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

Positioning biologics in the treatment of IBD: A practical guide – Which mechanism of action for whom?

“…Additional head to head trials have been conducted in the etrolizumab study program (GARDENIA vs. infliximab ( Danese et al., 2021 ) and HIBISCUS vs. adalimumab ( Rubin et al., 2021 )) and Guselkumab phase II study (GALAXY vs. Ustekinumab ( Sandborn et al., 2022 )) which were presented at the United European Gastroenterology (UEG) conference in 2020. These studies didn't show significant differences in the primary endpoints.…”

“…However, striking efficacy differences have not been shown to support their superiority and anti-TNF agents remain the most appropriate medications in presence of most concomitant extraintestinal manifestations or in fistulizing CD ( Juillerat et al., 2020 ; Papamichael et al., 2021 ; Singh et al., 2021 ). Additionally, other biologicals such as etrolizumab ( Danese et al., 2021 ; Peyrin-Biroulet et al., 2021 ; Rubin et al., 2021 ) (monoclonal antibody against the B7 subunit of integrins α4β7 and αΕβ7) as well as guselkumab, mirikizumab and risankizumab, other monoclonal antibodies which binds to p19 subunit of interleukin 23 ( Sandborn et al., 2020 ; Schett et al., 2021 ) are emerging in the market.…”

An Overview of Tissue-Resident Memory T Cells in the Intestine: From Physiological Functions to Pathological Mechanisms

“…For instance, etrolizumab is a humanized monoclonal antibody that targets the β7 subunits of αEβ7 and α4β7 integrins. In a completed phase III trial in UC, etrolizumab met its primary endpoint in two induction studies but not in any maintenance studies ( 78 – 81 ). Phase III trials assessing etrolizumab in CD are still ongoing with positive results in an exploratory induction cohort ( 82 ).…”

Integrating new and emerging therapies into inflammatory bowel disease clinical practice

“…A subcutaneous formulation will also be available soon. Data from other antiadhesion molecules, such as etrolizumab and ontamalimab, has been less impressive and it seems unlikely that further development will be pursued [45 ▪ ,46,47 ▪ ,48]. Etrolizumab proved to be an example of a drug with positive early data and a theoretically-successful mechanism of action that did not translate into significant outcomes in phase 3 trials.…”

“…The SEAVUE trial was another head-tohead randomized controlled trial with preliminary results showing that ustekinumab and adalimumab were equally effective in a biologic-naı ¨ve CD population [61 && ]. The GARDENIA trial compared www.co-gastroenterology.com etrolizumab to infliximab in moderate to severe UC, and showed a comparable efficacy [46].…”