Guselkumab FDA Approved for Pediatric Psoriasis and Psoriatic Arthritis Save

FDA announced yesterday that guselkumab (Tremfya) is approved for use in pediatric patients moderate to severe plaque psoriasis (PsO) or active psoriatic arthritis (PsA) in children six years and older (weighing at least 40 kg).  

This is the first IL-23 inhibitor approved for use in pediatric psoriatic disease, and is based on the phase III PROTOSTAR study.  Guselkumab was approved for use in adults with plaque PsO in 2017 and active PsA in 2020.

The manufacturer, Johnson & Johnson, estimates this availabilty may apply to roughly 20,000 children with plaque PsO and approximately 14,000 children with PsA. Active PsA accounts for approximately five percent of the juvenile idiopathic arthritis population. 

The plaque PsO approval is based on the Phase 3 PROTOSTAR study in pediatric patients with moderate to severe plaque PsO. The co-primary endpoints in the PROTOSTAR study included the Psoriasis Area Severity Index (PASI) 90 and Investigator's Global Assessment (IGA) score of 0/1 at Week 16.  Main outcomes included: 

• GUS outperformed PBO (56% vs 16%; p<0.01). 
• Week 16 high level skin clearance (IGA score of 0/1) was 66% with GUS vs 16% on PBO (p<0.001)
• Complete skin clearance (IGA 0) at Week was 40% on GUS vs 4% on placebo (p<0.01)

Approval for use in active PsA was based on pharmacokinetic extrapolation analyses in other PsO and PsA studies. 

For pediatric plaque PsO and PsA, Guselkumab is administered as a subcutaneous injection at Week 0, Week 4 and then every 8 weeks thereafter. The recommended dosage for moderate to severe pediatric plaque PsO and active PsA in these patients is 100 mg administered by subcutaneous injection using a 1 mL prefilled syringe.

The adverse event profile was unchange in these pediatric PsO studies. 

For full prescribing information, click here.