Limitations in assessment of mucosal healing in inflammatory bowel disease

Abstract

An emerging parameter to define the effectiveness of new therapeutic agents in clinical trials, and by extension, for use in day-to-day clinical practice has been labeled mucosal healing. It has been hypothesized that complete healing of the intestinal mucosa in inflammatory bowel diseases should result in reduced disease complications, reduced hospitalization and reduced surgical treatment. By implication, the natural history of inflammatory bowel disease might then be altered. Measurement of mucosal healing, however, is largely observational, requiring repeated invasive endoscopic examinations, sometimes with mucosal biopsies. Other indirect imaging methods may play a role in this assessment along with other surrogate markers, including intestinal permeability. These measurements may have significant limitations that prohibit precise correlation with symptom-based disease activity indices in clinical trials. This likely reflects the dynamic nature of this evolving and individualized inflammatory process that tends to be focused, but not limited, to the mucosa of the intestinal tract.