EMA: Draft qualification opinion on the paediatric ulcerative colitis activity index (PUCAI)

The paediatric ulcerative colitis activity index (PUCAI) measures disease activity in pediatric ulcerative colitis (Turner D. et al., 2007). It was developed to act as an accurate non-invasive (i.e. suitable for children) reflection of endoscopic inflammatory activity and has proven to have high reliability and responsiveness to change in clinical trials. After its publication, it has also proved to be highly accurate in predicting clinical course of pediatric ulcerative colitis and hence was incorporated in international clinical algorithms for the management of acute severe ulcerative colitis and ambulatory pediatric ulcerative colitis.