The U.S. Food and Drug Administration (FDA) approved guselkumab (Tremfya) for the treatment of children six years and up who also weigh at least 40 kg with moderate-to-severe plaque psoriasis, who are candidates for systemic therapy or phototherapy, or active psoriatic arthritis (PsA).
The plaque psoriasis approval was based on results from the Phase 3 PROTOSTAR study in pediatric patients with moderate-to-severe plaque psoriasis and supportive data from the Phase 3 VOYAGE 1 and 2 studies in adult patients with moderate-to-severe plaque psoriasis. In the PROTOSTAR study, the co-primary endpoints of Psoriasis Area Severity Index (PASI) 90 and Investigator’s Global Assessment (IGA) score of 0/1 were achieved at Week 16.
Approximately 56% of patients receiving guselkumab, an interleukin (IL)-23 blocker, achieved PASI 90, compared to 16% of patients receiving placebo. At Week 16, 66% of patients receiving guselkumab compared to 16% of patients receiving placebo achieved high levels of skin clearance (IGA score of 0/1). Nearly 40% of pediatric patients receiving guselkumab achieved complete clearance (IGA 0) at Week 16 compared to 4% on placebo.
Approval of the active PsA indication was supported by evidence from pharmacokinetic extrapolation analyses from guselkumab psoriasis and PsA studies, including VOYAGE 1 and 2, DISCOVER 1 and 2, and PROTOSTAR. Findings from these analyses corroborated the efficacy and safety data from adults with psoriasis and PsA and children with moderate-to-severe plaque psoriasis to children with active PsA.
For the treatment of pediatric plaque psoriasis and PsA, guselkumab is administered as a subcutaneous injection at Week 0, Week 4, and then every 8 weeks thereafter. The recommended dosage for moderate-to-severe pediatric plaque psoriasis and active PsA in these patients is 100mg administered by subcutaneous injection using a 1mL prefilled syringe.
Experts React
“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, Clinical Associate Professor, University of Calgary, Councilor for the International Psoriasis Council, as well as Co-Founder and Co-Director of the Skin Health & Wellness Centre, Dermatology Research Institute, and Dermphi Centre, and study investigator, in a news 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.”
“Every child deserves to feel comfortable in their own skin and to be active without the limitations of joint pain, stiffness, and swelling,” adds Brandee Pappalardo, PhD, MPH, Vice President of Medical Affairs in 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. We remain committed to advancing research that demonstrates the long-term safety and efficacy of TREMFYA and to exploring its full potential for adult and pediatric patients.”
“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,” says Leah M. Howard, JD, President and CEO of the National Psoriasis Foundation. “The National Psoriasis Foundation welcomes any new treatment option that provides hope for relief from the pain, discomfort, and the emotional burden of these conditions.”
