The FDA approval of guselkumab expands biologic therapies to pediatric patients.

The US Food and Drug Administration approved guselkumab (Tremfya) for children aged 6 years and older weighing at least 40 kg with moderate to severe plaque psoriasis requiring systemic therapy or phototherapy, and for those with active psoriatic arthritis. Guselkumab is the first and only interleukin-23 (IL-23) inhibitor authorized for these pediatric indications, extending its prior approvals in adults with plaque psoriasis (2017) and psoriatic arthritis (2020).

The approval for pediatric plaque psoriasis was supported by the Phase 3 PROTOSTAR trial. At Week 16, 56% of patients treated with guselkumab achieved a Psoriasis Area Severity Index 90 response compared with 16% receiving placebo. Investigator’s Global Assessment (IGA) scores of 0/1 were observed in 66% of patients treated with guselkumab versus 16% on placebo. Complete clearance (IGA 0) was achieved in 40% of patients treated with guselkumab compared with 4% receiving placebo. Approval for pediatric psoriatic arthritis was supported by pharmacokinetic extrapolation from adult plaque psoriasis and psoriatic psoriasis studies, including VOYAGE and DISCOVER, which demonstrated consistent efficacy and safety.

Leah M. Howard, JD, President and CEO, National Psoriasis Foundation noted, “the physical and emotional impact of psoriasis and psoriatic arthritis can have children sitting on the sidelines of life, not attending social events because they are embarrassed of their plaques or their joint pain is too intense.”

The recommended regimen for pediatric plaque psoriasis and psoriatic arthritis is 100 mg administered subcutaneously at Week 0, Week 4, and every 8 weeks thereafter. Guselkumab is a fully-human, dual-acting monoclonal antibody that blocks IL-23 and binds to CD64, a receptor on IL-23–producing cells.

Source: Johnson & Johnson