Predictors of Tissue Healing in Inflammatory Bowel Disease Patients Treated With Anti-TNF

Crohn's disease and ulcerative colitis (UC) are both chronic idiopathic inflammatory conditions of the gastrointestinal tract that result in a considerably decreased quality of life. Long term experience with standard therapies for inflammatory bowel disease patients up to the late 1990s demonstrated diverse limitations. Corticosteroids have good short term efficacy, but are not suitable for maintaining remission, while treatment with immunomodulators are associated with an important risk of side effects. The introduction of monoclonal antibody to tumor necrosis factor a (TNFa) therapy has offered new treatment options originally in patients with Crohn's disease and more recently in those with ulcerative colitis as well. Several clinicians based on the results of clinical trials, now advocate the early use of intensive therapy (immunosuppressants and/or biologics) to maintain a good quality of life from the first flare up and prevent any irreversible consequence of the disease.

Meanwhile, the assessment of tissue healing has become of paramount importance in patients treated for inflammatory bowel disease. Simple clinical assessment does not reflect real activity and inflammation at the tissue level. Moreover, cumulative tissue damage generated by the persisting tissue inflammation leads to non reversible anatomic and functional consequences. Therefore, in order to evaluate both the natural history and impact of treatment in inflammatory bowel disease standardized assessment of tissue healing must be available. Endoscopic and histological healing has been shown to be associated with a reduced risk of recurrence of the disease, in addition to reduced hospitalization and surgery. Furthermore, in patients treated with costly and highly immunosuppressive TNF-a antagonists, achievement of an objective treatment response is essential. Consequently, endoscopic healing should be regarded as the primary approach in the treatment of inflammatory bowel disease.

Although several clinical trials have identified, at diagnosis, factors predictive of a subsequent disabling course of the disease, therefore identifying patients that would mostly benefit from early aggressive therapy with anti-TNF, factors predictive of mucosal healing have not yet been identified.

Endoscopy (ileocolonoscopy) will be performed at baseline (i.e. before anti-TNF administration) for all patients included in the study. The outcome of anti-TNF therapy will be evaluated by two follow up endoscopies, at 3 months and at 12 months after the start of therapy. At the same time periods the disease activity will be documented as well.

For Crohn's disease patients, the simplified endoscopic severity index will be recorded (SES-CD), table 1. According to current guidelines, mucosal healing will be defined as an SES-CD of lower than 5 points. For all CD patients, the CD activity index (CDAI) will also be determined.