness Centre, Dermatology Research Institute, and Dermphi Centre, and study investigator, said in a statement.1 "The approval of [guselkumab] offers physicians, as well as parents and care partners, an established treatment option with proven safety and demonstrated efficacy that can significantly improve the signs and symptoms in children living with these diseases."

As described by Johnson & Johnson, guselkumab is the first and only fully-human, dual-acting monoclonal antibody approved that blocks IL-23 while also binding to CD64, a receptor on cells that produce IL-23. IL-23 is a cytokine secreted by activated monocyte/macrophages and dendritic cells that is known to be a driver of immune-mediated diseases including active PsA, moderate to severe PsO, moderate to severely active ulcerative colitis (UC) and moderately to severely active Crohn's disease (CD).1

Most recently, on September 19, 2025, the FDA approved a subcutaneous (SC) induction regimen of guselkumab for the treatment of adults with moderately to severely active UC, making guselkumab the first and only IL-23 inhibitor to offer both SC and intravenous (IV) induction options for the treatment of UC and CD.2

The approval for plaque PsO was based on results from the phase 3 PROTOSTAR study in pediatric patients with moderate to severe plaque PsO and supportive data from the phase 3 VOYAGE 1 and 2 studies in adult patients with moderate to severe plaque PsO. In the PROTOSTAR study, the co-primary endpoints of Psoriasis Area Severity Index (PASI) 90 and Investigator's Global Assessment (IGA) score of 0/1 were achieved at week 16.1

Approximately 56% of patients receiving guselkumab achieved PASI 90, compared to 16% of patients receiving placebo (P <.01). At week 16, 66% of patients receiving guselkumab compared to 16% of patients receiving placebo (P <.001) achieved high levels of skin clearance (IGA score of 0/1). Additionally, nearly 40% of pediatric patients receiving guselkumab achieved complete clearance (IGA 0) at week 16 compared to 4% on placebo (P <.01).1

Approval of the active PsA indication was supported by evidence from pharmacokinetic extrapolation analyses from guselkumab PsO and PsA studies, including VOYAGE 1 and 2, DISCOVER 1 and 2 and PROTOSTAR, which corroborate the efficacy and safety data from adults with PsO and PsA and children with moderate to severe plaque PsO to children with active PsA.1

"The physical and emotional impact of psoriasis and psoriatic arthritis can have children sitting on the sidelines of life, not attending social events because they are embarrassed of their plaques or their joint pain is too intense," said Leah M. Howard, JD, President and CEO, National Psoriasis Foundation.1 "The National Psoriasis Foundation welcomes any new treatment option that provides hope for relief from the pain, discomfort and the emotional burden of these conditions."

As described in the press release, for the treatment of pediatric plaque PsO and PsA, guselkumab is administered as a subcutaneous injection at week 0, week 4 and then every 8 weeks thereafter. The recommended dosage for moderate to severe pediatric plaque PsO and active PsA in these patients is 100 mg administered by subcutaneous injection using a 1 mL prefilled syringe.1

"Every child deserves to feel comfortable in their own skin and to be active without the limitations of joint pain, stiffness and swelling," Brandee Pappalardo, PhD, MPH, Vice President, Medical Affairs, Dermatology & Rheumatology, Johnson & Johnson Innovative Medicine, said in a statement.1 "The approval of the first and only pediatric indications for an IL-23 inhibitor marks an important step forward not only for children, but also for the parents and care partners who support them every day. We remain committed to advancing research that demonstrates the long-term safety and efficacy of [guselkumab] and to exploring its full potential for adult and pediatric patients."

References

1. Johnson & Johnson. 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. September 29, 2025. Accessed September 29, 2025. https://www.prnewswire.com/news-releases/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-302569442.html

2. Brooks A. FDA Approves Guselkumab (Tremfya) Subcutaneous Induction Regimen for Ulcerative Colitis. HCPLive. September 19, 2025. Accessed September 29, 2025. https://www.hcplive.com/view/fda-approves-guselkumab-tremfya-subcutaneous-induction-regimen-for-ulcerative-colitis