Entyvio SC (vedolizumab SC) / Takeda, Halozyme - LARVOL DELTA

PANORAMA: A Study of Vedolizumab in Adults With Ulcerative Colitis (UC) or Crohn's Disease (CD) 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

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

New P4 trial • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

PANORAMA: A Study of Vedolizumab in Adults With Ulcerative Colitis (UC) or Crohn's Disease (CD) in the Community Setting (clinicaltrials.gov) - P4 | N=200 | Recruiting | Sponsor: Takeda | N=400 ➔ 200 | Trial primary completion date: Oct 2027 ➔ May 2027

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

Persistence, Safety and Pharmacokinetics of Vedolizumab After Switching to the Subcutaneous Route in a Prospective French National Cohort Study. (PubMed, Aliment Pharmacol Ther) - "In this multicentric cohort, the persistence at 1 year from switch to SC-VDZ in IBD patients was 84%."

Journal • PK/PD data • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

Beyond the Label? Real-World Dosing Strategies for Newer Biologic Therapies in Ulcerative Colitis (ACG 2026) - "The following are considered unique advanced therapies: adalimumab, etrasimod, golimumab, guselkumab, infliximab, mirikizumab, risankizumab, ustekinumab (includes biosimilars), upadacitinib, vedolizumab, tofacitinib, ozanimod assessed 12-months prior to index date...on-label refers to FDA label maintenance dosing: Q2W (vedolizumab [subcutaneous]), Q4W (mirikizumab) and Q8W (ustekinumab, risankizumab, vedolizumab [intravenous])... The maintenance cohorts comprised patients receiving USTE (n=7641), MIRI (n=322), RISA (n=707), and VEDO (n=15167) ( Table 1 ). Patients with â¥2 unique advanced therapies within 12 mo prior to index drug were 13.4% in MIRI, 10.9% in RISA, 7.1% in USTE and 1.7% in VEDO cohorts. During the maintenance period, most fills occurred at the on-label dosing interval for each therapy."

Clinical • Real-world • Real-world evidence • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis • IL12A • IL23A

ADVANCED THERAPIES PRESCRIBING PREFERENCES OF UK BASED GASTROENTEROLOGISTS FOR PATIENTS WITH INFLAMMATORY BOWEL DISEASE (UEGW 2026) - "Analysis of survey response data shows that despite a proliferation of new agents in the last 5 years, the older agents still dominate treatment preferences for UK based Gastroenterologists for patients with inflammatory bowel disease.Infliximab, Ustekinumab and Vedolizumab were popular first- and second-line treatment preferences for patients with moderate to severe UC, selective JAK inhibitors were popular second line.Infliximab, adalimumab and ustekinumab were popular first- and second-line treatment preferences for patients with small bowel CD, with Upadacitinib and Risankizumab popular preferences for second and third line, Vedolizumab was a third line treatment preference for many.Reasons for prescribing indicated included cost, response rate and safety profile."

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

Treatment Persistence of Patients With Inflammatory Bowel Disease Switching From Vedolizumab Intravenous to Subcutaneous Maintenance Versus Intravenous Long-Term Maintenance: Real-World Canadian Cohort Data (ACG 2026) - P3 | "Introduction: Vedolizumab subcutaneous (SC) is approved as maintenance therapy for adults with moderate to severe ulcerative colitis (UC) or Crohn's disease (CD), with approvals in Canada in 2020 (UC) and 2021 (CD) and in the USA in 2023 (UC) and 2024 (CD)... There were 1,814 patients in the IV to SC switch cohort and 6,087 patients in the IV long-term maintenance cohort. Table 1 shows baseline characteristics. During 200 weeks of follow-up, treatment persistence was greater in the IV to SC switch cohort than the IV long-term maintenance cohort ( Figure 1 ); a lower proportion of patients discontinued vedolizumab for both UC (19.6% vs 36.7%) and CD (21.2% vs 41.2%)."

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

Vedolizumab for Refractory Microscopic Colitis: Long-Term Outcomes From a Single-Center Longitudinal Cohort (ACG 2026) - "Eleven patients transitioned to subcutaneous vedolizumab, of whom 72.7% remained in remission at last follow-up... Forty-nine patients were included (mean age 60 years; 83.7% female). MC subtypes included lymphocytic colitis (49.0%), collagenous colitis (34.7%), and microscopic colitis incomplete (16.3%). In the intention-to-treat analysis under target trial emulation, remission rates were 66.7% at 14 weeks, 64.1% at 1 year, 45.2% at 2 years, 52.4% at 3 years, 53.3% at 4 years, and 60% at 5 years."

Clinical • Gastroenterology • Gastrointestinal Disorder • Immunology

Real-World Assessment of Injection Experience and Treatment Satisfaction Among Patients With Inflammatory Bowel Disease Initiating Subcutaneous Vedolizumab (ACG 2026) - "á¶Including mesalamine and balsalazide. Of 54 patients, 68.5% were women and the mean age was 42 years (standard deviation, 14 years). The new start and transition groups had 18 (33.3%) and 36 (66.7%) patients, respectively ( Table 1 ). Numerical improvements were observed from baseline to week 6 in multiple domains of both scales and in each group."

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

A Study of Vedolizumab Intravenous (IV) and Adalimumab or Vedolizumab and Ustekinumab in Adults With Crohn's Disease (clinicaltrials.gov) - P4 | N=50 | Recruiting | Sponsor: Takeda | N=100 ➔ 50

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

Evaluating the access process for patients transitioning from intravenous to subcutaneous biologic administration for inflammatory bowel disease. (PubMed, Crohns Colitis 360) - "Research is needed to evaluate challenges associated with payers' and patients' uptake of vedolizumab and infliximab subcutaneous (SC) formulations, which were recently approved by the U.S. Food and Drug Administration. Over a quarter of patients prescribed SC vedolizumab or infliximab do not start due to payer restrictions or patient preference. Patients with commercial insurance may be less likely to access SC therapy."

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

A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease (clinicaltrials.gov) - P3 | N=70 | Recruiting | Sponsor: Takeda | Trial completion date: Nov 2027 ➔ May 2028 | Trial primary completion date: Nov 2027 ➔ May 2028

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

PANCCO Clinical Practice Guideline Update for the treatment of ulcerative colitis in adults (PubMed, Rev Gastroenterol Peru) - "PANCCO adapted the Colombian guideline 2025 for upadacitinib, tofacitinib, ozanimod and the switch to subcutaneous formulations, and developed de novo recommendations for etrasimod, guselkumab, risankizumab, ustekinumab, mirikizumab, filgotinib and appendectomy...In patients with response to intravenous induction, switching to subcutaneous vedolizumab or subcutaneous infliximab is suggested...This third update expands the therapeutic armamentarium for moderate-to-severe UC in Latin America. Treatment choice should be individualized according to prior therapy, comorbidities, cardiovascular and thrombotic risk, availability and patient preferences."

Clinical guideline • Journal • Cardiovascular • 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 | Recruiting | Sponsor: Takeda | Trial completion date: Jan 2032 ➔ Aug 2030 | Trial primary completion date: Jan 2032 ➔ Aug 2030

Trial completion date • Trial primary completion date • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Pediatrics • 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: Mar 2026 ➔ Dec 2026

Trial completion date • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • 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 | Trial completion date: Jun 2027 ➔ Nov 2027 | Trial primary completion date: Jun 2027 ➔ Nov 2027

Trial completion date • Trial primary completion 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 | N=30 ➔ 70

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

Efficacy and Safety of Switching From Intravenous to Subcutaneous Vedolizumab in Japanese Patients With Ulcerative Colitis: A Study Focusing on Injection-Site Reactions. (PubMed, JGH Open) - "Although ISRs were common after switching, most were self-limiting. Therefore, switching back to IV formulation solely for ISR management should be cautiously considered."

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

The SILVER Platter for Patients with Inflammatory Bowel Disease (IBD): An IBD Pharmacy Technician-Led Subcutaneous Biologic Home Delivery Service Is Associated with Sustained Improvement in Adherence and Active Health Management. (PubMed, Dig Dis Sci) - "A novel pharmacy technician-led subcutaneous biologic home delivery service was associated with improvement in IBD-related quality of life, medication adherence, health literacy, and disease outcomes, sustained to 12 months. Larger studies are warranted to evaluate home delivery of subcutaneous biologics in IBD."

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

NL80854.018.22: SILVER-study (clinicaltrialsregister.eu) - P4 | N=40 | Recruiting | Sponsor: Amsterdam UMC Stichting | Not yet recruiting ➔ Recruiting

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

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

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

Vedolizumab Subcutaneous (SC) Versus Intravenous (IV) in Ulcerative Colitis or Crohn's Disease (clinicaltrials.gov) - P2 | N=0 | Withdrawn | Sponsor: Takeda

New P2 trial • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis • Venous Ulcer • CRP

VedolizumabSC-3004: Vedolizumab Subcutaneous Long-term Open-label Extension Study in Pediatric Subjects (clinicaltrialsregister.eu) - P2/3 | N=32 | Recruiting | Sponsor: Takeda Development Center Americas Inc.

New P2/3 trial • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Pediatrics • Ulcerative Colitis

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