|Former: Atención Farmacéutica|
|Journal edited by Rasgo Editorial since 1983|
Virginia Hernández Corredoira
EDITOR IN CHIEF
Manuela Velázquez Prieto
Jaime E. Poquet Jornet
Ramón Jódar Masanés
Lluís Campins Bernadas
Tomás Casasín Edo
Juan Carlos Juárez Giménez
Carles Quiñones Ribas
Volume 21 - Issue 2, April-June 2019
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