The approval was based on the PROTOSTAR study, which showed pediatric patients receiving the treatment achieved high levels of skin clearance versus placebo at week 16.
The US Food and Drug Administration (FDA) has approved Johnson & Johnson’s Tremfya (guselkumab) for treating children six years and older with moderate to severe plaque psoriasis or active psoriatic arthritis.
The approval makes Tremfya the first interleukin-23 (IL-23) inhibitor cleared for these pediatric indications. It applies to children who weigh at least 40 kg and, for plaque psoriasis, are candidates for systemic therapy or phototherapy. The decision expands on the drug’s previous approvals for adults with moderate to severe plaque psoriasis in 2017 and active psoriatic arthritis in 2020.
The approval for plaque psoriasis was based on results from the Phase 3 PROTOSTAR study. At week 16, approximately 56% of patients receiving guselkumab achieved a Psoriasis Area Severity Index (PASI) 90 response, compared to 16% of patients receiving a placebo. Additionally, 66% of the treatment group achieved an Investigator’s Global Assessment (IGA) score of clear or minimal (0/1), versus 16% in the placebo group. Nearly 40% of pediatric patients receiving the treatment achieved complete skin clearance.
Approval for the active psoriatic arthritis indication was supported by pharmacokinetic extrapolation analyses from existing studies in adults and children.
“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,” says Vimal Hasmukh Prajapati, MD, a clinical associate professor at the University of Calgary and a study investigator, in a 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.”
For both pediatric indications, Tremfya is administered as a 100 mg subcutaneous injection at week 0 and week 4, followed by a maintenance dose every eight weeks thereafter.
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