P602 Health-related quality of life improves during 1-year of postoperative prophylactic drug therapy after ileocecal intestinal resection in Crohn’s disease patients: results of the APPRECIA randomised trial
C. Taxonera*1, A. Lopez-Sanroman2, M. I. Vera3, P. Nos4
1Hospital Clínico San Carlos, IBD Unit, Madrid, Spain, 2Hospital Universitario Ramón y Cajal, Gastroenterology, Madrid, Spain, 3Hospital Puerta de Hierro, Gastroenterology, Madrid, Spain, 4Hospital La Fe, Gastroenterology, Valencia, Spain
Health-related quality of life (HRQoL) is impaired in patients with Crohn´s disease (CD). HRQoL improvement after intestinal resection for complicated CD is uncertain, due to the high rate of postoperative disease recurrence. The aim of our study was to assess HRQoL changes in CD patients undergoing ileocecal intestinal resection, who received postoperative drug therapy with either adalimumab or azathioprine.
In the prospective multicentre APPRECIA trial, CD patients undergoing ileocecal intestinal resection were randomised 1/1 to receive postoperative therapy with azathioprine or adalimumab. Primary endpoint was endoscopic recurrence (Rutgeerts score 2b, 3, and 4) at week 52. Changes in HRQoL were a secondary objective of the study. HRQoL was measured at baseline (2 weeks after surgery) and at weeks 24 and 52, using the generic EuroQoL-5 dimensions questionnaire (EQ-5D) and the disease-specific Short Inflammatory Bowel Disease Questionnaire (SIBDQ). Baseline-endpoint changes in SIBDQ and EQ-5D were assessed using 2-samples t-test for SIBDQ score and Wilcoxon test for EQ-5D score.
In the APPRECIA trial, study drugs were administered to 86 patients. In total, 73 CD patients (44 adalimumab group, 29 azathioprine group) completed all questionnaires and were evaluable. HRQoL was poor at baseline, but improved significantly at weeks 24 and 52 in both treatment groups (p < 0.01 for SIBDQ and EQ-5D at weeks 24 and 52). At both weeks 24 and 52, we found no significant differences between treatments, either in total scores or in individual dimensions of the EQ-5D and SIBDQ scores. Mean improvement in HRQoL scores from baseline to week 52 were significantly greater in patients without endoscopic recurrence (p = 0.01 for SIBDQ and p = 0.04 for EQ-5D).
In CD patients, postoperative prophylactic drug therapy (with azathioprine or adalimumab) after ileocecal intestinal resection, resulted in a significant and sustained improvement in HRQoL. There were no significant differences in HRQoL between treatment groups. Patients without endoscopic recurrence had greater increases in the HRQoL scores. Both EQ-5D and SIBDQ questionnaires performed similarly in the detection of changes in HRQoL.