In the phase 3 HICKORY trial, researchers evaluated etrolizumab in patients with moderate-to-severe ulcerative colitis who previously received anti-tumor necrosis factor therapy. Reportedly, a significantly higher proportion of participants treated with etrolizumab achieved remission at week 14 compared with those treated with placebo.

However, there was not a significant difference in remission at week 66 between the etrolizumab and placebo patients who had a response at week 14. These findings were published in The Lancet Gastroenterology & Hepatology.

The 14-week induction phase was evaluated in 2 cohorts. The first included 130 patients who were openly administered subcutaneous etrolizumab 105 mg every 4 weeks. The remaining 479 patients formed the second blinded cohort, of which 384 patients received etrolizumab and 95 received placebo. Subsequently, maintenance therapy was evaluated in 232 patients, with 117 going from etrolizumab induction to etrolizumab maintenance and 115 going from etrolizumab to placebo.

In the induction phase, 71 (18.5%) of 384 patients in the etrolizumab group and 6 (6.3%) of 95 patients in the placebo group achieved the primary outcome of remission at week 14 (P=.0033). In the maintenance phase, 27 (24.1%) of 112 patients in the etrolizumab group and 23 (20.2%) of 114 patients in the placebo group achieved the primary maintenance outcome of remission at week 66 (P=.50).

Additionally, the proportion of reported adverse events was similar between the groups in both the induction phase and the maintenance phase. The most common adverse event for both groups was ulcerative colitis flare, mostly mild or moderate, according to the report.

The authors concluded that etrolizumab therapy appeared superior to placebo during induction, but the advantage was not seen after maintenance.

Reference: Peyrin-Biroulet L, Hart A, Bossuyt P, et al. Etrolizumab as induction and maintenance therapy for ulcerative colitis in patients previously treated with tumour necrosis factor inhibitors (HICKORY): a phase 3, randomised, controlled trial. Lancet Gastroenterol Hepatol. 2022;7(2):128-140. doi:10.1016/S2468-1253(21)00298-3

Link: https://www.thelancet.com/journals/langas/article/PIIS2468-1253(21)00298-3/fulltext