Tumor necrosis factor production is increased in the mucosa of patients with active ulcerative colitis.
In this study, researchers from Europe investigated the efficacy of infliximab in ulcerative colitis.
The team conducted a randomized placebo controlled trial of infliximab (5 mg/kg) in the treatment of glucocorticoid resistant ulcerative colitis. Patients received infusions at weeks 0 and 2.
|A Baron score of 0 was equally likely in either group.|
The researchers evaluated the disease activity and quality of life during an 8 week follow-up period. They defined disease remission as an ulcerative colitis symptom score (UCSS) of 2 and/or Baron score of 0, at week 6.
Any patients who were not in remission were offered open label infliximab (10 mg/kg). They were reviewed 2 weeks later.
The team found that, after 2 weeks, there was no significant difference in the proportion of patients with a Baron score of 0, between the infliximab and placebo groups. They observed that, after 6 weeks, remission (UCSS 2) rates were 39% versus 30%.
The researchers determined that the median improvement in UCSS was 3 for the infliximab group and 2.5 for the placebo group. This difference was not statistically significant.
In addition, they found that a Baron score of 0 was equally likely in either group.
The team also found that improvement in the IBDQ and EuroQol was not significantly different between the groups.
Overall, 28 patients were given open labeled infusions. Following this, the researchers established that remission was achieved in 27% patients initially treated with infliximab, and in 11% of patients in the placebo group.
Dr Probert's team concluded, "These data do not support the use of infliximab in the management of moderately active glucocorticoid resistant ulcerative colitis".