Entyvio SC (vedolizumab SC) / Takeda - LARVOL DELTA

Therapeutic Drug Monitoring of the Subcutaneous Formulations of Infliximab and Vedolizumab-Current Knowledge and Future Directions. (PubMed, J Clin Med) - "In summary, we recommend performing TDM of the IV formulations prior to switching and then measuring drug levels at 8 weeks after switching to SC infliximab and at 16 weeks for SC vedolizumab. We recommend performing reactive TDM in cases of loss of response to SC therapy. In conclusion we offer suggested areas for future research."

Journal • Review

The efficacy and safety of vedolizumab as first-line advanced therapy for ulcerative colitis in patients after liver transplantation (ECCO-IBD 2026) - "One patient had an uncomplicated pregnancy while continuing subcutaneous vedolizumab...However, the modest remission rate indicates that longer treatment may be necessary to reach optimal targets in this population. Close surveillance remains crucial for early detection of UC/PSC-related and treatment-associated complications."

Clinical • Metastases • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Utilising Advanced Therapies in Inflammatory Bowel Disease: Real-World Experience from a UK Centre (ECCO-IBD 2026) - "Biologics and small-molecule medications included anti-TNFα (Adalimumab, Infliximab IV/SC, Golimumab), anti-integrin (Vedolizumab IV/SC), anti-IL12/23 (Ustekinumab), anti-IL23 (Risankizumab), JAK inhibitors (Tofacitinib, Upadacitinib, Filgotinib), and anti-IL23p19 (Mirikizumab)...The observed shift toward subcutaneous Infliximab and Vedolizumab is consistent with global trends that support self-administration and service efficiency...Conclusion Although there is a substantial variability between consultants, the adoption of biologics within this large NHS Trust is consistent with national and international prescribing trends. The results corroborate the need for multidisciplinary assessment and standardization of biologic initiation pathways in order to optimize equality and consistency in advanced IBD treatment."

Clinical • Metastases • Real-world • Real-world evidence • Crohn's disease • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis • IL12A • IL23A

Persistence and treatment patterns of vedolizumab subcutaneous maintenance therapy in patients with Inflammatory Bowel Disease: data from a Canadian cohort (ECCO-IBD 2026) - P3 | "Conclusion In a real-world setting, patients who received vedolizumab SC maintenance after IV induction demonstrated similar persistence to those who received IV maintenance, with approximately 4 years of follow-up, consistent with clinical trial findings. Only a small proportion of the patients in the SC maintenance cohort required dose escalation."

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

Therapeutic Adherence to Subcutaneous biologic agents in patients with inflammatory bowel disease: a single Centre retrospective observational study (ECCO-IBD 2026) - "Background Therapeutic adherence to subcutaneous(SC)biologic agents in inflammatory bowel disease(IBD)patients is a key determinant of clinical remission, reduced hospitalization, and improved quality of life.Real-world Italian data on adherence patterns remain limited, especially regarding recently introduced SC formulations Methods This retrospective observational study included adult patients diagnosed with Crohn’s disease or ulcerative colitis who initiated SC biologics (adalimumab, infliximab, ustekinumab, golimumab, vedolizumab SC) between January 2019 and December 2024 at the ASUFC (Udine, Italy).Data were obtained from electronic health records and pharmacy dispensing archives. Conclusion Adherence to SC biologics in this real-world Italian IBD cohort was generally high,with variability across agents.Early identification higher risk patients of non-adherence could improve therapeutic outcomes.Targeted nursing interventions including structured education programs,..."

Adherence • Observational data • Retrospective data • Crohn's disease • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

Comparative Efficacy and Safety of Advanced Therapies in Maintenance Treatment of Adult Patients with Moderate-to-Severe Crohn's Disease: A Systematic Literature Review and Network Meta-Analysis. (PubMed, Adv Ther) - "The current NMA integrating recently updated phase 3 data in CD indicated that no single treatment significantly outperformed others in achieving clinical remission and endoscopic response, although SC infliximab 120 mg q.2.w exhibited highest numerical efficacy as both a first-line and second-or-later-line maintenance treatment in adult patients with moderate-to-severe CD."

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

IMPACT OF BODY MASS INDEX ON EFFICACY AND SAFETY OUTCOMES OF VEDOLIZUMAB IN PATIENTS WITH ULCERATIVE COLITIS: A POST HOC ANALYSIS OF THE VISIBLE 1 CLINICAL TRIAL (CCCongress 2026) - P3 | "Conclusion This post hoc analysis demonstrates that, when stratified by baseline BMI, the proportions of patients with UC who achieved efficacy outcomes during VISIBLE 1 were higher for those receiving vedolizumab SC than placebo. Safety outcomes were similar across all BMI groups."

Clinical • Retrospective data • Gastroenterology • Gastrointestinal Disorder • Genetic Disorders • Immunology • Inflammation • Inflammatory Bowel Disease • Obesity • Ulcerative Colitis

COMPARATIVE REAL WORLD OUTCOMES OF INTRAVENOUS VERSUS SUBCUTANEOUS VEDOLIZUMAB IN ULERCATIVE COLITIS AND CROHNS DISEASE (CCCongress 2026) - "Vedolizumab 300 mg IV and 108 mg SC demonstrated largely similar safety and effectiveness profiles in UC and CD. However, IV administration was associated with higher rates of hospitalization and steroid use, particularly in UC, and with shock in CD. These findings highlight potential differences by formulation that may inform individualized treatment strategies in inflammatory bowel disease."

Clinical • Real-world • Real-world evidence • Cardiovascular • Crohn's disease • Diabetes • Gastroenterology • Gastrointestinal Disorder • Genetic Disorders • Hypertension • Immunology • Infectious Disease • Inflammation • Inflammatory Bowel Disease • Metabolic Disorders • Septic Shock • 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 | Trial completion date: Dec 2025 ➔ Mar 2026 | Trial primary completion date: Dec 2025 ➔ Mar 2026

Trial completion date • Trial primary completion date • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

Halozyme Announces Global Collaboration and License Agreement with Takeda to Develop and Commercialize Vedolizumab with ENHANZE (PRNewswire) - "Under the terms of the agreement, Takeda will make an upfront payment to Halozyme, and potential future development and commercial milestone payments. Halozyme will also be entitled to up to low-mid single digit royalties on sales of products containing vedolizumab in combination with ENHANZE."

Licensing / partnership • Crohn's 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 | 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