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

SWITCHING FROM INTRAVENOUS TO SUBCUTANEOUS INFLIXIMAB IN PATIENTS WITH IMMUNE MEDIATED DISEASES IN CLINICAL REMISSION (Front Med) - "Between April 2023 and April 2024, a total of 344 patients (CD=136, UC=62, SpA=52, PsA=38, RA=7, PsO=44, co-existence of more than one disease=5) were switched from IFX-IV to IFX-SC. After a mean± (SD) follow up period of 8±4 (4) months, 12 patients (3.5%) discontinued treatment with IFX-SC. Five of them (1.5%) because of disease worsening and the remaining 7 (2.0%) because of the occurrence of side effects. All other 332332 other patients (96.5%) showed favorable response, none of them requested an unscheduled visit, or developed an adverse event (clinical or laboratory) or needed escalation of treatment."

Retrospective data • Crohn's disease • Psoriasis • Psoriatic Arthritis • Rheumatoid Arthritis • Spondylarthritis • Ulcerative Colitis

Population Pharmacokinetic Model for the Use of Intravenous or Subcutaneous Infliximab in Patients with Inflammatory Bowel Disease: Real-World Data from a Prospective Cohort Study. (PubMed, Gut Liver) - "We developed an infliximab population PK model using body mass index, albumin, C-reactive protein level, and the anti-drug antibody level and validated its predictive performance. It may be possible to predict the infliximab trough level of both IV and SC infliximab in patients with inflammatory bowel disease during maintenance treatment by using our model in real-world practice."

Journal • PK/PD data • Real-world evidence • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis • CRP

Subcutaneous Infliximab (CT-P13 SC) as Maintenance Therapy for Crohn's Disease and Ulcerative Colitis: 2-Year Results from Open-Label Extensions of Two Randomized Controlled Trials (LIBERTY). (PubMed, J Crohns Colitis) - "CT-P13 SC is an effective and well-tolerated long-term maintenance treatment in moderate-to-severe CD and UC."

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

A Risk Stratification Tool for Relapse After Intravenous-to-Subcutaneous Switching of Infliximab in Patients with Inflammatory Bowel Diseases. (PubMed, Am J Gastroenterol) - "Pre-switch infliximab clearance and fecal calprotectin are accurate predictors of relapse after switching to subcutaneous infliximab. An interactive risk stratification tool facilitates confirmation of a stratified medicine approach to improve infliximab therapy in IBD."

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

Celltrion secures bids for three autoimmune disease biosimilars in Italy [Google translation] (Chosun Biz) - "First, the Steqeyma biosimilar of Ustekinumab...has recently been awarded contracts in the Ustekinumab bids held by the governments of four regions in Italy, including Piedmont, Aosta Valley, Liguria, and Sardinia. Steqeyma is expected to be supplied to these areas until 2028...The YUFLYMA biosimilar of Adalimumab, for the treatment of rheumatoid arthritis and psoriasis from AbbVie, has also been successful in bidding. It was awarded in the Adalimumab bids held in regions including Lazio, Lombardy, and Umbria. Starting this month, YUFLYMA will be supplied to Lazio and Lombardy for the next three years and to Umbria for two years....The REMSIMA biosimilar of Infliximab from J&J has recently been awarded in the Umbria bids and is expected to be supplied for two years until 2027. The subcutaneous injection (SC) product of REMSIMA, REMSIMA SC, has also created a new market in the Sardinia state government, where there has been no bidding market for the Infliximab SC..."

Commercial • Ankylosing Spondylitis • Crohn's disease • Immunology • Inflammatory Bowel Disease • Psoriasis • Rheumatoid Arthritis • Ulcerative Colitis

PRIME: IBD Disease Course of Infliximab-naïve IBD Patients Treated With Subcutaneous Infliximab CT-P13 Remsima® (clinicaltrials.gov) - P=N/A | N=120 | Active, not recruiting | Sponsor: Assistance Publique - Hôpitaux de Paris | Recruiting ➔ Active, not recruiting | Trial completion date: Feb 2026 ➔ Nov 2025 | Trial primary completion date: Feb 2026 ➔ Nov 2025

Enrollment closed • Trial completion date • Trial primary completion date • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease

Switching from intravenous to subcutaneous infliximab is safe and feasible in patients with perianal Crohn's disease. (PubMed, Therap Adv Gastroenterol) - "Only one patient (1/40, 2.5%) had a perianal relapse (at month 25) with remission recapture after SC infliximab intensification. Switching from IV to SC infliximab in CD with perianal lesions is safe and feasible."

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

ASSOCIATION OF SUBCUTANEOUS INFLIXIMAB CT-P13 SERUM CONCENTRATIONS AND THERAPEUTIC OUTCOMES IN PATIENTS WITH INFLAMMATORY BOWEL DISEASE: A RETROSPECTIVE INTERNATIONAL MULTICENTRE STUDY (DDW 2025) - No abstract available

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

REAL-WORLD EVIDENCE OF RECAPTURING CLINICAL REMISSION WITH SUBCUTANEOUS INFLIXIMAB AFTER SWITCHING FROM INTRAVENOUS THERAPY IN PATIENTS WITH ULCERATIVE COLITIS: A 2-YEAR MULTICENTER PROSPECTIVE STUDY IN KOREA (DDW 2025) - No abstract available

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

EFFICACY AND DRUG SURVIVAL OF SUBCUTANEOUS INFLIXIMAB AFTER SWITCHING FROM INTRAVENOUS THERAPY IN PATIENTS WITH INFLAMMATORY BOWEL DISEASE: A 2-YEAR MULTICENTER REAL-WORLD STUDY IN KOREA (DDW 2025) - No abstract available

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

SUBCUTANEOUS INFLIXIMAB IN ANAL FISTULAS OF CROHN'S DISEASE: BETTER OUTCOMES WITH LONG-TERM INTRAVENOUS INFLIXIMAB INFUSIONS BEFORE THE SWITCH (DDW 2025) - No abstract available

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

IS IT TIME TO SWITCH TO SUBCUTANEOUS INFLIXIMAB? THE RE-WATCH MULTICENTRE STUDY. (DDW 2025) - No abstract available

Clinical • Inflammatory Bowel Disease

OPTIMIZING THE SWITCH FROM ESCALATED INTRAVENOUS TO SUBCUTANEOUS INFLIXIMAB: A POPULATION PHARMACOKINETICS–PHARMACODYNAMICS STUDY (DDW 2025) - No abstract available

Clinical • PK/PD data • Inflammatory Bowel Disease

TIME TO CLINICAL RECAPTURE AFTER DOSE ESCALATION OF SUBCUTANEOUS INFLIXIMAB FOLLOWING LOSS OF RESPONSE: A POST HOC ANALYSIS OF THE 2-YEAR PHASE 3 LIBERTY-CD & LIBERTY-UC TRIALS (DDW 2025) - No abstract available

Clinical • P3 data • Retrospective data • Inflammatory Bowel Disease

CHARACTERIZATION OF PATIENTS WHO EXPERIENCE LOSS OF RESPONSE DURING MAINTENANCE TREATMENT WITH SUBCUTANEOUS INFLIXIMAB (IFX SC): A POST HOC ANALYSIS OF THE 2-YEAR PHASE 3 LIBERTY-CD AND LIBERTY-UC TRIALS (DDW 2025) - No abstract available

Clinical • P3 data • Retrospective data • Inflammatory Bowel Disease

IMPACT OF IMMUNOGENICITY ON 2-YEAR CLINICAL OUTCOMES IN PATIENTS WITH MODERATE-TO-SEVERE CROHN'S DISEASE TREATED WITH SUBCUTANEOUS INFLIXIMAB: A POST HOC ANALYSIS OF THE PHASE 3 LIBERTY-CD STUDY (DDW 2025) - No abstract available

Clinical • Clinical data • P3 data • Retrospective data • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

PRELIMINARY RESULTS ON EXPECTATIONS AND SATISFACTION OF SWITCHING FROM INTRAVENOUS TO SUBCUTANEOUS INFLIXIMAB IN PATIENTS PREVIOUSLY TREATED WITH AN OPTIMIZED INTRAVENOUS INFLIXIMAB DOSING SCHEDULE. (DDW 2025) - No abstract available

Clinical • Inflammatory Bowel Disease

EFFICACY OF SUBCUTANEOUS INFLIXIMAB MAINTENANCE THERAPY ACCORDING TO DISEASE LOCATION IN PATIENTS WITH MODERATE-TO-SEVERE CROHN'S DISEASE: A POST HOC ANALYSIS OF THE PHASE 3 LIBERTY-CD STUDY (DDW 2025) - No abstract available

Clinical • P3 data • Retrospective data • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

ENDOSCOPIC AND HISTOLOGIC OUTCOMES IN PATIENTS WITH MODERATE-TO-SEVERE ULCERATIVE COLITIS TREATED WITH SUBCUTANEOUS INFLIXIMAB: A POST HOC ANALYSIS OF THE PHASE 3 LIBERTY-UC STUDY (DDW 2025) - No abstract available

Clinical • P3 data • Retrospective data • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Celltrion's Remsima becomes Korea's first 'blockbuster' drug (KoreaTimes) - "Celltrion’s Remsima surpassed 1 trillion won ($699 million) in sales last year, making it the first drug developed by a Korean company to achieve blockbuster status, the biotech company said Wednesday...Celltrion reported sales of 3.56 trillion won and an operating profit of 492 billion won last year. Remsima accounted for 35.6 percent of total sales, generating 1.27 trillion won."

Sales • Rheumatoid Arthritis

Additional Post-Hoc Analyses (Businesswire) - P3 | N=548 | LIBERTY-UC (NCT04205643) | N=396 | LIBERTY-CD (NCT03945019) | Sponsor: Celltrion | "A separate post-hoc analysis on dose escalation in both UC and CD patients (LIBERTY-CD & UC Dose Escalation) found that dose escalation with SC infliximab after loss of response (LoR) resulted in rapid clinical recapture in both CD and UC patients, with significantly elevated serum infliximab levels in early recapturers...Finally, a post-hoc analysis from LIBERTY-CD study (LIBERTY-CD 2Y Immunogenicity) examined the role of anti-drug antibodies (ADA) in patients treated with SC infliximab. The analysis shows that despite the occurrences of ADAs, there was no significant impact on drug persistence and clinical efficacy up to and including Week 102."

P3 data • Crohn's disease • Ulcerative Colitis

LIBERTY-CD Phase III Post-Hoc Analysis (LIBERTY-CD Disease Location) (Businesswire) - P3 | N=396 | LIBERTY-CD (NCT03945019) | Sponsor: Celltrion | "The finding shows SC infliximab maintenance therapy was effective across all disease locations with statistically significant higher rate of endoscopic response at Week 54 compared to placebo. At Week 54, patients receiving SC infliximab maintenance therapy achieved a significantly higher numerical and/ or statistical clinical remission rate compared to placebo across all disease locations (ileal: 45.5% vs 16.7%, P=0.065; ileocolonic: 68.1% vs 48.5%, P=0.083; colonic: 67.0% vs 29.1%, P<0.001). A greater proportion of patients who received SC infliximab achieved endoscopic response than those who received placebo across all disease locations (ileal: 36.4% vs 5.6%, P=0.019; ileocolonic: 61.1% vs 27.3%, P=0.006; colonic: 52.5% vs 18.2%, P<0.001)."

P3 data • Crohn's disease

LIBERTY-UC Phase III Post-Hoc Analysis (LIBERTY-UC Endo-Histological Outcome) (Businesswire) - P3 | N=548 | LIBERTY-UC (NCT04205643) | Sponsor: Celltrion | "A post-hoc analysis of the Phase 3 LIBERTY-UC study showed that maintenance therapy with SC infliximab resulted in significantly greater improvements in endoscopic and histologic outcomes at Week 54 compared to placebo...Endoscopic improvements were observed in half of the patients in both groups at week 8. However, from Week 22 onwards, the difference in rates of endoscopic improvement between the two groups was statistically significant, with SC infliximab showing higher rates (50.7% vs 34.0%; p=0.0011) up to Week 54 (43.9% vs 22.2%; p<0.0001). Similar findings were observed for histologic remission. Endoscopic normalisation rate in the SC infliximab group increased with continued treatment while it declined in the placebo group (23.8% vs 21.5% at Week 8; 26.9% vs 18.8% at Week 22; 32.7% vs 11.1% at Week 54)."

P3 data • Ulcerative Colitis

Real-world quality of life experience of subcutaneous infliximab use in children with Inflammatory Bowel Disease (IBD) at a tertiary paediatric centre (ECCO-IBD 2025) - "Our real-world experience of paediatric SC-IFX use suggests this well tolerated and preferable alternative to IV-IFX dosing in children in with IBD. Further large-cohort and long-term paediatric data is required."

Clinical • HEOR • Real-world • Real-world evidence • Immunology • Inflammation • Inflammatory Bowel Disease

Is it time to switch to subcutaneous infliximab? The RE-WATCH multicentre study. (ECCO-IBD 2025) - "IBD- related hospitalization occurred in 3 patients and only one of them underwent surgery during follow-up in Group 6M. Conclusion Our study showed that an early switch to SC IFX at 6 weeks is effective in terms of clinical and endoscopic remission at one year, similarly -or even better- than a switch performed at 6 months."

Clinical • Inflammatory Bowel Disease • CRP