Vedolizumab

(Entyvio®)

Entyvio®

Latest News

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Drug updated on 4/16/2024

Dosage FormInjection (intravenous: 300 mg; subcutaneous: 108 mg/0.68 mL)
Drug ClassIntegrin receptor antagonists
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for adult patients with moderately to severely active ulcerative colitis (UC).
  • Indicated for adult patients with moderately to severely active Crohn’s disease (CD).

Summary
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  • Vedolizumab (Entyvio) is approved for use in adult patients with moderately to severely active ulcerative colitis and Crohn's disease, showing efficiency particularly in the maintenance phase for ulcerative colitis. It has been highlighted as a leading medication based on its efficacy endpoints, including histologic remission.
  • Thirty-one systematic reviews/meta-analyses provided insights into vedolizumab's comparative effectiveness and safety against other treatments such as ustekinumab, adalimumab, and infliximab.
  • Subcutaneous infliximab was found to be more effective than vedolizumab in achieving clinical remission during maintenance treatment for both ulcerative colitis and Crohn's disease. Yet, vedolizumab indicated better outcomes concerning treatment emergent adverse events during the initiation phase for ulcerative colitis.
  • Vedolizumab exhibited comparable effectiveness for patients who had not responded to TNF antagonist therapy, significant due to its safety and tolerance. The switch from intravenous to subcutaneous formulations has continued to demonstrate the drug's effectiveness along with maintaining a similar safety profile.
  • Dose escalation strategies involving vedolizumab have been beneficial; about half of the IBD patients showed a positive response when doses were increased, highlighting its importance in personalized treatment approaches.
  • Vedolizumab showed variable effectiveness between Crohn's disease vs. ulcerative colitis cases, with a stronger association seen within the latter, especially among biologic-naive individuals, suggesting that patient history is a crucial factor.
  • In special populations, such as liver transplant recipients or those with extra-intestinal manifestations (EIMs), no malignancies were reported following the use of Entyvio, underscoring its significance beyond traditional IBD treatments without worsening liver function abnormalities.
  • Vedolizumab was associated with a safety profile comparable to placebo across various studies, displaying low rates of serious infections, adverse events, and immunogenicity, making it a potentially preferable choice among IBD patients seeking treatments with minimal risk profiles.

Product Monograph / Prescribing Information

Document TitleYearSource
Entyvio (vedolizumab) prescribing information.2023Takeda Pharmaceuticals U.S.A., Inc., Lexington, MA

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Comparative efficacy of subcutaneous and intravenous infliximab and vedolizumab for maintenance treatment of TNF-naive adult patients with inflammatory bowel disease: A systematic literature review and network meta-analysis.2024Digestive Diseases and Sciences
Comparative efficacy of advanced treatments in biologic-naïve or biologic-experienced patients with ulcerative colitis: A systematic review and network meta-analysis. 2023International Journal of Clinical Pharmacy
Network meta-analysis on efficacy and safety of different biologics for ulcerative colitis. 2023BMC Gastroenterology
Vedolizumab for induction and maintenance of remission in Crohn's disease. 2023The Cochrane Database of Systematic Reviews
An indirect comparison of efficacy including histologic assessment and safety in biologic therapy in ulcerative colitis: Systemic review and network meta-analysis. 2023PLoS One
Systematic literature review of real-world evidence on dose escalation and treatment switching in ulcerative colitis.2023ClinicoEconomics and Outcomes Research
Vedolizumab subcutaneous formulation maintenance therapy for patients with IBD: A systematic review and meta-analysis. 2023Therapeutic Advances in Gastroenterology
Efficacy and safety of vedolizumab in the treatment of patients with inflammatory bowel disease: A systematic review and meta analysis of randomized controlled trials.2023Experimental and Therapeutic Medicine
Dose escalation patterns of advanced therapies in Crohn's disease and ulcerative colitis: A systematic literature review.2023Advances in Therapy
The efficacy and safety of biologic drugs in the treatment of moderate-severe Crohn's disease: A systematic review.2023Pharmaceuticals
Use of biologics for the management of Crohn's disease: IG-IBD technical review based on the GRADE methodology. 2023Digestive and Liver Disease
Comparative efficacy of advanced treatments in biologic-naïve or biologic-experienced patients with ulcerative colitis: A systematic review and network meta-analysis.2022International Journal of Clinical Pharmacy
The effect of pregnancy and inflammatory bowel disease on the pharmacokinetics of drugs related to inflammatory bowel disease-a systematic literature review.2022Pharmaceutics
Comparative efficacy and safety of infliximab and vedolizumab therapy in patients with inflammatory bowel disease: A systematic review and meta-analysis. 2022BMC Gastroenterology
Comparative efficacy of biologic therapies for inducing response and remission in fistulizing Crohn’s disease: Systematic review and network meta-analysis of randomized controlled trials.2022Inflammatory Bowel Diseases
Vedolizumab for perianal fistulizing Crohn’s disease: Systematic review and meta-analysis.2022Intestinal Research
Vedolizumab as the first line of biologic therapy for ulcerative colitis and Crohn's disease-a systematic review with meta-analysis.2022Digestive and Liver Disease
Efficacy and safety of vedolizumab for inflammatory bowel diseases: A systematic review and meta-analysis of randomized controlled trials. 2022Medicine
Real-world effectiveness of vedolizumab dose escalation in patients with inflammatory bowel disease: A systematic literature review.2022Crohn's & Colitis 360
Vedolizumab for perianal fistulizing Crohn's disease: Systematic review and meta-analysis. 2022Intestinal Research
Integrating efficacy and safety of vedolizumab compared with other advanced therapies to assess net clinical benefit of ulcerative colitis treatments: A network meta-analysis.2021Expert Review of Gastroenterology & Hepatology
Systematic review and network meta-analysis: Comparative efficacy and safety of biosimilars, biologics and JAK1 inhibitors for active Crohn disease.2021Frontiers in Pharmacology
Comparative risk of serious infections with biologic and/or immunosuppressive therapy in patients with inflammatory bowel diseases: A systematic review and meta-analysis.2020Clinical Gastroenterology and Hepatology
Biologics for inflammatory bowel disease and their safety in pregnancy: A systematic review and meta-analysis.2020Clinical Gastroenterology and Hepatology
First- and second-line pharmacotherapies for patients with moderate to severely active ulcerative colitis: An updated network meta-analysis. 2020Clinical Gastroenterology and Hepatology
Safety of vedolizumab in liver transplant recipients: A systematic review.2019United European Gastroenterology Journal
Vedolizumab treatment in extra-intestinal manifestations in inflammatory bowel disease: A systematic review.2019Journal of Crohn’s and Colitis
Systematic review with meta‐analysis: Association between vedolizumab trough concentration and clinical outcomes in patients with inflammatory bowel diseases.2019Alimentary Pharmacology & Therapeutics
Dual biological therapy with anti-TNF, vedolizumab or ustekinumab in inflammatory bowel disease: A systematic review with pool analysis.2019Scandinavian Journal of Gastroenterology
Ulcerative colitis-treatment with biologicals. 2019Revista da Associação Médica Brasileira
Efficacy and safety of biologic agents and tofacitinib in moderate-to-severe ulcerative colitis: A systematic overview of meta-analyses. 2019United European Gastroenterology Journal

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