Entyvio SC (vedolizumab SC) / Takeda - LARVOL DELTA

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 | Recruiting | Sponsor: Takeda | Not yet recruiting ➔ Recruiting

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

Cost-Effectiveness Analysis of Etrasimod Compared With Biologic Therapies for the Treatment of Patients with Moderately-to-Severely Active Ulcerative Colitis in Spain. (PubMed, Pharmacoecon Open) - "In AT-naïve and AT-experienced patients, etrasimod is a dominant therapy (cost savings, greater effectiveness) compared with commonly used ATs."

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

Enhancing Biologic Therapy Access in Inflammatory Bowel Disease: A Quality Improvement Initiative for Intravenous-to-Subcutaneous Transition (ACG 2025) - "Of 239 IBD patients receiving 1,855 IV infusions last year, 75 (31.4%) transitioned to SC therapy (20 infliximab, 55 vedolizumab). At six-month follow-up, 85% maintained clinical remission; 15% had mild disease activity, half requiring SC vedolizumab every 10 days. Persistence on SC therapy was 100%."

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

Adherence to STRIDE-II Treat-to-Target Guidelines in Recent FDA-Approved IBD Drug Trials: A Comparative Review (ACG 2025) - "It remains unclear to what extent pivotal trials leading to these approvals adhered to STRIDE-II targets. A structured review was conducted of Phase 3 clinical trials that supported FDA approval of the following agents between 2021 and 2025: mirikizumab (Omvoh), guselkumab (Tremfya), upadacitinib (Rinvoq), etrasimod (Velsipity), infliximab-dyyb (Zymfentra), and subcutaneous vedolizumab (Entyvio SC). All six trials included clinical remission and endoscopic healing as primary or co-primary endpoints, consistent with STRIDE-II recommendations. However, none of the pivotal trials included biomarker normalization or validated QoL instruments as formal endpoints. Mirikizumab's LUCENT trials uniquely evaluated bowel urgency as a patient-reported symptom, a symptomatic target identified in STRIDE-II."

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

Acneiform Eruption Following Transition From Intravenous to Subcutaneous Vedolizumab Injection in a Patient With Crohn's Disease (ACG 2025) - "Treatment with oral doxycycline, topical clindamycin, and hydroxyzine led to partial resolution within two weeks. Early recognition of this uncommon reaction can prevent prolonged discomfort and allow alternative strategies for the continued management of inflammatory bowel disease. This abstract was prepared with the assistance of a generative AI tool.Figure: Multiple erythematous papules and pustules on the forehead, chin, and cheeksFigure: Complete resolution of the facial lesions after the course of oral and topical antibiotics"

Clinical • Crohn's disease • Dermatology • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Immunology • Inflammation • Inflammatory Bowel Disease • Neutropenia • Ulcerative Colitis

Efficacy and Safety of Novel Biological Therapies in Ulcerative Colitis: A Systematic Review (ACG 2025) - "Databases including PubMed, EMBASE, and Cochrane Central were searched through April 2024 for randomized controlled trials (RCTs) investigating novel biologics in UC, such as etrasimod, mirikizumab, ozanimod, and vedolizumab SC. Fourteen RCTs met inclusion criteria (N=8,612). Mirikizumab demonstrated superior clinical remission rates at week 12 (RR 2.24, 95% CI 1.71–2.94) compared to placebo. Etrasimod significantly improved endoscopic scores (RR 1.96, 95% CI 1.43–2.68)."

Clinical • Review • Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

Evaluating the Shift From Intravenous to Subcutaneous Vedolizumab for Inflammatory Bowel Disease (clinicaltrials.gov) - P=N/A | N=120 | Active, not recruiting | Sponsor: Vanderbilt University Medical Center | Not yet recruiting ➔ Active, not recruiting

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

REAL WORD DATA: THE VEDOLIZUMAB EXPERIENCE IN A TERTIARY CENTRE (UEGW 2025) - "Subcutaneous (SC) vedolizumab was the commonest formulation administered in 71.3% of patients, while 28.7% were given intravenous (IV)... Our data contributes to the growing body of evidence that Vedolizumab is a safe and effective therapy, regardless of the delivery method. It is particularly beneficial for vulnerable patients, demonstrating good persistence of response beyond the initial induction of remission. Additionally, when used as a first-line treatment in the appropriate patient, it offers a better chance for a sustained drug response."

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

COST-EFFECTIVENESS ANALYSIS OF ETRASIMOD COMPARED WITH BIOLOGIC THERAPIES FOR PATIENTS WITH MODERATE-TO-SEVERE ACTIVE ULCERATIVE COLITIS EXPERIENCED TO PREVIOUS ADVANCED THERAPIES IN SPAIN (UEGW 2025) - "Rates of efficacy, safety, and loss of response of etrasimod, adalimumab, ustekinumab, intravenous (IV) vedolizumab and subcutaneous (SC) vedolizumab were obtained from a Bayesian network meta-analysis4,5.After loss of response, a loop of subsequent AT in perpetuity was applied...Concomitant treatment with azathioprine (35% patients, biologics only), mercaptopurine (15% patients, biologics only), mesalazine (40% patients), prednisone (20% patients) and beclomethasone (10% patients) were considered7,15... Etrasimod represents a cost-effective alternative for AT-experienced patients with moderate-to-severe active UC compared with biologics available in Spain."

Clinical • Cost effectiveness • HEOR • Metastases • Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease • Inflammatory Bowel Disease • Ulcerative Colitis

HOME-MONITORING OF PATIENTS WITH INFLAMMATORY BOWEL DISEASE ON SUBCUTANEOUS VEDOLIZUMAB – A 2 YEARS OBSERVATIONAL STUDY (UEGW 2025) - "Home monitoring using CC has the potential to transform IBD care by delivering continuous, long-term data on patient reported outcomes. Subcutaneous vedolizumab as maintenance treatment in active, moderate to severe IBD proved to be feasible to monitor by telemedicine and effective for both UC and CD in terms of improving disease activity and quality of life with high rate of adherence to medication. However, local adverse events could lead to treatment discontinuation."

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

SAFETY AND EFFICACY OF ELECTIVE SWITCHING FROM INTRAVENOUS TO SUBCUTANEOUS VEDOLIZUMAB IN IBD PATIENTS IN REMISSION: A SINGLE-CENTER RETROSPECTIVE COHORT STUDY (UEGW 2025) - "Elective switching from IV to SC Vedolizumab seems to be an effective and safe approach in real-world every day clinical practice in IBD patients in clinical remission."

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

PARTIAL RESPONSE FOLLOWING INDUCTION OF REMISSION WITH INTRAVENOUS VEDOLIZUMAB (PRIVEDO): EARLY OPTIMIZATION OR SWITCH TO SUBCUTANEOUS FORMULATION? A SN-IBD PROSPECTIVE OBSERVATIONAL STUDY (UEGW 2025) - "The study aims to evaluate the efficacy of subcutaneous (SC) vedolizumab compared to early optimization of the IV formulation in patients with CD or UC who experienced a partial response after IV induction therapy... These preliminary findings suggest that in patients with an incomplete response to VDZ induction, switching to SC administration may offer a more profound remission at mid-term follow-up (26 weeks) compared to continued intensified IV therapy. Further analysis of the complete 52-week data set is required to confirm these observations."

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

VEDOLIZUMAB PERSISTENCE IN INFLAMMATORY BOWEL DISEASE PATIENTS AFTER SWITCHING FROM INTRAVENOUS TO SUBCUTANEOUS ADMINISTRATION: THE REAL-LIFE MULTICENTRE DOPER STUDY (UEGW 2025) - "In this multicentre prospective cohort of patients with CD or UC in clinical remission who switched from IV to SC vedolizumab, drug persistence rate at 6 months was over 90%, with good safety results. 12-month results are pending."

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

Multicenter Spanish study on vedolizumab intravenous to subcutaneous switch in patients with inflammatory bowel disease in clinical remission. (PubMed, Rev Esp Enferm Dig) - "Transitioning from IV to SC vedolizumab in patients with IBD in remission showed comparable effectiveness in maintaining disease remission and persistence. Patients on IV are more likely to need drug intensification during follow-up."

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

Real-World Experience of Switching from Intravenous to Subcutaneous Vedolizumab in Korean Patients with Inflammatory Bowel Disease. (PubMed, Gut Liver) - "The recapture success rate after reverting to IV VDZ was 73.7%, with higher success in those who discontinued because of injection-site reactions or poor adherence. SC VDZ persistence is significantly influenced by disease activity at the time of switching."

Journal • Real-world evidence • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Genetic Disorders • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

Subcutaneous vedolizumab dose intensification in inflammatory bowel disease patients: the OPTI-VEDO multicenter study from the GETAID. (PubMed, J Crohns Colitis) - "In this real-world study evaluating SC VDZ intensification, a SFCr was observed in at least one third of IBD patients at 3 months, suggesting the benefit of this strategy in clinical practice."

Clinical • Journal • Cardiovascular • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease • Inflammation • Inflammatory Bowel Disease • Pneumonia • Respiratory Diseases • Ulcerative Colitis

VARIETY: A Study in Adults With Ulcerative Colitis (UC) or Crohn's Disease (CD) Receiving Vedolizumab in Real-World Practice in Poland (clinicaltrials.gov) - P=N/A | N=165 | Completed | Sponsor: Takeda | Active, not recruiting ➔ Completed

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

Clinical use of vedolizumab subcutaneous formulation in inflammatory bowel diseases: a review of real-world evidence. (PubMed, Int J Colorectal Dis) - "Clinical practice experience in inflammatory bowel disease patients who transitioned from vedolizumab IV to SC showed no change in effectiveness or safety outcomes, and a high level of patient satisfaction overall."

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

Evaluating the Shift From Intravenous to Subcutaneous Vedolizumab for Inflammatory Bowel Disease (clinicaltrials.gov) - P=N/A | N=120 | Not yet recruiting | Sponsor: Vanderbilt University Medical Center

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

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