Introduction: Concordance between endoscopy and histology scores for patients (pts) with Crohn's disease (CD) is not well known. Methods: Agreement between complete endoscopic healing and histological healing at baseline (BL) and week (wk) 52 in colon and ileum segments of pts with moderate/severe CD randomized in EXTEND (N=129) was assessed. Concordance of each of the Simple Endoscopic Score for CD (SES-CD) subscores (ulcer size, ulcerated surface, and affected surface) measured in pooled samples from 3 colon segments (sigmoid/left, transverse, right colon) with Colonic Global Histologic Disease Activity Scores [CGHAS] or from ileum with Ileal Global Histologic Disease Activity Scores [IGHAS] was performed using kappa statistic. Complete endoscopic healing was defined as SES-CD ulcer size subscore=0, ulcerated surface subscore=0, and affected surface subscore=0 in colon segments or ileum. SES-CD subscores in each colon segments had to =0 to qualify as complete endoscopic healing. Two biopsies from each ileocolonic segment were evaluated for 8 histological variables, which were scored independently and summed to create CGHAS/IGHAS ranging from 1 (least severe) to 16 (most severe). Histologic healing was defined as CGHAS/IGHAS ≤2. Centrally read SES-CD and CGHAS/IGHAS were used; pts were analyzed regardless of randomized treatment, disease location, and presence of ulcers at BL. Data are reported as-observed. Results: Fair/moderate to high agreement was observed at BL and wk 52 between SES-CD subscores and CGHAS/IGHAS (Table). At wk 52, for pts with evaluable colonic biopsies, SES-CD subscores=0 were observed in 68% (53/78) of pts for ulcer size and ulcerated surface and by 65% (51/78) for affected surface. 67% (52/78) of pts had CGHAS≤2. 83% (44/53) of pts had CGHAS ≤2 and SES-CD subscores= 0 for ulcer size or ulcerated surface; corresponding value for pts also with affected surface=0 was 84% (43/51). For pts with evaluable ileal biopsies, 68% (52/77) had SES-CD subscore=0 for the 3 subscores evaluated and 75% (58/77) had IGHAS≤2 at wk 52. Of pts with SES-CD subscores=0 in ileum, 96% (50/52) also had IGHAS≤2. Table shows concordance between SES-CD components and IGHAS/CGHAS. Conclusion: A high degree of concordance between SES-CD subcores and IGHAS/CGHAS was observed at wk 52, as majority of pts with complete endoscopic healing (using a very stringent SES-CD definition) also had histological healing. There was a greater concordance in ileum than in colon.Table 1: Degree of Agreement (kappa values) Between SES-CD Subscores and IGHAS/CGHAS at Baseline and Week 52
Read full abstract