FDA Approves Guselkumab for Children 6 and Older With PsO

The US Food and Drug Administration (FDA) has approved guselkumab (Tremfya®, Johnson & Johnson) for the treatment of children 6 and older, weighing at least 40 kg, with moderate-to-severe plaque psoriasis (PsO) or active psoriatic arthritis (PsA), making it the first IL-23 inhibitor approved for these pediatric indications. Guselkumab was approved for adults with plaque PsO in 2017 and PsA in 2020.

Approval of the pediatric PsO indication was supported by the Phase 3 PROTOSTAR trial in children with moderate-to-severe plaque psoriasis, in addition to adult data from the Phase 3 VOYAGE 1 and 2 studies. In PROTOSTAR, 56% of pediatric patients treated with guselkumab achieved Psoriasis Area and Severity Index (PASI) 90 at Week 16, compared with 16% on placebo (P < .01). Similarly, 66% of patients treated with guselkumab achieved an Investigator’s Global Assessment (IGA) score of 0/1 versus 16% of placebo-treated patients (P < .001). Complete clearance (IGA 0) was achieved by 40% of pediatric patients on guselkumab compared with 4% on placebo (P < .01).

The pediatric PsA indication was supported by pharmacokinetic extrapolation analyses from PROTOSTAR and adult studies including VOYAGE 1 and 2 and DISCOVER 1 and 2, which demonstrated comparable efficacy and safety profiles between pediatric and adult populations.

“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 study investigator Vimal Hasmukh Prajapati, MD, Clinical Associate Professor, University of Calgary.

For children with PsO or PsA, guselkumab is administered subcutaneously at Weeks 0 and 4, followed by every 8 weeks. The recommended dose is 100 mg via a 1 mL prefilled syringe.

“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, Medical Affairs, Dermatology & Rheumatology, 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.”