FDA Receives sBLA for Guselkumab Treatment of Psoriasis, Juvenile PsA in Adolescents

Johnson & Johnson announced their submission of 2 supplemental Biologics License Applications (sBLAs) to the US Food and Drug Administration (FDA) for the approval of guselkumab (Tremfya) treatment of children aged 6 and older with moderate-to-severe psoriasis and those aged 5 and older with active juvenile psoriatic arthritis (jPsA).¹

Plaque psoriasis is an inflammatory disorder characterized by inflamed, scaly, and often painful or itchy patches on the skin. Juvenile psoriatic arthritis is a subtype of juvenile idiopathic arthritis which is characterized by swelling, chronic inflammation of patients’ joints, and psoriasis. It also is known to frequently manifest first with skin symptoms prior to joint issues.

“This milestone underscores our commitment to transform the standard of care for patients of all ages and builds on our expertise and legacy in IL-23 and immune-mediated diseases,” Liza O’Dowd, MD, vice president and immunodermatology disease area leader at Johnson & Johnson Innovative Medicine, said in a statement. “There is a critical gap in the treatment of children and adolescents with these skin and joint conditions, where debilitating symptoms can present challenges related to physical appearance and ability to function.”¹

Guselkumab is a monoclonal antibody which is the first therapy option approved specifically for the purposes of targeting the p19 subunit of interleukin (IL)-23. IL-23 is known to be a key contributor to immune-mediated diseases such as iPsA and psoriasis, and guselkumab was formulated to impact the interaction between IL-23 and its receptor.

The treatment was approved by the FDA in 2017 for the treatment of adult patients with moderate-to-severe plaque psoriasis who are also candidates for either systemic therapy or phototherapy.² This prior approval had been based on results from the phase 3 VOYAGE 1, VOYAGE 2, and NAVIGATE trials.

The latest FDA submission for pediatric psoriasis results from findings from the phase 3 PROTOSTAR study findings on children with moderate-to-severe disease as well as pharmacokinetic (PK) findings from the phase 3 VOYAGE 1 and 2 studies on adults. The jPsA-related submission draws on PK extrapolation analyses from the DISCOVER 1 and 2 studies on PsA and findings from PROTOSTAR.

PROTOSTAR was a randomized, multicenter, placebo- and active comparator-controlled analysis designed to assess the effectiveness, safety, and pharmacokinetics of guselkumab administered subcutaneously for those aged 6 years and older with psoriasis.

The trials’ co-primary endpoints were Investigator’s Global Assessment (IGA) 0/1 and PASI 75 by Week 16. The VOYAGE 1 and 2 trials were randomized, double-blind, placebo- and active comparator-controlled analyses which assessed both the effectiveness and safety of guselkumab versus placebo and versus adalimumab in adults with psoriasis.

The investigators’ co-primary endpoints were the proportions of individuals given guselkumab versus placebo achieving IGA 0/1 and PASI 90 at the 16-week mark.

The DISCOVER-1 and 2 analyses were multicenter, randomized, double-blinded studies assessing subcutaneous guselkumab injection in patients with active PsA, with DISCOVER-1 including individuals given previous treatment with 1 to 2 tumor necrosis factor inhibitors (TNFi).

In terms of primary endpoints, DISCOVER-1 investigators looked at responses of ACR20 at Week 24. DISCOVER-2 looked at guselkumab’s treatment of biologic-naïve individuals with active PsA, and their primary endpoint was determined to be a response of ACR20 at Week 24.

References

1. ^{Johnson & Johnson seeks U.S. FDA approval for first pediatric indications for TREMFYA® (guselkumab). Johnson & Johnson. December 2, 2024. https://www.jnj.com/media-center/press-releases/johnson-johnson-seeks-u-s-fda-approval-for-first-pediatric-indications-for-tremfya-guselkumab. Date accessed: December 2, 2024.}
2. ^{Inman S. FDA Approves Guselkumab for Plaque Psoriasis. HCPLive. July 17, 2024. https://www.hcplive.com/view/fda-approves-guselkumab-for-plaque-psoriasis. Date accessed: December 2, 2024.}