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Volume 21 - Issue 2, March-April 2019
SPECIAL ARTICLES
VEDOLIZUMAB FOR THE TREATMENT OF MODERATELY TO SEVERELY ACTIVE ULCERATIVE
COLITIS JIMÉNEZ GUERRERO LORENA, GIL SIERRA MANUEL DAVID, FÉNIX CABALLERO SILVIA


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, multicentre, 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 or treatment of moderate-severe active UC.

EFFICACY – SAFETY – THERAPEUTIC POSITIONING – ULCERATIVE – VEDOLIZUMAB



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