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- New data show favorable outcomes with subcutaneous infliximab following intravenous infliximab interruption, regardless of prior antibody status, in adult patients with moderate to severely active Crohn’s disease and ulcerative colitis
- Late-breaking analysis shows significantly higher rates of clinical remission and improved endoscopic outcomes with subcutaneous versus intravenous infliximab in patients with ileum-dominant Crohn’s disease
JERSEY CITY, N.J., Oct. 12, 2026 /PRNewswire/ — Celltrion USA, Inc. today announced that two analyses evaluating ZYMFENTRA® (infliximab-dyyb) will be presented in oral presentations on Oct. 13 and 14 at the American College of Gastroenterology (ACG) 2026 Annual Scientific Meeting in Nashville, Tennessee. The data include a late-breaking pooled and propensity score-matched analysis comparing subcutaneous (SC) and intravenous (IV) infliximab in patients with ileum-dominant Crohn’s disease, as well as a post hoc analysis from the Phase 3 LIBERTY-CD and LIBERTY-UC studies assessing the impact of prior anti-drug antibody (ADA) status on clinical outcomes following SC infliximab 240 mg initiation after interruption of IV infliximab treatment.[1,2]
“People living with inflammatory bowel disease (IBD) can have varied disease characteristics, presentations, and treatment histories that may shape a unique care pathway, and clinicians need evidence that reflects the range of patients they see,” said Dr. Juby Jacob-Nara, Senior Vice President and Chief Medical Officer at Celltrion USA. “We’re pleased to share new analyses at ACG that provide additional information about subcutaneous infliximab in Crohn’s disease and ulcerative colitis and reflect Celltrion’s commitment to advancing clinically meaningful research for the IBD community.”
Presentation Details
Both analyses will be presented by Marla Dubinsky, M.D., Professor of Pediatrics and Director of the IBD Center at the Icahn School of Medicine, Mount Sinai, New York.
Post Hoc Analysis of LIBERTY-CD and -UC Studies Following an IV Infliximab Treatment Interruption
Date: Tuesday, Oct. 13, from 2:45-2:55 p.m. CT
Room: Karl F. Dean Grand Ballroom A, Level 4
Abstract Title: “Impact of Prior Anti-drug Antibody Status on Clinical Outcomes Following Subcutaneous Infliximab Initiation After Intravenous Infliximab Interruption: A Post Hoc Analysis of LIBERTY-CD and -UC Studies”
Session: Plenary Session 3A: IBD
Presentation: 40
A separate post hoc analysis evaluated efficacy, serum infliximab concentrations, and immunogenicity among patients from the placebo arms of the Phase 3 LIBERTY-CD and LIBERTY-UC studies who initiated SC infliximab 240 mg every two weeks following an interruption in IV infliximab treatment. Patients were assessed according to whether anti-drug antibodies (ADAs) had been detected before they began SC infliximab.[2]
Among patients who initiated SC infliximab 240 mg, 72.5% (37 of 51) of patients with Crohn’s disease and 92.2% (71 of 77) of patients with ulcerative colitis had prior ADA positivity. The median interval between the last IV infliximab infusion and initiation of SC infliximab was 16 weeks in ADA-positive and ADA-negative patients in both the Crohn’s disease and ulcerative colitis groups.[2]
Across Crohn’s disease and ulcerative colitis populations, the analysis found clinical outcomes were generally similar regardless of whether patients had ADAs before starting SC infliximab, with clinical response in Crohn’s disease and partial clinical response in ulcerative colitis observed by 8±2 weeks and sustained through 78 to 80 weeks. Serum infliximab concentrations increased after initiation of SC infliximab and were generally comparable over time across ADA-status groups. Levels of fecal calprotectin and C-reactive protein decreased at the first assessment after treatment began and remained lower through the final assessment. ADA positivity declined among patients with pre-existing ADAs, while new ADA development was uncommon in patients without prior ADAs.
“Anti-drug antibodies to intravenous infliximab can compromise infliximab reinitiation after treatment interruption. Data on subcutaneous infliximab initiation after a drug holiday are limited, particularly regarding the impact of prior ADA status on clinical outcomes,” said Marla Dubinsky, M.D., Professor of Pediatrics and Director of the IBD Center at the Icahn School of Medicine, Mount Sinai, New York. “These post hoc findings suggest that prior ADA status did not appear to compromise clinical outcomes after initiating subcutaneous infliximab following drug holiday after intravenous infliximab induction.”
Late-Breaking Data in Ileum-Dominant Crohn’s Disease
Date: Wednesday, Oct. 14, from 9:30-9:40 a.m. CT.
Late-Breaking Abstract Title: “Comparative Efficacy of Subcutaneous Versus Intravenous Infliximab in Ileum-Dominant Crohn’s Disease: A Pooled Analysis and Propensity Score-Matched Analysis of Infliximab Registrational Studies”
Session: Plenary Session 4B: Liver, Esophagus, CRC, IBD
Presentation: 72
The late-breaking abstract reports a pooled analysis of individual patient data from four infliximab registrational studies. The analysis included patients with ileal or ileocolonic Crohn’s disease who received standard maintenance treatment with SC infliximab 120 mg every two weeks or IV infliximab 5 mg/kg every eight weeks. Of 884 patients across the studies, 200 met the eligibility criteria; a 1:1 propensity score-matched analysis included 70 patients in each treatment group.[1]
In the matched population at Week 54, patients receiving SC infliximab had higher rates of clinical remission, endoscopic response, and endoscopic remission than those receiving IV infliximab:[1]
- Clinical remission: 71.4% vs. 51.4% (P = 0.023)
- Endoscopic response: 65.7% vs. 27.1% (P < 0.001)
- Endoscopic remission: 41.4% vs. 17.1% (P = 0.003)
The analysis also found that, in both treatment groups, endoscopic responders had significantly higher serum infliximab concentrations than nonresponders.
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About ZYMFENTRA® (infliximab-dyyb; subcutaneous infliximab)
ZYMFENTRA® (infliximab-dyyb) is a prescription medicine used as an injection under the skin (subcutaneous injection) by adults for the maintenance treatment of moderately-to-severely active ulcerative colitis following treatment with an infliximab product given by intravenous infusion (IV), Moderately-to-severely active Crohn’s disease following treatment with an infliximab product given by intravenous infusion (IV). ZYMFENTRA blocks the action of tumor necrosis factor-alpha (TNF-alpha), a protein that can be overproduced in response to certain diseases and cause the immune system to attack normal, healthy parts of the body.
ZYMFENTRA was approved by the FDA through the Biologics License Application (BLA) under the 351 (a) pathway of the Public Health Service Act (a “stand-alone” BLA). ZYMFENTRA is considered a new biologic with a first-approved subcutaneous administration form and thus will be under patent protection for its dosage form by 2037 and for its route of administration by 2040.
Indication and Important Safety Information
ZYMFENTRA® is a prescription medicine indicated in adults for maintenance treatment of:
Moderately-to-severely active Crohn’s disease following treatment with an infliximab product administered intravenously.
Moderately-to-severely active ulcerative colitis following treatment with an infliximab product administered intravenously.
It is not known if ZYMFENTRA is safe and effective in children under 18 years of age.
What is the most important information I should know about ZYMFENTRA?
SERIOUS INFECTIONS
Patients treated with ZYMFENTRA are at increased risk for developing serious infections involving various organ systems and sites that may lead to hospitalization or death. Discontinue ZYMFENTRA if a patient develops a serious infection or sepsis.
Reported infections include:
- Active tuberculosis (TB), including reactivation of latent TB. Patients frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent TB before and during treatment with ZYMFENTRA. Treatment for latent infection should be initiated prior to treatment with ZYMFENTRA.
- Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients may present with disseminated, rather than localized, disease. Empiric anti-fungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness.
- Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria.
The risks and benefits of treatment with ZYMFENTRA should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection. Closely monitor patients for the development of signs and symptoms of infection during and after treatment with ZYMFENTRA, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.
Risk of infection may be higher in patients greater than 65 years of age, patients with comorbid conditions and/or patients taking concomitant immunosuppressant therapy. In clinical trials, other serious infections observed in patients treated with infliximab included arthritis bacterial, pneumonia, and urinary tract infection.
MALIGNANCIES
Malignancies, some fatal, have been reported in children, adolescents, and young adults treated with TNF blockers, including infliximab products.
Approximately half of these cases were lymphomas, including Hodgkin’s and non-Hodgkin’s lymphoma. The other cases represented a variety of malignancies, including rare malignancies that are usually associated with immunosuppression and malignancies that are not usually observed in children and adolescents. The malignancies occurred after a median of 30 months after the first dose of therapy. Most of the patients were receiving concomitant immunosuppressants.
Post-marketing cases of hepatosplenic T-cell lymphoma, a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including infliximab products. These cases have had a very aggressive disease course and have been fatal. The majority of reported cases have occurred in patients with Crohn’s disease or ulcerative colitis, and most were in adolescent and young adult males. Almost all of these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. Carefully assess the risks and benefits of treatment with ZYMFENTRA, especially in these patient types.
In clinical trials of all TNF blockers, more cases of malignancies were observed compared with controls and the expected rate in the general population. In clinical trials of some TNF blockers, including infliximab products, more cases of other malignancies were observed compared with controls. As the potential role of TNF blocker therapy in the development of malignancies is not known, caution should be exercised when considering treatment of patients with a current or a past history of malignancy.
Melanoma and Merkel cell carcinoma have been reported in patients treated with TNF blocker therapy, including infliximab products. Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer.
CONTRAINDICATIONS
ZYMFENTRA is contraindicated in patients with a previous severe hypersensitivity reaction to infliximab-dyyb, other infliximab products, any of the inactive ingredients of ZYMFENTRA or any murine proteins (severe hypersensitivity reactions have included anaphylaxis, hypotension and serum sickness).
HEPATITIS B VIRUS REACTIVATION
TNF blockers, including infliximab products, have been associated with reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. Some cases were fatal. Patients should be tested for HBV infection before initiating ZYMFENTRA. For patients who test positive, consult a physician with expertise in the treatment of hepatitis B. Exercise caution when prescribing ZYMFENTRA for patients identified as carriers of HBV and monitor closely for active HBV infection during and following termination of therapy with ZYMFENTRA. Discontinue ZYMFENTRA in patients who develop HBV reactivation and initiate antiviral therapy with appropriate supportive treatment. Exercise caution when considering resumption of ZYMFENTRA and monitor patients closely.
HEPATOTOXICITY
Hepatobiliary disorders, including acute liver failure, jaundice abnormal hepatic function, hepatic steatosis, hepatitis, hepatotoxicity, hyperbilirubinemia and non-alcoholic fatty liver, have been reported in patients receiving infliximab products post-marketing. Some cases were fatal or required liver transplant. Aminotransferase elevations were not noted prior to discovery of liver injury in many cases. Patients with symptoms or signs of liver dysfunction should be evaluated for evidence of liver injury. If jaundice and/or marked liver enzyme elevations (eg, ≥5 times the upper limit of normal) develop, ZYMFENTRA should be discontinued and a thorough investigation of the abnormality should be undertaken.
CONGESTIVE HEART FAILURE
Cases of worsening congestive heart failure (CHF) and new onset CHF have been reported with TNF blockers. Some cases had a fatal outcome. In several exploratory trials of other TNF blockers in the treatment of CHF, there were greater proportions of TNF-blocker-treated patients who had CHF exacerbations requiring hospitalization or increased mortality. ZYMFENTRA has not been studied in patients with a history of CHF and ZYMFENTRA should be used with caution in patients with CHF.
HEMATOLOGIC REACTION
Cases of leukopenia, neutropenia, thrombocytopenia and pancytopenia (some fatal) have been reported. The causal relationship to infliximab-product therapy remains unclear. Exercise caution in patients who have ongoing or a history of significant hematologic abnormalities. Advise patients to seek immediate medical attention if they develop signs and symptoms of blood dyscrasias or infection. Consider discontinuation of ZYMFENTRA in patients who develop significant hematologic abnormalities.
HYPERSENSITIVITY AND OTHER ADMINISTRATION REACTIONS
In post-marketing experience, serious systemic hypersensitivity reactions (including anaphylaxis, hypotension and serum sickness) have been reported following administration of infliximab products. If an anaphylactic or other clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue ZYMFENTRA.
INJECTION SITE REACTIONS
In clinical studies, localized injection-site reactions were reported following administration of ZYMFENTRA. If a clinically significant injection-site reaction occurs, institute appropriate therapy and discontinue ZYMFENTRA.
NEUROLOGIC REACTIONS
Agents that inhibit TNF have been associated with central nervous system (CNS) manifestation of systemic vasculitis, seizure and new onset or exacerbation of CNS demyelinating disorders, including multiple sclerosis and optic neuritis and peripheral demyelinating disorders, including Guillain-Barré syndrome. Exercise caution when considering ZYMFENTRA in patients with these disorders and consider discontinuation if these disorders develop.
RISK OF INFECTION WITH CONCURRENT ADMINISTRATION OF OTHER BIOLOGICS PRODUCTS
Serious infections and neutropenia have been reported with concurrent use of ZYMFENTRA with other immunosuppressive biological products. The concurrent use of ZYMFENTRA with other immunosuppressive biological products used to treat UC and CD may increase the risk of infection and is not recommended.
RISK OF ADDITIVE IMMUNOSUPPRESSIVE EFFECTS FROM PRIOR BIOLOGICAL PRODUCTS
Consider the half-life and mode of action of prior biological products to avoid unintended additive immunosuppressive effects when initiating ZYMFENTRA.
AUTOIMMUNITY
Treatment with TNF blockers may result in the formation of autoantibodies and in the development of a lupus-like syndrome. Discontinue ZYMFENTRA treatment if symptoms of a lupus-like syndrome develop.
VACCINATIONS AND USE OF LIVE VACCINES/THERAPEUTIC INFECTIOUS AGENTS
Prior to initiating ZYMFENTRA, update vaccinations in accordance with current vaccination guidelines. Live vaccines or therapeutic infectious agents should not be given with ZYMFENTRA due to the possibility of clinical infections, including disseminated infections. At least a 6-month waiting period following birth is recommended before the administration of any live vaccine to infants exposed in utero to ZYMFENTRA.
ADVERSE REACTIONS
In clinical trials with ZYMFENTRA, the most common adverse reactions occurring in ≥3% of ZYMFENTRA-treated patients included site reactions, COVID-19, anemia, arthralgia, infection site reaction, increased alanine aminotransferase and abdominal pain for UC, and COVID-19, headache, upper respiratory tract infection, injection site reaction, diarrhea, increased blood creatine phosphokinase, arthralgia, increased alanine aminotransferase, hypertension, urinary tract infection, neutropenia, dizziness and leukopenia for CD.
Please click for Full U.S. Prescribing Information.
Globally, prescribing information varies; refer to the individual country product label for complete information.
About American College of Gastroenterology (ACG)
The American College of Gastroenterology (ACG) is a recognized leader in educating GI professionals and the general public about digestive disorders. ACG’s mission is to advance world-class care for patients with gastrointestinal disorders through excellence, innovation, and advocacy in the areas of scientific investigation, education, prevention, and treatment. The 2026 ACG Annual Scientific Meeting & Postgraduate Course will convene in Nashville, Tennessee, from October 9 to 14, 2026. To learn more about ACG, visit website.
About Celltrion
Celltrion is a leading biopharmaceutical company that specializes in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people’s lives worldwide. Celltrion is a pioneer in the biosimilar space, having launched the world’s first monoclonal antibody biosimilar. Our global pharmaceutical portfolio addresses a range of therapeutic areas including immunology, oncology, hematology, ophthalmology and endocrinology. Beyond biosimilar products, we are committed to advancing our pipeline with novel drugs to push the boundaries of scientific innovation and deliver quality medicines. For more information, please visit our website www.celltrion.com/en-us and stay updated with our latest news and events on our social media: LinkedIn, Instagram, X, and Facebook.
About Celltrion USA
Celltrion USA is Celltrion’s U.S. subsidiary established in 2018. Headquartered in New Jersey, Celltrion USA is committed to expanding access to innovative biologics to improve care for U.S. patients. Celltrion’s FDA-approved biosimilar products in immunology, oncology, hematology, endocrinology and ophthalmology include: INFLECTRA® (infliximab-dyyb), TRUXIMA® (rituximab-abbs), HERZUMA® (trastuzumab-pkrb), VEGZELMA® (bevacizumab-adcd), YUFLYMA®(adalimumab-aaty), AVTOZMA® (tocilizumab-anho), STEQEYMA® (ustekinumab-stba), STOBOCLO® (denosumab-bmwo), OSENVELT® (denosumab-bmwo), OMLYCLO® (omalizumab-igec), and EYDENZELT® (aflibercept-boav), as well as the novel biologic ZYMFENTRA® (infliximab-dyyb). Celltrion USA will continue to leverage Celltrion’s unique heritage in biotechnology, supply chain excellence and best-in-class sales capabilities to improve access to high-quality biopharmaceuticals for U.S. patients. For more information, please visit www.celltrionusa.com and stay updated with our latest news and events on our social media – LinkedIn.
FORWARD-LOOKING STATEMENT
Certain information set forth in this press release contains statements related to our future business and financial performance and future events or developments involving Celltrion Inc. and its subsidiaries that may constitute forward-looking statements, under pertinent securities laws.
These statements may be also identified by words such as “prepares”, “hopes to”, “upcoming”, “plans to”, “aims to”, “to be launched”, “is preparing”, “once gained”, “could”, “with the aim of”, “may”, “once identified”, “will”, “working towards”, “is due”, “become available”, “has potential to”, the negative of these words or such other variations thereon or comparable terminology.
In addition, our representatives may make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Celltrion Inc. and its subsidiaries’ management, of which many are beyond its control.
Forward-looking statements are provided to allow potential investors the opportunity to understand management’s beliefs and opinions in respect to the future so that they may use such beliefs and opinions as one factor in evaluating an investment. These statements are not guarantees of future performance and undue reliance should not be placed on them.
Such forward-looking statements necessarily involve known and unknown risks and uncertainties associated with the company’s business, including the risk factors disclosed in its Annual Report and/or Quarterly Reports, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or results expressed or implied by such statements.
Celltrion Inc. and its subsidiaries undertake no obligation to update forward-looking statements if circumstances or management’s estimates or opinions should change except as required by applicable securities laws.
Trademarks
ZYMFENTRA® is a registered trademark of CELLTRION, Inc.
References
- Dubinsky M, et al. Comparative Efficacy of Subcutaneous Versus Intravenous Infliximab in Ileum-Dominant Crohn’s Disease: A Pooled Analysis and Propensity Score-Matched Analysis of Infliximab Registrational Studies. Late-breaking abstract to be presented at the American College of Gastroenterology 2026 Annual Scientific Meeting; Oct. 11-14, 2026; Nashville, Tennessee. Abstract 72.
- Dubinsky M, et al. Impact of Prior Anti-drug Antibody Status on Clinical Outcomes Following Subcutaneous Infliximab Initiation After Intravenous Infliximab Interruption: A Post Hoc Analysis of LIBERTY-CD and LIBERTY-UC Studies. Abstract to be presented at the American College of Gastroenterology 2026 Annual Scientific Meeting; Oct. 11-14, 2026; Nashville, Tennessee. Abstract 40.
For further information please contact:
Carly Scaduto,
[email protected]
202-591-4000
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