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

RCT (n=397) found etrolizumab was not superior to infliximab for the primary endpoint of combined clinical response at week 10 and clinical remission at week 54 (18.6% vs 19.7%, p=0.81). More patients given etrolizumab had serious adverse events (16% vs 10%).

SPS commentary:

Etrolizumab is a gut-targeted, anti-β7 integrin, monoclonal antibody currently under investigation.

 

Three other trials of etrolizumab have also been published in this journal:

 

  • The HIBISCUS trials (both n=358) found an improved remission rate for etrolizumab vs placebo at week 10 in HIBISCUS I (19.4% vs 6.9%, p=0.17), but not in HIBISCUS II (18.2% vs 11.1%, p=0.17). In the pooled analysis, etrolizumab had similar numerical results to adalimumab.

 

  • The HICKORY trial (n=609) found etrolizumab was superior to placebo for induction of remission at week 14 (18.5% vs 6.3%, p=0.0033), however, in those patients who achieved remission, the rate of maintenance of remission at week 66 was not significantly different (24.1% vs 20.2%, p=0.5).

 

  • The LAUREL trial (214 patients who had had a clinical response to etrolizumab at week 10) found maintenance etrolizumab was not superior to placebo for remission at week 62 (29.6% vs 20.6%, p=0.19). The rate of serious adverse effects was similar (9% vs 8% respectively).

 

A commentary summarises the results and provides some context and implications of this evidence.

Lancet Gastroenterology and Hepatology

Resource links:

HIBISCUS trials report

HICKORY trial

LAUREL trial

Comment