FDA
Tremfya now approved for children with plaque psoriasis, psoriatic arthritis
FDA has approved Tremfya (guselkumab) for the treatment of children ≥6 years of age weighing ≥40 kg with moderate to severe plaque psoriasis (PsO), who are candidates for systemic therapy or phototherapy, and for the treatment of active psoriatic arthritis (PsA).
Efficacy
Approval of the PsO indication was based on data from the phase 3 PROTOSTAR study (NCT03451851) in pediatric patients with moderate to severe plaque PsO and supportive data from the phase 3 VOYAGE 1 and 2 studies in adult patients with moderate to severe plaque PsO. In the PROTOSTAR study, the co-primary endpoints of Psoriasis Area Severity Index (PASI) 90 and Investigator’s Global Assessment (IGA) score of 0/1 were achieved at week 16. Approximately 56% of patients receiving Tremfya achieved PASI 90, vs. 16% of patients receiving placebo (p<0.01). At week 16, 66% of patients receiving Tremfya vs. 16% of patients receiving placebo (p<0.001) achieved high levels of skin clearance (IGA score of 0/1). Nearly 40% of pediatric patients receiving Tremfya achieved complete clearance (IGA 0) at week 16 vs. 4% with placebo (p<0.01).
Approval of the active PsA indication was supported by evidence from pharmacokinetic extrapolation analyses from prior Tremfya PsO and PsA studies, including VOYAGE 1 and 2, DISCOVER 1 and 2, and PROTOSTAR.
Recommended dose
For the treatment of pediatric plaque PsO and PsA, the recommended dosage of Tremfya is 100 mg SC given at week 0, week 4 and then every 8 weeks thereafter. It may be used alone or in combination with a conventional DMARD (e.g., methotrexate).
Sources:
Tremfy (guselkumab) [package insert]. Food and Drug Administration. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761061s028s029lbl.pdf Revised September 2025. Accessed October 3, 2025.
US 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]. 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