Vedolizumab

(Entyvio®)

Vedolizumab

Drug updated on 11/1/2024

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 Crohns disease (CD).

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Summary
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  • This summary is based on the review of 30 systematic review(s)/meta-analysis(es). [1-30]
  • Vedolizumab was effective in inducing and maintaining clinical remission and response in patients with both ulcerative colitis (UC) and Crohn’s disease (CD), with higher remission rates during both induction (RR (relative risk) = 2.09) and maintenance (RR = 1.98) phases compared to placebo.
  • Comparative data showed infliximab was more effective than vedolizumab in the induction phase for CD, with similar maintenance efficacy. For UC, infliximab demonstrated higher induction efficacy, while adalimumab was ranked highest for corticosteroid-free remission in the maintenance phase.
  • Vedolizumab was particularly beneficial for patients with prior TNF (tumor necrosis factor) antagonist failure, enhancing clinical remission and response, and was notably effective in maintaining remission in UC. Additionally, vedolizumab demonstrated efficacy in biologic-naive patients, showing comparable outcomes to tofacitinib, especially in those with prior TNF antagonist exposure.
  • Vedolizumab generally exhibited a favorable safety profile, with overall adverse events (AEs) and serious adverse events (SAEs) similar to placebo; no significant increase in Clostridium difficile infection risk was noted in UC patients.
  • Specific adverse events associated with vedolizumab included cases of acute interstitial nephritis (AIN), which were rare but potentially serious, and nasopharyngitis in CD patients.
  • Comparative safety findings indicated that infliximab had a higher infection rate in CD compared to vedolizumab, while adalimumab had a greater risk of infection during induction. Ustekinumab showed fewer infections and SAEs, making it the top-ranked drug for safety during both induction and maintenance phases.
  • Vedolizumab demonstrated effectiveness in moderate-to-severe IBD, UC, and CD, particularly in patients with prior TNF antagonist failure, where it improved clinical remission and response; pediatric studies also suggested potential for achieving remission, though data quality was low. Specific subgroup findings included a majority female prevalence in AIN cases and fistula healing in approximately one-third of perianal fistulizing CD patients treated with vedolizumab, especially those with prior TNF therapy failure.

Product Monograph / Prescribing Information

Document TitleYearSource
Entyvio (vedolizumab) Prescribing Information.2024Takeda Pharmaceuticals U.S.A., Inc., Lexington, MA

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Association between vedolizumab and risk of clostridium difficile infection in patients with ulcerative colitis: A systematic review and meta-analysis2024Saudi Journal of Gastroenterology
Acute interstitial nephritis in patients with inflammatory bowel disease treated with vedolizumab: a systematic review2024Scandinavian Journal of Gastroenterology
Comparative efficacy and safety of subcutaneous infliximab and vedolizumab in patients with Crohn's disease and ulcerative colitis included in randomised controlled trials2024BMC Gastroenterology
The Efficacy and Safety of Biologic Drugs in the Treatment of Moderate-Severe Crohn's Disease: A Systematic Review2023Pharmaceuticals (Basel, Switzerland)
An indirect comparison of efficacy including histologic assessment and safety in biologic therapy in ulcerative colitis: Systemic review and network meta-analysis2023PloS One
Network meta-analysis on efficacy and safety of different biologics for ulcerative colitis2023BMC Gastroenterology
Vedolizumab for induction and maintenance of remission in Crohn's disease2023Cochrane Database of Systematic Reviews
Efficacy and safety of vedolizumab in the treatment of patients with inflammatory bowel disease: A systematic review and meta‑analysis of randomized controlled trials2023Experimental and Therapeutic Medicine
Vedolizumab subcutaneous formulation maintenance therapy for patients with IBD: a systematic review and meta-analysis2023Therapeutic Advances in Gastroenterology
Use of biologics for the management of Crohn's disease: IG-IBD technical review based on the GRADE methodology2023Digestive and Liver Disease
Dose Escalation Patterns of Advanced Therapies in Crohn's Disease and Ulcerative Colitis: A Systematic Literature Review2023 Advances in Therapy
Cost-Effectiveness Analysis of Tofacitinib Compared with Biologics in Biologic-Naive Patients with Moderate-to-Severe Ulcerative Colitis in Japan2023PharmacoEconomics
Systematic Literature Review of Real-World Evidence on Dose Escalation and Treatment Switching in Ulcerative Colitis2023ClinicoEconomics and Outcomes Research
Comparative efficacy of advanced treatments in biologic-naive or biologic-experienced patients with ulcerative colitis: a systematic review and network meta-analysis2023International Journal of Clinical Pharmacy
Vedolizumab for acute gastrointestinal graft-versus-host disease: A systematic review and meta-analysis2022Frontiers in Immunology
Efficacy and safety of vedolizumab for inflammatory bowel diseases: A systematic review and meta-analysis of randomized controlled trials2022 Medicine
Immune checkpoint Inhibitor-Induced diarrhea and Colitis: Incidence and Management. A systematic review and Meta-analysis2022Cancer Treatment Reviews
The Effect of Pregnancy and Inflammatory Bowel Disease on the Pharmacokinetics of Drugs Related to Inflammatory Bowel Disease-A Systematic Literature Review2022Pharmaceutics
Comparative efficacy and safety of infliximab and vedolizumab therapy in patients with inflammatory bowel disease: a systematic review and meta-analysis2022BMC Gastroenterology
Efficacy and safety of vedolizumab for pediatrics with inflammatory bowel disease: a systematic review2022BMC Pediatrics
Vedolizumab for perianal fistulizing Crohn's disease: systematic review and meta-analysis2022Intestinal Research
Cost-effectiveness analysis of using innovative therapies for the management of moderate-to-severe ulcerative colitis in Spain2022Expert Review of Pharmacoeconomics & Outcomes Research
Cost-Effectiveness Analysis of Vedolizumab Compared With Infliximab in Anti-TNF-alpha-Naive Patients With Moderate-to-Severe Ulcerative Colitis in China2021Frontiers in Public Health
Systematic Review and Network Meta-Analysis: Comparative Efficacy and Safety of Biosimilars, Biologics and JAK1 Inhibitors for Active Crohn Disease2021Frontiers in Pharmacology
Predictive value of blood concentration of biologics on endoscopic inactivity in inflammatory bowel disease: A systematic review2021World Journal of Gastroenterology
Treatment Algorithms for Crohn's Disease2020Digestion
Efficacy of ustekinumab vs. advanced therapies for the treatment of moderately to severely active ulcerative colitis: a systematic review and network meta-analysis2020Current Medical Research and Opinion
First- and Second-Line Pharmacotherapies for Patients With Moderate to Severely Active Ulcerative Colitis: An Updated Network Meta-Analysis2020Clinical Gastroenterology and Hepatology
Efficacy and safety of biologic agents and tofacitinib in moderate-to-severe ulcerative colitis: A systematic overview of meta-analyses2019United European Gastroenterology Journal
Vedolizumab Treatment in Extra-Intestinal Manifestations in Inflammatory Bowel Disease: A Systematic Review2019Journal of Crohn’s & Colitis

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