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

More than 80% of those treated with TREMFYA® were in clinical remission and more than 50% were in endoscopic remission at Week 140 of the QUASAR long-term extension study, showing lasting disease control for patients 

78% of patients achieved intestinal healing at both the tissue and visual level (histo-endoscopic mucosal improvement)

STOCKHOLM, Feb. 21, 2026 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced new long-term data from the QUASAR long-term extension (LTE) study showing that TREMFYA® (guselkumab) sustained clinical, endoscopic, and histologic outcomes through Week 140 in adults with moderately to severely active ulcerative colitis (UC). These data are among the 30 company-sponsored abstracts being presented at the European Crohn's and Colitis Organisation (ECCO) 2026 conference.

At Week 140, 80.8% of patients taking TREMFYA® were in clinical remissiona. Additionally, 78.6% of patients achieved histo-endoscopic mucosal improvement (HEMI)b, and 53.6% of patients were in endoscopic remissionc, respectively.d  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 eight weeks.1

The study also showed that of those in clinical remission at Week 44, 87.5% maintained clinical remission through Week 140. Efficacy was sustained regardless of prior biologic and/or JAK inhibitor treatment history, and 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 sustained ability of TREMFYA 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 TREMFYA in ulcerative colitis." 

"These findings highlight the endoscopic outcomes that can be achieved with TREMFYA, raising expectations for what is possible for patients with ulcerative colitis," said Esi Lamousé-Smith, MD, PhD, Vice President, Gastroenterology Disease Area Lead, Immunology, Johnson & Johnson. "Patients who achieve endoscopic remission experience fewer flare-ups and are less likely to need steroids or require surgery over time. We are energized by these findings and remain focused on delivering treatments that help more patients achieve meaningful, lasting disease control."

TREMFYA® is the first and only approved, dual-acting monoclonal antibody that blocks IL-23 while also binding to CD64, a receptor on cells that produce IL-23. IL-23 is a cytokine secreted by activated monocyte/macrophages and dendritic cells that is known to be a driver of immune-mediated diseases. Findings are based on in vitro studies. 2 3 4 5 6 

TREMFYA® has received U.S. Food and Drug Administration (FDA) and European Commission (EC) approval for both SC and IV induction options for the treatment of adults with moderately to severely active Crohn's disease and U.S. FDA approval for both SC and IV induction options for the treatment of adults with moderately to severely active ulcerative colitis. TREMFYA® is approved by the EC for the treatment of adult patients with moderately to severely active ulcerative colitis and is currently administered via an IV induction regimen, followed by a SC maintenance regimen.

Two other Johnson & Johnson-sponsored abstracts were selected as Top 10 oral abstracts by ECCO, highlighting continued commitment to providing treatment options to those with inflammatory bowel disease:

For a full list of all Johnson & Johnson data being presented at ECCO 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 30) through 52 weeks of treatment (8 weeks of induction and 44 weeks of maintenance treatment).1,3 The study included an open-label induction treatment with a single ustekinumab intravenous dose of approximately 6mg/kg followed by a randomized double-blind subcutaneous maintenance regimen of 90mg administered either every 8 weeks or every 12 weeks.

About Ulcerative ColitisUlcerative 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. It is the result of the immune system's overactive response. 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.11 

About Crohn's Disease Crohn's disease is one of the two main forms of inflammatory bowel disease, which affects an estimated three million Americans and an estimated four million people across Europe.12 13 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.14 Symptoms of Crohn's disease can vary, but often include abdominal pain and tenderness, frequent diarrhea, rectal bleeding, weight loss, and fever. Currently no cure is available for Crohn's disease.15

About TREMFYA® (guselkumab)Developed by Johnson & Johnson, TREMFYA® is the first fully-human, dual-acting monoclonal antibody designed to neutralize inflammation at the cellular source by blocking IL-23 and binding to CD64 (a receptor on cells that produce IL-23). Findings for the dual-acting mechanism 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. The clinical significance of this finding is not known.

TREMFYA® is a prescription medicine approved in the U.S. to treat:

TREMFYA® is approved in Europe, Canada, Japan, and a number of other countries for the treatment of adults with moderate-to-severe plaque psoriasis, adults with active psoriatic arthritis, adults with moderate-to-severe Crohn's disease and adults with moderate-to-severe ulcerative colitis.

The legal manufacturer for TREMFYA® is Janssen Biotech, Inc. 

Johnson & Johnson maintains exclusive worldwide marketing rights to TREMFYA®. For more information, visit: www.tremfya.com.

About Icotrokinra (JNJ-77242113, JNJ-2113)Investigational icotrokinra is the first targeted oral peptide designed to precisely block the IL-23 receptor16, which underpins the inflammatory response in moderate-to-severe plaque psoriasis, ulcerative colitis and offers potential in other IL-23-mediated diseases.17 18 Icotrokinra binds to the IL-23 receptor with single-digit picomolar affinity and demonstrated potent, precise inhibition of IL-23 signaling in human T cells.19 The license and collaboration agreement established between Protagonist Therapeutics, Inc. and Janssen Biotech, Inc., a Johnson & Johnson company, in 2017 enabled the companies to work together to discover and develop next-generation compounds that ultimately led to icotrokinra.20 

Icotrokinra was jointly discovered and is being developed pursuant to the license and collaboration agreement between Protagonist and Johnson & Johnson. Johnson & Johnson retains exclusive worldwide rights to develop icotrokinra in Phase 2 clinical trials and beyond, and to commercialize compounds derived from the research conducted pursuant to the agreement against a broad range of indications.21 22 23

Icotrokinra is being studied in the pivotal Phase 3 ICONIC clinical development program in moderate-to-severe plaque psoriasis, active psoriatic arthritis, moderately to severely active ulcerative colitis and moderately to severely active Crohn's disease.

TREMFYA® IMPORTANT SAFETY INFORMATION

What is the most important information I should know about TREMFYA®?

TREMFYA® is a prescription medicine that may cause serious side effects, including:

Tell your healthcare provider right away if you have an infection or have symptoms of an infection, including:

Do not use TREMFYA® if you have had a serious allergic reaction to guselkumab or any of the ingredients in TREMFYA®.

Before using TREMFYA®, tell your healthcare provider about all of your medical conditions, including if you:

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What are the possible side effects of TREMFYA®?

TREMFYA® may cause serious side effects. See "What is the most important information I should know about TREMFYA®?"

The most common side effects of TREMFYA® include: respiratory tract infections, headache, injection site reactions, joint pain (arthralgia), diarrhea, stomach flu (gastroenteritis), fungal skin infections, herpes simplex infections, stomach pain, and bronchitis.

These are not all the possible side effects of TREMFYA®. Call your doctor for medical advice about side effects.

Use TREMFYA® exactly as your healthcare provider tells you to use it.

Please read the full Prescribing Information, including Medication Guide, for TREMFYA® and discuss any questions that you have with your doctor.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Dosage Forms and Strengths: TREMFYA® is available as 100 mg/mL and 200 mg/2mL for subcutaneous injection and as a 200 mg/20 mL (10 mg/mL) single dose vial for intravenous infusion.

WHAT IS STELARA® (ustekinumab)?STELARA® is a prescription medicine used to treat:

IMPORTANT SAFETY INFORMATIONSTELARA® is a prescription medicine that affects your immune system. STELARA® can increase your chance of having serious side effects, including:

Serious InfectionsSTELARA® may lower your ability to fight infections and may increase your risk of infections. Some people have serious infections during treatment with STELARA®, which may require hospitalization, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses.

Before starting STELARA®, tell your healthcare provider if you:

After starting STELARA®, call your healthcare provider right away if you have any symptoms of an infection (see above). These may be signs of infections such as chest infections, or skin infections or shingles that could have serious complications. STELARA® can make you more likely to get infections or make an infection that you have worse.

People who have a genetic problem where the body does not make any of the proteins interleukin 12 (IL-12) and interleukin 23 (IL-23) are at a higher risk for certain serious infections that can spread throughout the body and cause death. People who take STELARA® may also be more likely to get these infections.

CancersSTELARA® may decrease the activity of your immune system and increase your risk for certain types of cancer. Tell your healthcare provider if you have ever had any type of cancer. Some people who had risk factors for skin cancer developed certain types of skin cancers while receiving STELARA®. Tell your healthcare provider if you have any new skin growths.

Serious Allergic ReactionsSerious allergic reactions can occur. Stop using STELARA® and get medical help right away if you get any symptoms of a serious allergic reaction such as: feeling faint, swelling of your face, eyelids, tongue, or throat, chest tightness, or skin rash.

Posterior Reversible Encephalopathy Syndrome (PRES)PRES is a rare condition that affects the brain and can cause death. Tell your healthcare provider right away if you get any symptoms of PRES during treatment with STELARA®, including: headache, seizures, confusion, and vision problems.

Lung InflammationCases of lung inflammation have happened in some people who receive STELARA® and may be serious. These lung problems may need to be treated in a hospital. Tell your healthcare provider right away if you develop shortness of breath or a cough that doesn't go away during treatment with STELARA®.

Before you use or receive STELARA®, tell your healthcare provider about all of your medical conditions, including if you:

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

When prescribed STELARA®:

Common side effects of STELARA® include: nasal congestion, sore throat, and runny nose, upper respiratory infections, fever, headache, tiredness, itching, nausea and vomiting, influenza, redness at the injection site, vaginal yeast infections, urinary tract infections, sinus infection, bronchitis, diarrhea, stomach pain, and joint pain. These are not all of the possible side effects with STELARA®. Tell your doctor about any side effect that you experience. Ask your doctor or pharmacist for more information.

Please read the full Prescribing Information and Medication Guide for STELARA® and discuss any questions you have with your doctor.

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/ or at www.innovativemedicine.jnj.com 

Follow us at @JNJInnovMed. 

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.

SOURCE Johnson & Johnson