Entyvio SC (vedolizumab SC) / Takeda - LARVOL DELTA

Obesity Is Associated with Inferior Clinical Treatment Outcomes in Inflammatory Bowel Disease: A Nationwide Dutch Registry Study. (PubMed, Dig Dis Sci) - "Obesity was associated with lower steroid-free clinical remission at week 24. Obese patients with IBD should be encouraged to lose weight not only to improve their overall health, but also to optimize their treatment outcomes."

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

PANORAMA: A Study of Vedolizumab in Adults With Ulcerative Colitis or Crohn's Disease in the Community Setting (clinicaltrials.gov) - P4 | N=400 | Recruiting | Sponsor: Takeda | Not yet recruiting ➔ Recruiting

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

LONG-TERM SAFETY OF SUBCUTANEOUS VEDOLIZUMAB IN ULCERATIVE COLITIS AND CROHN'S DISEASE: FINDINGS FROM THE VISIBLE OLE STUDY (DDW 2025) - No abstract available

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

QUALITY OF LIFE AND COST-EFFECTIVENESS OF TRANSITIONING FROM INTRAVENOUS TO SUBCUTANEOUS VEDOLIZUMAB IN A VETERAN POPULATION: A PROSPECTIVE STUDY (DDW 2025) - No abstract available

Clinical • Cost effectiveness • HEOR • Inflammatory Bowel Disease

HOSPITALISATION AND SURGERY RATES IN PATIENTS WITH ULCERATIVE COLITIS AND CROHN'S DISEASE TREATED WITH SUBCUTANEOUS VEDOLIZUMAB: LONG-TERM FINDINGS FROM THE VISIBLE OLE STUDY (DDW 2025) - No abstract available

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

A Long-Term Extension Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis (UC) or Crohn's Disease (CD) (clinicaltrials.gov) - P3 | N=70 | Not yet recruiting | Sponsor: Takeda | Initiation date: Dec 2024 ➔ Jul 2025

Trial initiation date • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Pediatrics • Ulcerative Colitis

A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease (clinicaltrials.gov) - P3 | N=70 | Recruiting | Sponsor: Takeda | Not yet recruiting ➔ Recruiting

Enrollment open • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Pediatrics • Ulcerative Colitis

Real-world application of the Crohn’s disease clinical decision support tool (CDST) in both intravenous and subcutaneous vedolizumab (ECCO-IBD 2025) - "Our data demonstrates that the tool has predictive ability for long term treatment persistence regardless of the method of administration, as well as outcomes at 12 months. Our study supports a role for CDST in guiding treatment selection in clinical practice."

Clinical • Real-world • Real-world evidence • Crohn's disease • Immunology • Inflammatory Bowel Disease

Switching to standard-dose subcutaneous vedolizumab increases the percentage of patients in biochemical remission even in those intensified with intravenous vedolizumab: one year results of a Spanish multicentre observational study. (ECCO-IBD 2025) - "All patients were maintained on sc vedolizumab at a dose of 108mg/2 weeks without requiring intensification at medical criteria during the one-year follow-up. Conclusion Up to 20% more patients, after switching from iv to sc vedolizumab, achieved biochemical remission, which was higher in the intensified group (34%), after one year of follow-up with a standard dose of sc vedolizumab."

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

Dose intensification of subcutaneous vedolizumab is an effective and safe option in Inflammatory Bowel Disease patients: Results from the multicentre OPTI-VEDO study (ECCO-IBD 2025) - "Conclusion This first real-world study evaluating SC VDZ intensification demonstrated a SF clinical response at 3 months in more than one third of IBD patients, suggesting the interest of this strategy in clinical practice. Acknowledgment Takeda"

Clinical • Crohn's disease • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

Population pharmacokinetics of subcutaneous vedolizumab in Crohn’s disease and Ulcerative Colitis (ECCO-IBD 2025) - "This model could be used in the considerations of an extended SC dose regimen. Our results highlight the importance of defining clear targets for SC vedolizumab in clinical practice."

Clinical • PK/PD data • Crohn's disease • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Hospitalisation and surgery rates in patients with Ulcerative Colitis and Crohn’s disease treated with subcutaneous vedolizumab: Long-term findings from the VISIBLE OLE study (ECCO-IBD 2025) - P3 | "Conclusion Findings from VISIBLE OLE showed that few pts with UC and CD treated with long-term VDZ SC required IBD related hospitalisations over the course of the study. Notably, very few patients with UC or CD required colectomies or bowel surgery."

Clinical • Surgery • Crohn's disease • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Long-term safety of subcutaneous vedolizumab in Ulcerative Colitis and Crohn’s disease: Findings from the VISIBLE OLE study (ECCO-IBD 2025) - P3 | "Conclusion No new long-term safety events were identified with the VDZ SC route of administration compared to IV, except for ISRs. A higher proportion of patients who had previously been treated with placebo than those treated with VDZ during VISIBLE 1 and 2 were AVA positive during VISIBLE OLE, supporting a benefit of continued therapy with VDZ SC after IV induction, rather than cessation of treatment for a period of time."

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

Observational Real-World Study of Switching from Intravenous to Subcutaneous Vedolizumab in IBD Patients: Clinical and Pharmacokinetic Analysis (ECCO-IBD 2025) - "By month 6, two of them were switched (one to intensified VDZ-iv and the changed to ustekinumab). Patients’ perception of the treatment's utility and IBD control was positive and remained consistent during the switch. Patients with a perception of poor control and lack of deep remission at baseline are at higher risk of losing response when switching to VDZ-sc."

Clinical • PK/PD data • Real-world • Real-world evidence • Crohn's disease • Inflammatory Bowel Disease • Ulcerative Colitis

Proactive switching to subcutaneous vedolizumab in Inflammatory bowel disease correlates with raised trough levels and confers a clinical benefit: a real-world experience. (ECCO-IBD 2025) - "Over the one-year follow-up period, one patient (4.34%) required rescue steroid therapy, compared to three (4.83%) in the IV group. Conclusion Implementing proactive subcutaneous switching of vedolizumab in a real-world setting correlates with higher levels confers improved clinical response, and has a good safety profile, reflecting clinical trial results."

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

Obesity is associated with inferior treatment outcomes in inflammatory bowel disease: a nationwide Dutch registry study (ECCO-IBD 2025) - "Methods Patients ≥ 16 years old with IBD, a documented baseline BMI, and starting thiopurines and allopurinol, intravenous (iv) vedolizumab, subcutaneous (sc) vedolizumab, ustekinumab, ozanimod, filgotinib, or tofacitinib were selected from the Dutch Initiative on Crohn and Colitis (ICC) registry. Surprisingly, at week 12, overweight was associated with a higher rate of steroid-free clinical remission. However, despite this apparent faster treatment response, this advantage disappeared at 24 weeks."

Clinical • Crohn's disease • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

The real-world use of intravenous and subcutaneous Vedolizumab in IBD across Australia and New Zealand, Crohn’s Colitis Cure Data Insight’s Program. (ECCO-IBD 2025) - "SC formulations have the potential to reduce the patient’s burden of disease by reducing travel costs and time out of role, promoting autonomy and empowering people living with IBD. However, in the absence of economic incentive or policy change, there will remain inertia to change to SC formulation."

Clinical • Real-world • Real-world evidence • Crohn's disease • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

High persistence rate at one year- follow-up of subcutaneous vedolizumab at standard dose after switching endovenous vedolizumab, even in those previously intensified: results of a Spanish multicentre observational study. (PubMed, Gastroenterol Hepatol) - "After switching to sc vedolizumab in patients with endovenous vedolizumab treatment, high persistence rate at one year of follow-up is achieved, with a greater tendency to biochemical remission, which is more pronounced in previously intensified patients without the need for subcutaneous vedolizumab intensification."

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

Network Meta-analysis to Evaluate the Comparative Efficacy of Advanced Therapies as First-Line Treatment for Maintenance Treatment of Adult Patients With Moderate to Severe Crohn's Disease (AIBD 2024) - "Background: Subcutaneous (SC) CT-P13 provides patients and physicians with a new opportunity for maintenance treatment of Crohn's disease (CD)... Eligible studies, identified by systematic literature review (PROSPERO no: CRD42023413752), evaluated the efficacy of maintenance therapy using intravenous (IV) or SC infliximab, SC adalimumab, IV or SC vedolizumab, SC ustekinumab, SC risankizumab or oral upadacitinib, in patients with moderate to severe CD who responded to induction therapy... In this updated NMA, SC infliximab 120 mg Q2W demonstrated a favorable profile in achieving clinical remission and endoscopic response when administered as a first-line advanced therapy for maintenance treatment of patients with moderate to severe CD."

Metastases • Retrospective data • Crohn's disease • Immunology • Inflammatory Bowel Disease

The Real-Time Nondrug Cost Savings of Switching Patients With Inflammatory Bowel Disease From Intravenous to Subcutaneous Vedolizumab: A Time and Motion Study (AIBD 2024) - "This study highlights the potential for substantial time and cost savings with SC vedolizumab. By eliminating hospital visits, infusion-related personnel, and supplies, SC vedolizumab offers a more efficient and cost-effective treatment. Larger studies are needed to confirm these findings and assess long-term impacts on patient outcomes and healthcare resource utilization."

Clinical • Drug cost • HEOR • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

All About the ENTYVIO® (vedolizumab) Subcutaneous Pen (AIBD 2024) - "Supported by Takeda"

Immunology

Comparative Efficacy and Safety of Subcutaneous Vedolizumab versus Other Targeted Inflammatory Bowel Disease Therapies in Patients With Moderate to Severe Ulcerative Colitis: A Network Meta-Analysis (ACG 2024) - "Phase 3, randomized controlled trials of targeted IBD therapies (adalimumab, etrasimod, golimumab, infliximab, mirikizumab, ozanimod, tofacitinib, upadacitinib, ustekinumab and vedolizumab) in adults with moderate to severe UC were included. Of the 29 studies, 10 were newly included in this update. The odds of achieving clinical response or clinical remission with vedolizumab SC were either higher or not significantly different to other targeted IBD therapies ( Figure 1 ). For most safety outcomes, except serious infections, vedolizumab SC had a similar or favorable profile compared with other targeted IBD therapies; there were no significant differences between vedolizumab SC and vedolizumab IV ( Table 1 )."

Retrospective data • Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease • Inflammation • Inflammatory Bowel Disease • Oncology • Ulcerative Colitis

Exhibitor Product Theater - All About ENTYVIO® (vedolizumab) Subcutaneous Pen (ACG 2024) - "These programs are independent of the ACG 2024 Annual Scientific Meeting and Postgraduate Course programs. No CME is provided for Exhibitor Product Theater presentations."

Switching rate from intravenous to subcutaneous vedolizumab in managing inflammatory bowel diseases is lower than expected. (PubMed, Minerva Gastroenterol (Torino)) - "Switching to SC route is a safe and effective choice for IBD patients under remission using VDZ. However, this choice is not preferred by the majority of patients on stable remission under IV VDZ."

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

Outcomes of treatment cessation after switching to subcutaneous vedolizumab treatment in inflammatory bowel diseases. (PubMed, Therap Adv Gastroenterol) - "The transition from i.v. to s.c. VDZ treatment was effective, the overall persistence rate was associated with high serum drug levels, and no novel safety issues were reported. Although s.c. administration after induction can save resources, some patients still insisted on i.v. VDZ treatment, due to its proven formulation."

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