Comparison of Los Angeles Grades of Erosive Esophagitis Scored by Local Investigators vs Central Adjudicators in a Clinical Trial

Abstract

Approximately 30% of patients with typical gastroesophageal reflux disease (GERD) symptoms have endoscopic evidence of erosive esophagitis (EE).1 The severity of EE is commonly graded using the Los Angeles (LA) classification system as grade A (minimal) to D (very severe), depending on the extent of endoscopically visible mucosal breaks (Supplementary Figure1).2 Accurate grading of EE severity is crucial in clinical trials of medical EE treatments, as EE severity strongly influences both initial rates of healing and the likelihood of recurrence during maintenance treatment.3,4 Almost all EE treatment studies have relied exclusively on local investigators' grading of EE severity to determine study eligibility and response to treatment. Those few studies that included central adjudication did not assess the reliability of grading by local investigators.5 Unlike typical studies of EE treatment, the phase III clinical trial of vonoprazan versus lansoprazole for the treatment of EE (NCT04124926) mandated central adjudication of endoscopic grading for study participation.6 The aim of the present investigation was to evaluate the rate of agreement between local investigators and central adjudicators for EE grading during screening for entrance into that clinical trial.