Mauna Kea Technologies Announces Success of Clinical Trial on Prediction of Remission in Patients with Inflammatory Bowel Disease (IBD) and its Publication in Gastroenterology
Dynamic monitoring of the intestinal barrier with Confocal Laser Endomicroscopy demonstrated to be far superior to endoscopic and histologic biomarkers as predictors of long-term remission
Intestinal Barrier Healing emerges as a new key therapeutic endpoint for IBD
Mauna Kea Technologies today 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 flagship 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”1.
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.
Prof. Dr. med. Timo Rath, Head of the Ludwig Demling Endoscopy Center of Excellence at the University Hospital Erlangen, said: “Our data clearly show that intestinal barrier healing, as assessed by dynamic and functional visualization with Confocal Laser Endomicroscopy is a prognostic parameter that by far outcompetes endoscopic and histologic remission, or their combination, in the forecasting of the occurrence of major clinical events in both Ulcerative Colitis and Crohn’s Disease patients. This has far-reaching consequences on the way patients suffering from these debilitating diseases should be monitored during remission.”
“The importance of these new clinical results for the 6 to 8 million people who suffer from Inflammatory Bowel Disease globally could not be overstated as they are paving the way to a much improved management of their condition, and in particular how the colonoscopies they are undergoing every one to two years are being conducted”, said Sacha Loiseau, Ph.D., Chairman and CEO of Mauna Kea Technologies. “This remarkable clinical study, led by some of the world’s authorities on IBD, further exemplifies Cellvizio’s differentiated value proposition as the unique advanced imaging solution providing real-time, dynamic and functional cellular imaging of tissues. This publication in the leading peer-reviewed journal in the field of gastroenterology confirms the essential role that Cellvizio can play in the way physicians monitor and treat their patients with IBD and how new therapeutic targets can be designed.”
For key clinical results, please see the full press release.