# Celltrion to Present New Analyses of ZYMFENTRA® (infliximab-dyyb) in Crohn's Disease and Ulcerative Colitis at ACG 2026

- Link: https://www.thailand-business-news.com/pr-news/celltrion-to-present-new-analyses-of-zymfentra-infliximab-dyyb-in-crohns-disease-and-ulcerative-colitis-at-acg-2026
- Published: 2026-10-12T00:00:00+07:00
- Author: PR Newswire

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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 DetailsBoth 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
InterruptionDate: Tuesday, Oct. 13, from 2:45-2:55 p.m. CT
Room: Karl F. Dean Grand
Ballroom A, Level 4Abstract 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 DiseaseDate: 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.

### 

**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.**](https://www.zymfentra.com/wp-content/uploads/2023/11/zymfentra_prescribing_information_final.pdf)

**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](http://www.gi.org/).

**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 ](https://www.celltrion.com/en-us)and
stay updated with our latest news and events on our social media: [LinkedIn](https://www.linkedin.com/company/celltrioninc/?viewAsMember=true),
[Instagram](https://www.instagram.com/celltrion_global/), [X](https://x.com/Celltrioninc),
and [Facebook](https://www.facebook.com/celltrionglobal/). 

**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](http://www.celltrionusa.com/) and stay updated with
our latest news and events on our social media – [LinkedIn](https://www.linkedin.com/company/celltrionusa/about/?viewAsMember=true).

**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**

 1. 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.
 2. 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,
[cscaduto@jpa.com](https://www.thailand-business-news.com/pr-news/cscaduto@jpa.com)
202-591-4000

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