Johnson & Johnson study shows TREMFYA® (guselkumab) is the first and only IL-23 inhibitor to demonstrate efficacy in perianal fistulizing Crohn's disease

Rhea-AI Summary

Johnson & Johnson (NYSE: JNJ) announced Phase 3 FUZION results showing TREMFYA (guselkumab) met the primary endpoint of combined fistula remission in adults with active perianal fistulizing Crohn's disease at Week 24.

Combined remission rates: 28.3% (100 mg q8w) and 27.0% (200 mg q4w) versus 10.3% placebo; both differences were statistically significant (p=0.007; p=0.013). Adverse events through 24 weeks were consistent with the known safety profile. The company is also initiating the CHARGE head-to-head study vs risankizumab for Crohn's disease.

Positive

• Primary endpoint met: combined fistula remission at Week 24
• Remission rates 28.3% (100 mg q8w) and 27.0% (200 mg q4w) versus 10.3% placebo
• Statistical significance: p=0.007 (100 mg q8w) and p=0.013 (200 mg q4w)
• First randomized trial in 20 years to show efficacy in perianal fistulizing Crohn's disease

Negative

• Absolute remission rate remained under 30% for both active dosing regimens
• Adverse events reported through 24 weeks were consistent with the known safety profile of TREMFYA

News Market Reaction – JNJ

+0.60%

+0.60% Session close to close

In the May 5 session, JNJ gained 0.60%, reflecting a mild positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement highlights robust Phase 3 results for TREMFYA in a difficult Crohn’s disease popul...

Analysis

This announcement highlights robust Phase 3 results for TREMFYA in a difficult Crohn’s disease population, with fistula remission rates of 28.3% and 27.0% versus 10.3% on placebo and statistically significant p‑values (0.007, 0.013). It adds to JNJ’s recent stream of immunology and neuromuscular updates. Investors may watch for longer‑term outcomes, regulatory or label developments, and uptake data, as well as read‑through to future GI studies such as the CHARGE head‑to‑head IL‑23 trial.

Key Figures

Fistula remission rate: 28.3% Fistula remission rate: 27.0% Fistula remission rate: 10.3% +5 more

8 metrics

Fistula remission rate 28.3% TREMFYA 100 mg q8w arm at Week 24 in FUZION study

Fistula remission rate 27.0% TREMFYA 200 mg q4w arm at Week 24 in FUZION study

Fistula remission rate 10.3% Placebo arm at Week 24 in FUZION study

P-value (100 mg q8w) p=0.007 Treatment difference vs placebo for combined fistula remission

P-value (200 mg q4w) p=0.013 Treatment difference vs placebo for combined fistula remission

TREMFYA dose 100 mg q8w Dose regimen achieving combined fistula remission in FUZION

TREMFYA dose 200 mg q4w Dose regimen achieving combined fistula remission in FUZION

CD patients affected 25% Estimated share of Crohn’s disease patients with perianal fistulizing disease

Historical Context

5 past events · Latest: Apr 30 (Neutral)

Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
Apr 30	Leadership change	Neutral	+1.1%	New VP of Investor Relations appointed, succeeding outgoing IR head.
Apr 27	Conference appearance	Neutral	+1.1%	Planned presentation at Bernstein Strategic Decisions Conference announced.
Apr 27	Regulatory milestone	Positive	-0.9%	FDA granted Priority Review for IMAAVY in warm autoimmune hemolytic anemia.
Apr 22	Clinical data update	Positive	-1.0%	Over two years of sustained disease control data in generalized myasthenia gravis.
Apr 21	Conference appearance	Neutral	-1.0%	Participation in RBC Capital Markets Global Healthcare Conference announced.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Recent positive regulatory/clinical headlines (IMAAVY Priority Review and gMG data) were followed by negative 24h moves, while routine corporate or conference items saw modest gains, suggesting the stock has sometimes sold off on good news.

Recent Company History

Over the last few weeks, JNJ news has centered on investor outreach, regulatory progress, and neuromuscular disease data. On Apr 30, a new VP of Investor Relations was appointed, and on Apr 27 and Apr 21 the company highlighted participation in major healthcare conferences. Clinically, the FDA granted Priority Review for IMAAVY in wAIHA on Apr 27, and long-term IMAAVY data in gMG were reported on Apr 22. Those positive clinical/regulatory updates saw negative next‑day reactions, while neutral corporate items had small gains.

Key Terms

perianal fistulizing crohn's disease, il-23 inhibitor, phase 3, fistula, +4 more

8 terms

perianal fistulizing crohn's disease medical

"adults with active perianal fistulizing Crohn's disease (CD). At Week 24..."

A severe form of Crohn’s disease in which chronic inflammation creates painful, abnormal tunnels and abscesses around the anus and rectum, often causing persistent drainage, infections and scarring. It matters to investors because it is hard to treat, typically requires long-term therapies or surgery, and represents a clear medical need that drives demand for new drugs, clinical trials, regulatory decisions and potential long-term revenues—like discovering a durable fix for recurring structural damage.

il-23 inhibitor medical

"TREMFYA® (guselkumab) is the first and only IL-23 inhibitor to demonstrate..."

An IL-23 inhibitor is a medicine that blocks the immune-signaling protein interleukin-23, which helps drive excessive inflammation in certain autoimmune and inflammatory conditions. By dampening that specific signal, these drugs can reduce symptoms and tissue damage without broadly suppressing the whole immune system. For investors, IL-23 inhibitors are important because they are often high-value biologic therapies with clear clinical targets and market potential, but their commercial success depends on trial results, safety, and pricing.

phase 3 medical

"results from the Phase 3 FUZION study evaluating TREMFYA..."

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

fistula medical

"A fistula is an abnormal connection or tunnel that develops between the intestine..."

An abnormal connection or “tunnel” that forms between two body parts—such as organs, blood vessels, or skin—that aren’t normally joined. For investors, fistulas matter because they can signal complications from disease, surgery, or medical devices, affecting patient outcomes, treatment costs, regulatory reviews, and the commercial prospects of therapies or products designed to prevent or repair them.

mri medical

"absence of fluid collection on MRI, compared to placebo."

Magnetic resonance imaging (MRI) is a medical scan that uses magnetic fields and radio waves to create detailed pictures of the inside of the body, like a high-resolution camera for tissues and organs. Investors care because MRI drives demand for imaging machines, hospital services, diagnostics and can be central to clinical trial results and regulatory decisions—changes in MRI use or technology can affect revenue, capital spending and reimbursement in healthcare and medical device markets.

inflammatory bowel disease medical

"approved therapy in inflammatory bowel disease (IBD) that demonstrates efficacy..."

Inflammatory bowel disease is a group of long‑lasting conditions that cause repeated inflammation of the digestive tract, leading to symptoms like belly pain, diarrhea, bleeding and weight loss. For investors it matters because IBD drives steady demand for medications, ongoing clinical trials, medical devices and diagnostics; think of it as a chronic maintenance market where successful treatments can create predictable, long‑term revenue streams and regulatory milestones can move stock prices.

ibd medical

"first head-to-head study of IL-23 inhibitors in IBD, which will evaluate..."

A financial news and research service that provides stock market data, company ratings, charts, and curated stock lists used by active investors and traders. Think of it as a scoreboard and scout combined: it highlights fast-growing or strong-performing stocks, summarizes market trends, and supplies screening tools so investors can find and compare opportunities quickly. Its coverage and proprietary ratings can influence investor attention and short-term trading flows.

head-to-head study medical

"initiating the CHARGE study, the first head-to-head study of IL-23 inhibitors..."

A head-to-head study directly compares two treatments, drugs, devices, or products to see which performs better on the same measures and in the same conditions. For investors, these studies matter because they show relative effectiveness or safety—like a side-by-side car comparison—helping predict which option is likely to win market share, secure regulatory approvals, or drive sales and valuation changes.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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TREMFYA^® demonstrated significantly higher rates of combined fistula remission – complete external closure of draining fistulas and absence of fluid collection on MRI – compared to placebo at Week 24

First study of its kind in 20 years for this debilitating manifestation of Crohn's disease presented as late-breaking data at Digestive Disease Week 2026

CHICAGO, May 5, 2026 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced results from the Phase 3 FUZION study evaluating TREMFYA^® (guselkumab) in adults with active perianal fistulizing Crohn's disease (CD). At Week 24, TREMFYA demonstrated significantly higher rates of combined fistula remission, a highly stringent endpoint defined as complete external closure of draining fistulas and absence of fluid collection on MRI, compared to placebo.¹ Remission in patients with this complicated manifestation remains difficult to achieve, and this is the first randomized control trial of an approved therapy in inflammatory bowel disease (IBD) that demonstrates efficacy in adults with active perianal fistulizing Crohn's disease in 20 years. These late-breaking data are among the 32 company-sponsored abstracts at Digestive Disease Week (DDW) 2026.

Key findings from the FUZION study
TREMFYA met the primary endpoint of combined fistula remission at Week 24, defined as complete closure of all external fistula openings with no drainage, without development of new fistulas and no evidence of underlying fluid collections on MRI.^a Combined fistula remission was achieved by 28.3% of patients receiving TREMFYA 100 mg every 8 weeks (q8w) and 27.0% of patients receiving TREMFYA 200 mg every 4 weeks (q4w), compared with 10.3% for placebo.

The treatment differences versus placebo were statistically significant for both the 100 mg q8w and 200 mg q4w dosing regimens (p=0.007 and p=0.013, respectively). Adverse events through 24 weeks were consistent with the known safety profile of TREMFYA in CD.

"The pain, swelling and persistent drainage associated with perianal fistulizing Crohn's disease can be profoundly disruptive to patients' daily lives," said Laurent Peyrin-Biroulet, MD, PhD, study investigator.^b "Achieving durable fistula closure without repeated surgical interventions remains a significant unmet need. The results from the FUZION study demonstrate the ability of TREMFYA to achieve combined fistula remission, which is an exciting step forward for patients, expanding what's possible for managing this debilitating and chronic condition."

"It has been more than two decades since a highly rigorous study has been dedicated to perianal fistulizing Crohn's disease, a very difficult-to-treat and complex manifestation of this already challenging condition," said Ludovic de Beaucoudrey, PhD, J&J Innovative Medicine Vice President, Immunology, Global Medical Affairs, Gastroenterology and Autoantibody. "Building on decades of experience in immunology, Johnson & Johnson continues to address areas of significant unmet need, and the FUZION study reflects our commitment to delivering meaningful, evidence-based advances for patients and the healthcare providers who care for them."

Addressing a significant unmet need in perianal fistulizing Crohn's disease
A fistula is an abnormal connection or tunnel that develops between the intestine and another organ or the skin, typically arising when inflammation causes ulceration in the intestinal wall or surrounding tissue. Over time, these ulcers may penetrate the full thickness of the bowel, forming a channel that allows infected material to drain. Perianal fistulizing Crohn's disease affects nearly 25% of patients with CD and represents a severe, often debilitating manifestation of the disease that has profound impacts on a person's physical and mental health.^2,3 It is characterized by pain, swelling, persistent drainage, recurrent abscesses, and a frequent need for surgical intervention.

As another example of this commitment for evidence-based advances for CD patients and providers, Johnson & Johnson is also initiating the CHARGE study, the first head-to-head study of IL-23 inhibitors in IBD, which will evaluate TREMFYA compared to risankizumab in treatment of Crohn's disease. Trial sites are now open for patient enrollment. For more information, visit ClinicalTrials.gov.

With the addition of the results from the breakthrough Phase 2b DUET studies in CD and UC, Johnson & Johnson products were featured in three late-breaking abstracts at DDW.^4,5 For a full list of all Johnson & Johnson data being presented at DDW visit: https://www.jnj.com/innovativemedicine/immunology/gastroenterology.

Editor's Notes: 

a. Defined as >2cm of the perianal fistulas in at least two of three dimensions, confirmed by a blinded central review of the MRI results.
b. Dr. Laurent Peyrin-Biroulet is a paid consultant for Johnson & Johnson. He has not been compensated for any media work.

About the FUZION study (NCT05347095)
FUZION is a randomized, placebo-controlled, double-blind, multicenter, Phase 3 study designed to evaluate the efficacy and safety of TREMFYA in adults with perianal fistulizing Crohn's disease. Patients enrolled in the study had one or more active draining perianal fistulas confirmed by blinded central MRI review, CD Activity Index [CDAI] <350, and inadequate response to oral corticosteroids, azathioprine, 6-mercaptopurine, methotrexate, or up to 2 advanced therapy classes. Patients were randomized 2:2:1 to receive TREMFYA 200 mg intravenous (IV) induction at Weeks 0, 4, 8 weeks followed by TREMFYA 100 mg subcutaneous (SC) induction every 8 weeks (q8w); or TREMFYA 200 mg IV infusion in at Weeks 0, 4, 8 weeks followed by TREMFYA 200 mg SC every 4 weeks (q4w); or placebo.⁶

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.^7,8 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.⁹ 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.¹⁰

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:

• 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 legal 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:

o fainting, dizziness, feeling lightheaded (low blood pressure) o swelling of your face, eyelids, lips, mouth, tongue or throat

o trouble breathing or throat tightness o chest tightness o skin rash, hives o itching

• 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:

o fever, sweats, or chills o muscle aches o weight loss o cough o warm, red, or painful skin or sores on your body different from your psoriasis

o diarrhea or stomach pain o shortness of breath o blood in your phlegm (mucus) o burning when you urinate or urinating more often than normal

• 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:

o unexplained rash o vomiting o tiredness (fatigue) o yellowing of the skin or the whites of your eyes

o nausea o stomach pain (abdominal) o loss of appetite o dark urine

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 MotherToBaby@health.ucsd.edu. 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: 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 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.

¹ Laurent Peyrin-Biroulet, et al. Guselkumab for Perianal Fistulizing Crohn's Disease: Week 24 Results from the Phase 3, Randomized, Double-blind, Placebo-Controlled, Multicenter FUZION Study. (Abstract 1058b) Presented at Digestive Disease Week (DDW) May 2-5, 2026
² Sulak A., et al. Where Are We and Where to Next?—The Future of Perianal Crohn's Disease Management, Journal of Clinical Medicine, Volume 12, Issue 19, October 2023, 6379, https://doi.org/10.3390/jcm12196379.
³ Spinelli A, Yanai H, Girardi P, Milicevic S, Carvello M, Maroli A, Avedano L. The Impact of Crohn's Perianal Fistula on Quality of Life: Results of an International Patient Survey. Crohns Colitis 360. 2023 Jul 25;5(3):otad036. doi: 10.1093/crocol/otad036. PMID: 37529012; PMCID: PMC10390083.
⁴ Sands BE, et al. Efficacy And Safety Of The First Co-Antibody Therapy, Jnj-78934804, In Patients With Moderately To Severely Active Crohn's Disease Refractory To Systemic Therapies. (Abstract 979f) Presented at Digestive Disease Week (DDW) May 2-5, 2026.
⁵ Maria T. Abreu, et al. Efficacy And Safety Of The First Co-Antibody Therapy, Jnj-78934804, In Patients With Moderately To Severely Active Ulcerative Colitis Refractory To Systemic Therapies. (Abstract 1058d) Presented at Digestive Disease Week (DDW) May 2-5, 2026.
⁶ National Institutes of Health: Clinicaltrials.gov. A Study of Guselkumab in Participants With Fistulizing, Perianal Crohn's Disease (FUZION CD). Identifier: NCT05347095. https://clinicaltrials.gov/study/NCT05347095?tab=researcher. Accessed March 2026.
⁷ Crohn's & Colitis Foundation. Overview of Crohn's disease. Available at: https://www.crohnscolitisfoundation.org/what-is-crohns-disease/overview. Accessed February 2026.
⁸ Ng SC, et al. Worldwide incidence and prevalence of inflammatory bowel disease in the 21st century: a systematic review of population-based studies. The Lancet. 2017;390:2769-78.
⁹ Crohn's & Colitis Foundation. What is Crohn's disease? Available at: https://www.crohnscolitisfoundation.org/what-is-crohns-disease/causes. Accessed March 2026.
¹⁰ Crohn's & Colitis Foundation. Signs and symptoms of Crohn's disease. Available at https://www.crohnscolitisfoundation.org/patientsandcaregivers/what-is-crohns-disease/symptoms. Accessed March 2026.

Media contact: Craig Stoltz cstoltz@its.jnj.com

Investor contact: Jess Margevich investor-relations@its.jnj.com

 

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SOURCE Johnson & Johnson

FAQ

What did Johnson & Johnson (JNJ) report about TREMFYA in perianal fistulizing Crohn's disease on May 5, 2026?

TREMFYA met the Phase 3 primary endpoint, achieving combined fistula remission at Week 24. According to Johnson & Johnson, remission rates were 28.3% (100 mg q8w) and 27.0% (200 mg q4w) versus 10.3% for placebo, with statistically significant p-values.

How effective was TREMFYA (guselkumab) vs placebo in the FUZION study (JNJ)?

TREMFYA produced higher combined fistula remission rates than placebo at Week 24. According to Johnson & Johnson, rates were 28.3% and 27.0% for two dosing regimens versus 10.3% with placebo, both comparisons reaching statistical significance.

What is the safety profile for TREMFYA in the FUZION Phase 3 trial (JNJ)?

Adverse events through 24 weeks were consistent with the known safety profile of TREMFYA. According to Johnson & Johnson, no new safety signals were reported in the study's 24-week period, aligning with prior Crohn's disease data.

Why is the FUZION study important for TREMFYA and JNJ investors?

FUZION is the first randomized trial in 20 years showing efficacy in perianal fistulizing Crohn's disease. According to Johnson & Johnson, meeting the primary endpoint could expand TREMFYA's clinical label relevance for this difficult-to-treat population.

What follow-up studies will Johnson & Johnson (JNJ) run after the FUZION results?

Johnson & Johnson is initiating the CHARGE study, a head-to-head trial comparing IL-23 inhibitors in Crohn's disease. According to Johnson & Johnson, CHARGE will evaluate TREMFYA versus risankizumab and is now open for site enrollment.