FDA Approves Guselkumab for Pediatric Plaque Psoriasis and Psoriatic Arthritis

Johnson & Johnson recently announced that the FDA has approved guselkumab (Tremfya) for the treatment of pediatric patients aged 6 years and older who also weigh at least 40 kg with moderate to severe plaque psoriasis (PsO), who are candidates for systemic therapy or phototherapy, or active psoriatic arthritis (PsA). This approval 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

Guselkumab's approval was supported by the phase 3 PROTOSTAR study (NCT03451851) evaluating pediatric patients with moderate to severe PsO and supporting data from the phase 3 VOYAGE 1 (NCT02207231) and VOYAGE 2 (NCT02207244) studies in adult patients with moderate to severe plaque PsO. At week 16, PASI 90 was achieved by approximately 56% of patients treated with guselkumab compared to 16% of those receiving placebo (p<0.01). High levels of skin clearance, defined as an IGA score of 0/1, were seen in 66% of patients on guselkumab versus 16% on placebo (p<0.001). Nearly 40% of pediatric patients receiving guselkumab reached complete clearance (IGA 0) at week 16, compared to 4% of patients on placebo (p<0.01).

"IL-23 inhibition is a mainstay of psoriasis therapy, and the approval of guselkumab for pediatric plaque psoriasis and psoriatic arthritis is a huge step forward for providing patients with effective and safe treatment options. This approval also reminds and empowers dermatologists to intervene earlier in the management of psoriatic disease, whose systemic consequences can be significant, especially to joints," said Christopher Bunick, MD, PhD, associate professor of dermatology at Yale School of Medicine in New Haven, Connecticut, and editor in chief of Dermatology Times, in a statement.

The approvals expand treatment options for pediatric patients, including the estimated 20,000 children under 10 years of age diagnosed with plaque PsO each year and the approximately 14,000 affected by PsA. One-third of psoriasis cases begin in childhood, and the disease can lead to lasting physical and psychological impact. Active PsA represents approximately 5% of the juvenile idiopathic arthritis population and is marked by chronic joint inflammation, swelling, and psoriasis.

“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 at the University of Calgary, and study investigator, in the news release. “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.”

Brandee Pappalardo, PhD, MPH, vice president of medical affairs, dermatology, and rheumatology at Johnson & Johnson Innovative Medicine, emphasized in the news release that the new pediatric approval represents a meaningful advance, giving children the opportunity to live more comfortably and actively while also supporting the families and caregivers involved in their care.

"Pediatric psoriasis patients are entering their IL-23 inhibitor era. This has been something that I have been eagerly awaiting! The IL-23 inhibitors offer a lot for patients, including high-level efficacy, infrequent shots, and excellent safety. All of these features are ideally suited to the pediatric patient population, so I am so excited to be able to consider guselkumab for pediatric patients with psoriasis," said Lisa Swanson, MD, a pediatric dermatologist at Ada West Dermatology in Boise, Idaho, in a statement to Dermatology Times.

For pediatric patients with moderate to severe plaque psoriasis or active psoriatic arthritis, guselkumab is administered as a subcutaneous injection at weeks 0 and 4, followed by dosing every 8 weeks. The recommended regimen is 100 mg delivered via a 1 mL prefilled syringe.

"Although less prevalent than commonly seen atopic dermatitis, pediatric psoriasis presents a distinct and persistent treatment challenge for clinicians. Psoriasis develops in childhood or adolescence in approximately 40% of adults with psoriasis. Why is this important? It is well known that psoriasis is a multisystem disease that can have longstanding impact and systemic comorbidities," wrote Karan Lal, DO, MS.²

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. Lal K. Recognizing the hidden burdens of pediatric psoriasis. Dermatology Times. August 18, 2025. Accessed September 29, 2025. https://www.dermatologytimes.com/view/recognizing-the-hidden-burdens-of-pediatric-psoriasis