Zymfentra (infliximab-dyyb subcutaneous) / Celltrion - LARVOL DELTA

Maintenance of Clinical and Endoscopic Remission Following Transition From Intravenous to Subcutaneous Infliximab in Inflammatory Bowel Disease: A Real-World Cohort Study (ACG 2026) - "90 patients with IBD (70 CD, 20 UC) transitioned from IV to SC IFX between 2024-2026. At the time of SC IFX start, median age was 40 and median disease duration was 13 years. Among patients on maintenance IV IFX prior to transitioning, dosing regimens included 5 mg/kg every 8 weeks (n=26), 10 mg/kg every 8 weeks (n=39), and 10 mg/kg every 6 weeks (n=12), other (n=4), with mean duration of 7.2 (SD 5.6) years prior to transition."

Clinical • Real-world • Real-world evidence • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

Intestinal Ultrasound-Monitored Accelerated Infliximab Dosing to Achieve Deep Remission in a Pregnant Patient With Acute Severe Ulcerative Colitis (ACG 2026) - "Following IV methylprednisolone and IFX induction (10 mg/kg), she flared during prednisone taper. Follow-up intestinal ultrasound three months later. IUS of the sigmoid colon after initiation of subcutaneous infliximab demonstrating dramatic improvement with a bowel wall thickness of 1.7 mm, improvement in inflammatory fat, and a modified Limberg score of 0."

Clinical • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Obstetrics • Ulcerative Colitis

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 (ACG 2026) - "Abstract text will be released on Sunday, October 11, 2026, at 12:00 pm CT (1:00 pm ET) when the ACG 2026 embargo lifts."

Clinical • Clinical data • Retrospective data • Inflammatory Bowel Disease

Exhibitor Product Theater - Evolving Infliximab Maintenance: Insights from Emerging Post-hoc and Real-World Evidence of ZYMFENTRA� (infliximab-dyyb) (ACG 2026) - "These programs are independent of the ACG 2026 Annual Scientific Meeting and Postgraduate Course programs. No CME is provided for Exhibitor Product Theater presentations."

Clinical • HEOR • Real-world • Real-world evidence • Retrospective data

Outcomes of Direct Subcutaneous Remsima (Infliximab) Initiation Without a Loading Dose Compared With Conventional Induction Regimens in Chronic Inflammatory Rheumatic Diseases (ACR Convergence 2026) - No abstract available

Rheumatology

Switching from intravenous to subcutaneous infliximab in hidradenitis suppurativa: a French multicenter retrospective study (EADV 2026) - No abstract available

Retrospective data • Dermatology • Hidradenitis Suppurativa • Immunology

Switching standard dosed intravenous to subcutaneous infliximab leads to similar drug exposure in inflammatory bowel disease patients independent of concomitant immunosuppressants (SHUFFLE study). (PubMed, Br J Clin Pharmacol) - "SC IFX in IBD patients maintained equivalent drug exposure with higher trough levels, reduced time burden and stable quality-of-life, independent of concomitant immunosuppressants."

Journal • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Arthritis • Inflammatory Bowel Disease • Rheumatoid Arthritis • Rheumatology

The South Korean biopharmaceutical company said Tuesday that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for a Phase 4 study designed to establish clinical evidence for a 240mg dose of Zymfentra (Korea IT Times) - "The trial will enroll 447 patients with Crohn’s disease or ulcerative colitis across 55 U.S. medical centers. Researchers will compare the 240mg subcutaneous formulation with high-dose intravenous infliximab, with the study primarily designed to assess non-inferiority. Celltrion expects the study to generate additional evidence supporting dose selection based on disease severity and individual patient needs. If successful, the company could offer U.S. physicians a two-dose treatment approach combining the existing 120mg regimen with the higher 240mg option."

IND • New P4 trial • Crohn's disease • Ulcerative Colitis

Pharmacokinetic Predictor of Infection in Patients With Inflammatory Bowel Disease Treated With Intravenous and Subcutaneous Infliximab. (PubMed, J Clin Gastroenterol) - "Cumulative exposure, rather than Ctrough, predicts infection risk, supporting AUC monitoring for safer IFX dosing."

Journal • PK/PD data • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease • Inflammation • Inflammatory Bowel Disease

Comparison of the Risk of Acute Anterior Uveitis Flare Between Adalimumab and Subcutaneous Infliximab in Patients with Radiographic Axial Spondyloarthritis and Prior Acute Anterior Uveitis: A Randomized Controlled Trial. (PubMed, BioDrugs) - "No statistically significant differences in AAU flare risk or secondary ocular and rheumatologic outcomes were observed between ADA and IFX-SC over 48 weeks in patients with r-axSpA and prior AAU. These findings suggest that IFX-SC may represent a potential alternative to ADA for AAU flare prevention as well as disease activity control in this population."

Journal • Ankylosing Spondylitis • Immunology • Inflammatory Arthritis • Musculoskeletal Diseases • Ocular Inflammation • Ophthalmology • Rheumatology • Seronegative Spondyloarthropathies • Spondylarthritis • Uveitis

Navigating the Treatment Journey with Subcutaneous Infliximab across Clinical Scenarios (UEGW 2026) - "Sponsored by Celltrion"

Clinical

COMPARISON OF EFFECTIVENESS BETWEEN SUBCUTANEOUS INFLIXIMAB AS MONOTHERAPY OR COMBINED WITH AN IMMUNOSUPPRESSANT IN PATIENTS WITH ULCERATIVE COLITIS: INTERIM RESULTS FROM THE REMONO-UC STUDY (UEGW 2026) - No abstract available

Clinical • Monotherapy • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

PERSISTENCE, EFFICACY AND TOLERANCE OF SUBCUTANEOUS INFLIXIMAB AFTER SWITCH FROM INTRAVENOUS ROUTE IN IBD PATIENTS IN REMISSION: WEEK 96 RESULTS FROM A FRENCH MULTICENTER PROSPECTIVE COHORT (UEGW 2026) - No abstract available

Clinical • Inflammatory Bowel Disease

HIGH EFFICACY OF SUBCUTANEOUS INFLIXIMAB INDUCTION WITH AND WITHOUT CONCOMITANT IMMUNOMODULATORS FOR ACTIVE CROHN'S DISEASE: TOPLINE RESULTS OF THE DIRECT-CD STUDY (UEGW 2026) - No abstract available

Clinical • Immunomodulating • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

PHARMACOKINETIC AND IMMUNOGENIC PROFILE OF SUBCUTANEOUS INFLIXIMAB AFTER SWITCHING FROM INTRAVENOUS INFLIXIMAB: A POST HOC ANALYSIS OF THE PEREM COHORT (UEGW 2026) - No abstract available

PK/PD data • Retrospective data • Inflammatory Bowel Disease

CLIMATE IMPACT OF INTRAVENOUS VERSUS SUBCUTANEOUS INFLIXIMAB ADMINISTRATION: A LIFE CYCLE ASSESSMENT (UEGW 2026) - No abstract available

Inflammatory Bowel Disease

COMPARISON OF EFFECTIVENESS BETWEEN SUBCUTANEOUS INFLIXIMAB AS MONOTHERAPY OR COMBINED WITH AN IMMUNOSUPPRESSANT IN PATIENTS WITH CROHN'S DISEASE: FINAL RESULTS FROM THE REMONO-CD STUDY (UEGW 2026) - No abstract available

Clinical • Monotherapy • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

ATYPICAL MESANGIAL PROLIFERATIVE GLOMERULONEPHRITIS IN A PATIENT WITH ULCERATIVE COLITIS TREATED WITH SUBCUTANEOUS INFLIXIMAB (UEGW 2026) - No abstract available

Clinical • Gastroenterology • Gastrointestinal Disorder • Glomerulonephritis • Immunology • Inflammatory Bowel Disease • Lupus Nephritis • Nephrology • Ulcerative Colitis

A PROPENSITY SCORE WEIGHTED COMPARISON OF INTRAVENOUS AND SUBCUTANEOUS INFLIXIMAB AS MAINTENANCE TREATMENT IN PATIENTS WITH INFLAMMATORY BOWEL DISEASE: THE CISI STUDY (UEGW 2026) - No abstract available

Clinical • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease

THE HIDDEN COST OF CONVENIENCE: PHARMACY WORKFLOW DETERMINES THE REAL-WORLD VALUE OF SUBCUTANEOUS INFLIXIMAB IN INFLAMMATORY BOWEL DISEASE (UEGW 2026) - No abstract available

Clinical • Real-world • Real-world evidence • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease

REAL-WORLD EXPERIENCE OF PATIENT OUTCOMES FOLLOWING RETURN TO INTRAVENOUS INFLIXIMAB FROM SUBCUTANEOUS INFLIXIMAB (UEGW 2026) - No abstract available

Clinical • Real-world • Real-world evidence • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease

REAL-WORLD COMPARISON OF SUBCUTANEOUS INFLIXIMAB AND VEDOLIZUMAB IN INFLAMMATORY BOWEL DISEASE: CLINICAL OUTCOMES, SAFETY, AND PHARMACOKINETICS (UEGW 2026) - No abstract available

Clinical • Clinical data • PK/PD data • Real-world • Real-world evidence • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease

TWO-YEAR REAL-WORLD EFFECTIVENESS, PHARMACOKINETICS AND PERSISTENCE OF SUBCUTANEOUS INFLIXIMAB IN INFLAMMATORY BOWEL DISEASE: A SLOVAK SINGLE-CENTRE RETROSPECTIVE COHORT (UEGW 2026) - No abstract available

PK/PD data • Real-world • Real-world effectiveness • Real-world evidence • Retrospective data • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease

OPTIMAL TIMING FOR SWITCHING FROM INTRAVENOUS TO SUBCUTANEOUS INFLIXIMAB: PREDICTIVE ROLE OF BASELINE TROUGH LEVEL IN INFLAMMATORY BOWEL DISEASE (UEGW 2026) - No abstract available

Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease

DOES DOSE MATTER? OUTCOMES FOLLOWING TRANSITION FROM INTRAVENOUS TO SUBCUTANEOUS INFLIXIMAB FROM THE IRESWITCH STUDY (UEGW 2026) - No abstract available

Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease