Tumour
necrosis factor (
TNF)-alpha is an inflammatory
cytokine that plays a main role in the inflammatory process underlying
inflammatory bowel disease (IBD). Despite the fact that the
cytokine profiles associated with
ulcerative colitis (UC) and
Crohn's disease (CD) are classically considered different (a Th2 pattern in UC and a Th1 pattern in CD), there are several evidences in vitro and in vivo that
TNF-alpha has an important role in UC. For this reason,
infliximab, the chimeric
monoclonal antibody to
TNF-alpha, has been evaluated in the
therapy of UC. The
drug has been evaluated in different clinical settings both in adults and in children: in moderate-severe
steroid-dependent UC, in severe refractory UC as rescue
therapy, in active non-
steroid-refractory UC, in resistant
pouchitis and in maintenance of moderate-severe UC responsive to
infliximab. On the basis of the randomised controlled trials (RCTs), it is possible to draw the following conclusions for adults:
infliximab seems active in severe
steroid-refractory UC, allowing
colectomy to be spared even if further controlled trials are needed with a larger sample of patients adopting strict and well-defined inclusion criteria. The
drug seems active in inducing remission after 8 weeks in
steroid-refractory patients, in patients taking
steroids (even if it is not clear at which dosage of
steroid dependence the
drug is more active) and also in patients failing aminosalicylates
therapy. The long-term response of
infliximab in comparison to placebo in these subgroups of patients is not clinically impressive even if it is statistically significant. Further trials are warranted in order to establish the role of
infliximab in
steroid-dependent UC (defined with clear criteria), in maintaining remission after severe UC, in non-
steroid-dependent moderate-severe UC and in refractory
pouchitis. For children it is not possible to draw the same conclusions, due to a lack of RCTs, despite the encouraging data coming from open studies, mainly in
steroid-refractory UC.