TREMFYA® (guselkumab) demonstrated sustained clinical and endoscopic remission through 3 years in moderately to severely active Crohn's disease

• New long-term data showed clinical remission rates of up to 94% and endoscopic remission rates of up to 61% in adults with moderately to severely active Crohn's disease
• 88% of patients achieved 90-day corticosteroid-free clinical remission

SPRING HOUSE, Pa., Oct. 12, 2026 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced new three-year data from the Phase 3 GALAXI 2 and 3 studies showing durable efficacy and a consistent safety profile for TREMFYA^® (guselkumab) in adults with moderately to severely active Crohn's disease.¹ The Week 144 long-term extension (LTE) results being presented at the American College of Gastroenterology (ACG) 2026 Annual Scientific Meeting reveal long-term clinical and endoscopic outcomes across both TREMFYA maintenance regimens in this chronic disease.

Clinical and endoscopic outcomes sustained through three years with TREMFYA

Patients in the GALAXI 2 and 3 studies received intravenous induction followed by one of two TREMFYA maintenance dosing regimens: 100 mg administered subcutaneously every eight weeks (q8w) or 200 mg administered subcutaneously every four weeks (q4w). At Week 144 the LTE data show:^1a

• 94% of patients receiving TREMFYA 100 mg q8w and 91% receiving TREMFYA 200 mg q4w achieved clinical remission.^b
• 88% of patients receiving TREMFYA 100 mg q8w and 88% receiving TREMFYA 200 mg q4w achieved 90-day corticosteroid-free clinical remission, respectively.
• 52% of patients receiving TREMFYA 100 mg q8w and 61% receiving TREMFYA 200 mg q4w achieved endoscopic remission.^c
• 74% of TREMFYA-treated patients remained on treatment through three years. 

Safety findings through Week 144 were consistent with the well-established safety profile of TREMFYA in Crohn's disease.¹

"In a chronic, lifelong disease, the ability to sustain clinical and endoscopic outcomes through three years is particularly meaningful for patients," said David Rubin, MD, Director of the Inflammatory Bowel Disease Center at the University of Chicago.^d "These results contribute to the growing body of evidence that TREMFYA can provide patients with deep and sustained remission over time, creating a strong foundation for long-term disease management."

Long-term disease control is an important need in Crohn's disease management

As Crohn's disease is a lifelong disease with no cure, patients and physicians need treatments that can provide sustained control of symptoms and intestinal inflammation over time. These results represent one of the most comprehensive three-year datasets in Crohn's disease reported to date, demonstrating durable clinical, corticosteroid-free and endoscopic remission across both TREMFYA maintenance regimens.

"Johnson & Johnson has built deep expertise in immune-mediated diseases including inflammatory bowel disease, and our research is designed to answer questions that arise over the course of this chronic condition," said David M. Lee, M.D., Ph.D., Global Immunology Therapeutic Area Head, Johnson & Johnson. "The clinical and endoscopic remission observed with TREMFYA through three years reinforces our commitment to generating long-term evidence that can help physicians make informed treatment decisions for people living with Crohn's disease."

TREMFYA is the only approved dual-acting monoclonal antibody in inflammatory bowel disease (IBD) 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 including UC. Findings are based on in vitro studies.^{2 3 4 5 6}

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

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. 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 include
b. Clinical remission was defined as a CDAI score <150.
c. Endoscopic remission was defined as an SES-CD ≤4, with a ≥2-point reduction and no subscore >1 on any subcomponent.
d. Dr. David Rubin is a paid consultant for Johnson & Johnson. He has not been compensated for any media work.

About the GALAXI program (NCT03466411) 

GALAXI is a randomized, double-blind, placebo-controlled, active-controlled (ustekinumab), global, multicenter Phase 2/3 program designed to evaluate the efficacy and safety of TREMFYA in participants with moderately to severely active Crohn's disease with inadequate response/intolerance to conventional therapies (corticosteroids or immunomodulators) and/or biologics (TNF antagonists or vedolizumab). GALAXI includes a Phase 2 dose-ranging study (GALAXI 1) and two independent, identically designed confirmatory Phase 3 studies (GALAXI 2 and 3). Each GALAXI study employed a treat-through design and includes a long-term extension period that will assess clinical, endoscopic, and safety outcomes with TREMFYA treatment through a total of five years. Patients received TREMFYA 200 mg intravenous induction at Weeks 0, 4 and 8 followed by TREMFYA 200 mg subcutaneous maintenance every 4 weeks; or TREMFYA 200 mg intravenous induction at Weeks 0, 4 and 8, followed by TREMFYA⁷

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.⁸⁹ 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.¹⁰ Symptoms of Crohn's disease can vary, but often include abdominal pain and tenderness, frequent diarrhea, rectal bleeding, weight loss, and fever.  Some patients may also develop fistulas, abnormal connections between the intestine and other organs or tissues, which can be associated with pain, drainage, infection, and substantial impairment in quality of life. Currently no cure is available for Crohn's disease.¹¹

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 TREMFYA 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:

• adults and children 6 years and older who also weigh at least 88 pounds (40 kg) with moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet or UV light).
• adults and children 6 years and older who also weigh at least 88 pounds (40 kg) with active psoriatic arthritis.
• adults with moderately to severely active ulcerative colitis.
• adults with moderately to severely active Crohn's disease. 

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 manufacturer for TREMFYA is Janssen Biotech, Inc. 

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

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:

• Serious Allergic Reactions. Stop using TREMFYA and get emergency medical help right away if you develop any of the following symptoms of a serious allergic reaction:

• Infections. TREMFYA may lower the ability of your immune system to fight infections and may increase your risk of infections. Your healthcare provider should check you for infections and tuberculosis (TB) before starting treatment with TREMFYA and may treat you for TB before you begin treatment with TREMFYA if you have a history of TB or have active TB. Your healthcare provider should watch you closely for signs and symptoms of TB during and after treatment with TREMFYA.

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

• Liver problems. With the treatment of Crohn's disease or ulcerative colitis, your healthcare provider will do blood tests to check your liver before and during treatment with TREMFYA. Your healthcare provider may stop treatment with TREMFYA if you develop liver problems. Tell your healthcare provider right away if you notice any of the following symptoms:

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:

• have any of the conditions or symptoms listed in the section "What is the most important information I should know about TREMFYA?"
• have an infection that does not go away or that keeps coming back.
• have TB or have been in close contact with someone with TB.
• have recently received or are scheduled to receive an immunization (vaccine). You should avoid receiving live vaccines during treatment with TREMFYA.
• are pregnant or plan to become pregnant. It is not known if TREMFYA can harm your unborn baby.
  Pregnancy Registry: If you become pregnant during treatment with TREMFYA, talk to your healthcare provider about registering in the pregnancy exposure registry for TREMFYA. You can enroll by visiting www.mothertobaby.org/ongoing-study/tremfya-guselkumab, by calling 1-877-311-8972, or emailing [email protected]. The purpose of this registry is to collect information about the safety of TREMFYA during pregnancy.
• are breastfeeding or plan to breastfeed. It is not known if TREMFYA passes into your breast milk.

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.

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.

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SOURCE Johnson & Johnson Innovative Medicine

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