Etrolizumab Not Superior to Infliximab in Patients With Moderately to Severely Active Ulcerative Colitis

stomach pain
stomach pain
Investigators assessed the safety and efficacy of etrolizumab vs infliximab in patients with moderately to severely active ulcerative colitis.

Etrolizumab was not superior to infliximab in patients naïve to tumor necrosis factor inhibitors with moderately to severely active ulcerative colitis, according to a study in the Lancet Gastroenterology & Hepatology.

The randomized, double-blind, phase 3 GARDENIA study was conducted in 114 treatment centers in 19 countries ( Identifier: NCT02136069). Eligible participants were adults aged 18 to 80 years with moderately to severely active ulcerative colitis (Mayo Clinic total score [MCS] 6-12 with a centrally read endoscopic subscore of ≥2, a rectal bleeding subscore of ≥1, and a stool frequency subscore of ≥1). Participants also had to have an established diagnosis of ulcerative colitis for at least 3 months.

Participants in the etrolizumab group received subcutaneous etrolizumab 105 mg once every 4 weeks, along with an intravenous dummy infliximab treatment of 250 mL saline placebo at weeks 0, 2, and 6, and then every 8 weeks afterward until week 54. Patients randomly assigned to the infliximab group received intravenous infliximab 5 mg/kg at weeks 0, 2, and 6, and then every 8 weeks, plus a subcutaneous dummy etrolizumab treatment of 0.7 mL placebo once every 4 weeks until week 54.

The primary efficacy endpoint was clinical response at week 10 and clinical remission at week 54. Clinical response was defined as having a ≥3-point decrease and ≥30% decline in MCS from baseline, and a ≥1-point decrease in rectal bleeding subscores or an absolute rectal bleeding score of 0 or 1. Clinical remission was defined as having an MCS ≤2 with individual subscores of ≤1.

A total of 730 patients were screened from December 24, 2014, to June 23, 2020. Of this group, 397 were enrolled and randomly assigned to receive either etrolizumab (n=199; median age, 37 years; 59% men) or infliximab (n=198; median age, 37 years; 67% men). About half of the participants in both groups completed the study through week 54 (etrolizumab group, 95 patients [48%]; infliximab group, 103 patients [52%]).

In the modified intention-to-treat population, 37 patients (18.6%) in the etrolizumab group and 39 (19.7%) in the infliximab group met the primary endpoints. Etrolizumab was not superior to infliximab, with an adjusted treatment difference of -0.9% (95% CI, -8.7 to 6.8; P =.81).

A total of 154 patients (77%) in the etrolizumab group and 151 patients (76%) in the infliximab group had 1 or more adverse events. Ulcerative colitis was the most common adverse event in both groups (55 patients [28%] in the etrolizumab group; 43 patients [22%] in the infliximab group).

Serious adverse events, including serious infections, occurred more frequently in the etrolizumab group (32 patients [16%]) vs the infliximab group (20 patients [10%]), with ulcerative colitis the most common (12 patients [6%] in the etrolizumab group and 11 patients [6%] in the infliximab group).

“Although the study did not show statistical superiority for the primary endpoint, etrolizumab performed similarly to infliximab from a clinical viewpoint,” stated the investigators.

Disclosure: This study was funded by F Hoffmann-La Roche. Some of the study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.


Danese S, Colombel J-F, Lukas M, et al. 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. 2022;7(2):118-127. doi: 10.1016/S2468-1253(21)00294-6