Guselkumab Improves Quality of Life in Pediatric Patients With Psoriasis and Their Caregivers

“The US FDA approval of guselkumab for moderate to severe plaque psoriasis in the pediatric population is a historic moment or milestone, as guselkumab is now the first and only IL-23 inhibitor approved for children and adolescents,” said Vimal Prajapati, MD, FRCPC, DABD, in a recent interview with Dermatology Times.

Prajapati, clinical associate professor at the University of Calgary, co-founder and co-director of the Skin Health & Wellness Centre, Dermphi Centre, Dermphi Shop, and Dermatology Research Institute in Canada, and study investigator, reviewed key findings from the PROTOSTAR study and the growing clinical relevance of guselkumab in pediatric patients with moderate to severe plaque psoriasis and their quality of life.¹

In a previous interview, Prajapati discussed the initial results of the PROTOSTAR study.

Prajapati highlighted results from the phase 3 PROTOSTAR (NCT03451851) withdrawal arm, which demonstrated durable efficacy after treatment cessation. Among the 41 pediatric patients initially randomized to guselkumab, 56% achieved PASI 90 at week 16. Of those responders, 30% maintained PASI 90 through week 52 after discontinuation, with a median time to loss of PASI 90 of approximately 24 weeks. These data suggest that a subset of pediatric patients can achieve and sustain high levels of skin clearance even after withdrawal—an insight that may help clinicians counsel families interested in the possibility of “medication holidays.”

Safety outcomes in PROTOSTAR were consistent with the established adult safety profile. Rates of adverse events were comparable between guselkumab and placebo, and there were no reports of serious or opportunistic infections, malignancy, or death. Prajapati emphasized that this alignment across age groups reinforces confidence in the long-term use of IL-23 inhibition for younger patients, calling it “great news for dermatologists, pediatric patients, and their caregivers.”

Importantly, improvements extended beyond skin clearance. Guselkumab demonstrated statistically significant, clinically meaningful gains in quality of life, reflected by reductions in Children’s Dermatology Life Quality Index scores at week 16 compared with placebo. Prajapati noted that pediatric psoriasis impacts the entire family dynamic, and therapies that restore quality of life for both patients and caregivers represent a crucial advance.

As Prajapati noted, guselkumab’s recent US FDA approval for pediatric patients with moderate to severe plaque psoriasis marks a pivotal milestone—it is now the first and only IL-23 inhibitor approved for children and adolescents.² With demonstrated efficacy, favorable safety, and convenient dosing, Prajapati anticipates that guselkumab will emerge as a first-line and potentially preferred biologic for pediatric psoriasis. He further noted the expanded approval for pediatric psoriatic arthritis, reinforcing guselkumab’s role as a versatile and evidence-backed option for dermatologists treating inflammatory skin disease in younger populations.

References

1. 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 Mar 18;192(4):618-628. doi: 10.1093/bjd/ljae502
2. 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 October 16, 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