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Pediatric Efficacy AnalysisPediatric Safety AnalysisPediatric Dosing
FDA Approved

TREMFYA® is approved for pediatric patients 6 years of age and older who also weigh at least 40 kg with moderate to severe plaque PsO or active PsA1

Pediatric efficacy/safety supported by1-3:
  • PsO: phase 3 PROTOSTAR study (120 pediatric patients aged ≥6 to ≤17 years)
  • PsA: data extrapolation analyses from TREMFYA® PsO and PsA studies, including VOYAGE 1 and
    VOYAGE 2, DISCOVER 1 and DISCOVER 2, and PROTOSTAR

In pediatric patients 6 years of age and older who also weigh at least 40 kg with moderate to severe plaque PsO

PROTOSTAR Pivotal Trial: TREMFYA® skin clearance rates in pediatric patients
at Week 161,3

PROTOSTAR study results skin clearance rates at Week 16 in pediatric patients
PROTOSTAR study results skin clearance rates at Week 16 in pediatric patients

Nonresponder imputation (NRI) was used
for analyses.

IN PEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER WHO ALSO WEIGH AT LEAST 40 KG WITH MODERATE TO SEVERE PLAQUE PsO

PROTOSTAR Safety Results3

The safety profile observed in pediatric patients 6 years of age and older treated with TREMFYA® up to 52 weeks was
consistent with the safety profile observed in adult patients with moderate to severe plaque psoriasis.

PROTOSTAR: Adverse events reported at Week 16

TREMFYA vs placebo adverse events reported at Week 16 in PROTOSTAR study
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TREMFYA vs placebo adverse events reported at Week 16 in PROTOSTAR study

Approval & ExtrapolationApproval &Extrapolation

To evaluate the treatment of active PsA in pediatric patients 6 years of age and older, data were extrapolated from five phase 3 studies to determine the pharmacokinetics, efficacy, and safety of TREMFYA® among related populations, including adult patients with moderate to severe plaque PsO (VOYAGE 1 and VOYAGE 2), adult patients with active PsA (DISCOVER 1 and DISCOVER 2), and children (≥6 to <18 years of age) with moderate to severe plaque PsO (PROTOSTAR). Findings were evaluated to extrapolate data for the treatment of active psoriatic arthritis in pediatric patients 6 years of age and older. Use of TREMFYA® in this age group is supported by the extrapolation of data
from these trials.1,2

IN PEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER WHO ALSO WEIGH AT LEAST 40 KG WITH MODERATE TO SEVERE PLAQUE PsO OR ACTIVE PsA

Pediatric Dosing1

TREMFYA® is administered by subcutaneous injection at Week 0, Week 4, and every 8 weeks thereafter.
  • The recommended dose for adults and pediatric patients 6 years of age and older who also weigh at least 40 kg is 100 mg
  • Pretreatment Evaluation: Evaluate for tuberculosis (TB) infection; if clinically indicated, evaluate liver enzymes and bilirubin levels, and complete all age-appropriate vaccinations according to current immunization guidelines
  • Monitor: For signs and symptoms of active TB during and after treatment with TREMFYA®. If clinically indicated, evaluate liver enzymes and bilirubin levels periodically according to routine patient management
  • TREMFYA® is intended for use under the guidance and supervision of a healthcare professional. After proper training in subcutaneous injection technique, adults may self-inject. Pediatric self-administration is not recommended. Administration of TREMFYA® to pediatric patients should be performed by a healthcare provider or by a caregiver who has received training and demonstrated proper subcutaneous injection technique
  • In active PsA, TREMFYA® can be used alone or in combination with a conventional DMARD (eg, methotrexate)
Caregivers can sign up for patient support here

DMARD=disease-modifying antirheumatic drug; IGA=Investigator's Global Assessment; IV=intravenous; LAAD=longitudinal access and adjudication data; PASI=Psoriasis Area and Severity Index.

‡Included a radius fracture (TREMFYA® group).

References: 1. TREMFYA® (guselkumab) [Prescribing
Information]. Horsham, PA: Janssen Biotech, Inc. 2. Crauwels H, Ringold S, Howard S, et al. Extrapolating guselkumab efficacy to juvenile psoriatic arthritis from adult psoriatic arthritis and adult and pediatric psoriasis data. Pediatric Drugs. 2026;28:69-81. 3. Prajapati V, Seyger M, 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;192:618-628.

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