Infliximab discontinuation increases relapse risk

In a randomised prospective trial, discontinuation of maintenance infliximab increased the risk of relapse of ulcerative colitis (UC) [1]. Retreatment was found to be effective. Endoscopic normalisation did not guarantee successful withdrawal.

UC patients treated with infliximab who were in clinical remission were enrolled from 23 specialised centres in Japan in this first-ever prospective, multicentre, randomised controlled trial to evaluate the effects of discontinuing a TNF inhibitor. Participants had to be in clinical remission for >6 months, be steroid-free, and have a Mayo endoscopic subscore (MES) of 0 or 1. They were randomised 1:1 to continuation or discontinuation of infliximab. The primary endpoint was remission rate after 48 weeks in a full analysis set. A total of 92 patients were included in the full analysis set; 46 in each group.

After 48 weeks, remission was maintained by 37 of 46 patients (80.4%) who had continued infliximab (95% CI 66.1–90.6), versus 25 of 46 patients (54.3%) who had not (95% CI 39.0–69.1; P=0.008). C-reactive protein and Nancy histological index were associated with remission at week 48 (P=0.039 and P=0.019, respectively). Not predictive of remission were infliximab concentration or treatment duration, use of concomitant immunomodulators, and a MES of 0 at randomisation. Retreatment in patients who had discontinued infliximab was well-tolerated and led to renewed remission in 8 of 12 patients (66.7%) after 8 weeks.

1. Kobayashi T, et al. ECCO-IBD 2020, DOP39.

 



Posted on 14 April 202016 February 2024