Applications filed for TREMFYA® to treat children with moderate to severe plaque psoriasis and active juvenile psoriatic arthritis
SPRING HOUSE, Pa. (December 2, 2024) – Johnson & Johnson today announced the submission of two supplemental Biologics License Applications (sBLAs) to the U.S. Food and Drug Administration (FDA) seeking approval of TREMFYA® (guselkumab) for the treatment of children 6 years and older with moderate-to-severe plaque psoriasis (PsO) and children 5 years of age and older with active juvenile psoriatic arthritis (jPsA).a
The PsO submission is based on data from the Phase 3 PROTOSTAR study in pediatric patients with moderate to severe plaque PsO and bridging pharmacokinetic (PK) data from the Phase 3 VOYAGE 1 and 2 studies in adult patients with moderate to severe plaque PsO. The jPsA submission is based on PK extrapolation analyses from adult PsA studies (DISCOVER 1 and 2) and TREMFYA efficacy and safety data from the PROTOSTAR study.b
“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,” said Liza O’Dowd, M.D., Vice President, Immunodermatology Disease Area Leader, Johnson & Johnson Innovative Medicine. “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. At Johnson & Johnson, we are working to address this gap by investigating the efficacy and well-characterized safety profile of TREMFYA for pediatric patients.”
TREMFYA® is the first approved monoclonal antibody that selectively binds to the p19 subunit of IL-23 and inhibits its interaction with the IL-23 receptor. IL-23 is an important driver of immune-mediated diseases such as plaque PsO and PsA.
Editor’s Notes:
a. TREMFYA® is not currently approved to treat moderate to severe pediatric plaque psoriasis or active juvenile psoriatic arthritis (jPsA).
b. Data extrapolation is the process of estimating future trends or effects based on previous observations. With limited pediatric patients available for clinical trial inclusion, researchers can extrapolate data from adult patient trials to determine the potential efficacy and tolerability of a treatment for the pediatric population.
ABOUT PEDIATRIC PLAQUE PSORIASIS
Plaque psoriasis (PsO) is an immune-mediated disease resulting in overproduction of skin cells, which causes inflamed, scaly plaques that may be itchy or painful.[i] Almost one-third of PsO cases begin in childhood, with roughly 20,000 children under 10 diagnosed with psoriasis each year.1 Having visible skin disease can be highly stressful for children and adolescents and can have a long-term impact on those affected.2
ABOUT JUVENILE PSORIATIC ARTHRITIS
Juvenile psoriatic arthritis (jPsA) is a form of juvenile idiopathic arthritis (JIA) characterized by chronic joint inflammation, swelling and psoriasis. Juvenile PsA is relatively rare, accounting for approximately 5% of the JIA population. In many cases, the skin manifestations start before the arthritis.3
ABOUT THE PHASE 3 PROTOSTAR STUDY (NCT03451851)
PROTOSTAR is a Phase 3, multicenter, randomized, placebo- and active comparator-controlled study evaluating the efficacy, safety, and pharmacokinetics of subcutaneously administered TREMFYA® for the treatment of chronic plaque psoriasis in pediatric patients six years of age and older. Co-primary endpoints of the study were Investigator’s Global Assessment (IGA) 0/1 and PASI 75 at Week 16.4
ABOUT THE PHASE 3 VOYAGE STUDIES (NCT02207231 and NCT02207244)
VOYAGE 1 and 2 were Phase 3 randomized, double-blind, placebo- and active comparator-controlled studies designed to evaluate the efficacy and safety of TREMFYA® compared with placebo and adalimumab in adults with moderate to severe plaque PsO. The co-primary endpoints of the studies were the proportions of patients receiving TREMFYA® versus patients receiving placebo achieving Investigator’s Global Assessment (IGA) 0/1 (clear/almost clear skin) and PASI 90 at week 16.5,6
ABOUT THE PHASE 3 DISCOVER STUDIES (NCT03162796 and NCT03158285)
DISCOVER-1 was a Phase 3, multicenter, randomized, double-blind study evaluating the efficacy and safety of TREMFYA® administered by subcutaneous injection in participants with active PsA, including those previously treated with one to two tumor necrosis factor inhibitors (TNFi). The primary endpoint was response of ACR20 at week 24.7 DISCOVER-2 was a Phase 3, multicenter, randomized, double-blind study evaluating the efficacy and safety of TREMFYA® administered by subcutaneous injection in biologic-naïve patients with active PsA. The primary endpoint was response of ACR20 at week 24.8
ABOUT TREMFYA® (guselkumab)
Developed by Johnson & Johnson, TREMFYA® is the first approved fully-human, dual-acting monoclonal antibody designed to neutralize inflammation at the cellular source by blocking IL-23 and binding to CD64 (a receptor on cell that produce IL-23). Findings for dual-acting are limited to in vitro studies that demonstrate guselkumab binds to CD64, which is expressed on the surface of IL-23 producing cells in an inflammatory monocyte model. The clinical significance of this finding is not known.
TREMFYA® is a prescription medicine approved in the U.S. to treat:
· adults with moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet or UV light).
· adults with active psoriatic arthritis.
· adults with moderately to severely active ulcerative colitis.9
TREMFYA® is approved Europe, Canada, Japan, and a number of other countries for the treatment of adults with moderate-to-severe plaque psoriasis and for the treatment of adults with active psoriatic arthritis.
Johnson & Johnson maintains exclusive worldwide marketing rights to TREMFYA®.
ABOUT JOHNSON & JOHNSON
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.
Footnotes
1 National Psoriasis Foundation. About psoriasis. Available at: https://www.psoriasis.org/children-with-psoriasis/. Accessed October 2024.
2 Bronckers IM, Paller AS, van Geel MJ, van de Kerkhof PC, Seyger MM. Psoriasis in Children and Adolescents: Diagnosis, Management and Comorbidities. Paediatr Drugs. 2015 Oct;17(5):373-84. doi: 10.1007/s40272-015-0137-1.
3 Brunello, Francesco et al. New Insights on Juvenile Psoriatic Arthritis. Frontiers in pediatrics. 2022. Available at: https://pmc.ncbi.nlm.nih.gov/articles/PMC9199423/#:~:text=Juvenile%20psoriatic%20arthritis%20(JPsA)%20is,Idiopathic%20Arthritis%20(JIA)%20population. Accessed October 2024.
4 ClinicalTrials.gov.A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Guselkumab for the Treatment of Chronic Plaque Psoriasis in Pediatric Participants (PROTOSTAR). Identifier: NCT03451851. Available at: https://clinicaltrials.gov/study/NCT03451851
5 Clinicaltrials.gov. A Study of Guselkumab in the Treatment of Participants With Moderate to Severe Plaque-Type Psoriasis (VOYAGE 1). Identifier NCT02207231. https://www.clinicaltrials.gov/ct2/show/NCT02207231. Accessed October 2024.
6 Clinicaltrials.gov. A Study of Guselkumab in the Treatment of Participants With Moderate to Severe Plaque-Type Psoriasis With Randomized Withdrawal and Retreatment (VOYAGE 2). Identifier NCT02207244. https://www.clinicaltrials.gov/ct2/show/NCT02207244. Accessed October 2024.
7 ClinicalTrials.gov. A Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants With Active Psoriatic Arthritis Including Those Previously Treated With Biologic Anti-Tumor Necrosis Factor (TNF) Alpha Agent(s) (DISCOVER 1). Identifier: NCT03162796. Available at: https://clinicaltrials.gov/ct2/show/NCT03162796. Accessed October 2024.
8 ClinicalTrials.gov. A Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants With Active Psoriatic Arthritis. Identifier: NCT03158285. Available at: https://clinicaltrials.gov/ct2/show/NCT03158285. Accessed October 2024.
9 TREMFYA® Prescribing Information. Available at: https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/TREMFYA-pi.pdf. Accessed October 2024.