Entyvio® (vedolizumab) is subsidised on the Pharmaceutical Benefits Scheme (PBS) for moderately to severely active ulcerative colitis (UC) and severe Crohn’s disease (CD) where conventional treatments have failed.
Vedolizumab is a humanised monoclonal antibody that selectively binds to the protein, α4β7 integrin. This protein is found on a subclass of T lymphocytes that, when activated, migrate to the gut and cause the inflammation associated with UC and CD. Entyvio® selectively inhibits these T lymphocytes from interacting with gut endothelial cells, thereby inhibiting the inflammation associated with these conditions. It does not cause systemic immunosuppression.
The GEMINI group of trials evaluated the safety and efficacy of vedolizumab in both UC and CD patients. Patients receiving vedolizumab demonstrated an improved clinical response, clinical remission, mucosal healing, and corticosteroid-free remission compared with placebo. Entyvio® appears to be well tolerated. Common adverse effects reported are nausea, nasopharyngitis, arthralgia, and headache. Development of anti-vedolizumab antibodies during the clinical trials was low at 4%.
Entyvio® is presented as a 300mg single dose powder for injection that must be stored between 2°C and 8°C. Upon reconstitution, Entyvio® is administered by IV infusion over 30 minutes. Treatment involves an induction regimen where doses are given at zero, two, and six weeks, and every eight weeks after that.
- Entyvio® (vedolizumab) Australian approved product information. Macquarie Park: Takeda Pharmaceuticals Australia Pty Ltd. Approved June 2014.
- Feagan BG, Rutgeerts P, Sands BE, Hanauer S, Colombel JF, Sandborn WJ, et al. GEMINI 1 Study Group. Vedolizumab as induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2013; 369: 699-710.
- Sandborn WJ, Feagan BG, Rutgeerts P, Hanauer S, Colombel JF, GEMINI 2 Study Group. Vedolizumab as induction and maintenance therapy for Crohn’s disease. N Engl J Med. 2013; 369: 711-21.