Sandborn WJ, Feagan BG, Rutgeerts P et al. N Engl J Med 2013;369:711–21.
Vedolizumab as induction and maintenance therapy for ulcerative colitis
Feagan BG, Rutgeerts P, Sands BE et al. N Engl J Med 2013;369:699–710.
Vedolizumab is a humanized immunoglobulin G monoclonal antibody that targets the α4β7 integrin, thus inhibiting leukocyte adhesion and selectively reducing intestinal inflammation without enhancing opportunistic brain infections. These two articles report the results of the GEMINI 1 (Study of Vedolizumab [MLN0002] in Patients with Moderate to Severe Ulcerative Colitis [UC]) and GEMINI 2 (Study of Vedolizumab [MLN0002] in Patients with Moderate to Severe Crohn’s Disease) Phase III trials. Vedolizumab was shown to be effective and safe relative to placebo, particularly in UC patients.
Results from previous Phase II studies demonstrated that vedolizumab was effective in IBD, with a similar mode of action to natalizumab. Natalizumab was the first integrin-blocking antibody therapy able to inhibit the homing mechanism of T lymphocytes/inflammatory cells but has been found to be associated with an increased risk of the devastating brain infection, progressive multifocal leukoencephalopathy. Vedolizumab was shown to produce a greater induction response in patients with ulcerative colitis (UC) than in patients with Crohn’s disease, although maintenance of clinical remission at 1 year was approximately 40% in both groups.