The U.S. Food and Drug Administration has approved Johnson & Johnson’s (J&J) TREMFYA (guselkumab) for children aged six years and older weighing at least 40 kg with moderate to severe plaque psoriasis (PsO) or active psoriatic arthritis (PsA).

This marks the first approval of an IL-23 inhibitor for these pediatric indications, expanding the drug’s use beyond its prior approvals for adults with moderate to severe plaque PsO in 2017 and active PsA in 2020.

The approval addresses a significant need for the estimated 20,000 children under 10 diagnosed annually with plaque PsO and approximately 14,000 children affected by PsA in the U.S. Plaque PsO, characterized by inflamed, scaly skin, affects about one-third of PsO cases beginning in childhood, often causing physical discomfort and emotional distress. PsA, which accounts for roughly 5% of juvenile idiopathic arthritis cases, involves chronic joint inflammation and swelling, potentially limiting a child’s physical abilities.

“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,” said Vimal Hasmukh Prajapati, M.D., Clinical Associate Professor at the University of Calgary and study investigator.

The plaque PsO approval was supported by the Phase 3 PROTOSTAR study, which showed that 56% of pediatric patients receiving TREMFYA achieved a 90% improvement in the Psoriasis Area Severity Index (PASI 90) at Week 16, compared to 16% on placebo (p<0.01). Additionally, 66% of TREMFYA-treated patients achieved high skin clearance (Investigator’s Global Assessment score of 0/1), compared to 16% on placebo (p<0.001), with nearly 40% achieving complete clearance (IGA 0) versus 4% on placebo (p<0.01). The PsA approval relied on pharmacokinetic extrapolation from adult and pediatric PsO and PsA studies, including VOYAGE 1 and 2, DISCOVER 1 and 2, and PROTOSTAR.

“Every child deserves to feel comfortable in their own skin and to be active without the limitations of joint pain, stiffness and swelling,” said Brandee Pappalardo, PhD, MPH, Vice President of Medical Affairs, Dermatology & Rheumatology at Johnson & Johnson Innovative Medicine. “The approval of the first and only pediatric indications for an IL-23 inhibitor marks an important step forward not only for children, but also for the parents and care partners who support them every day.”

TREMFYA, a fully-human, dual-acting monoclonal antibody that inhibits IL-23 and binds to CD64, is administered via subcutaneous injection at Week 0, Week 4, and every eight weeks thereafter, with a recommended 100 mg dose for pediatric patients. The drug is also approved for adults with moderately to severely active ulcerative colitis and Crohn’s disease.

Furthermore, Johnson & Johnson recently applied to the FDA to update TREMFYA’s label to include evidence of its ability to inhibit joint structural damage in adults with active PsA, further expanding its potential impact.