A recent study found that maintaining ulcerative colitis (UC) remission was significantly more common in patients who continued treatment with infliximab, compared to those who discontinued treatment.
The use of anti-tumor necrosis factor (TNF) agents is common in the treatment of refractory UC, but the long-term use of anti-TNF therapy can increase the risk of malignancy or infection.
No previous study trial has evaluated the safety of anti-TNF agent discontinuation in patients with UC in remission.
The team, led by Taku Kobayashi, MD of the Center for Advanced IBD Research and Treatment, Kitasato University Kitasato Institute Hospital in Tokyo, looked to compare outcomes in patients who continued and discontinued infliximab treatment.
Thus, investigators conducted an open-label, randomized controlled trial at 24 specialist centers in Japan.
The study enrolled patients with UC in remission who had been treated with intravenous infliximab (5mg/kg) every 8 weeks. Patients were required to have started treatment 14 weeks prior to enrollment in the study.
Patients were also required to be in remission for more than 6 months, to be corticosteroid-free and have a Mayo Endoscopic Subscore (MES) of 0 or 1. The group was then randomized and put into either the infliximab-continued group or the infliximab-discontinued group.
The study took place between June 2014 and July 2017. Of the 122 patients screened, a total of 95 were randomly assigned to the infliximab-continued group (n = 48) and the infliximab-discontinued group (n = 47). The final analysis included 92 patients, with 46 in each group.
In the infliximab-continued group, 37 of 46 patients (80.4%) were in remission at week 48.
In the infliximab-discontinued group, 25 of 46 patients (54.3%) were in remission at week 48.
Adverse events were found in 8 (17%) patients in the infliximab-continued group, including a patient who experienced an infusion reaction. This is compared to 6 (13%) in the infliximab-discontinued group, with 2 patients experiencing psoriatic skin lesions.
The team stated that 8 of 12 patients in the infliximab-discontinuation group, who were then re-treated with infliximab after relapse were in remission in 8 weeks of new treatment. None had infusion reactions.
Investigators cautioned against the discontinuation of infliximab, stating patients should take the risks of relapse and efficacy of re-treatment into account before making the decision to discontinue.
The study, “Discontinuation of infliximab in patients with ulcerative colitis in remission (HAYABUSA): a multicenter, open-label, randomized controlled trial,” was published online in The Lancet Gastroenterology & Hepatology.