Mauna Kea Technologies announced the success of a long term prospective clinical study on the prediction of major adverse outcomes for patients suffering from Inflammatory Bowel Disease (IBD) using Confocal Laser Endomicroscopy with Cellvizio®. Final results of the ERIca trial (Erlangen Remission in IBD, clinicaltrials.gov NCT05157750) are now published in the peer-reviewed journal Gastroenterology, the journal of the American Gastroenterological Association, in the article “Intestinal barrier healing is superior to endoscopic and histologic remission for predicting major adverse outcomes in IBD: the prospective ERIca trial”. Endoscopy is the key technique for the surveillance of patients suffering from IBD, with patients undergoing surveillance colonoscopy every one to two years.

Endoscopic and histologic remission, characterized by visual assessment of the colon and analysis of random biopsies, have emerged as key therapeutic goals in the management of IBD that are associated with favorable long-term disease outcomes. In this study, the authors prospectively compared the predictive value of intestinal barrier healing visualized dynamically and functionally in real time with Confocal Laser Endomicroscopy (Cellvizio®) versus endoscopic and histologic remission for predicting long-term disease behavior in a large cohort of IBD patients in clinical remission. Key clinical results: Between 2017 and 2019, a total of 296 IBD patients were screened for eligibility.

Out of these, 181 IBD patients (100 with Crohn's Disease (CD) and 81 with Ulcerative Colitis (UC)) patients were finally eligible and included in the study, with a mean follow-up of 25 months for UC and 35 months for CD. Endoscopic and histologic disease activity as well as barrier healing were prospectively assessed along established scores. During subsequent follow-up, patients were closely monitored for clinical disease activity and the occurrence of major adverse outcomes (MAO): disease flares, IBD-related hospitalization or surgery, initiation or dose escalation of systemic steroids, immunosuppressants, small molecules or biological therapy.

The authors found that Barrier Healing assessed with Confocal Laser Endomicroscopy was far superior to endoscopic and histologic remission for predicting MAO-free survival in both UC and CD: For patients suffering from UC and with Barrier Healing in the Colon confirmed with Cellvizio, the MAO-free survival probability was 81% compared to 47.7% - 64.7% for all other predictors. For patients suffering from CD and with Barrier Healing in the Colon confirmed with Cellvizio, the MAO-free survival probability was 70.4% compared to 43.9% - 50% for all other endoscopic and histologic predictors. When Barrier Healing was confirmed in the Ileum, this probability reached 100% compared to 43.9% - 50% for all other predictors.