Guselkumab: Pediatric First Approval

Boutet MA, Nerviani A, Gallo Afflitto G, et al. Role of the IL-23/IL-17 axis in psoriasis and psoriatic arthritis: the clinical importance of its divergence in skin and joints. Int J Mol Sci. 2018;19(2):530.

Article  PubMed  PubMed Central  Google Scholar 

Schett G, McInnes IB, Neurath MD. Reframing immune-mediated inflammatory diseases through signature cytokine hubs. N Engl J Med. 2021;385:628–39.

Article  CAS  PubMed  Google Scholar 

Al-Salama ZT, Scott LJ. Guselkumab: a review in moderate to severe plaque psoriasis. Am J Clin Dermatol. 2018;19(6):907–18.

Article  PubMed  Google Scholar 

Dragasevic S, Stankovic B, Sokic-Milutinovic A, et al. Importance of TLR9-IL23-IL17 axis in inflammatory bowel disease development: gene expression profiling study. Clin Immunol. 2018;197:86–95.

Article  CAS  PubMed  Google Scholar 

Johnson & Johnson. TREMFYA® (guselkumab): US prescribing information. 2025. https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/TREMFYA-pi.pdf. Accessed 11 Nov 2025.

Janssen-Cilag International NV. Tremfya: EU summary of product characteristics 2025. https://www.ema.europa.eu/en/medicines/human/EPAR/tremfya. Accessed 8 Jan 2026.

Janssen Biotech, Inc. Janssen announces U.S. FDA approval of TREMFYA™ (guselkumab) for the treatment of moderate to severe plaque psoriasis [media release]. 13 July 2017. https://www.jnj.com/media-center/press-releases/janssen-announces-us-fda-approval-of-tremfya-guselkumab-for-the-treatment-of-moderate-to-severe-plaque-psoriasis.

Janssen-Cilag International NV. European Commission approves TREMFYA® (guselkumab) for the treatment of moderate to severe plaque psoriasis in the European Union [media release]. 23 Nov 2017. http://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.

Janssen Pharmaceutical Companies of Johnson & Johnson. TREMFYA® (guselkumab) approved by U.S. Food and Drug Administration as the first selective interleukin (IL)-23 inhibitor for active psoriatic arthritis [media release]. 14 July 2020. https://www.prnewswire.com/news-releases/tremfya-guselkumab-approved-by-us-food-and-drug-administration-as-the-first-selective-interleukin-il-23-inhibitor-for-active-psoriatic-arthritis-301093009.html.

Janssen Pharmaceutical Companies of Johnson & Johnson. European Commission approves Janssen’s TREMFYA®▼ (guselkumab), a first-in-class treatment for active psoriatic arthritis (PsA) [media release]. 25 Nov 2020. https://www.investor.jnj.com/investor-news/news-details/2020/European-Commission-Approves-Janssens-TREMFYA-guselkumab-a-First-in-Class-Treatment-for-Active-Psoriatic-Arthritis-PsA-11-25-2020/default.aspx.

Johnson & Johnson. TREMFYA® (guselkumab) receives U.S. FDA approval for adults with moderately to severely active ulcerative colitis, strengthening Johnson & Johnson’s leadership in inflammatory bowel disease [media release]. 11 Sep 2024. https://www.jnj.com/media-center/press-releases/tremfya-guselkumab-receives-u-s-fda-approval-for-adults-with-moderately-to-severely-active-ulcerative-colitis-strengthening-johnson-johnsons-leadership-in-inflammatory-bowel-disease.

Johnson & Johnson. U.S. FDA approves TREMFYA® (guselkumab), the first and only IL-23 inhibitor offering both subcutaneous and intravenous induction options, for adult patients with moderately to severely active Crohn’s disease [media release]. 20 Mar 2025. https://www.jnj.com/media-center/press-releases/u-s-fda-approves-tremfya-guselkumab-the-first-and-only-il-23-inhibitor-offering-both-subcutaneous-and-intravenous-induction-options-for-adult-patients-with-moderately-to-severely-active-crohns-disease.

Johnson & Johnson. TREMFYA® (guselkumab) receives European Commission approval for adults with moderately to severely active ulcerative colitis, strengthening Johnson & Johnson’s leadership in inflammatory bowel disease [media release]. 25 Apr 2025. https://www.jnj.com/innovativemedicine/emea/newsroom/tremfya-guselkumab-receives-european-commission-approval-for-adults-with-moderately-to-severely-active-ulcerative-colitis-strengthening-johnson-johnsons-leadership-in-inflammatory-bowel-disease.

Johnson & Johnson. European Commission approves TREMFYA® (guselkumab), the first dual-acting IL-23 inhibitor offering both subcutaneous and intravenous induction options, for adult patients with moderately to severely active Crohn’s disease [media release]. 7 May 2025. https://innovativemedicine.jnj.com/emea/newsroom/european-commission-approves-tremfya-guselkumab-the-first-dual-acting-il-23-inhibitor-offering-both-subcutaneous-and-intravenous-induction-options-for-adult-patients-with-moderately-to-severely-active-crohns-disease.

Johnson & Johnson. U.S. FDA approves TREMFYA® (guselkumab) for the treatment of pediatric plaque psoriasis and active psoriatic arthritis, marking a first and only approval for an IL-23 inhibitor [media release]. 29 Sep 2025. https://www.jnj.com/media-center/press-releases/u-s-fda-approves-tremfya-guselkumab-for-the-treatment-of-pediatric-plaque-psoriasis-and-active-psoriatic-arthritis-marking-a-first-and-only-approval-for-an-il-23-inhibitor.

Johnson & Johnson. European Commission approves TREMFYA® (guselkumab) for the treatment of children with plaque psoriasis, marking the first paediatric indication for an IL-23 inhibitor [media release]. 19 Dec 2025. https://www.jnj.com/innovativemedicine/emea/media-center/press-releases/european-commission-approves-tremfya-guselkumab-for-the-treatment-of-children-with-plaque-psoriasis-marking-the-first-paediatric-indication-for-an-il-23-inhibitor.

Blauvelt A, Papp KA, Griffiths CE, et al. Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the continuous treatment of patients with moderate to severe psoriasis: results from the phase III, double-blinded, placebo- and active comparator-controlled VOYAGE 1 trial. J Am Acad Dermatol. 2017;76(3):405–17.

Article  CAS  PubMed  Google Scholar 

Reich K, Armstrong AW, Foley P, et al. Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the treatment of patients with moderate to severe psoriasis with randomized withdrawal and retreatment: results from the phase III, double-blind, placebo- and active comparator-controlled VOYAGE 2 trial. J Am Acad Dermatol. 2017;76(3):418–31.

Article  CAS  PubMed  Google Scholar 

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. Pediatr Drugs. 2025. https://doi.org/10.1007/s40272-025-00725-2.

Article  Google Scholar 

Schanberg LE, Mulugeta LY, Akinlade B, et al. Therapeutic development in polyarticular course juvenile idiopathic arthritis: extrapolation, dose selection, and clinical trial design. Arthritis Rheumatol. 2023;75(10):1856–66.

Article  PubMed  PubMed Central  Google Scholar 

US FDA. E11A pediatric extrapolation: guidance document. 2025. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/e11a-pediatric-extrapolation. Accessed 12 Dec 2024.

Deodhar A, Helliwell PS, Boehncke WH, et al. Guselkumab in patients with active psoriatic arthritis who were biologic-naive or had previously received TNFα inhibitor treatment (DISCOVER-1): a double-blind, randomised, placebo-controlled phase 3 trial. Lancet. 2020;395(10230):1115–25.

Article  CAS  PubMed  Google Scholar 

Mease PJ, Rahman P, Gottlieb AB, et al. Guselkumab in biologic-naive patients with active psoriatic arthritis (DISCOVER-2): a double-blind, randomised, placebo-controlled phase 3 trial. Lancet. 2020;395(10230):1126–36.

Article  CAS  PubMed  Google Scholar 

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):618–28.

Article  CAS  PubMed  Google Scholar 

Johnson & Johnson. Johnson & Johnson development pipeline. 2025. https://www.investor.jnj.com/pipeline/development-pipeline/. Accessed 2 Dec 2025.

Sinha V, Crauwels H, Obianom O, et al. Guselkumab pharmacokinetics and immunogenicity in pediatric psoriasis: phase 3 PROTOSTAR study [abstract no. 0432]. J Invest Dermatol. 2025;145(8):S74.

Article  Google Scholar 

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