FDA Approves Guselkumab for the Treatment of Pediatric Plaque Psoriasis, Psoriatic Arthritis

The FDA approved guselkumab (Tremfya) for the treatment of plaque psoriasis and active psoriatic arthritis for patients 6 years and older weighing at least 40 kg. This marks the first and only IL-23 approval for pediatric indications, building upon the approvals for moderate to severe plaque psoriasis in 2017 and active psoriatic arthritis in 2020.¹

This marks the first and only IL-23 approval for these indications in pediatric populations. | Image Credit: GRON777 - stock.adobe.com

“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,” Brandee Pappalardo, PhD, MPH, vice president of medical affairs in dermatology and rheumatology at Johnson & Johnson Innovative Medicine, said in a news release.¹ “We remain committed to advancing research that demonstrates the long-term safety and efficacy of Tremfya and to exploring its full potential for adult and pediatric patients.”

For the pediatric treatment, the drug is administered via a subcutaneous injection at week 0, week 4, and then every 8 weeks after.¹

The approval was based on data from the phase 3 PROTOSTAR (NCT03451851) trial, which was used to evaluate the efficacy and safety of the drug in pediatric patients with plaque psoriasis. Patients included had a diagnosis of chronic plaque-type psoriasis for at least 6 months prior to the first administration of the study drug, were candidates for phototherapy or systemic treatment of plaque psoriasis, and had immunity to varicella and measles, mumps, and rubella, according to the clinical trial information.²

The primary outcomes included the percentage of individuals who achieved an Investigator’s Global Assessment (IGA) score of cleared or minimal and the percentage of patients who achieved Psoriasis Area and Severity Index (PASI) 75 response at week 16. Secondary end points included percentage of individuals who achieved PASI 90 at week 16, patients who achieved IGA score of cleared at week 16, patients who achieved PASI 100 at week 16, change from baseline in Children’s Dermatology Life Quality Index score at week 16, patients who achieved PASI 50 at week 16, and improvement from baseline in PASI through week 16.²

There were 92 patients enrolled in part 1 of the study, with 41, 25, and 26 patients receiving guselkumab, the placebo, and etanercept, respectively. Approximately 86% of patients completed the study through week 52. At baseline, the mean PASI score was 18.8, and 78% and 22% of patients had IGA scores of 3 and 4, respectively. In part 2, there were 28 patients, with only 1 person discontinuing treatment before week 52. The mean PASI score was 21.2, and 54% and 46% of patients had an IGA score of 3 and 4, respectively.³

Investigators found that guselkumab was superior to the placebo for the coprimary and major secondary end point, according to the study results. Approximately 66% of patients treated with guselkumab achieved IGA 0/1 compared with 16% receiving the placebo. Further, 75% and 20% achieved PASI 75, respectively. As for adverse events, the most common included nasopharyngitis, upper respiratory tract infection, and headache.³

“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,” Leah M. Howard, JD, president and CEO of the National Psoriasis Foundation, said in the news release.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.”

READ MORE: FDA Resource Center

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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. News release. Johnson & Johnson. 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. 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 identification: NCT03451851. Updated September 12, 2025. Accessed September 29, 2025. https://clinicaltrials.gov/study/NCT03451851

3. 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