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

Abstract:

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.

journal_name

Dig Dis Sci

authors

Fernández-Blanco JI,Fernández-Díaz G,Cara C,Vera MI,Olivares D,Taxonera C

doi

10.1007/s10620-018-4935-5

subject

Has Abstract

pub_date

2018-03-01 00:00:00

pages

731-737

issue

3

eissn

0163-2116

issn

1573-2568

pii

10.1007/s10620-018-4935-5

journal_volume

63

pub_type

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