Vedolizumab for the Treatment of Active Ulcerative Colitis: A Randomized Controlled Phase 2 Dose-ranging Study

Abstract

Vedolizumab demonstrated dose-proportional pharmacokinetics and maximally saturated α(4) β(7) receptors over the tested dose range. Multiple dosing up to 10 mg/kg was well tolerated. Over the course of follow-up a greater proportion of patients treated with vedolizumab were in clinical response than those who were assigned to placebo.

Review of vedolizumab for the treatment of ulcerative colitis

“…The large GEMINI 1 trial [16] reported the most common adverse effects included an exacerbation of colitis, headache and nasopharyngitis. A similar set of adverse effects were reported by Parikh et al [15] However, overall the frequency for which these events occur are uncommon. Certainly Parikh et al [15] reported no withdrawal from their clinical trial as a consequence of adverse effects.…”

“…A similar set of adverse effects were reported by Parikh et al [15] However, overall the frequency for which these events occur are uncommon. Certainly Parikh et al [15] reported no withdrawal from their clinical trial as a consequence of adverse effects. The concern regarding PML has also not proven to be of significance [15,16] .…”

“…Certainly Parikh et al [15] reported no withdrawal from their clinical trial as a consequence of adverse effects. The concern regarding PML has also not proven to be of significance [15,16] .…”

“…A further Phase Ⅱ dose ranging, randomised controlled trial was undertaken by Parikh et al [15] in 2012, using an improved formulation of vedolizumab made with a substance produced in hamster ovary. The study randomised 47 patients from 11 centres in Canada and Russia.…”

Domain 1 of Mucosal Addressin Cell Adhesion Molecule Has an I1-set Fold and a Flexible Integrin-binding Loop

“…Antibody natalizumab to ␣ 4 is approved for Crohn disease (43), and vedolizumab specific for ␣ 4 ␤ 7 is advancing in human trials (44). Targeting MAdCAM is an alternative and highly specific method of treating inflammatory bowel disease.…”