Beerse, Belgium (5 May 2025) – Johnson & Johnson today announced new data from the TREMFYA® (guselkumab) Phase 3 QUASAR long-term extension (LTE) study in adults with moderately to severely active ulcerative colitis (UC). These data are among 24 abstracts highlighting Johnson & Johnson’s research being presented at Digestive Disease Week (DDW) 2025.
Data from the QUASAR LTE study demonstrate patients who had an induction baseline modified Mayo score of 5 to 9 randomised to guselkumab at maintenance Week 0 who continued to receive guselkumab treatment in the LTE, sustained clinical and endoscopic efficacy at Week 92a,1:
- 71% and 73.6% of the 303 patients treated with guselkumab 100 mg q8w (155) and 200 mg q4w (148), respectively were in clinical remissionb, with 99.5% of those patients remaining corticosteroid free for 8 or more weeks before Week 92.
- 41.9% (guselkumab 100 mg) and 43.9% (guselkumab 200 mg) of patients were in endoscopic normalisationc.
- Among patients achieving endoscopic improvementd at Week 44, 87.2% (guselkumab 100 mg q8w) and 80.2% (guselkumab 200 mg q4w) maintained endoscopic improvement at Week 92.
Patients treated with guselkumab sustained clinical and endoscopic remission regardless of prior biologic and/or JAK inhibitor treatment history.1 Safety data was consistent with the established safety profile of guselkumab.1,2
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.e,2,3,4,5,6,7 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.7
Guselkumab recently received approval from the European Commission (EC) to expand the market authorisation (MA) for the treatment of adults with moderately to severely active UC.8 The EC is also currently reviewing the CHMP positive opinion to expand MA for Crohn’s disease,9 which included both subcutaneous (SC) and intravenous (IV) options for induction treatment, and a decision is expected later this year.
Editor’s Notes:
a. Nonresponder imputation results. Data were analysed using two methods: nonresponder imputation’ (NRI) accounting for patients with treatment failure or missing data, and ‘as observed’. NRI results were consistent with as observed.1
b. Clinical remission was defined as a Mayo stool frequency subscore of 0 or 1 and not increased from induction baseline, a Mayo rectal bleeding subscore of 0, and a Mayo endoscopic subscore (MES) of 0 or 1.2
c. Also known as endoscopic remission. It is defined as a Mayo Endoscopic Subscore (MES) of 0.2
d. Endoscopic improvement (healing) was defined as a MES of 0 or 1.2
e. Findings for dual-acting are limited to in vitro studies and the clinical significance of this finding is not known.10
ABOUT THE QUASAR PROGRAMME (EudraCT 2018-004002-25)11
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)).12,13 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.13 Efficacy, safety, pharmacokinetics, immunogenicity, and biomarkers are assessed at specified time points.11 Full results are available in The Lancet.12
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.14,15 It is the result of the immune system’s overactive response.14 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.15 Ulcerative colitis patients also have increased rates of depression.16
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-23.2,3,4,5,6,7 Findings for dual-acting are limited to in vitro studies and the clinical significance of this finding is not known.10
Guselkumab is approved in the European Union 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. 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 treatment.2 It is also approved in the U.S,17 Canada,18 Japan19 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.
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).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 regarding 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 Janssen Research & Development, LLC, Janssen Biotech, Inc., Janssen-Cilag International NV and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including 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 or on request from Johnson & Johnson. None of Janssen Research & Development, LLC, Janssen Biotech, Inc., Janssen-Cilag International NV nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
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Investor contact:
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CP-517822
May 2025