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.

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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