FDA Approves Guselkumab for Pediatric Plaque Psoriasis, Active Psoriatic Arthritis

On Monday, the FDA approved guselkumab (Tremfya; Johnson & Johnson) for the treatment of children 6 and older who also weigh at least 40 kg with plaque psoriasis (PsO) and active psoriatic arthritis (PsA).¹ This approval makes guselkumab the first interleukin (IL)-23 inhibitor approved for children to treat these conditions.

"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," said Vimal Hasmukh Prajapati, MD, clinical associate professor, University of Calgary, councilor for the International Psoriasis Council, as well as cofounder and codirector of the Skin Health & Wellness Centre, Dermatology Research Institute, and Dermphi Centre, and study investigator, in a statement. "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."

The approval was based on results from the phase 3 PROTOSTAR study (NCT03451851), which evaluated children with moderate to severe disease. At week 16, 56% of patients on guselkumab reached the coprimary end point of Psoriasis Area Severity Index 90 vs. 16% on placebo (P < .01). Similarly, 66% of patients who received guselkumab achieved an Investigator’s Global Assessment (IGA) score of 0/1 (clear or almost clear skin) compared with 16% of patients who received placebo (P < .001). Notably, nearly 40% of pediatric patients on guselkumab achieved complete clearance (IGA 0) at week 16 compared with just 4% on placebo (P < .01), underscoring the therapy’s efficacy in this population.

These findings were further reinforced by data from the VOYAGE 1 (NCT02207231) and VOYAGE 2 (NCT02207244) adult psoriasis studies. For pediatric PsA, approval was supported through pharmacokinetic extrapolation analyses from guselkumab studies in both adult PsO and PsA populations, combined with PROTOSTAR data, confirming efficacy and safety consistent with adult outcomes.

On March 21, 2025, the FDA approved guselkumab for adults with moderate to severe active Crohn disease, making it the first and only IL-23 inhibitor to offer both subcutaneous and intravenous induction options.² The approval was supported by the phase 3 GRAVITI trial (NCT05197049), which showed that patients treated with guselkumab achieved meaningful rates of clinical remission and endoscopic response at 1 year.

For pediatric patients with moderate to severe PsO or active PsA, guselkumab is given as a subcutaneous injection at week 0, week 4, and every 8 weeks thereafter.¹ The recommended dose is 100 mg, delivered via a 1 mL prefilled syringe.

"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 of medical affairs, Dermatology & Rheumatology, at Johnson & Johnson Innovative Medicine, said in a statement. "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. 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.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?tc=eml_cleartime

2. McCormick B. 5 notable FDA approvals from March highlight advancements across therapeutic areas. AJMC®. Published April 18, 2025. Accessed September 29, 2025. https://www.ajmc.com/view/5-notable-fda-approvals-from-march-highlight-advancements-across-therapeutic-areas