Advancing the Treatment Landscape for Pediatric Psoriatic Disease Save
FDA-approved treatment offers pediatric patients who are 6 years and older who also weigh at least 40 kg, and their physicians and adult caregivers, an established option that may improve skin clearance for moderate to severe plaque psoriasis or treat active psoriatic arthritis, collectively known as psoriatic disease.
- Not all systemic and biologic therapies approved for moderate to severe plaque psoriasis (PsO) or active psoriatic arthritis (PsA) in adults have been approved for use in children.1,2
- Approximately 5% of the juvenile idiopathic arthritis population are patients with juvenile psoriatic arthritis (jPsA).3
- Approximately one-third of patients who get psoriasis are under 18 years old when the disease first surfaces.4
“Children diagnosed with moderate to severe plaque psoriasis or active psoriatic arthritis may face a lifetime of managing the symptoms of these diseases,”5,6 says Soumya Chakravarty, MD, PhD, FACP, FACR, Senior Director & Strategic Lead, Rheumatology at Johnson & Johnson.
“Studies have shown an interconnectivity between psoriatic disease—including moderate to severe plaque psoriasis and active psoriatic arthritis—and other immune-mediated diseases,”7 explains Dr. Chakravarty. “Additionally, it is important that physicians and care partners have the option to prescribe a biologic with proven safety and efficacy in the treatment of pediatric patients with moderate to severe plaque psoriasis or active psoriatic arthritis.”
IL-23 is a key driver of inflammation
The interleukin-23 (IL-23) pathway is highly important for treating a broad range of immune-mediated diseases, including pediatric moderate to severe plaque PsO or active PsA. It is a key driver of the inflammatory processes involved in the pathogenesis of these conditions.8
Research and clinical use have shown that targeting IL-23 with specific biologics to effectively block the downstream effects of this pathway has proven to be an effective therapeutic strategy.8
Guselkumab is a selective, dual-acting IL-23 inhibitor that neutralizes inflammation at the cellular source by binding to cluster of differentiation 64 (CD64). Dual-acting is defined as blocking IL-23, a cytokine responsible for inflammation, and binding to CD64, a receptor on IL-23-producing cells.7,9 Findings are based on in vitro studies, and the clinical significance is unknown.
First IL-23 approved for pediatric patients
Johnson & Johnson conducted the phase 3 PROTOSTAR study that evaluated the efficacy, safety, and pharmacokinetics of guselkumab for the treatment of moderate to severe plaque psoriasis in pediatric patients. Findings from this trial led to the U.S. Food and Drug Administration (FDA) approval of guselkumab for the treatment of children 6 years and older who also weigh at least 88 lbs (40 kg) with moderate to severe plaque PsO, and who are candidates for systemic therapy or phototherapy.9
U.S. FDA approval of guselkumab for the treatment of the active PsA indication in children 6 years and older who weigh at least 88 lbs (40 kg) with active PsA was supported by a data extrapolation analysis among evidence in related populations in phase 3 trials, including adult patients with moderate to severe plaque PsO, adult patients with active PsA, and data from the PROTOSTAR study.9,10
“The approval of guselkumab offers physicians, and care partners, an established treatment option with proven safety and demonstrated efficacy that may improve the symptoms of children living with moderate to severe plaque PsO or active PsA,” said Dr. Chakravarty.9
Selected Important Safety Information
TREMFYA® is contraindicated in patients with a history of serious hypersensitivity reaction to guselkumab or to any of the excipients. Serious hypersensitivity reactions, including anaphylaxis, may occur. TREMFYA® may increase the risk of infection. Do not initiate treatment in patients with clinically important active infection until the infection resolves or is adequately treated. If such an infection develops, discontinue TREMFYA® until infection resolves. Evaluate for tuberculosis (TB) before treating with TREMFYA®. Monitor patients for signs and symptoms of active TB during and after treatment with TREMFYA®. Drug-induced liver injury has been reported. For the treatment of plaque psoriasis or psoriatic arthritis, if clinically indicated, evaluate liver enzymes and bilirubin at baseline, and periodically thereafter according to routine patient management. Interrupt treatment if drug-induced liver injury is suspected, until this diagnosis is excluded. Avoid use of live vaccines in patients treated with TREMFYA®. Please see related and other Important Safety Information below.
Data supporting pediatric indications for guselkumab
This milestone makes guselkumab the first IL-23 inhibitor approved for children 6 years and older who also weigh at least 88 pounds (40 kg) living with moderate to severe plaque PsO or active PsA and builds on FDA approvals in adults living with moderate to severe plaque PsO in 2017 or active PsA in 2020.9
The plaque PsO approval was based on results from the phase 3 PROTOSTAR study (NCT03451851) in pediatric patients with moderate to severe plaque PsO and supportive data from the phase 3 VOYAGE 1 and VOYAGE 2 studies (NCT02207231 and NCT02207244) in adult patients with moderate to severe plaque PsO.9,11
PROTOSTAR is a phase 3, multicenter, randomized, placebo- and active comparator-controlled (etanercept) study evaluating the efficacy, safety, and pharmacokinetics of subcutaneously administered TREMFYA® for the treatment of moderate to severe plaque PsO in pediatric patients six years of age and older. The co-primary endpoints of Psoriasis Area and Severity Index (PASI) 90 and Investigator's Global Assessment (IGA) score of 0/1 were achieved at Week 16.9,11
- Approximately 56% of patients receiving guselkumab achieved PASI 90 at Week 16, compared to 16% of patients receiving placebo (p=0.003).11
- At Week 16, 66% of patients receiving guselkumab compared to 16% of patients receiving placebo (p<0.001) achieved high levels of skin clearance (IGA score of 0/1).11
- Nearly 40% of pediatric patients receiving guselkumab achieved complete clearance (IGA 0) at Week 16 compared to 4% on placebo (p=0.004).11
- For safety through Week 16, 42% of patients receiving guselkumab and 68% of patients receiving placebo reported adverse events (AEs). Common AEs experienced by patients receiving guselkumab included nasopharyngitis, upper respiratory tract infection, and headache. No serious or opportunistic infections occurred.11
Approval of the active PsA indication in pediatric patients was supported by evidence from a data extrapolation analysis that evaluated the efficacy, safety, and pharmacokinetics of guselkumab among related populations in phase 3 trials. These trials included: adult patients with moderate to severe plaque PsO (VOYAGE 1 and VOYAGE 2), adult patients with active PsA (DISCOVER 1 and DISCOVER 2), and children with moderate to severe plaque PsO (PROTOSTAR).9,10
Findings from these analyses corroborate the efficacy and safety data from adults with PsO or PsA and children with moderate to severe plaque PsO to children with active PsA.10
Johnson & Johnson continues to invest in generating new clinical research that adds to the comprehensive body of scientific evidence for guselkumab and ultimately addresses the evolving needs of patients with immune-mediated diseases.
For more information, please visit www.tremfya.com and be sure to follow Johnson & Johnson on LinkedIn and Instagram for updates and announcements surrounding upcoming trial readouts.
INDICATIONS
TREMFYA® (guselkumab) is indicated for the treatment of adults and pediatric patients 6 years of age and older who also weigh at least 40 kg with moderate to severe plaque psoriasis and who are candidates for systemic therapy or phototherapy.
TREMFYA® is indicated for the treatment of adults and pediatric patients 6 years of age and older who also weigh at least 40 kg with active psoriatic arthritis.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
TREMFYA® is contraindicated in patients with a history of serious hypersensitivity reaction to guselkumab or to any of the excipients.
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions
Serious hypersensitivity reactions, including anaphylaxis, have been reported with postmarket use of TREMFYA®. Some cases required hospitalization. If a serious hypersensitivity reaction occurs, discontinue TREMFYA® and initiate appropriate therapy.
Infections
TREMFYA® may increase the risk of infection. Treatment with TREMFYA® should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated.
Consider the risks and benefits of treatment prior to prescribing TREMFYA® in patients with a chronic infection or a history of recurrent infection. Instruct patients receiving TREMFYA® to seek medical help if signs or symptoms of clinically important chronic or acute infection occur. If a patient develops a clinically important or serious infection, or is not responding to standard therapy, closely monitor and discontinue TREMFYA® until the infection resolves.
Tuberculosis (TB)
Evaluate patients for TB infection prior to initiating TREMFYA® treatment. Do not administer TREMFYA® to patients with active TB infection. Initiate treatment of latent TB prior to administering TREMFYA®. Consider anti-TB therapy prior to initiating TREMFYA® in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Monitor all patients for signs and symptoms of active TB during and after TREMFYA® treatment.
Hepatotoxicity
A serious adverse reaction of drug-induced liver injury was reported in a clinical trial subject with Crohn’s disease following three doses of a higher than recommended induction regimen.
In patients with plaque psoriasis or psoriatic arthritis, if clinically indicated, evaluate liver enzymes and bilirubin at baseline, and periodically thereafter according to routine patient management.
Consider other treatment options in patients with evidence of acute liver disease or cirrhosis. Prompt investigation of the cause of liver enzyme elevation is recommended to identify potential cases of drug-induced liver injury. Interrupt treatment if drug-induced liver injury is suspected, until this diagnosis is excluded. Instruct patients to seek immediate medical attention if they experience symptoms suggestive of hepatic dysfunction.
Immunizations
Prior to initiating TREMFYA®, complete all age-appropriate vaccinations according to current immunization guidelines. Avoid use of live vaccines in patients treated with TREMFYA®.
ADVERSE REACTIONS
Most common adverse reactions associated with TREMFYA® include: plaque psoriasis and psoriatic arthritis adverse reactions (≥1%): upper respiratory infections, headache, injection site reactions, arthralgia, bronchitis, diarrhea, gastroenteritis, tinea infections, and herpes simplex infections.
The safety profile observed in pediatric patients 6 years of age and older treated with TREMFYA® up to 52 weeks was consistent with the safety profile observed in adult patients with moderate to severe plaque psoriasis.
The overall safety profile observed in adult patients with psoriatic arthritis is generally consistent with the safety profile in adult patients with plaque psoriasis, with the addition of bronchitis and neutrophil count decreased.
Please read the full Prescribing Information and Medication Guide for TREMFYA®.
Provide the Medication Guide to your patients and encourage discussion.
TREMFYA® is available as a 100 mg/mL subcutaneous injection.
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1 Costello A, Weiss P. The Challenges of New Biologic Therapies in Pediatrics: An Update on the Limited Therapeutic Options for Juvenile Psoriatic Arthritis. Rheum Dis Clin North Am. 2025;51(3):469-481. doi:10.1016/j.rdc.2025.05.002
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;17(5):373-384. doi:10.1007/s40272-015-0137-1
3 Brunello F, Tirelli F, Pegoraro L, et al. New Insights on Juvenile Psoriatic Arthritis. Front Pediatr. 2022;10:884727. Published 2022 May 26. doi:10.3389/fped.2022.884727
4 The National Psoriasis Foundation. Psoriasis in children. The National Psoriasis Foundation. Last updated October 01, 2025. Accessed December 16, 2025. https://www.psoriasis.
5 Lokhandwala S, Townsend J, Ciurtin C. Existing and Emerging Targeted Therapies in Juvenile Psoriatic Arthritis: Challenges and Unmet Needs. Paediatr Drugs. 2024;26(3):217-228. doi:10.1007/s40272-023-00618-2
6 The National Psoriasis Foundation. For parents: What is psoriasis? The National Psoriasis Foundation. Accessed December 16, 2025. https://www.psoriasis.
7 Krueger JG, Eyerich K, Kuchroo VK, et al. IL-23 past, present, and future: a roadmap to advancing IL-23 science and therapy. Front Immunol. 2024;15:1331217. Published 2024 Apr 15. doi:10.3389/fimmu.2024.1331217
8 Gooderham MJ, Papp KA, Lynde CW. Shifting the focus - the primary role of IL-23 in psoriasis and other inflammatory disorders. J Eur Acad Dermatol Venereol. 2018;32(7):1111-1119. doi:10.1111/jdv.14868
9 TREMFYA® [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.
10 Crauwels H, Ringold S, Howard S, et al. Extrapolating Guselkumab Efficacy to Juvenile Psoriatic Arthritis from Adult Psoriatic Arthritis and Adult and Pediatric Psoriasis Data. Paediatr Drugs. Published online October 28, 2025. doi:10.1007/s40272-025-00725-2
11 Prajapati VH, Seyger MMB, Wilsmann-Theis D, et al. Guselkumab for the treatment of moderate-to-severe plaque psoriasis in paediatric patients: results of the phase III randomized placebo-controlled PROTOSTAR study. Br J Dermatol. 2025;192(4):618-628. doi:10.1093/bjd/ljae502
