- 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. 11, 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.