Entyvio (vedolizumab) / Takeda - LARVOL DELTA

Vedolizumab for steroid-refractory gastrointestinal acute graft-versus-host disease: A real-world VAST study (ASH 2025) - "Our real-world findings suggest that vedolizumab is an effective and safe treatment for SR-GI-aGVHD."

Clinical • Real-world • Real-world evidence • Acute Graft versus Host Disease • Bone Marrow Transplantation • Graft versus Host Disease • Immunology

Early detection of emerging safety signals in GVHD prophylaxis agents using a 12-year faers "slope-watch" approach (ASH 2025) - "In addition to tacrolimus and cyclosporine, contemporary prophylaxis regimens employ sirolimus and everolimus, mycophenolate mofetil, methotrexate, post-transplant cyclophosphamide (PTCy), JAK inhibitors (ruxolitinib, baricitinib, tofacitinib), co-stimulation blockade with abatacept, gut-homing integrin antagonism via vedolizumab, and the ROCK2 inhibitor belumosudil. Sequential IC-Δ offers a robust, forward-looking pharmacovigilance framework that identifies adverse event acceleration 12–24 months before regulatory action. By emphasizing directional change and incorporating a simple confidence approximation, this approach enhances early signal detection in large safety datasets. Integration with electronic health records, regulatory pipelines, and interactive dashboards could further streamline horizon scanning and improve patient safety in GVHD prophylaxis."

Clinical • Bone Marrow Transplantation • CNS Disorders • Cytomegalovirus Infection • Dyslipidemia • Graft versus Host Disease • Hemophagocytic lymphohistiocytosis • Hepatology • Immunology • Infectious Disease • Metabolic Disorders • Pneumonia • Rare Diseases • Respiratory Diseases • Septic Shock

Targeted GvHD prophylaxis: Vedolizumab in the GvHD prevention regime with post-transplant cyclophophospamide, abatacept, calceneurin inhibitors in adults with hematologic disease: Result prospective study (ASH 2025) - "This study evaluated the efficacy of a four-drug regimen combining vedolizumab (300 mg IV on days -1, +14, +28), tacrolimus (0.03 mg/kg from day -1 to +120), abatacept (10 mg/kg IV on days -1, +5, +14, +28, +60, +90), and post-transplant cyclophosphamide (PTCy) (50 mg/kg on days +3, +4 in 60.7% of patients). Favorable safety without compromising engraftment. Warranting further validation in randomized trials."

Clinical • Post-transplantation • Acute Graft versus Host Disease • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Graft versus Host Disease • Hematological Malignancies • Immunology • Leukemia • Myelodysplastic Syndrome • Transplantation

Efficacy of iptacopan in treatment of transplant-associated thrombotic microangiopathy (TA-TMA) post-allogeneic hematopoietic stem cell transplantation: A case series analysis (ASH 2025) - "Case III (28M, MDS-LB) . Baseline Characteristics Diagnosis Severe Aplastic Anemia (SAA) Myelodysplastic Syndrome with Excess Blasts-2 (MDS-EB-2) Myelodysplastic Syndrome-Low Blast (MDS-LB) Pre-Treatment Labs - WBC: ↓ (2.13×10⁹/L) - HGB: 65g/L↓ - PLT: 4×10⁹/L↓↓ - ALT/AST: ↑ (44.56/50.96 U/L) - WBC: ↓ (3.73×10⁹/L) - HGB: 44g/L↓↓ - PLT: 19×10⁹/L↓ - PT/INR: ↑ (24.8s/2.17) - WBC: ↑ (15.42×10⁹/L) - HGB: 105g/L↓ - ALT/AST: ↑ (35.49/47.32 U/L) - D-dimer: 3.56 mg/L↑ Complications CMV viremia, TA-TMA, intestinal GVHD, heart failure EBV infection, TA-TMA, intestinal GVHD EBV viremia, liver GVHD, intestinal GVHD, TA-TMA New Drugs Used Iptacopan, Vedolizumab Iptacopan Iptacopan, Vedolizumab, Ruxolitinib Post-Treatment Trends Blood Routine - WBC/HGB/PLT: Continued fluctuations (no stabilization) - PLT: ↑ (improvement) - WBC/HGB: Partial stabilization - WBC: Stabilized - HGB/PLT: Gradual improvement Liver Function - ALT/AST: Persistent fluctuations..."

Clinical • Aplastic Anemia • Bone Marrow Transplantation • Cardiovascular • Congestive Heart Failure • Cytomegalovirus Infection • Epstein-Barr Virus Infections • Graft versus Host Disease • Heart Failure • Hematological Disorders • Hematological Malignancies • Immunology • Infectious Disease • Myelodysplastic Syndrome • Transplantation

Haploidentical donor regulatory T cells and memory T cells are safe and effective in children with refractory graft-versus-host disease with concurrent viral infections (ASH 2025) - "All patients had received multiple lines of priorIST, including glucocorticosteroids, cyclosporine, and biologics (tocilizumab,infliximab, abatacept, etarnecept, vedolizumab)...Nine patients recieved lymphodepletion with cyclophosphamideat 400 mg/m2... Combined haploidentical Treg and memory T cell therapy, with memory T cellsgenerated solely by flow cytometry-based sorting, is feasible and safe in pediatricpatients with refractory GVHD and viral infections. This approach resulted incomplete IST withdrawal and GVHD control in the majority of evaluable patients at 1year. The promising outcomes in immune reconstitution and viral control supportfurther clinical investigation of this integrative cellular strategy for high-risk pediatrictransplant recipients."

Clinical • Acute Graft versus Host Disease • Bone Marrow Transplantation • Chronic Graft versus Host Disease • Graft versus Host Disease • Immunology • Infectious Disease • CD8 • FOXP3 • IL2RA • IL7R

Donor-derived CAR-T cells co-infused with the allogenic graft on the platform of T cell depletion or post-transplant cyclophosphamide in children with advanced B-cell neoplasms (ASH 2025) - "All patients had disease relapse after multiple lines of treatmentincluding previous HSCT(n=13), blinatumomab (n=22), inotuzumab (n=2), blinatumomab+inotuzumab(n=6) and CAR-T cell infusion(n=12)...The median proportion ofCD19-positive cells in the leukemic population was 100% (0–100%), while the median proportion of CD22-positive cells was 100% (36–100%).Fourteen (36%) pts received treosulfan-based myeloablative preparative regimen and TBI-based regimenwas used in 25 (64%) pts...Inthe PtCy group GVHD prophylaxis included abatacept, vedolizumab and CsA or baricitinib ResultsThere was no suspected conflict between the graft and CAR-T cells...We have documented CAR-T expansion and persistence. Prospective testing of theapproach is warranted."

CAR T-Cell Therapy • Clinical • Metastases • Post-transplantation • Acute Lymphocytic Leukemia • Bone Marrow Transplantation • Chronic Graft versus Host Disease • Graft versus Host Disease • Hematological Malignancies • Immunology • Infectious Disease • Leukemia • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases • Transplantation • CD22

Vedolizumab for treating steroid-refractory lower gastrointestinal acute graft-versus-host disease: a single-center real-world study (ASH 2025) - "24.6%(17/69) received VDZ as second-line therapy, and 75.4% (52/69) as third-line therapy, and all received VDZin combination with basiliximab...No significant differences were observed regarding theline of VDZ therapy (P=0.365), duration of treatment (P=0.232), aGVHD severity before VDZ treatment(P=0.235), or concomitant first-line ruxolitinib use (P=0.187).The one-year incidence of cGVHD was 26.1% (18/69)...Infections were the most common complications, including pneumonia(59.4%, 41/69), bloodstream infections (18.8%, 13/69), urinary tract infections (14.5%, 10/69),cytomegalovirus viremia (18.8%, 13/69), and Epstein-Barr virus viremia (15.9%, 11/69).ConclusionVDZ demonstrated remarkable efficacy and safety as a second-line or third-line therapy for SR-LGI-aGVHD. This treatment approach achieved rapid and durable remission while improving survival ratesand reducing steroid dependence."

Clinical • Real-world • Real-world evidence • Acute Graft versus Host Disease • Bone Marrow Transplantation • Chronic Graft versus Host Disease • Cytomegalovirus Infection • Epstein-Barr Virus Infections • Gastrointestinal Disorder • Graft versus Host Disease • Hematological Disorders • Immunology • Infectious Disease • Nephrology • Pneumonia • Respiratory Diseases • IL12A • TNFA

New Age GVHD Prophylaxis Regimens: What Works for What Donor and Why (ASH 2025) - "These include post-transplantation cyclophosphamide (PTCy), Abatacept (Aba), and Vedolizumab (Vedo)-based approaches. Addtional options including JAK inhibitors, Sirolimus, Alpha-1 antitrypsin, ATG and Obinutuzumab maintenance will also be briefly reviewed."

Acute Graft versus Host Disease • Chronic Graft versus Host Disease • Graft versus Host Disease • Immunology

New Age Hematopoietic Stem Cell Transplantation: Same Donors, New Prophylaxis, Novel Engineering (Adult and Pediatric Perspectives) (ASH 2025) - "He highlights the effectiveness of post-transplant cyclophosphamide (PTCy), abatacept, and vedolizumab in preventing both acute and chronic GVHD. Therapies including JAK inhibitors, sirolimus, alpha-1 antitrypsin, anti-thymocyte globulin (ATG), and obinutuzumab maintenance are also reviewed, offering tailored options based on donor type and patient risk profiles.Dr...Agents like treosulfan provide safer conditioning with a favorable toxicity profile for individuals who are older, pediatric patients, or those with medical comorbidities. Additionally, methodologies for precise and targeted radiation delivery with minimal off-target effects are emerging. These advancements necessitate reexamination and harmonization of conditioning intensity stratification schemes for a more personalized and selective approach."

Clinical • Acute Graft versus Host Disease • Bone Marrow Transplantation • Chronic Graft versus Host Disease • Graft versus Host Disease • Immunology • Pediatrics • Transplantation • CD34

Efficacy and Safety of Vedolizumab IV in Chinese Participants With Ulcerative Colitis (clinicaltrials.gov) - P3 | N=402 | Recruiting | Sponsor: Takeda | Trial completion date: Jul 2028 ➔ Jan 2028 | Trial primary completion date: May 2028 ➔ Sep 2027

Trial completion date • Trial primary completion date • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Integrin Inhibitors for Ulcerative Colitis Treatment. (PubMed, Digestion) - "This article describes the mechanism of integrin inhibitors' action, the usefulness and positioning of vedolizumab and carotegrast methyl, which are currently available for clinical use to treat ulcerative colitis, and the status of integrin inhibitor development."

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

Efficacy of Advanced Therapies as Prophylaxis and for Active Disease in Postoperative Crohn's Disease: A Comprehensive Review. (PubMed, J Clin Med) - "Infliximab and vedolizumab have the strongest evidence for preventing endoscopic recurrence in postoperative Crohn's disease. Adalimumab and ustekinumab are viable alternatives supported by observational and post hoc trial data...Approaches that integrate disease location, clinical risk profiles, and knowledge of underlying immunopathogenic pathways could provide more precise clinical guidance. Finding molecular predictors of recurrence, directly comparing cutting-edge treatments, and integrating precision medicine techniques into standard postoperative care should be the main priorities of future research."

Journal • Review • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease • IL23A

VedAryo® (Vedolizumab) Effectiveness and Safety Evaluation (clinicaltrials.gov) - P=N/A | N=150 | Completed | Sponsor: AryoGen Pharmed Co.

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

Combination Therapy With Fecal Microbiota Transplantation and Vedolizumab for Induction of Remission in Ulcerative Colitis: An Open-Label Pilot Study. (PubMed, Inflamm Bowel Dis) - No abstract available

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

Mayo Endoscopic Subscore at Week 24 Is a Predictor of Future Loss of Response to Vedolizumab in Patients with Ulcerative Colitis in Clinical Remission. (PubMed, Inflamm Intest Dis) - "The impact of immunomodulator and 5-aminosalicylic acid co-administration on treatment persistence was minimal. Endoscopic improvement at week 24 was a key predictor of long-term VDZ persistence."

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

Risk of Incident Immune-Mediated Inflammatory Diseases with Second Tumor Necrosis Factor Inhibitor Versus Alternative Biologic Therapy in Patients with Inflammatory Bowel Disease and First TNFi Exposure: A Real-World Cohort Study. (PubMed, Dig Dis Sci) - "In this large real-world IBD cohort with exposure to a TNFi, second TNFi use was associated with a higher risk of de-novo IMIDs compared to ustekinumab or vedolizumab."

Journal • Real-world evidence • Ankylosing Spondylitis • Crohn's disease • Dermatology • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Arthritis • Inflammatory Bowel Disease • Oncology • Psoriasis • Rheumatoid Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Ulcerative Colitis

Successful Desensitization to Vedolizumab in a Patient with Ulcerative Colitis. (PubMed, J Investig Allergol Clin Immunol) - No abstract available

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

Five-year effectiveness of either ustekinumab or vedolizumab in 239 patients with Crohn's disease refractory to anti-tumour necrosis factor. (PubMed, Clin Res Hepatol Gastroenterol) - "In this study, ustekinumab was associated with higher rate of steroid-free clinical remission and treatment persistence than vedolizumab after 5 years of follow-up, particularly in patients with ileal CD, stricturing or penetrating behaviour and history of CD-related intestinal surgery."

Journal • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease • Oncology

A Multicentre, Randomized, Double-Blinded, Phase 2b Study Evaluating the Efficacy and Safety of MaaT033, an Oral, Pooled Microbiome Ecosystem Therapy in Patients Undergoing Allogenic Hematopoietic Cell Transplantation to Improve Overall Survival: The Phoebus Trial (ASH 2023) - P2 | "Exclusion criteria comprise non-myeloablative conditioning regimen, conventional myeloablative conditioning regimen, in-vitro T-cell depletion, alloHCT with cord blood cells, alloHCT from an unrelated donor with ≥ 3/10 HLA-mismatches, use of alemtuzumab, vedolizumab or abatacept for GvHD prophylaxis, history of chronic digestive disease...Exploratory endpoints will describe the impact of MaaT013 on immune recovery, the nutritional status of the patients, and resource utilization...The study is approved in France and Germany; expansion to other countries is planned for 2024. Study start is expected in September 2023."

Clinical • P2b data • Acute Graft versus Host Disease • Chronic Graft versus Host Disease • Gastroenterology • Gastrointestinal Disorder • Graft versus Host Disease • Hematological Malignancies • Immunology • Infectious Disease • Oncology • Transplantation

Utilisation and real-world effectiveness of advanced therapies for inflammatory bowel disease in Middle Eastern populations: a systematic review. (PubMed, BMJ Open Gastroenterol) - "Advanced therapies for IBD appear to be effective in Middle Eastern cohorts; however, the available evidence is methodologically diverse, with substantial heterogeneity in study design, population characteristics and outcome reporting, which limits the ability to draw strong conclusions and highlights the need for further robust evaluation. Prospective, collaborative regional registries are imperative to address these gaps and inform local guidelines."

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

New age GVHD prophylaxis regimens: what works for what donor and why. (PubMed, Hematology Am Soc Hematol Educ Program) - "Standard approaches for GVHD prevention have been calcineurin-inhibitor (CNI) based, while newer approaches have focused on adding in-vivo T-cell modulation to a CNI backbone with antimetabolites such as posttransplant cyclophosphamide (PTCy), checkpoint blocking agents such as abatacept, or mammalian target of rapamycin (mTOR) inhibition with sirolimus. Still other approaches focus on blocking T-cell trafficking to target organs via integrin blockade (vedolizumab), cytokine blockade (JAK inhibitors), and B-cell blockade for chronic GVHD prevention. The use of PTCy and abatacept have improved allotransplantation safety and efficacy with human leukocyte antigen (HLA)-mismatched as well as HLA-matched donors, thus expanding the donor pool greatly for patients of all ancestries, and ushering in a new era in transplantation where donors are available for almost every patient."

Journal • Review • Acute Graft versus Host Disease • Aplastic Anemia • Bone Marrow Transplantation • Chronic Graft versus Host Disease • Fibrosis • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Immunology • Oncology • Transplantation

Thromboembolic Risk in Ulcerative Colitis Patients on Advanced Therapy: A Real-World Data Analysis. (PubMed, Inflamm Bowel Dis) - "Vedolizumab demonstrated a favorable thromboembolic and cardiovascular safety profile compared with TNF inhibitors, whereas tofacitinib did not increase the risk at either dose. Concomitant 5-aminosalicylic acid may have a preventive effect against VTE. These findings may aid therapeutic decision-making for UC patients with elevated thrombotic risk."

Journal • Real-world evidence • Cardiovascular • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Oncology • Ulcerative Colitis • Venous Thromboembolism

A narrative review on the frequency, pathophysiology and management of bowel urgency associated with ulcerative colitis. (PubMed, Best Pract Res Clin Gastroenterol) - "Evidence suggests that mesalazine and budesonide foam may help reduce BU. Among advanced therapies, vedolizumab and Janus kinase inhibitors have demonstrated early improvements in urgency, anti-interleukin-23 antibodies have also shown promising effects. Additionally, the novel S1P receptor modulator etrasimod has been associated with symptomatic relief...Despite these therapeutic options, the management of BU remains challenging. Further research and the development of targeted treatments are warranted to address this unmet clinical need."

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

Case Report: Severe kidney involvement in a case of very early onset inflammatory bowel disease. (PubMed, Front Immunol) - "We report the first case of VEO-IBD with a probable vedolizumab-related acute TIN treated with corticosteroids, with a good response and maintenance of vedolizumab. Persisting sterile leukocyturia could represent an early sign."

Clinical • Journal • Fatigue • Fibrosis • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Nephrology • Renal Disease • Ulcerative Colitis

Coexistence of ulcerative colitis and neurofibromatosis type 1: a case report and literature review. (PubMed, Front Med (Lausanne)) - "Treatment with corticosteroids, vedolizumab, and five-flavor sophora flavescens enteric-coated capsules (SFEC), a traditional Chinese medicine, successfully achieved remission...This case illustrates the intricate relationship between UC and NF1, supporting a common inflammatory mechanism that may involve mast cells. This case highlights the importance of clinicians being aware of the rare coexistence of UC and NF1 to ensure accurate diagnosis and appropriate management."

Journal • Gastroenterology • Gastrointestinal Disorder • Genetic Disorders • Immunology • Inflammation • Inflammatory Bowel Disease • Neurofibromatosis • Solid Tumor • Ulcerative Colitis • NF1