Abstract
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.
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