Infliximab in moderately severe XXXX : a randomised controlled trial.

@entity1 @entity31 @entity30 @entity39
BACKGROUND: Tumour @entity39 factor production is increased in the mucosa of @entity1 with active @entity31 . The benefits of infliximab in @entity30 are established. We investigated its efficacy in @entity31 . METHODS: We conducted a randomised placebo controlled trial of infliximab (5 mg/kg) in the treatment of @entity31 . Infusions were given at weeks 0 and 2. Disease activity and quality of life were recorded over eight weeks of follow up. Remission was defined as an @entity31 symptom score (UCSS) of < or =2 and/or Baron score of 0 at week 6. @entity1 not in remission were offered open label infliximab 10 mg/kg and reviewed two weeks later. RESULTS: After two weeks, there was no statistically significant difference between the infliximab and placebo groups in the proportion of @entity1 with a Baron score of 0 (13% (3/23) v 5% (1/19) (95% confidence interval (CI) -9% to 24%); p=0.74). After six weeks, remission (UCSS < or =2) rates were 39% (9/23) versus 30% (6/20) (95% CI -19 to 34%; p=0.76). The median improvement in UCSS was 3 for the infliximab group and 2.5 for the placebo group (p=0.82, Mann-Whitney U test). A Baron score of 0 was likely in either group (26% (6/23) v 30% (6/20) (95% CI -30% to 23%); p=0.96). Improvement in the IBDQ and EuroQol was not significantly different between the groups (p=0.22 and 0.3, respectively, Mann-Whitney U test). Twenty eligible @entity1 were given open labelled infusions. Remission was achieved in 3/11 (27%) @entity1 initially treated with infliximab and in 1/9 (11%) @entity1 treated with placebo. CONCLUSION: These data do not support the use of infliximab in the management of moderately active @entity31 .
