Johnson & Johnson announces new TREMFYA® (guselkumab) data showing durable 3-year outcomes in moderate to severe Crohn’s disease and expanding evidence in perianal fistula

New guselkumab 3-year as-observed data show clinical remission rates of 94% (172/183 patients) and endoscopic remission rates of 52% (89/172 patients) in adults with moderate to severe Crohn’s disease in the 100 mg q8w dose group¹

FUZION data show combined fistula remission was maintained through Week 48 across both maintenance dose regimens, including an increase from 28% at Week 24 to 35% at Week 48 in the 100 mg q8w dose group²

Together, these findings expand the evidence for guselkumab across long-term disease management and one of the most difficult-to-treat manifestations of Crohn’s disease^1,2

High Wycombe, UK (19 October 2026) – Johnson & Johnson today announced new data that further expands the clinical evidence supporting TREMFYA® (guselkumab) in Crohn’s disease (CD) at the 2026 United European Gastroenterology Week (UEG Week). Research from the Phase 3 GALAXI studies shows durable efficacy and a consistent safety profile for guselkumab through three years (Week 144) of maintenance treatment in adults with moderately to severely active CD, reinforcing its long-term benefit in this chronic, progressive disease.¹ Additionally, late-breaking one-year results from the Phase 3 FUZION study showed that guselkumab maintained or improved fistula remission through Week 48 in adults with CD with perianal fistula.²

Experts and company perspectives

“At Johnson & Johnson, our ambition is to address the challenges faced by people living with conditions such as Crohn’s disease. Our patient-first approach is underpinned by continued scientific research, including the GALAXI and FUZION studies presented at this year’s UEG Week,” said Dr John Fleming, Country Medical Director, UK at Johnson & Johnson Innovative Medicine. “The findings from both studies provide important new insights into the durable efficacy of guselkumab in Crohn’s disease. In addition to guselkumab providing sustained remission over three years, further confirming its long-term benefit, it has also demonstrated encouraging findings in adults with Crohn’s disease with perianal fistulas, which impact one third of all people diagnosed with the condition. Overall, the data presented at UEGW 2026 further solidifies guselkumab’s position as a potential effective treatment option for people living with Crohn’s disease and their healthcare providers.”

“We know that for many people with fistulising Crohn’s disease, finding an effective long-term treatment can be a real struggle. The condition can have a major impact on everyday life, so it’s encouraging to see findings like these,” said Marianne Radcliffe, CEO of Crohn’s & Colitis UK. “They bring hope that more people may be able to achieve fistula healing and improve their overall wellbeing. We welcome further research into new treatment options and look
forward to seeing what future studies reveal.”

“Perianal fistula remains one of the most debilitating complications of Crohn’s disease, where achieving durable disease control beyond symptom improvement is a challenge,” said Professor Ailsa Hart, Ph.D., Director of St Mark’s Hospital Inflammatory Bowel Disease Research, Consultant Gastroenterologist, and study investigator.ᶠ “The latest findings from the FUZION study show that patients treated with guselkumab maintained or improved upon the clinical benefits observed at Week 24, providing encouraging evidence for its use in this patient population.”

The ongoing burden of Crohn’s disease

Crohn’s disease is one of the two main forms of inflammatory bowel disease (IBD), affecting at least 1 in every 323 people in the UK.³ Guselkumab is an IL-23p19 subunit inhibitor approved in IBD that blocks IL-23 and binds to CD64, a receptor on cells that produce IL-23.⁴ Findings for the unique mechanism of action are limited to in vitro studies, and the clinical significance of this finding is not known.⁵ IL-23 is a cytokine secreted by activated monocytes/macrophages and dendritic cells that is known to be a driver of immune-mediated diseases, including Crohn’s disease.⁶

Three-year GALAXI results support the known efficacy and safety profile of guselkumab

Patients in the GALAXI 2 and 3 studies received intravenous induction followed by one of two guselkumab maintenance dosing regimens: 100 mg administered subcutaneously every eight weeks (q8w; n=286) or 200 mg administered subcutaneously every four weeks (q4w; n=296).¹ In total, 432/582 patients continued treatment through Week 144.¹ Participants who discontinued, lacked Week 144 data or underwent dose adjustment were not included.¹ Across both regimens, clinical and endoscopic remission were maintained through three years of treatment.¹ At Week 144 in the long-term extension (LTE), the data show:^a

• 94% (172/183) of patients receiving guselkumab 100 mg q8w and 91% (185/204) receiving guselkumab 200 mg q4w achieved clinical remission.^b,1
• 89% (162/183) of patients receiving guselkumab 100 mg q8w and 88% (179/204) receiving guselkumab 200 mg q4w achieved 90-day corticosteroid-free clinical remission.¹
• 52% (89/172) of patients receiving guselkumab 100 mg q8w and 61% (119/195) receiving guselkumab 200 mg q4w achieved endoscopic remission.^c,1
• 74% (432/582) of guselkumab-treated patients remained on treatment through three years.¹

Safety findings through Week 144 were consistent with the known safety profile of guselkumab in Crohn’s disease.¹ Common adverse reactions associated with guselkumab include respiratory tract infections, diarrhoea, headache, rash, arthralgia, increased transaminases and injection site reactions.⁵ The three-year results demonstrate durable clinical, corticosteroid-free and endoscopic remission across both guselkumab maintenance regimens.¹

New FUZION 48-week analysis extends evidence in Crohn’s disease with perianal fistula

The 48-week findings showed that combined fistula remission, which incorporates both clinical and radiological assessment, was maintained or improved in both guselkumab maintenance regimens from Week 24.² Among patients initially randomised to the guselkumab 100 mg q8w maintenance regime (n=113), combined fistula remission^d further increased from 28% at Week 24 to 35% at Week 48.^2,10 Results at Week 48 include patients who underwent blinded dose adjustment to guselkumab 200 mg every four weeks at Week 24 (n=55).² Similar findings were observed for rates of clinically assessed fistula remission.^e,2

Results among patients receiving guselkumab 200 mg every 4 weeks (q4w; n=115) remained consistent through Week 48 (combined fistula remission - 27% at Week 24 to 26% at Week 48).^2,7 Similar findings were observed for clinically assessed fistula remission.² Overall, 90% of all randomised patients, which included both bio-naïve and bioexperienced patients, completed treatment through Week 48.²

Safety findings through Week 48 were consistent with the known safety profile of guselkumab in Crohn’s disease.² Common adverse reactions associated with guselkumab include respiratory tract infections, diarrhoea, headache, rash, arthralgia, increased transaminases and injection site reactions.⁴

These results reinforce the previously shared Week 24 results from FUZION,^2,7 making guselkumab the only IL-23 inhibitor to demonstrate efficacy in a dedicated, randomised, placebo-controlled trial in patients with Crohn’s disease with perianal fistula, one of the most difficult-to-treat manifestations of the disease.²

Together, the GALAXI and FUZION findings presented at UEG Week 2026 underscore the growing breadth of evidence supporting guselkumab across Crohn’s disease, from sustained long-term remission in moderately to severely active disease to efficacy in patients living with complex fistulising complications.^1,2

#ENDS#

Editor’s notes

a. The Week 144 clinical remission, 90-day corticosteroid-free clinical remission and endoscopic remission results above represent the as observed data for the three-year GALAXI analysis.¹ The observed analysis set included participants who entered the LTE, received ≥1 partial or complete study drug dose during the LTE, remained on treatment, and had data available at Week 144; participants who had a dose adjustment were not included.¹
b. Clinical remission was defined as a CDAI score <150.¹
c. Endoscopic remission was defined as an SES-CD ≤4, with a ≥2-point reduction and no subscore >1 on any subcomponent.¹
d. Combined fistula remission was defined as 100% closure of all external openings without development of new fistulas or abscesses and without any drainage by external openings, occurring spontaneously or after gentle finger compression and absence of collections >2cm of the perianal fistulas in at least two of three dimensions, confirmed by a blinded central review of the MRI^.2
e. Clinically assessed fistula remission was defined as: 100% closure of all treated external openings without development of new fistulas or abscesses and without any drainage by external openings, occurring spontaneously or after gentle finger compression.²
f. Professor Ailsa Hart is a paid consultant for Johnson & Johnson. She has not been compensated for any media work.

About the GALAXI programme (EudraCT 2017-002195-13)⁸

GALAXI is a double-blind, placebo-controlled, active-controlled (ustekinumab), parallel group, global, multicentre Phase 2/3 programme designed to evaluate the efficacy and safety of guselkumab in participants with moderately to severely active Crohn’s disease with inadequate response/intolerance to conventional therapies (immunomodulators, corticosteroids) and/or biologics (infliximab, adalimumab, certolizumab pegol, vedolizumab).⁹ GALAXI includes a Phase 2 dose-ranging study (GALAXI 1) and two independent, identically designed confirmatory Phase 3 studies (GALAXI 2 and 3, n=1021).⁹ Each GALAXI study employed 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.^4,9,10 Clinical outcomes include clinical remission (Crohn’s Disease Activity Index [CDAI] <150), while endoscopic outcomes include endoscopic response and endoscopic remission as assessed using the Simple Endoscopic Score for Crohn’s Disease (SES-CD).⁹

About the FUZION study (EudraCT 2021-000491-10)¹¹

FUZION is a randomised, placebo-controlled, double-blind, multicentre, Phase 3 study designed to evaluate the efficacy and safety of guselkumab in adults with Crohn’s disease with perianal fistula.¹⁰ Patients enrolled in the study had one or more active draining perianal fistulas confirmed by blinded central MRI review, Crohn’s Disease Activity Index [CDAI] <350, and inadequate response to oral corticosteroids, azathioprine, 6-mercaptopurine, methotrexate, or up to 2 advanced therapy classes.7,10 Patients were randomised 2:2:1 to receive guselkumab 200 mg intravenous (IV) induction at Weeks 0, 4, 8 followed by guselkumab 100 mg subcutaneous (SC) maintenance therapy every 8 weeks (q8w); or guselkumab 200 mg IV infusion at Weeks 0, 4, 8 followed by guselkumab 200 mg SC maintenance therapy every 4 weeks (q4w); or placebo.⁷

About Crohn’s disease

Crohn’s disease is one of the two main forms of inflammatory bowel disease, which affects an estimated two million people across Europe.11 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.¹² Symptoms of Crohn’s disease can vary, but often include abdominal pain and tenderness, frequent diarrhoea, rectal bleeding, weight loss, and fever.¹³ There is currently no cure for Crohn’s disease.¹⁴

About guselkumab

Developed by Johnson & Johnson, guselkumab is the first approved fully-human, IL-23p19 subunit inhibitor that blocks IL-23 and binds to CD64, a receptor on cells that produce IL-23.4,16,17,18 Findings for the unique mechanism of action are limited to in vitro studies, and the clinical significance of this finding is not known.⁸

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.⁴ It is also approved in the EU and U.S. 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 JAK inhibitor 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.^18,19

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); uncommon: herpes simplex infections, tinea infections, gastroenteritis, urticaria, decreased neutrophil count. Rare: hypersensitivity, anaphylaxis.⁴

Please refer to the Summary of Product Characteristics for full prescribing information for guselkumab: https://mhraproducts4853.blob.core.windows.net/docs/743759e6e75be21b7f541753da7d32c9ce200e53

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 https://www.jnj.com/innovativemedicine/uk
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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 behaviour 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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CP-606431 | October 2026