Vedolizumab for the treatment of moderately to severely active Ulcerative colitis

Ulcerative colitis (UC) is a chronic disease that results in inflammation of gastrointestinal tract. Pivotal GEMINI I clinical trial compares VDZ versus placebo in refractory patients to one or more previous conventional therapies for UC or previous use of anti‐TNF. This is a phase III, multicenter, prospective, randomized and double‐blind, designed in two phases: induction and maintenance. According to clinical trials, most frequent adverse effects (AE) were headaches, nasopharyngitis, upper respiratory tract infection, arthralgia, nausea, abdominal pain and fatigue. GEMINI I trial studied safety in 895 patients (620 patients with VDZ and 275 with placebo), taking into account non‐responders in week 6. Incidence of AE was similar between VDZ and placebo (80% of population in each group), as well as incidence of severe AE (12‐13%). VDZ is considered as an effective alternative, in second or third line of treatment of moderate‐severe active UC.