FDA Approves Guselkumab for Pediatric Plaque Psoriasis, Psoriatic Arthritis | Pharmacy Times

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The FDA approved guselkumab (Tremfya; Johnson & Johnson) for the treatment of children aged 6 years and older who weigh at least 40 kg and have either moderate to severe plaque psoriasis (PsO) or active psoriatic arthritis (PsA).¹ This action makes guselkumab the first IL-23 inhibitor available for pediatric patients, extending its prior approvals in adults with PsO in 2017 and PsA in 2020.1

In the company’s announcement, investigators highlighted the significance of this new option for children, noting that available treatments remain limited despite ongoing advances. “Despite advancements in the treatment of pediatric PsO and active PsA, there continues to be a significant gap in available therapies for these debilitating immune-mediated diseases,” study investigator Vimal Hasmukh Prajapati, MD, clinical associate professor at the University of Calgary said in the news release. He added that guselkumab provides physicians, parents, and caregivers with a proven treatment capable of improving the signs and symptoms of disease.1

Guselkumab is a fully human, dual-acting monoclonal antibody that obstructs IL-23 and attaches to the CD64 receptor on IL-23–producing cells, according to Johnson & Johnson. The biologic is effective in treating psoriasis and PsA, as blocking the IL-23 pathway reduces inflammation and the progression of the diseases. The FDA has also approved guselkumab for adults with ulcerative colitis and Crohn disease, making it the first IL-23 inhibitor with both intravenous and subcutaneous administration options.1

The pediatric approval was primarily based on results from the phase 3 PROTOSTAR trial (NCT03451851), which evaluated guselkumab in children with moderate to severe plaque PsO.1-3 At week 16, guselkumab demonstrated significantly higher rates of response compared with placebo. Approximately 56% of patients achieved Psoriasis Area and Severity Index (PASI) 90, compared with about 16% of placebo recipients (P < .01). Two-thirds of patients in the treatment arm also reached Investigator’s Global Assessment (IGA) scores of 0/1 versus 16% with placebo (P < .001).1 Nearly 40% of children receiving guselkumab achieved complete skin clearance (IGA 0) at week 16 compared with only 4% of those receiving placebo (P < .01).1,2

For pediatric PsO and PsA, guselkumab is administered as a subcutaneous injection at week 0, week 4, and every 8 weeks thereafter, at a dose of 100 mg via a prefilled syringe.1 According to Johnson & Johnson, the availability of guselkumab in children represents a meaningful step forward for families navigating the challenges of chronic inflammatory skin and joint diseases.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 the news release.1

Upon receiving this approval, guselkumab is the first direct IL-23 treatment for kids, offering not only doctors but also pharmacists a fresh solution to relieve skin and joint issues in children suffering from PsO and PsA.

REFERENCES
  1. 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. JNJ.com. 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. Prajapati VH, Seyger MMB, Wilsmann-Theis D, et al. Guselkumab for the treatment of moderate-to-severe plaque psoriasis in paediatric patients: results of the phase III randomized placebo-controlled PROTOSTAR study. Br J Dermatol. 2025;192(4):618-628. doi:10.1093/bjd/ljae502
  3. A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Guselkumab for the Treatment of Chronic Plaque Psoriasis in Pediatric Participants (PROTOSTAR). ClinicalTrials.gov identifier: NCT03451851. Updated September 12, 2025. Accessed September 29, 2025. https://clinicaltrials.gov/study/NCT03451851

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