Etrolizumab versus infliximab for the treatment of moderately to severely active ulcerative colitis (GARDENIA): a randomised, double-blind, double-dummy, phase 3 study.

Publication

Etrolizumab versus infliximab for the treatment of moderately to severely active ulcerative colitis (GARDENIA): a randomised, double-blind, double-dummy, phase 3 study.

Journal Paper/Review - Nov 17, 2021

Danese Silvio, Colombel Jean-Frédéric, Lukas Milan, Gisbert Javier P, D'Haens Geert, Hayee Bu'hussain, Panaccione Remo, Kim Hyun-Soo, Reinisch Walter, Tyrrell Helen, Oh Young S, Tole Swati, Chai Akiko, Chamberlain-James Kirsten, Tang Meina Tao, Schreiber Stefan, GARDENIA Study Group

Citation

Danese S, Colombel J, Lukas M, Gisbert J, D'Haens G, Hayee B, Panaccione R, Kim H, Reinisch W, Tyrrell H, Oh Y, Tole S, Chai A, Chamberlain-James K, Tang M, Schreiber S, GARDENIA Study Group. Etrolizumab versus infliximab for the treatment of moderately to severely active ulcerative colitis (GARDENIA): a randomised, double-blind, double-dummy, phase 3 study. Lancet Gastroenterol Hepatol 2021; 7:118-127.

Type

Journal Paper/Review (English)

Journal

Lancet Gastroenterol Hepatol 2021; 7

Publication Date

Nov 17, 2021

Issn Electronic

2468-1253

Pages

118-127

Brief description/objective

Etrolizumab is a gut-targeted anti-β7 integrin monoclonal antibody. In a previous phase 2 induction study, etrolizumab significantly improved clinical remission versus placebo in patients with moderately to severely active ulcerative colitis. We aimed to compare the safety and efficacy of etrolizumab with infliximab in patients with moderately to severely active ulcerative colitis.