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

Reply: "Early Switching to Subcutaneous Infliximab as a Pragmatic Strategy for Optimized Inflammatory Bowel Disease Care". (PubMed, Inflamm Bowel Dis) - No abstract available

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

Celltrion announces publication of post-hoc analysis of LIBERTY-CD study of ZYMFENTRA (infliximab-dyyb), indicating consistent efficacy across disease location, including the terminal ileum in Clinical Gastroenterology and Hepatology journal (PRNewswire) - "Among 329 patients, 52.6% had colon-dominant CD (n=173) and 47.4% had ileum-dominant CD (n=105). At Week 54, patients receiving infliximab SC achieved significantly greater efficacy outcomes across all endpoints compared with placebo, regardless of disease location. Rates of clinical remission were 60.95% in the ileum-dominant group and 66.95% in the colon-dominant group, versus 37.25% and 29.09%, respectively, in the placebo group. Clinical response and endoscopic response rates similarly favored infliximab SC over placebo in both location groups..."

P3 data • Crohn's disease

Endoscopic response to subcutaneous infliximab by disease location: A post hoc analysis of the LIBERTY-CD study. (PubMed, Clin Gastroenterol Hepatol) - "Although ileal disease is often more treatment-resistant, IFX SC maintenance therapy was effective versus PBO regardless of disease location, demonstrating consistent efficacy across segments including the terminal ileum."

Journal • Retrospective data • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

A retrospective, multinational, cross-sectional survey of real-world outcomes for patients with axial spondyloarthritis receiving subcutaneous infliximab. (PubMed, BMC Rheumatol) - No abstract available

Journal • Real-world evidence • Retrospective data • Ankylosing Spondylitis • Immunology • Seronegative Spondyloarthropathies • Spondylarthritis

Subcutaneous infliximab use in children with inflammatory bowel disease in an Australian center. (PubMed, J Pediatr Gastroenterol Nutr) - "Our experience suggests SC-IFX may be an effective and well-tolerated alternative to intravenous infliximab (IV-IFX) in pediatric IBD. Median serum infliximab levels increased across over the study period. Use of SC-IFX may offer a positive impact on patient and caregiver QOL, along with resource and cost saving benefits for healthcare systems. Larger-scale studies are needed to validate these findings and optimize treatment protocols."

Journal • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Genetic Disorders • Immunology • Inflammation • Inflammatory Bowel Disease • Pediatrics • Ulcerative Colitis

Treatment optimization of subcutaneous infliximab in patients with inflammatory bowel disease. (PubMed, Expert Rev Gastroenterol Hepatol) - "However, there are still major gaps in understanding the role of drug clearance, immunogenicity, and the role of TDM for optimizing SC-IFX. Moreover, the impact of body mass index and concomitant IMM therapy on clinical outcomes as well as the efficiency of SC-IFX in more complicated IBD phenotypes remains to be elucidated."

Journal • Review • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

Early Switching to Subcutaneous Infliximab as a Pragmatic Strategy for Optimized Inflammatory Bowel Disease Care. (PubMed, Inflamm Bowel Dis) - No abstract available

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

Successful Switch to Subcutaneous Infliximab (Zymfentra) After Development of High Titer Antibodies in a Patient With Ulcerative Colitis (ACG 2025) - "He was diagnosed with UC andstarted on prednisone and IFX 5 mg/kg. Although azathioprine may have influencedimmunogenicity, ATI levels remained high despite improved IFX levels.To our knowledge, this is the first case describing successful transition from intravenousIFX to Zymfentra® in the setting of high-titer ATI, with restoration of therapeutic levels andsustained remission. Subcutaneous IFX may help mitigate immunogenicity in select patients,though further studies are warranted.Figure: Mayo 3 colitis"

Clinical • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Beyond the Gut: TNF-Alpha Inhibitor-Induced Demyelinating Neuropathy and Bladder Dysfunction in a Crohn's Disease Patient With Negative MRI Findings (ACG 2025) - "She was initially treated with dexamethasone and azathioprine with partial symptom control. Subcutaneous infliximab was initiated, improving GI symptoms...New-onset urinary or motor symptoms in young patients should prompt early neurologic evaluation and discontinuation of the agent, even with a normal MRI. A delayed diagnosis may result in irreversible deficits.Figure: Timeline of Events"

Clinical • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Pain • Peripheral Neuropathic Pain • Urinary Incontinence • Urology

Effectiveness of Switching From Intravenous to Subcutaneous Infliximab in Inflammatory Bowel Disease: A Systematic Review and Meta-Analysis (ACG 2025) - "Across the eight studies comprising 1,076 patients, Crohn's disease was the predominant subtype in most cohorts, with males representing a greater proportion of participants in several studies. Twelve-month clinical remission was achieved in 80.8% of patients (95% CI: 77.2–84.4), with moderate heterogeneity (I² = 42.26%), suggesting consistent benefit across studies. Biochemical remission was observed in 61.3% (95% CI: 55.1–67.5), also with moderate heterogeneity (I² = 49.29)."

Retrospective data • Review • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

Intravenous versus Subcutaneous Infliximab for Inflammatory Bowel Disease: A Systematic Review and Meta-Analysis (ACG 2025) - "Seventeen studies (n = 2,885) met inclusion criteria. Pooled analysis showed significantly higher remission rates with IV infliximab (RR = 0.90; 95% CI: 0.83–0.97; I² = 68%; p < 0.01). Subgroup analysis by disease type (UC, CD, or IBD) revealed no significant effect modification (p = 0.48)."

Retrospective data • Review • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

A Snapshot of Subcutaneous Infliximab Use in Inflammatory Rheumatic Diseases: A Multicenter Italian Study (ACR Convergence 2025) - "Background/Purpose: A new subcutaneous formulation of infliximab (CT-P13) has recently become available for the treatment of inflammatory rheumatic diseases (IRDs), psoriasis and inflammatory bowel diseases. The study results suggest that scIFX provides sustained effectiveness over time for the treatment of IRDs. While factors such as line of treatment or BMI class do not affect DRR, the use of an induction dose appears to predict better treatment persistence."

Clinical • Ankylosing Spondylitis • Dermatology • Gastroenterology • Gastrointestinal Disorder • Idiopathic Arthritis • Immunology • Inflammation • Inflammatory Arthritis • Inflammatory Bowel Disease • Psoriasis • Psoriatic Arthritis • Rare Diseases • Rheumatoid Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Spondylarthritis • Vasculitis

Anti-tumor necrosis factor treatment from diagnosis is more effective and less costly than conventional "step-up" care for patients with active Crohn's disease: a cost-effectiveness analysis from the PROFILE trial. (PubMed, J Crohns Colitis) - ""Top-down" treatment from diagnosis with anti-TNF results in lower healthcare resource use and better clinical outcomes in patients with Crohn's disease compared to an "accelerated step-up" strategy."

HEOR • Journal • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease • Oncology

PATIENT REPORTED ATTITUDES TO INTRAVENOUS AND SUBCUTANEOUS ADMINISTERED THERAPIES FOR INFLAMMATORY BOWEL DISEASE (UEGW 2025) - "[1] Adalimumab, Golimumab, Ustekinumab & Risankizumab are administered subcutaneously (SC), Infliximab and Vedolizumab are administered intravenously (IV), and have additionally been available SC since 2020. SC Infliximab was used during the pandemic to limit exposure to hospitals & reduce risk of Covid-19, [2] as well as for convenience...6/29 (20.7%) stated SE not affected their quality of life (QoL), 12 (41.4%) little impact QoL, 10 (34.5%) moderate impact, 1 (3.4%) severe impact.96/105 (91.4%) would recommend IV routeSC survey106/113 (93.8%) completed the survey..54/106 patients were on Adalimumab (50.9%), 24 (22.6%) Ustekinumab, 13 (12.2%) Vedolizumab , 13 (12.3%) Infliximab, 2 (1.9%) Golimumab10/106 (9.4%) for 1-6 months, 21 (19.8%) for 6-12 months, 33 (31.1%) for 1-3yrs, 21 (19.8%) for 3-5 years and 20 (18.9%) for >5 years.89/106 (83.9%) rated treatment administration as easy, 10 (9.4%) intermediate, 2 (1.9%) difficult59/106 (55.7%) were previously on..."

Clinical • Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease • Inflammation • Inflammatory Bowel Disease • Novel Coronavirus Disease

SWITCHING TO SUBCUTANEOUS INFLIXIMAB FOR REGAINING CLINICAL REMISSION IN IBD PATIENTS WHO LOST RESPONSE TO INTRAVENOUS INFLIXIMAB: AN OBSERVATIONAL STUDY FROM THE ENEIDA REGISTRY (UEGW 2025) - "Introduction: Subcutaneous infliximab (SC-IFX) has demonstrated efficacy and safety in maintaining remission in inflammatory bowel disease (IBD) patients. Switching from IV-IFX to SC-IFX could be an effective and safe strategy to recapture clinical remission in IBD patients with active disease that lose response to IV-IFX."

Clinical • Observational data • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Inflammatory Bowel Disease • Ulcerative Colitis

EFFICACY OF BIOLOGIC AGENTS AND SMALL MOLECULES FOR ENDOSCOPIC IMPROVEMENT AND MUCOSAL HEALING IN PATIENTS WITH MODERATE-TO-SEVERE ULCERATIVE COLITIS: A SYSTEMATIC REVIEW AND META-ANALYSIS (UEGW 2025) - "In biologic-naïve patients or those without prior biologic failure, all interventions—except filgotinib 100 mg and vedolizumab—were significantly superior to placebo, with etrasimod showing the highest efficacy (RR 3.12, 95% CI: 1.79–5.43). Among biologic-exposed patients or those with prior biologic failure, upadacitinib, mirikizumab, ustekinumab, etrasimod, tofacitinib, and risankizumab 180 mg were significantly superior to placebo...In biologic-naïve patients or those without prior biologic failure, only etrasimod, mirikizumab, upadacitinib 30 mg and subcutaneous infliximab were significantly superior to placebo, with upadacitinib showing the highest efficacy (RR 3.02, 95% CI: 1.18–7.71)... Biologic and small-molecule therapies demonstrated substantial efficacy in achieving key endoscopic and histologic endpoints in moderate to severe UC. Upadacitinib consistently showed the highest efficacy across both induction and maintenance phases. Stratified analyses..."

Retrospective data • Review • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

SWITCHING TO SUBCUTANEOUS INFLIXIMAB IMPROVES WORK PRODUCTIVITY IN PATIENTS WITH IBD: THE BIO-BETTER SWITCH STUDY (UEGW 2025) - "Switching from IV to SC infliximab is associated with significant improvements in work productivity at week 52 in both UC and CD. No new safety issues were found. These findings support the SC formulation of infliximab as a safe and effective option in the management of inflammatory bowel disease."

Clinical • Crohn's disease • Dermatology • Gastroenterology • Gastrointestinal Disorder • Infectious Disease • Inflammatory Bowel Disease • Nephrology • Ulcerative Colitis

OPTIMAL DOSING OF SUBCUTANEOUS ADMINISTERED INFLIXIMAB DURING SWITCH AND START IN ADULTS AND CHILDREN WITH INFLAMMATORY BOWEL DISEASE: A SIMULATION STUDY (UEGW 2025) - "Infliximab exposure (AUC) remains largely similar when transitioning from standard IV to SC dosing. Current dosing regimens may not be optimal for morbidly obese patients, paediatric patients and patients on high-frequency infliximab regimens. These findings provide a foundation for future clinical research to refine SC infliximab dosing in these populations."

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

CHARACTERISATION OF PATIENTS WHO EXPERIENCE LOSS OF RESPONSE DURING MAINTENANCE TREATMENT WITH SUBCUTANEOUS INFLIXIMAB: A POST HOC ANALYSIS OF THE 2-YEAR PHASE 3 LIBERTY-CD AND LIBERTY-UC TRIALS (UEGW 2025) - "Patients who experienced LoR during maintenance therapy with SC IFX 120mg EOW had different patterns of baseline characteristics and clinical profiles at W10 compared to those who did not. BMI and CDAI at baseline, and reduction in CRP from baseline at W10 were predictors of LoR in CD, while prior exposure to biologics and/or JAKi and disease duration at baseline, MES at baseline and W10 were predictors of LoR in UC."

Clinical • P3 data • Retrospective data • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis • CRP

BAYESIAN PRIOR ELICITATION ON THE EFFICACY OF SEVEN MEDICAL THERAPIES FOR FISTULATING PERIANAL CROHN'S DISEASE (UEGW 2025) - "The prior mean, together with a 90% prior credible interval, of the one-year fistula remission rate was 0.22 (0.05, 0.46) for placebo, 0.58 (0.09, 0.96) for intravenous infliximab, 0.39 (0.06, 0.82) for adalimumab, 0.53 (0.09, 0.93) for subcutaneous infliximab, 0.24 (0.03, 0.60) for intravenous vedolizumab, 0.44 (0.05, 0.90) for upadacitinib, 0.34 (0.04, 0.77) for ustekinumab, and 0.36 (0.04, 0.82) for risankizumab. We have conducted, to the best of our knowledge, the first formal Bayesian prior elicitation exercise for efficacy of medical therapies in perianal Crohn's disease. These priors developed for the efficacy of licensed medical therapies can be internationally validated and potentially taken forward for planning of dedicated clinical trials. Importantly, these results could be used to enhance the design and analysis of clinical trials for fistulating perianal Crohn's disease."

Clinical • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • IL12A • IL23A

EVALUATION OF SUBCUTANEOUS INFLIXIMAB FOR PERIANAL FISTULA HEALING IN CROHN'S DISEASE: PRELIMINARY RESULTS FROM THE REMSILAP MULTICENTER OBSERVATIONAL COHORT STUDY (UEGW 2025) - "Forty-three patients (79.6%) received SC IFX in combination with immunomodulators (azathioprine, methotrexate, or 6-mercaptopurine). Subcutaneous infliximab following surgical drainage of Crohn's disease perianal fistula demonstrates high treatment persistence and promising rates of fistula healing."

Clinical • Observational data • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease

INTRAVENOUS INFLIXIMAB, SUBCUTANEOUS INFLIXIMAB AND SUBCUTANEOUS ADALIMUMAB AS "TOP-DOWN" TREATMENT FROM DIAGNOSIS, ARE ALL MORE EFFECTIVE, SAFER AND LESS COSTLY THAN CONVENTIONAL 'STEP-UP' CARE FOR PATIENTS WITH ACTIVE CROHN'S DISEASE (UEGW 2025) - "This health economic analysis demonstrates that early effective "top-down" treatment with anti-TNF therapy from diagnosis results in lower healthcare resource use compared to an "accelerated step-up" strategy. The economic benefits align with improved clinical outcomes, as early, effective treatment better controls inflammation. Patients experience longer periods in remission, fewer disease-related flares, and enhanced quality of life."

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

USE AND PERSISTANCE OF INFLIXIMAB IV AND SC IN FRANCE BASED ON THE FRENCH ADMINISTRATIVE HEALTH DATABASES 2021-2023: THE RIPOSTE IBD STUDY (UEGW 2025) - "Introduction: Subcutaneous infliximab (IFX-SC) is available in France since February 2021... Based on data from the entire French population, IBD patients who switched from IFX-IV to IFX-SC may benefit from a better persistence. Further analyses including propensity score matching to control for residual confounding are ongoing."

Ankylosing Spondylitis • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Infectious Disease • Inflammatory Arthritis • Inflammatory Bowel Disease • Rheumatology • Seronegative Spondyloarthropathies • Ulcerative Colitis

Treatment discontinuation rates due to lack of efficacy through 1 year of maintenance treatment with vedolizumab or subcutaneous infliximab in patients with inflammatory bowel disease: a systematic literature review and meta-analysis. (PubMed, Therap Adv Gastroenterol) - "In this meta-analysis, rates of discontinuation due to lack of efficacy during maintenance treatment were lower with subcutaneous infliximab than with vedolizumab (intravenous and subcutaneous formulations) in patients with moderate-to-severe IBD. PROSPERO number CRD42023438330."

Journal • Retrospective data • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Oncology • Ulcerative Colitis

The transition from intravenous to subcutaneous infliximab in a cohort of patients with inflammatory bowel disease: results of the INESTIMABLE retrospective observational study. (PubMed, Adv Med Sci) - "The findings suggest that SC infliximab may be a viable option for IBD patients in remission who are eligible for switching, offering a self-administered alternative to IV therapy."

Journal • Observational data • Retrospective data • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Oncology • Ulcerative Colitis