TREMFYA® (guselkumab) long-term data show sustained clinical and endoscopic remission in ulcerative colitis through 3 years

Beerse, Belgium (February 23, 2026) – Johnson & Johnson today announced new long-term data from the QUASAR LTE study showing that TREMFYA^® (guselkumab) sustained clinical, endoscopic, and histologic outcomes through Week 140 in adults 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.

These data are among the 30 company-sponsored abstracts being presented at the European Crohn’s and Colitis Organisation (ECCO) 2026 conference.

Study results

At Week 140, 80.8% of patients taking guselkumab were in clinical remission^a. Additionally, 78.6% of patients achieved histo-endoscopic mucosal improvement (HEMI)^b, and 53.6% of patients were in endoscopic remission^c, respectively^d (average of GUS100 and GUS200) (as observed (AO) analysis).¹

Approximately 89% of eligible study participants combined completed treatment through Week 140. Nearly all participants who achieved clinical remission at Week 140 were corticosteroid-free for at least 8 weeks (AO).¹

The study also showed that of those in clinical remission at Week 44, 87.5% maintained clinical remission through Week 140 (average of GUS100 and GUS200) (AO). Efficacy was sustained regardless of prior biologic and/or Janus kinase (JAK) inhibitor history. No new safety concerns were observed.¹

“Ulcerative colitis is a lifelong condition that can significantly impact patients’ overall health and they need treatment options that remain effective and well-tolerated over time,” said Laurent Peyrin-Biroulet, MD, PhD, study investigator.^e “The QUASAR long-term study shows the ability of guselkumab to deliver durable results, with consistent outcomes regardless of previous biologic or JAK inhibitor treatment. With high study retention and no new safety concerns over this extended time period, the data strengthen confidence in the long-term use of guselkumab in ulcerative colitis.”

The unmet need

Ulcerative colitis is a chronic condition which can significantly impact a patient’s quality of life.² Reducing the risk of relapse is a key treatment challenge – this is why endoscopic remission and histological improvement are such important endpoints; they go deeper than symptomatic remission to decrease the risk of relapse.³

“These findings highlight the endoscopic outcomes that can be achieved with guselkumab, raising the efficacy bar for patients with ulcerative colitis,” said Mark Graham, Senior Director, Therapeutic Area Head, Immunology, Johnson & Johnson Innovative Medicine EMEA. “Patients who achieve endoscopic remission experience fewer flare-ups and are less likely to need steroids or require surgery over time. We are energised by these findings and remain focused on delivering treatments that help more patients achieve meaningful, lasting disease control.”

Further ECCO 2026 activity

Two other Johnson & Johnson-sponsored abstracts were selected as Top 10 oral abstracts by ECCO, highlighting our continued commitment to researching and developing therapies that improve patients’ health:

• Results from the Phase 2b ANTHEM-UC study of icotrokinra, the first targeted oral peptide that selectively blocks the interleukin-23 receptor, demonstrating its impact on systemic and tissue biomarkers of inflammatory burden in UC.⁴
• Primary safety results from the UNITI Jr study of STELARA® (ustekinumab) showing that it was effective and well-tolerated, with no new safety signals, in treating paediatric patients (2 to <18) with moderately-to-severely-active ulcerative colitis.⁵

For a full list of all Johnson & Johnson data being presented at ECCO 2026 visit: https://www.jnj.com/innovativemedicine/immunology/gastroenterology.

Editor’s Notes: 

a. 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.
b. Histo-endoscopic mucosal improvement was defined as a combination of endoscopic improvement and histologic improvement (neutrophil infiltration in <5% of crypts, no crypts destruction, and no erosions, ulcerations or granulation tissue according to the Geboes grading system.
c. Endoscopic remission (normalization) was defined as a MES of 0.
d. As observed. Data were analyzed using 2 methods: ‘nonresponder imputation’ (NRI) accounting for patients with treatment failure or missing data, and ‘as observed’. NRI results were consistent with as observed.
e. Dr. Laurent Peyrin-Biroulet is a paid consultant for Johnson & Johnson. He has not been compensated for any media work.

ABOUT THE QUASAR PROGRAMME (EudraCT 2018-004002-25)⁶

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 701 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)).⁷ 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.^7,8 Efficacy, safety, pharmacokinetics, immunogenicity, and biomarkers are assessed at specified time points.⁶ Week 12 induction and week 44 maintenance results are available in The Lancet.⁷

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.⁹ It is the result of the immune system’s overactive response.⁹ 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.¹⁰ Ulcerative colitis patients also have increased rates of depression.¹¹

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. ^{12,13,14,15,16} Findings for dual-acting are limited to in vitro studies and the clinical significance of this finding is not known.^17,18

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.¹² 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 treatment¹² 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.¹² 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 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).¹²

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 https://www.jnj.com/innovativemedicine/emea/. Follow us at https://www.linkedin.com/company/jnj-innovative-medicine-emea.

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.

Media contact:
Sophie Daneau
+33 6 3178 8798

Investor contact:
Lauren Johnson
investor-relations@its.jnj.com

CP-566183
February 2026