Guselkumab offers the flexibility of self-administration from the start of treatment in both ulcerative colitis (UC) and Crohn’s disease (CD),1,2,3 providing the simplicity of a fully subcutaneous dose regimen in both diseases2,4
Guselkumab achieved significant rates of clinical remissiona and endoscopic healingb versus placebo at Week 12 with a subcutaneous induction dose regimen in UC,2,5 consistent with intravenous induction2,6
Beerse, Belgium (October 24, 2025) – Johnson & Johnson today announced that the European Commission (EC) has approved a subcutaneous (SC) induction dose regimen of TREMFYA® (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic treatment.2 With this approval, guselkumab is the first IL-23 inhibitor7,8,9,10 to offer both SC and intravenous (IV) induction dose options for the treatment of UC and CD.2 The combined incidence of CD and UC is estimated to affect up to approximately 3 million people across Europe, and that number is increasing every year.11
Guselkumab is the first approved fully-human, dual-acting IL-23p19 subunit inhibitor that blocks IL-23 and binds to CD64,c a receptor on cells that produce IL-23.2,7,8,9,10 IL-23 is a cytokine secreted by activated monocyte/macrophages and dendritic cells that is known to be a driver of immune-mediated diseases including UC and CD.10,12 Findings for dual-acting are limited to in vitro studiesd and the clinical significance of this finding is not known.12,13
“Historically, IL-23 inhibitors have required initial IV infusions,7,8,9 which can create barriers when starting treatment and inconveniences for some patients and physicians,” said Laurent Peyrin-Biroulet, M.D., Ph.D., Head of the Inflammatory Bowel Disease (IBD) Unit at Nancy University Hospital in France and study investigator. “With today’s approval, UC patients and healthcare teams now have the option of self-administered subcutaneous injections for their induction period,1,2 offering similar established clinical and endoscopic outcomes, marking a significant advancement in managing this chronic inflammatory disease.”
The UC SC induction dose regimen approval is based on results from the Phase 3 ASTRO trial, which employed a treat-through design to evaluate the efficacy and safety of guselkumab SC induction therapy in adults with moderately to severely active UCe who had an inadequate response or intolerance to conventional therapy and advanced therapies.1,2,5 All multiplicity-controlled primary and secondary endpoints at Week 12 demonstrated statistically significant and clinically meaningful improvements with guselkumab 400 mg SC induction dose compared to placebo across all clinical and endoscopic measures.1,2
- Significantly greater proportions of patients treated with guselkumab every four weeks (q4w) achieved clinical remission (28% vs. 6%; P<0.001) and endoscopic healing (37% vs. 13%; P<0.001) at Week 12 vs. those treated with placebo.2
- Results were consistent with the results obtained with the currently approved 200 mg IV induction dose regimen,6 which demonstrated clinical remission (23% vs. 8%; P<0.001) and endoscopic healing (27% vs. 11%; P<0.001) vs. those treated with placebo.2
- Guselkumab SC induction dose followed by SC maintenance dose (100 mg every eight weeks (q8w) or 200 mg q4w) at Week 24 also demonstrated statistically significant and clinically meaningful improvements in clinical remission (100 mg q8w: 35%, 200 mg q4w: 36% vs. 9%; P<0.001) and endoscopic healing (100 mg q8w: 40%, 200 mg q4w: 45% vs. 12%; P<0.001) vs. those treated with placebo.2
- Safety results were consistent with the known safety profile of guselkumab in approved indications, and in line with results seen from the GRAVITI study which evaluated SC induction administration of guselkumab in CD.2
“With today’s approval, guselkumab is the first IL-23 inhibitor to offer inflammatory bowel disease patients robust clinical and endoscopic results with a fully subcutaneous induction dose regimen,2,7,8,9,10 now across both ulcerative colitis and Crohn’s disease,” said Mark Graham, Senior Director, Therapeutic Area Head, Immunology, Johnson & Johnson Innovative Medicine EMEA. “This supports a tailored treatment approach that meets individual needs and lifestyles, demonstrating Johnson & Johnson’s commitment to innovating to improve the lives of people living with chronic immune-mediated diseases, including inflammatory bowel disease.”
In April 2025, guselkumab received EC approval for UC which included a 200 mg intravenous (IV) induction regimen at Weeks 0, 4, and 8 followed by either 100 mg q8w or 200 mg SC q4w maintenance dose regimens.6 In addition, guselkumab received EC approval in CD in May 2025 which included both SC and IV dose options for induction and SC maintenance treatment.3 The 400 mg SC induction dose regimen in UC provides an additional option to IV administration and offers flexibility,1 with several studies indicating a preference for SC over IV administration.4,14,15,16,17
Editor’s Notes:
a) Clinical remission is defined as a Mayo stool frequency subscore of 0 or 1 and not increased from baseline, a Mayo rectal bleeding subscore of 0, and a Mayo endoscopy subscore of 0, or 1 with no friability present on the endoscopy.2
b) Endoscopic healing is defined as an endoscopy subscore of 0, or 1 with no friability present on the endoscopy.2
c) CD64+ cells are the predominant source of IL-23 in CD. Cells not expressing CD64 may also contribute to IL-23 production but to a lesser extent.12,13
d) Based on in vitro studies in an inflammatory monocyte model.13
e) Moderately to severely active UC was defined as a modified Mayo score (mMS) between 5 and 9 and a centrally reviewed endoscopy (ES) score of 2 or 3.2
ABOUT THE ASTRO STUDY (EudraCT 2023-504719-34)5
ASTRO is a randomised, double-blind, placebo-controlled, parallel-group, multicentre, treat-through Phase 3 study designed to evaluate the efficacy and safety of guselkumab SC induction therapy (400 mg at Weeks 0, 4, and 8) in adults with moderately to severely active ulcerative colitis who had an inadequate response or intolerance to conventional therapy (e.g., thiopurines or corticosteroids), prior biologics (TNF antagonists or vedolizumab) and/or ozanimod or approved JAK inhibitors.5,18 Patients (n = 418) were randomised 1:1:1 to receive guselkumab 400 mg SC induction dose at Weeks 0, 4 and 8 followed by guselkumab 100 mg SC every eight weeks (q8w); or guselkumab 400 mg SC induction dose at Weeks 0, 4 and 8, followed by guselkumab 200 mg SC every four weeks (q4w); or placebo.1,2,5 The maintenance dose regimens in ASTRO (200 mg SC q4w and 100 mg SC q8w) are the same as those evaluated in the Phase 3 QUASAR programme which established the efficacy and safety profile of IV induction followed by SC maintenance therapy in patients with moderate to severely active UC.1,18,19
ABOUT THE QUASAR PROGRAMME (EudraCT 2018-004002-25)20
QUASAR is a randomised, double-blind, placebo-controlled, parallel group, multicentre, seamless Phase 2b/3 programme designed to evaluate the efficacy and safety of guselkumab, a selective IL-23 inhibitor, in adult patients with moderately to severely active ulcerative colitis who experienced an inadequate response or who demonstrate intolerance to conventional therapy (e.g., thiopurines or corticosteroids), other biologics and/or JAK inhibitors (i.e., tumor necrosis factor [TNF]-alpha antagonists, vedolizumab, and/or JAK inhibitors (tofacitinib)).20 QUASAR includes a Phase 2b dose-ranging induction study, a confirmatory Phase 3 induction study, and a Phase 3 randomised withdrawal maintenance study, through a total of five years.19,21 Efficacy, safety, pharmacokinetics, immunogenicity, and biomarkers are assessed at specified time points.20,21 Full results are available in The Lancet.19
ABOUT THE GRAVITI PHASE 3 STUDY (EudraCT 2020-006165-11)22
GRAVITI is a double-blind, placebo-controlled, parallel group, global, multicentre study to evaluate the efficacy and safety of guselkumab subcutaneous induction therapy in 347 participants with moderately to severely active Crohn’s disease with inadequate response or failure to tolerate previous conventional therapy (corticosteroids or immunomodulators) or biologic therapy (infliximab, adalimumab, certolizumab pegol, vedolizumab).2,22 The study has a treat-through design in which participants remained on the treatment to which they were initially randomised and includes a long-term extension that will assess clinical, endoscopic, and safety outcomes with guselkumab through a total of five years.2,23
ABOUT ULCERATIVE COLITIS
Ulcerative colitis is a chronic disease of the large intestine, also known as the colon, in which the lining of the colon becomes inflamed and develops tiny open sores, or ulcers, that produce pus and mucus.24 It is the result of the immune system’s overactive response.24 Symptoms vary but may typically include loose and more urgent bowel movements, rectal bleeding or bloody stool, persistent diarrhoea, abdominal pain, loss of appetite, weight loss, and fatigue.25 Ulcerative colitis patients also have increased rates of depression.26
ABOUT CROHN’S DISEASE
Crohn’s disease is a chronic inflammatory condition of the gastrointestinal tract with no known cause, but the disease is associated with abnormalities of the immune system that could be triggered by a genetic predisposition, diet, or other environmental factors.27 Symptoms of Crohn’s disease can vary, but often include abdominal pain and tenderness, frequent diarrhoea, rectal bleeding, weight loss, and fever.28 There is currently no cure for Crohn’s disease.29
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-23.2,7,8,9,10 Findings for dual-acting are limited to in vitro studies and the clinical significance of this finding is not known.12,13
Guselkumab is approved in the EU for the treatment of moderate to severe plaque psoriasis (Pso) in adults who are candidates for systemic therapy and for the treatment of active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modifying anti-rheumatic drug therapy.2 It is also approved for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response, or were intolerant to either conventional therapy, or a biologic treatment2 and for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic treatment.2 It is also approved in the U.S,30 Canada,31 Japan32 and a number of other countries for the treatment of adults with moderate-to-severe psoriasis 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.
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, and injection site reactions were common (≥1 to <10 percent); and herpes simplex infections, tinea infections, gastroenteritis, decreased neutrophil count, hypersensitivity, anaphylaxis, urticaria and rash were uncommon ADRs (≥0.1 percent to <1 percent).2
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 materialize, 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 behavior 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.
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1 J&J Data on file (RF-474846). Janssen Research & Development Clinical Overview. Treatment of Adult Patients With Moderately to Severely Active Ulcerative Colitis – SC Induction.
2 J&J Data on file (RF-484240). European Medicines Agency. Updated TREMFYA Summary of Product Characteristics.
3 Johnson & Johnson Innovative Medicine. 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. Available at: 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. Accessed October 2025.
4 Bittner, B, et al. Subcutaneous Administration of Biotherapeutics: An Overview of Current Challenges and Opportunities. BioDrugs. 2018;32(5), 425–440. Available at: https://doi.org/10.1007/s40259-018-0295-0. Accessed October 2025.
5 EU Clinical Trials Register. A Phase 3 Study to Evaluate the Efficacy and Safety of Guselkumab Subcutaneous Induction Therapy in Participants with Moderately to Severely Active Ulcerative Colitis (ASTRO). Identifier: EudraCT 2023-504719-34-00. Available at: https://euclinicaltrials.eu/ctis-public/view/2023-504719-34-00. Accessed October 2025.
6 Johnson & Johnson Innovative Medicine. TREMFYA® (guselkumab) receives European Commission approval for adults with moderately to severely active ulcerative colitis, strengthening Johnson & Johnson’s leadership in inflammatory bowel disease. Available at: https://innovativemedicine.jnj.com/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. Accessed October 2025.
7 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 October 2025.
8 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 October 2025.
9 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 October 2025.
10 Schinocca, C. et al. Role of the IL-23/IL-17 pathway in rheumatic diseases: An overview. Frontiers in Immunology. 2021 Feb 22;12:321. Available at: doi.org/10.3389/fimmu.2021.637829. Accessed October 2025.
11 Kumar, A, et al. Crossing barriers: the burden of inflammatory bowel disease across Western Europe. Therapeutic advances in gastroenterology. 2023;16:17562848231218615. Available at: https://pmc.ncbi.nlm.nih.gov/articles/PMC10748558/. Accessed October 2025.
12 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.
13 Kreuger, JG, et al. Il-23 past, present, and future: a roadmap to advancing IL-23 science and therapy. Front Immunol. 2024; 15:1331217. Available at: https://doi.org/10.3389/fimmu.2024.1331217. Accessed October 2025.
14 De Cock, E, et al. Time Savings with Rituximab Subcutaneous Injection versus Rituximab Intravenous Infusion: A Time and Motion Study in Eight Countries. PloS One. 2016;11(6), e0157957. Available at: https://doi.org/10.1371/journal.pone.0157957. Accessed October 2025.
15 Gardulf A. Immunoglobulin treatment for primary antibody deficiencies: advantages of the subcutaneous route. BioDrugs. 2007;21(2), 105–116. Available at: https://doi.org/10.2165/00063030-200721020-00005. Accessed October 2025.
16 Tetteh, E. K., and Morris, S. Evaluating the administration costs of biologic drugs: development of a cost algorithm. Health economics review. 2014;4(1), 26. Available at: https://doi.org/10.1186/s13561-014-0026-2. Accessed October 2025.
17 Usmani, S. Z, et al. Greater treatment satisfaction in patients receiving daratumumab subcutaneous vs. intravenous for relapsed or refractory multiple myeloma: COLUMBA clinical trial results. Journal of cancer research and clinical oncology. 2021;147(2), 619–631. Available at: https://doi.org/10.1007/s00432-020-03365-w. Accessed October 2025.
18 Janssen Research & Development. Clinical Protocol. A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Guselkumab Subcutaneous Induction Therapy in Participants with Moderately to Severely Active Ulcerative Colitis.
19 Rubin, D. et al. Guselkumab in Patients With Moderately to Severely Active Ulcerative Colitis: QUASAR Phase 3 Double-Blind, Randomised, Placebo-Controlled Induction and Maintenance Studies. The Lancet. December 2024. Available at: https://doi.org/10.1016/S0140-6736(24)01927-5. Accessed October 2025.
20 EU Clinical Trials Register: Clinicaltrialsregister.eu. A Phase 2b/3, randomised, double-blind, placebo-controlled, parallel-group, multicentre protocol to evaluate the efficacy and safety of guselkumab in participants with moderately to severely active ulcerative colitis (QUASAR). Identifier: 2018-004002-25. Available at: https://www.clinicaltrialsregister.eu/ctr-search/trial/2018-004002-25/SE/. Accessed October 2025.
21 National Institutes of Health: ClinicalTrials.gov. A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis. Protocol CNTO1959UCO3001; Phase 2b/3 Amendment 3. Available at: https://cdn.clinicaltrials.gov/large-docs/45/NCT04033445/Prot_000.pdf. Accessed October 2025.
22 EU Clinical Trials Register. Clinicaltrialsregister.eu. A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Guselkumab Subcutaneous Induction Therapy in Participants with Moderately to Severely Active Crohn’s Disease (GRAVITI). Identifier: 2020-006165-11. Available at: https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-006165-11/ES. Accessed October 2025.
23 National Institutes of Health: ClinicalTrials.gov. Janssen Research & Development Clinical Protocol. A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Guselkumab Subcutaneous Induction Therapy in Participants With Moderately to Severely Active Crohn’s Disease. Available at: https://cdn.clinicaltrials.gov/large-docs/49/NCT05197049/Prot_000.pdf. Accessed October 2025.
24 Crohn’s & Colitis Foundation. What is ulcerative colitis? Available at: https://www.crohnscolitisfoundation.org/what-is-ulcerative-colitis. Accessed October 2025.
25 NHS. Overview Ulcerative colitis. Available at: https://www.nhs.uk/conditions/ulcerative-colitis/. Accessed October 2025.
26 Barberio, B. et al. Prevalence of symptoms of anxiety and depression in patients with inflammatory bowel disease: a systematic review and meta-analysis. The Lancet Gastroenterology & Hepatology. 2021 May;6(5):359-370. Available at: https://www.thelancet.com/journals/langas/article/PIIS2468-1253(21)00014-5/abstract. Accessed October 2025.
27 Crohn’s & Colitis Foundation. Causes of Crohn’s disease. Available at: https://www.crohnscolitisfoundation.org/what-is-crohns-disease/causes. Accessed October 2025.
28 Crohn’s & Colitis Foundation. Signs and symptoms of Crohn’s disease. Available at: https://www.crohnscolitisfoundation.org/what-is-crohns-disease/symptoms. Accessed October 2025.
29 NHS. Crohn’s Disease Treatment. Available at: https://www.nhs.uk/conditions/crohns-disease/treatment/. Accessed October 2025.
30 US Food and Drug Administration. TREMFYA® Prescribing Information. Available at: https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/TREMFYA-pi.pdf. Accessed October 2025.
31 The Canadian Agency for Drugs & Technologies in Health. TREMFYA® prescribing information. Available at: https://pdf.hres.ca/dpd_pm/00042101.PDF. Accessed October 2025.
32 Japan Pharmaceuticals and Medical Devices Agency. Tremfya report on the deliberation results. Available at: https://www.pmda.go.jp/files/000234741.pdf. Accessed October 2025.
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