Development of Three Practical Indices for Mucosal Healing Among Patients With Moderate to Severe Crohnʼs Disease

Abstract

Background: Healing of the intestinal mucosa is considered a valid and important metric of improvement in Crohn's disease (CD). However, a patient must undergo an endoscopy to verify the presence of mucosal ulceration. Regular monitoring using endoscopy is challenging owing to its expensive and intrusive nature. There are currently no easily accessible proxy measures for identifying patients who are likely to have achieved mucosal healing (MH) in CD. Method(s): The practical MH indices were developed using intent-to-treat (ITT) patient-level data from the EXTend the Safety and Efficacy of Adalimumab Through ENDoscopic Healing (EXTEND) trial (160 mg adalimumab at Week 0, 80 mg at Week 2, and randomised to 40 mg every other week or placebo at Week 4). Each index corresponds to 1 of 3 mucosal healing measures: Simple Endoscopic Score for CD (SES-CD) <5, CD Endoscopic Index of Severity (CDEIS) score