Guselkumab has received approval for moderate to severe plaque psoriasis in children and adolescents from the age of 6 years who are candidates for systemic therapy.1
The decision is supported by the Phase 3 PROTOSTAR study, where guselkumab demonstrated higher levels of skin clearance vs. placebo at Week 16.2
BEERSE, Belgium (19 December 2025) – Johnson & Johnson today announced that the European Commission (EC) has extended the marketing authorisation for TREMFYA® (guselkumab) as a subcutaneous treatment to treat moderate to severe plaque psoriasis (Pso) in children and adolescents from the age of 6 years who are candidates for systemic therapy.1,a This milestone makes guselkumab the first IL-23 inhibitor approved for any paediatric indication, building on EC approval in adults living with moderate to severe plaque Pso in 2017.1
Almost one-third of Pso cases begin in childhood, and the inflamed, scaly plaques caused by chronic disease may be itchy or painful and can be highly stressful for children, leading to a potential long-term impact on those affected.3 Paediatric Pso has been associated with certain comorbidities, such as obesity, hypertension, hyperlipidemia, diabetes mellitus, and psoriatic arthritis, further impacting quality of life.3
“Despite progress in the treatment of paediatric Pso, there continues to be a significant gap in available therapies for children living with this debilitating immune-mediated disease, which can impact a child’s physical and mental wellbeing during critical years,” said Marieke Seyger, Associate Professor, Radboud University Medical Centre Nijmegen, Netherlands, and PROTOSTAR study investigator.b “The approval of guselkumab offers physicians, parents, and care givers a treatment option that can significantly improve the signs and symptoms of Pso in children living with this disease.”
The EC approval was based on results from the Phase 3 PROTOSTAR study in 120 paediatric 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.2,4,5,6,b,c In the PROTOSTAR study, the co-primary endpoints of Psoriasis Area Severity Index (PASI) 75 and Investigator’s Global Assessment (IGA) score of 0/1 were achieved at Week 16.2,d,e Approximately 76% of 41 patients receiving guselkumab achieved PASI 75, compared to 20% of 25 patients receiving placebo (p<0.001).2 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).2 Nearly 40% of patients receiving guselkumab achieved complete clearance (IGA 0) at Week 16, compared to 4% on placebo (p<0.01).2 The safety profile for guselkumab subcutaneous injection in paediatric patients 6 to 17 years was consistent with the safety profile reported in the adult plaque psoriasis studies.1
“Guselkumab is the first fully-human dual-acting IL-23 inhibitor approved for the treatment of moderate to severe paediatric plaque psoriasis,1 marking an important step forward not only for children, but also for the parents and care givers who support them every day,” commented Mark Graham, Senior Director, Therapeutic Area Head, Immunology, Johnson & Johnson Innovative Medicine EMEA. “We’re steadfast in our commitment to advancing research that supports the long-term efficacy and safety profile of guselkumab, and to meet the unmet needs of adult and paediatric patients.”
This EC approval is an important milestone for patients and is emblematic of Johnson & Johnson’s continuous commitment to innovating to improve the lives of people living with chronic immune-mediated diseases. Guselkumab first received approval in the EU in November 2017 for the treatment of moderate-to-severe Pso in adults who are candidates for systemic therapy.1,7 In November 2020, guselkumab received EU approval for active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug therapy.1,8 In 2025, guselkumab received EC approval for ulcerative colitis (UC) and Crohn’s Disease (CD) in adults, which includes both an intravenous (IV) and a subcutaneous (SC) induction dosing option followed by SC maintenance dosing.1,9
Editor’s Notes:
- Systemic therapy is prescription medicines which are aimed at those with varying degrees of psoriasis and psoriatic disease severity and work throughout the body.10
- PROTOSTAR is a Phase 3, multi-centre, randomised, placebo- and active comparator-controlled study evaluating the efficacy, safety, and pharmacokinetics of subcutaneously administered guselkumab for the treatment of chronic plaque Pso in paediatric patients six years of age and older.4
- Data extrapolation is the process of estimating future trends or effects based on previous observations. With limited paediatric patients available for clinical trial inclusion,11 researchers can extrapolate data from adult patient trials to determine the potential efficacy and tolerability of a treatment for the paediatric population.
- The PASI score grades the amount of surface area on each body region that is covered by psoriasis plaques and the severity of plaques for their redness, thickness and scaliness. PASI 75 means a 75% reduction in baseline PASI score.12
- The IGA is a five-point scale with a severity score ranging from 0 to 4, where 0 indicates clear, 1 is minimal, 2 is mild, 3 is moderate and 4 indicates severe disease.13
ABOUT THE PHASE 3 PROTOSTAR PROGRAMME (EudraCT 2017-003053-42)4
PROTOSTAR is a Phase 3, multi-centre, randomised, placebo- and active comparator-controlled study evaluating the efficacy, safety, and pharmacokinetics of subcutaneously administered guselkumab for the treatment of chronic plaque Pso in paediatric patients six years of age up to 18 years.4 Co-primary endpoints of the study were IGA 0/1 (clear/almost clear skin) and PASI 75 at Week 16.4
ABOUT THE PHASE 3 VOYAGE STUDIES (EudraCT 2014-00719-15 and EudraCT 2014-000720-18)5,6
VOYAGE 1 and 2 were Phase 3 randomised, double-blind, placebo- and active comparator-controlled studies designed to evaluate the efficacy and safety of guselkumab compared with placebo and adalimumab in adults with moderate to severe plaque Pso.5,6 The co-primary endpoints of the studies were the proportions of patients receiving guselkumab versus patients receiving placebo achieving IGA 0/1 (clear/almost clear skin) and PASI 90 at Week 16.5,6
ABOUT PAEDIATRIC PLAQUE PSORIASIS
Plaque psoriasis is an immune-mediated disease resulting in overproduction of skin cells, which causes inflamed, scaly plaques that may be itchy or painful.14 Almost one-third of Pso cases begin in childhood.3 Paediatric Pso can have a profound long-term impact on the psychological health of affected children.3 Additionally, paediatric Pso has been associated with certain comorbidities, such as obesity, hypertension, hyperlipidemia, diabetes mellitus and psoriatic arthritis.3
ABOUT GUSELKUMAB
Developed by Johnson & Johnson, guselkumab is the first approved fully-human, dual-acting IL-23p19 subunit inhibitor that blocks IL-23 and binds to CD64, a receptor on cells that produce IL-23.1,15,16,17,18 Findings for dual-acting are limited to in vitro studies and the clinical significance of this finding is not known.19,20
Guselkumab is approved in the EU for the treatment of moderate to severe plaque Pso in adults who are candidates for systemic therapy and for the treatment of active PsA in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modifying anti-rheumatic drug therapy.1 It is also approved to treat moderate to severe plaque Pso in children and adolescents from the age of 6 years who are candidates for systemic therapy.1 Guselkumab is approved for the treatment of adult patients with moderately to severely active UC who have had an inadequate response, lost response, or were intolerant to either conventional therapy, or a biologic treatment and for the treatment of adult patients with moderately to severely active CD who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic treatment.1
It is also approved in the U.S, Canada, Japan and a number of other countries for the treatment of adults with moderate-to-severe Pso who are candidates for injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light) and for the treatment of adult patients with active PsA.21,22,23
Johnson & Johnson maintains exclusive worldwide marketing rights to guselkumab.
GUSELKUMAB IMPORTANT SAFETY INFORMATION
In controlled periods of clinical studies with guselkumab, adverse drug reactions (ADRs) that consisted of respiratory tract infections were very common (≥10 percent); increased transaminases, headache, diarrhoea, arthralgia, rash and injection site reactions were common (≥1 to <10 percent); and herpes simplex infections, tinea infections, gastroenteritis, decreased neutrophil count, hypersensitivity, anaphylaxis, and urticaria were uncommon ADRs (≥0.1 percent to <1 percent). Hypersensitivity and anaphylaxis were rare (≥ 1/10 000 to
< 1/1000).1
Please refer to the Summary of Product Characteristics for full prescribing information for guselkumab: https://www.ema.europa.eu/en/documents/product-information/tremfya-epar-product-information_en.pdf
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. Learn more at www.innovativemedicine.jnj.com/emea. Follow us at J&J Innovative Medicine Europe, Middle East & Africa (EMEA). Janssen-Cilag International NV, Janssen Research & Development, LLC and Janssen Biotech, Inc. are Johnson & Johnson companies.
Cautions Concerning Forward-Looking Statements
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 related to TREMFYA®. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialise, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: competition, including technological advances, new products and patents attained by competitors; uncertainty of commercial success for new products; the ability of the company to successfully execute strategic plans; impact of business combinations and divestitures; challenges to patents; changes in behaviour and spending patterns or financial distress of purchasers of health care products and services; and global health care reforms and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s most recent Annual Report on Form 10-K, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission.
Copies of these filings are available online at www.sec.gov, www.jnj.com, www.investor.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.
If you are interested in a media interview please reach out to:
Lenny Peeters
Lpeeter8@its.jnj.com
+32 497 610029
# # #
1 European Medicines Agency. TREMFYA Summary of Product Characteristics.
2 Prajapati VH, 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 Mar 18;192(4):618-628. doi: 10.1093/bjd/ljae502.
3 Bronckers IM, et al. Psoriasis in Children and Adolescents: Diagnosis, Management and Comorbidities. Paediatr Drugs. 2015 Oct;17(5):373-84. doi: 10.1007/s40272-015-0137-1.
4 EU Clinical Trials Register. A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Guselkumab in the Treatment of Chronic Plaque Psoriasis in Paediatric Subjects. (PROTOSTAR) EudraCT 2017-003053-42. Available at: https://www.clinicaltrialsregister.eu/ctr-search/trial/2017-003053-42/HU. Accessed: November 2025.
5 EU Clinical Trials Register. A Study of Guselkumab in the Treatment of Participants with Moderate to Severe Plaque-Type Psoriasis (VOYAGE 1) EudraCT: 2014-00719-15. Available at: https://www.clinicaltrialsregister.eu/ctr-search/trial/2014-000719-15/DE. Accessed: November 2025
6 EU Clinical Trials Register. A Study of Guselkumab in the Treatment of Participants with Moderate to Severe Plaque-Type Psoriasis with Randomized Withdrawal and Retreatment (VOYAGE 2) EudraCT: 2014-000720-18. Available at: https://www.clinicaltrialsregister.eu/ctr-search/trial/2014-000720-18/DE. Accessed: November 2025
7 Johnson & Johnson PR Newswire. European Commission Approves TREMFYA® (guselkumab) for the Treatment of Moderate to Severe Plaque Psoriasis in the European Union. Available at: https://www.prnewswire.com/news-releases/european-commission-approves-tremfya-guselkumab-for-the-treatment-of-moderate-to-severe-plaque-psoriasis-in-the-european-union-300561383.html Accessed: December 2025
8 Johnson & Johnson. European Commission Approves Janssen’s TREMFYA®▼ (guselkumab), a First-in-Class Treatment for Active Psoriatic Arthritis (PsA). Available at: https://jnj-promomats.veevavault.com/ui/#doc_info/3197360/0/2. Accessed: December 2025
9 Johnson & Johnson. TREMFYA® (guselkumab) receives European Commission approval for subcutaneous induction through to maintenance in adults with ulcerative colitis, now the first IL-23 inhibitor with a fully subcutaneous dose regimen. Available at: https://www.jnj.com/innovativemedicine/emea/media-center/press-releases/tremfya-guselkumab-receives-european-commission-approval-for-subcutaneous-induction-through-to-maintenance-in-adults-with-ulcerative-colitis-now-the-first-il-23-inhibitor-with-a-fully-subcutaneous-dose-regimen. Accessed: December 2025
10 National Psoriasis Foundation. Systemics. Available at: https://www.psoriasis.org/systemics/. Accessed: December 2025.
11 Strengthening the paediatric clinical trial ecosystem to better inform policy and programmesBerkley, James A et al.cThe Lancet Global Health, Volume 13, Issue 4, e732 - e739
12 Manchanda Y, et al. Disease Assessment in Psoriasis. Indian J Dermatol. 2023 May-Jun;68(3):278-281. doi: 10.4103/ijd.ijd_420_23.
13 Langley RG, et al. The 5-point Investigator's Global Assessment (IGA) Scale: A modified tool for evaluating plaque psoriasis severity in clinical trials. J Dermatolog Treat. 2015 Feb;26(1):23-31. doi: 10.3109/09546634.2013.865009.
14 Psoriasis. National Institute of Arthritis and Musculoskeletal and Skin Diseases. Available at: https://www.niams.nih.gov/health-topics/psoriasis Accessed: November 2025.
15 EU SmPC: European Medicines Agency. Ilumetri Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/ilumetri-epar-product-information_en.pdf. Accessed: November 2025.
16 EU SmPC: European Medicines Agency. Skyrizi Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/skyrizi-epar-product-information_en.pdf. Accessed: November 2025.
17 Electronic Medicines Compendium. EU SmPC: European Medicines Agency. Omvoh Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/omvoh-epar-product-information_en.pdf. Accessed: November 2025.
18 Schinocca, C. et al. Role of the IL-23/IL-17 Pathway in Rheumatic Diseases: An Overview. Front Immunol. 2021 Feb 22;12:637829. doi: 10.3389/fimmu.2021.637829.
19 Atreya, R, et al. Guselkumab binding to CD64+ IL-23–producing myeloid cells enhances potency for neutralizing IL-23 signaling. J Crohns Colitis. 2024;18(suppl):S470.
20 Kreuger, JG, et al. IL-23 past, present, and future: a roadmap to advancing IL-23 science and therapy. Front Immunol. 2024 Apr 15;15:1331217. doi: 10.3389/fimmu.2024.1331217.
21 US Food and Drug Administration. TREMFYA® Prescribing Information. Available at: https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/TREMFYA-pi.pdf. Accessed: November 2025.
22 The Canadian Agency for Drugs & Technologies in Health. TREMFYA® prescribing information. Available at: https://pdf.hres.ca/dpd_pm/00042101.PDF. Accessed: November 2025.
23 Japan Pharmaceuticals and Medical Devices Agency. Tremfya report on the deliberation results. Available at: https://www.pmda.go.jp/files/000234741.pdf. Accessed: November 2025.
CP-550778
December 2025
For European and UK medical and trade media only
