The U.S. Food and Drug Administration has approved Johnson & Johnson’s Tremfya (guselkumab) for the treatment of plaque psoriasis and active psoriatic arthritis in children 6 years of age and older.
The approval is for pediatric patients living with either moderate-to-severe plaque psoriasis, who are candidates for systemic therapy or phototherapy, or active psoriatic arthritis. This approval expands indications of use beyond the initial adult population and is the first and only pediatric approval for an interleukin-23 inhibitor.
The approval is based on results from the Phase III PROTOSTAR study in which the coprimary end points of Psoriasis Area Severity Index (PASI) 90 and the Investigator’s Global Assessment (IGA) score of 0/1 were achieved at week 16. More than half of patients (56%) receiving Tremfya achieved PASI 90 versus 16% of patients receiving placebo.
For IGA score, at week 16, two-thirds (66%) of patients receiving Tremfya achieved high levels of skin clearance (score 0/1) versus 16% of patients receiving placebo. Complete clearance (IGA 0) at week 16 was achieved by nearly 40% of pediatric patients receiving Tremfya versus 4% on placebo.
“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,” study investigator Vimal Hasmukh Prajapati, M.D., from the University of Calgary in Alberta, Canada, said in a statement.
“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.”
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