Beerse, Belgium (6 May 2025) – Johnson & Johnson today announced new data from the Phase 3 ASTRO study evaluating TREMFYA® (guselkumab) subcutaneous (SC) induction therapy in adults with moderately to severely active ulcerative colitis (UC). The ASTRO Week 24 data builds on the Week 12 SC induction data that was presented at ECCO 2025 and showed statistically significant and clinically meaningful improvements compared to placebo across all controlled clinical and endoscopic endpoints.1,2 These findings are among 24 abstracts highlighting Johnson & Johnson’s research being presented at Digestive Disease Week (DDW) 2025.
Data at Week 24 show patients treated with guselkumab 400 mg SC induction followed by SC maintenance dose regimens of either 100 mg every eight weeks (q8w) or 200 mg every four weeks (q4w) demonstrated statistically significant and clinically meaningful improvements across all clinical and endoscopic measures compared with patients receiving placebo.1
At Week 24: |
Guselkumab 100 mg q8w (N=139) |
Guselkumab 200 mg q4w (N=140) |
Placebo (N-139) |
Clinical remission (p<0.001)a |
35.3% |
36.4% |
9.4% |
Symptomatic remission (p<0.001)c |
54.7% |
50.0% |
25.2% |
Endoscopic improvement (p<0.001)b |
40.3% |
45.0% |
12.2% |
Clinical response (p<0.001)d |
63.3% |
61.4% |
30.9% |
“In the ASTRO study, subcutaneous induction treatment with guselkumab provided clinically meaningful remission in patients with ulcerative colitis and is consistent with results seen with intravenous induction,” said Professor Silvio Danese, Director, Gastroenterology and Endoscopy, IRCCS Ospedale San Raffaele and University Vita-Salute San Raffaele, Milan, Italy. “With two different induction options available, guselkumab could provide more choice for healthcare professionals and patients when considering their treatment approach.”
Furthermore, at Week 24, in prespecified analyses of subpopulations defined by prior advanced therapy treatment status, greater proportions treated with guselkumab, versus placebo, achieved endpoints in both naïve and experienced biologic, Janus kinase (JAK) inhibitor, and/or sphingosine 1-phosphate inhibitor groups.2 Safety data from the ASTRO study were consistent with the established safety profile of guselkumab.1,2,3
“These results highlight the potential of guselkumab to redefine UC care with a fully subcutaneous induction and maintenance dose regimen that offers an additional option with meaningful clinical and endoscopic improvements,” said Esi Lamousé-Smith, M.D., Ph.D., Vice President, Gastroenterology Disease Area Lead, Immunology, Johnson & Johnson Innovative Medicine. “Our goal is to reshape UC care and empower healthcare professionals with a potentially differentiated treatment that offers the option of subcutaneous induction from day one.”
“With 2.5 million people in Europe living with UC, guselkumab has the potential to improve their quality of life,”4 stated Mark Graham, Senior Director, Therapeutic Area Lead, Immunology, Johnson & Johnson Innovative Medicine EMEA. “The ASTRO study reinforces our commitment to delivering differentiated treatment options to patients and healthcare professionals, with the aim to support long-term disease management, and ultimately achieve remission.”
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,3,5,6,7,8,9 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.9
Guselkumab recently received approval from the European Commission (EC) to expand the marketing authorisation (MA) for the treatment of adults with moderately to severely active UC.10 The EC is also currently reviewing the CHMP positive opinion to expand MA for Crohn’s disease, which included both subcutaneous (SC) and intravenous (IV) options for induction treatment, and a decision is expected later this year.11
Editor’s Notes:
a. Clinical remission was 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 endoscopic subscore of 0, or 1 with no friability present on the endoscopy.3
b. Symptomatic remission per Mayo score is defined as a stool frequency subscore of 0 (normal number of stools) or 1 (1 to 2 stools more than normal) and a rectal bleeding subscore of 0 (no blood seen).3
c. Endoscopic improvement (healing) is defined as an endoscopy subscore of 0 or 1 with no friability present on the endoscopy.3
d. Clinical response is defined as decrease from baseline in the modified Mayo score by greater than or equal to (>=) 30 percent (%) and >=2 points, with either a >=1-point decrease from baseline in the rectal bleeding subscore or a rectal bleeding subscore of 0 or 1.3
e. Findings for dual-acting are limited to vitro studies and the clinical significance of this finding is not known.12
ABOUT THE ASTRO STUDY (EudraCT 2022-000365-41)13
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.14 Patients (n = 418) were randomised 1:1:1 to receive guselkumab 400 mg SC induction at Weeks 0, 4 and 8 followed by guselkumab 200 mg SC every 4 weeks (q4w); or guselkumab 400 mg SC induction at Weeks 0, 4 and 8, followed by guselkumab 100 mg SC every 8 weeks (q8w); or placebo.1,14 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.15
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.16 It is the result of the immune system’s overactive response.16 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.17 Ulcerative colitis patients also have increased rates of depression.18
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-23.3,5,6,7,8 Findings for dual-acting are limited to in vitro studies and the clinical significance of this finding is not known.12
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.3 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.3 It is also approved in the U.S,19 Canada,20 Japan21 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).3
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
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May 2025