Adalimumab for Induction of Histological Remission in Moderately to Severely Active Ulcerative Colitis.

BACKGROUND: Histological remission represents a target distinct from endoscopic healing in ulcerative colitis (UC) and seems a better predictor of clinical outcomes. AIMS: The aim of this study was to assess the ability of adalimumab to achieve histological remission in UC patients. METHODS: Single-center, retrospective, open-label study of patients treated with adalimumab. Eligible patients were anti-TNF naïve adults with moderately to severely active UC. The Mayo score including endoscopy was performed at baseline and weeks 8 and 52. Histological activity was scored using the Geboes Index. The primary endpoint was histological remission, defined as a Geboes grade ≤ 3.0, at week 52. RESULTS: We included 34 patients. At week 8, 6 of 34 patients (17.6%) achieved histological remission. At week 52, 9 patients (26.5%, intention to treat; 31%, per protocol) had histological remission. Patients had a significant and progressive reduction in the most severe subgrades of Geboes Index from baseline at weeks 8 and 52. At weeks 8 and 52, 50 and 61.8% of patients achieved mucosal healing (Mayo endoscopic subscore 0-1). All patients who achieved histological remission also had mucosal healing. At week 8, 85.3 and 20.6% of patients achieved clinical response (decrease in Mayo score ≤ 3 points) or remission (Mayo score ≤ 2), respectively. At week 52, the corresponding values were 67.6 and 52.9%, respectively. At week 52, agreement between histological remission and mucosal healing was fair (kappa 0.293). Agreement between histological remission and Mayo endoscopic subscore 0 was good (kappa 0.71). CONCLUSIONS: Adalimumab was able to achieve histological remission in anti-TNF naïve patients with moderately to severely active UC.

Relationship between Mayo endoscopic score and histological scores in ulcerative colitis: A prospective study.

BACKGROUND: The Mayo endoscopic score (MES) remains the most commonly used index in clinical practice, as well as in various clinical trials. Recently, two validated histological indices (Nancy Index [NI] and Robert Histological Index [RHI]) have been developed for ulcerative colitis (UC). We aim to study the relationship between MES with NI, RHI, and the established Geboes Index (GI) in patients with UC. METHODS: This was a prospective single-center study. MES was documented from the most involved area. Biopsy was taken from the same area and reported by a single gastrointestinal histopathologist who was blinded to the endoscopic score. Histological activity was reported using GI, NI, and RHI. Statistical analysis was performed using Spearman's correlation coefficient and Cohen's kappa coefficient using SPSS version 23. RESULTS: Median age of patients with UC (n = 96) was 36 years. Seventeen patients were in endoscopic remission (MES 0/1). Correlation coefficient between MES and GI/NI/RHI was only weak to moderate (rho = 0.381/0.389/0.442, respectively; P < 0.001 for all three correlations). In patients with endoscopic mucosal healing (n = 17), the agreement coefficient between MES and GI/RHI was weak (κ = 0.253/0.336, respectively; P = 0.001 for both agreements). However, there was no significant agreement coefficient between MES and NI (P = 0.573). CONCLUSION: MES moderately correlated with histological scores. RHI had the best correlation with MES among all histological indices. Endoscopic mucosal healing is not strongly correlated with histological healing. Histological examination should be performed even in patients with mucosal healing to detect ongoing histological activity.