FDA Approves Tremfya for Pediatric Psoriasis, Psoriatic Arthritis
September 29, 2025
3 min read
Key takeaways:
- The FDA expanded the indication for Tremfya (guselkumab) to children with plaque psoriasis or active psoriatic arthritis.
- It is the first and only interleukin-23 inhibitor approved for these indications.
The FDA approved a supplemental new drug application for Tremfya for the treatment of children aged 6 years or older with moderate to severe plaque psoriasis or active psoriatic arthritis, according to a press release.
This approval makes Tremfya (guselkumab, Johnson & Johnson) the first and only interleukin-23 inhibitor approved in this indication. Children with moderate to severe plaque psoriasis must weigh at least 40 kg and be candidates for systemic therapy or phototherapy to receive Tremfya.
The FDA approved a supplemental new drug application for Tremfya for the treatment of children aged 6 years or older with moderate to severe plaque psoriasis or active psoriatic arthritis.
“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 well-being during critical years,” Vimal Hasmukh Prajapati, MD, clinical associate professor at the University of Calgary, councilor for the International Psoriasis Council, cofounder and codirector of the Skin Health & Wellness Centre, Dermatology Research Institute and Dermphi Centre and study investigator, said in the 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.”
The expanded indication for plaque psoriasis was supported by positive results from PROTOSTAR, a phase 3 study including children with moderate to severe plaque psoriasis, and VOYAGE 1 and 2a pair of phase 3 studies in adults with moderate to severe plaque psoriasis.
In the PROTOSTAR study, approximately 56% of participants receiving Tremfya achieved PASI 90 vs. 16% in the placebo group (P < .01) by week 16, according to the release. A higher proportion of participants treated with Tremfya vs. placebo also reached IGA 0 or 1 (66% vs. 16%, respectively; P < .001) and IGA 0 only (40% vs. 4%, respectively; P < .01) by week 16.
The supplemental approval for children with psoriatic arthritis was supported by pharmacokinetic extrapolation analyses of data from both psoriasis and psoriatic arthritis studies including the VOYAGE trials, DISCOVER 1 and 2 and PROTOSTAR, according to the release.
“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 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.”
Tremfya’s mechanism of action is unique in that it blocks IL-23 while also binding to the receptor located on cells, also known as the cluster of differentiation 64, which produces IL-23. IL-23 is a known driver of plaque psoriasis, psoriatic arthritis and other immune-mediated diseases.
For the treatment of children with plaque psoriasis or psoriatic arthritis, clinicians should administer a subcutaneous injection of Tremfya at week 0 and week 4. After these injections, Tremfya must be administered every 8 weeks. The recommended dose in this population is 100 mg using a 1 mL prefilled syringe.
The FDA approved a supplemental new drug application for Tremfya for the treatment of children aged 6 years or older with moderate to severe plaque psoriasis or active psoriatic arthritis
Perspective
There are significant data to support that the IL-23 inhibitors, as a class, have a combination of efficacy, safety and ease of dosing that is unparalleled compared to other systemic options available to treat moderate to severe psoriatic disease. The approval of Tremfya to treat children, who comprise a population of patients in whom all those characteristics have utmost importance, is a wonderful and very important milestone.
Anthony P. Fernandez, MD, PhD
Disclosures: Fernandez reports having financial relationships with Amgen, AstraZeneca, Biogen, BMS, Castle Biosciences, EMD Serono, Galderma, Incyte, Mallinckrodt, Pfizer, Priovant and Sanofi.