FDA Approves Guselkumab for Pediatric Psoriasis and Psoriatic Arthritis
The U.S. Food and Drug Administration (FDA) has approved guselkumab for the treatment of pediatric patients aged 6 years and older with moderate-to-severe plaque psoriasis and active psoriatic arthritis. Announced by Janssen on September 27, 2024, this decision marks the first and only approval of an interleukin-23 (IL-23) inhibitor for these pediatric conditions in the United States.
Study Findings: Safety and Efficacy for Pediatric Patients
The FDA approval was based on pivotal clinical trials evaluating the efficacy and safety of guselkumab in children with plaque psoriasis and psoriatic arthritis. Data demonstrated significant improvements in skin clearance and symptom control compared with placebo and standard therapies.
In pediatric plaque psoriasis, nearly 70% of patients achieved a 90% improvement in Psoriasis Area and Severity Index (PASI 90) at week 16, compared with fewer than 10% in the placebo group. For psoriatic arthritis, guselkumab demonstrated clinically meaningful improvements in joint symptoms and physical function, aligning with outcomes observed in adult populations.
Janssen emphasized that guselkumab is administered as a subcutaneous injection every 8 weeks after 2 starter doses. This regimen offers a manageable treatment schedule for children and adolescents, many of whom face lifelong disease management challenges.
“Children with plaque psoriasis or psoriatic arthritis often experience significant physical discomfort and psychosocial impact,” Janssen stated in its announcement. “The availability of Tremfya provides a new therapeutic option tailored to their needs.”
Clinical Implications: Expanding Biologic Options for Children
The approval expands treatment options for pediatric dermatology and rheumatology specialists managing complex inflammatory disorders. Plaque psoriasis affects an estimated 1% of children worldwide, while psoriatic arthritis develops in up to one-third of pediatric patients with psoriasis. Until now, biologic therapies with proven long-term safety data in children have been limited, particularly for IL-23 inhibition.
Guselkumab’s approval provides clinicians with an additional targeted mechanism of action beyond TNF and IL-17 inhibitors. By selectively inhibiting IL-23, guselkumab addresses upstream drivers of the psoriatic disease process. Clinicians may now consider guselkumab for pediatric patients who have failed topical therapies, phototherapy, or other systemic agents.
The long dosing interval (every 8 weeks) may also improve adherence—a known challenge in pediatric populations—and reduce treatment burden for families. Safety data indicated a favorable profile consistent with adult trials, with no new safety signals observed in pediatric cohorts.
Reference:
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 30, 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
