FDA Approves Tremfya for Children With Plaque Psoriasis, Psoriatic Arthritis

Key Takeaways

Tremfya is the first IL-23 inhibitor approved for pediatric plaque psoriasis and psoriatic arthritis, based on the PROTOSTAR trial's positive results.
The PROTOSTAR trial demonstrated significant skin clearance in children, with 56% achieving PASI 90 and 66% achieving IGA 0/1 by week 16.
Tremfya's approval addresses a significant gap in pediatric treatment options for immune-mediated diseases, offering a proven, safe, and effective therapy.
The drug is already approved for multiple adult conditions, including Crohn's disease, providing both subcutaneous and intravenous induction options.

The FDA has expanded Johnson & Johnson’s Tremfya (guselkumab) approval to children six years and older weighing at least 40 kilograms with moderate to severe plaque psoriasis or active psoriatic arthritis, marking the first pediatric approval of an IL-23 inhibitor for these conditions.

Image Credit: Adobe Stock Images/Марина Терехова. Tremfya was initially approved for adults with psoriasis in 2017 and for adults with active psoriatic arthritis in 2020.

The FDA has approved Johnson & Johnson’s Tremfya (guselkumab) to treat children aged six years and older who weigh at least 40 kilograms with moderate to severe plaque psoriasis or active psoriatic arthritis.¹

FDA expands Tremfya approval to pediatric patients

The regulatory action is the first approval of an interleukin (IL)-23 inhibitor for pediatric patients with these dermatologic conditions.

Tremfya was initially approved for adults with psoriasis in 2017 and for adults with active psoriatic arthritis in 2020.
The current approval was based on findings from the Phase III PROTOSTAR trial (NCT03451851), which demonstrated that more than half of treated children treated with Tremfya achieved major skin clearance by week 16.²

"The approval of Tremfya 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."

“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 press release. “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 Tremfya and to exploring its full potential for adult and pediatric patients.”¹

Addressing unmet needs in childhood psoriasis and psoriatic arthritis

Tremfya was the first FDA-approved, fully-human, dual-acting monoclonal antibody to block IL-23 by attaching to the p19 subunit of IL-23 and to CD64, a receptor on cells that produce IL-23, which contributes to the pathogenesis of inflammatory diseases.
Tremfya has also been approved for the treatment of adults with active psoriatic arthritis; for adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy; for adults with moderately to severely active ulcerative colitis; and for adults with moderately to severely active Crohn disease.³
The approval of Tremfya for Crohn disease earlier this year marked the first and only IL-23 inhibitor to offer both subcutaneous (SC) and intravenous induction options for the condition.
Approximately eight million people in the United States currently live with some form of psoriasis and 125 million people have psoriasis globally, the National Psoriasis Foundation estimates.
Approximately 30% of these patients will eventually go on to develop psoriatic arthritis.
Psoriasis typically manifests between 20 and 30 years of age and between 50 and 60 years of age, but one-third of cases manifest in childhood.^1,4
Approximately 20,000 children under 10 years of age are diagnosed with plaque psoriasis each year with approximately 14,000 affected by psoriatic arthritis.¹
Annual health costs associated with the condition account for an estimated total of approximately $135 billion annually.⁴

“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, National Psoriasis Foundation, said in the press release. “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.”¹

Clinical trial evidence supporting pediatric use of Tremfya

The multicenter, randomized, placebo- and active comparator-controlled PROTOSTAR trial analyzed the efficacy, safety, and pharmacokinetics of SC Tremfya treating plaque psoriasis in patients aged six years and older.
The trial’s co-primary endpoints were Investigator’s Global Assessment (IGA) 0/1 score and Psoriasis Area Severity Index (PASI) 90 at week 16.
Results show that at week 16, about 56% of patients administered Tremfya achieved PASI 90 vs. 16% administered placebo.
At week 16, approximately 66% of patients administered Tremfya achieved an IGA score of 0/1, meaning high levels of skin clearance, compared to 16% of patients administered placebo.
Further, 40% of pediatric patients administered Tremfya achieved complete skin clearance at week 16 compared to 4% administered placebo.
In terms of safety, 42% of patients administered Tremfya reported adverse events (AEs) compared to 68% of patients administered placebo.
The most frequently reported AEs among patients administered Tremfya included nasopharyngitis, upper respiratory tract infection, and COVID-19.

Broader therapeutic role of Tremfya

“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,” study investigator Vimal Hasmukh Prajapati, MD, clinical associate professor, University of Calgary; Councilor for the International Psoriasis Council; co-founder and co-director of the Skin Health & Wellness Centre, Dermatology Research Institute, and Dermphi Centre, said in the press release. “The approval of Tremfya 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.”¹

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. 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. Updated September 12, 2025. Accessed September 29, 2025. https://clinicaltrials.gov/study/NCT03451851

3. Tremfya (guselkumab) real-world data analyses show greater treatment persistence than IL-17s in both bio-naïve and bio-experienced patients living with moderate to severe plaque psoriasis. News release. Johnson & Johnson. March 17, 2023. Accessed September 29, 2025. https://www.jnj.com/tremfya-guselkumab-real-world-data-analyses-show-greater-treatment-persistence-than-il-17s-in-both-bio-naive-and-bio-experienced-patients-living-with-moderate-to-severe-plaque-psoriasis

4. Prevalence of Psoriasis. National Psoriasis Foundation. Accessed September 29, 2025. https://www.psoriasis.org/prevalence-of-psoriasis/#:~:text=Psoriasis%20affects%20an%20estimated%203.0,%25)%20and%20females%20(3.2%25)

Lead with insight with the Pharmaceutical Executive newsletter, featuring strategic analysis, leadership trends, and market intelligence for biopharma decision-makers.

Subscribe Now!