No reliable identification of quiescent Crohn's disease (CD) patients
with a high risk of relapse is available. The aim of this study was to
develop a prognostic index to identify those patients. Untreated adul
t patients with quiescent disease (not induced by surgery) included in
three phase III clinical trials were analysed retrospectively with re
spect to time to relapse. Nineteen factors related to biology, disease
history, and topography were investigated. A relapse was defined as e
ither a CD Activity Index (CDAI) greater than or equal to 200, a CDAI
greater than or equal to 150 but over the baseline value by more than
100, or acute complications requiring surgery. The inclusion criteria
were fulfilled by 178 patients. The median follow up was 23 months. Th
e Cox model retained the following bad prognostic factors: age less th
an or equal to 25 years, interval since first symptoms >5 years, inter
val since previous relapse less than or equal to 6 months, and colonic
involvement (p < 0.001). Bootstrapping confirmed the variable selecti
on. Patients were classified into three groups with an increasing risk
of relapse (p < 0.001). The worst risk group was composed of patients
presenting at least three of the four bad prognostic factors. These r
esults make possible the design of clinical trials in quiescent CD pat
ients with a high risk of relapse.