Entyvio SC (vedolizumab SC) / Takeda - LARVOL DELTA

HOME-MONITORING OF PATIENTS WITH INFLAMMATORY BOWEL DISEASE ON SUBCUTANEOUS VEDOLIZUMAB – A 2 YEARS OBSERVATIONAL STUDY (UEGW 2025) - No abstract available

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

SAFETY AND EFFICACY OF ELECTIVE SWITCHING FROM INTRAVENOUS TO SUBCUTANEOUS VEDOLIZUMAB IN IBD PATIENTS IN REMISSION: A SINGLE-CENTER RETROSPECTIVE COHORT STUDY (UEGW 2025) - No abstract available

Retrospective data • Inflammatory Bowel Disease

Low rates of transition from subcutaneous to intravenous formulation in patients with inflammatory bowel diseases treated with vedolizumab (BSG 2025) - "Introduction Vedolizumab subcutaneous (SC) formulation is used for maintenance therapy in Ulcerative colitis and Crohn's Disease after intravenous (IV) induction therapy...Transitions are mainly due to injection site and allergic reactions, and preferred administration route, rather than loss of response. The extent of switching back to IV because of the 'nocebo' effect due to negative perceptions of SC treatment delivery is unclear.This study was sponsored by Takeda"

Clinical • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease • Inflammation • Inflammatory Bowel Disease • Novel Coronavirus Disease • Ulcerative Colitis

Transition from intravenous to subcutaneous vedolizumab: real-world analysis of persistence, disease activity, and drug levels (BSG 2025) - "Clinical remission rates increased post-transition, with all patients achieving biomarker remission. These findings support SC vedolizumab as a safe and effective option for IBD patients transitioning from IV therapy."

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

A Study of Vedolizumab Intravenous (IV) and Adalimumab or Vedolizumab and Ustekinumab in Adults With Crohn's Disease (clinicaltrials.gov) - P4 | N=100 | Recruiting | Sponsor: Takeda | N=150 ➔ 100

Enrollment change • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

LONG-TERM SAFETY OF SUBCUTANEOUS VEDOLIZUMAB IN ULCERATIVE COLITIS AND CROHN'S DISEASE: FINDINGS FROM THE VISIBLE OLE STUDY (DDW 2025) - P3 | "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 • 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) - "71.4 % of patients on IV VDZ agreed to switch to SC VDZ. All, except one patient, was in remission at the time of the switch and the main reason to decline was fear of losing response with the SC formulation. Although the annual maintenance cost was slightly higher in SC than IV formulation, the transition to SC reduces the patients' time committed to medical care and improves the infusion center's accessibility."

Clinical • Cost effectiveness • HEOR • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • 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 (DDW 2025) - P3 | "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 • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Intravenous and subcutaneous vedolizumab for moderately to severely active ulcerative colitis in Iran: a model-based cost-effectiveness evaluation. (PubMed, Expert Rev Pharmacoecon Outcomes Res) - "To evaluate the cost-effectiveness of intravenous and subcutaneous vedolizumab compared to infliximab for moderately to severely active ulcerative colitis (UC) from an Iranian societal perspective. Vedolizumab (both IV and SC) resulted in reduced costs and improved QALYs compared to infliximab for moderate to severe UC in Iran. Therefore, we recommended including vedolizumab in the Iranian national formulary as a cost-effective treatment strategy."

HEOR • Journal • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

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

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