Phase 3 ASTRO study achieves primary and all secondary endpoints at Week 12 in ulcerative colitis patients
The first SC induction data for an IL-23 inhibitor show statistically significant and clinically meaningful improvements across clinical and endoscopic measures versus placebo, consistent with IV induction
Beerse, Belgium (February 21, 2025) – Johnson & Johnson today announced data from the Phase 3 ASTRO study of TREMFYA® (guselkumab) subcutaneous (SC) induction therapy in adults with moderately to severely active ulcerative colitis (UC) at the 20th Congress of the European Crohn’s and Colitis Organization (ECCO). Study findings through Week 12 showed statistically significant and clinically meaningful improvements compared to placebo across all clinical and endoscopic measures.1
“The Week 12 results from the ASTRO study build on data from the QUASAR study demonstrating that both guselkumab subcutaneous and intravenous induction achieved clinically differentiated results in patients with moderately to severely active UC,” 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.a “The flexibility of a fully subcutaneous treatment regimen would be a welcome option for many patients, especially those with busy and active lifestyles.”
At Week 12, significantly greater proportions of patients treated with guselkumab 400 mg SC induction compared with patients receiving placebo achieved all of the following multiplicity-controlled endpoints1:
• Clinical remission (27.6% vs 6.5%; P<0.001)b
• Clinical response (65.6% vs 34.5%; P<0.001)c
• Endoscopic improvement (37.3% vs 12.9%; P<0.001)d
In prespecified analyses of subpopulations defined by prior advanced therapy treatment status, guselkumab demonstrated statistically significant results across endpoints in both naïve and experienced biologic, Janus kinase inhibitor, and/or sphingosine 1-phosphate inhibitor patients.1
Safety data from the ASTRO study were consistent with the established safety profile of guselkumab.1 The proportions of patients with ≥1 adverse event (AE) (39.4% of guselkumab-treated patients vs 52.5% with placebo), serious AE (2.5% of guselkumab-treated patients vs 7.9% with placebo), or AE leading to treatment discontinuation (1.1% of guselkumab-treated patients vs 5.8% with placebo) were similar across the guselkumab and placebo treatment groups.1
“We aim to offer treatment options for patients with IBD that allow them to effectively manage their disease while also meeting the daily demands of life. These results further underscore the potential of guselkumab to transform the UC treatment paradigm,” said Esi Lamousé-Smith, M.D., Ph.D., Vice President, Gastroenterology Disease Area Lead, Immunology, Johnson & Johnson Innovative Medicine. “Pending approval, guselkumab would be the first IL-23 inhibitor with a fully subcutaneous induction and maintenance regimen, increasing options for both patients and healthcare providers.”
“The findings from the ASTRO study highlight guselkumab’s potential to bring meaningful improvements to the lives of individuals with UC,” stated Mark Graham, Senior Director, Therapeutic Area Lead, Immunology, Johnson & Johnson Innovative Medicine EMEA. “Subcutaneous induction therapy with guselkumab could help empower people living with UC to actively manage their symptoms while providing choice and simplicity for both patients and their healthcare providers.”
Johnson & Johnson has submitted regulatory applications seeking the approval of guselkumab for the treatment of adults with moderately to severely active Crohn’s disease (CD) & UC in Europe.
Editor’s Notes:
a. Prof. Peyrin-Biroulet is a paid consultant for Johnson & Johnson. He has not been compensated for any media work.
b. Clinical remission: 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.1
c. Clinical response was defined as a decrease from induction baseline in the modified Mayo score by ≥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 1.1
d. Endoscopic improvement was defined as an endoscopy subscore of 0 or 1 with no friability present on the endoscopy.1
ABOUT THE ASTRO STUDY (EudraCT 2022-000365-41)2
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.3 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.3 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 program which established the efficacy and safety profile of IV induction followed by SC maintenance therapy in patients with moderate to severely active UC.3,4
ABOUT THE QUASAR PROGRAM (EudraCT 2018-004002-25)5
QUASAR is a randomised, double-blind, placebo-controlled, parallel group, multicentre, Phase 2b/3 program designed to evaluate the efficacy and safety of guselkumab 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 JAK inhibitors (tofacitinib).4 QUASAR included a Phase 2b dose-ranging induction study, a confirmatory Phase 3 induction study, and a Phase 3 randomised withdrawal maintenance study.4 In the Phase 3 induction study, patients received either guselkumab 200 mg or placebo by intravenous infusion at Week 0, Week 4, and Week 8. 4 In the Phase 3 maintenance study, patients received a subcutaneous maintenance regimen of either guselkumab 100 mg every 8 weeks, guselkumab 200 mg every 4 weeks, or placebo.4
ABOUT ULCERATIVE COLITIS
Ulcerative colitis (UC) 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.6 It is the result of the immune system’s overactive response.6 Symptoms vary but may typically include loose and more urgent bowel movements, rectal bleeding or bloody stool, persistent diarrhea, abdominal pain, loss of appetite, weight loss, and fatigue.7 People with UC also have increased rates of depression.8
ABOUT GUSELKUMAB
Developed by Johnson & Johnson, guselkumab is the first approved fully-human monoclonal antibody that selectively binds to the p19 subunit of IL-23 and inhibits its interaction with the IL-23 receptor.9 IL-23 is an important driver of the pathogenesis of inflammatory diseases.10 Findings for dual-acting are limited to in vitro studies that demonstrate guselkumab binds to CD64, which is expressed on the surface of IL-23 producing cells in an inflammatory monocyte model.11 The clinical significance of this finding is not known.
Guselkumab is approved in 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.9 It is also approved in the U.S,12 Canada,13 Japan14 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, 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).9
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.janssen.com/EMEA or at https://www.janssen.com/johnson-johnson-innovative-medicine. 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 materialize, 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 Annual Report on Form 10-K for the fiscal year ended December 31, 2023, 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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Source: Johnson & Johnson