New Data from IBD Subgroup Analysis Demonstrates Improved Outcomes for Crohn's Disease Patients

DURHAM, N.C., May 17, 2024 /PRNewswire/ -- Real-world evidence leader, Target RWE, Real-world evidence leader Target RWE today announced a major expansion of its TARGET-GASTRO longitudinal registry, now 30,000+ patients strong, ahead of Digestive Disease Week (DDW) in Washington, D.C., May 18-21. The expansion builds on the recently announced partnership with the American Gastroenterological Association (AGA) which aims to validate disease severity scores from real-world data on patients with high unmet medical need gastrointestinal (GI) diseases, such as EoE and EGID's.

TARGET-GASTRO has enrolled patients with GI diseases including eosinophilic esophagitis (EoE) and other eosinophilic gastrointestinal diseases (EGIDs), inflammatory bowel disease (Crohn's disease and ulcerative colitis), Clostridioides difficile (C. diff) infection (CDI), and celiac disease (CeD), with an average of 42 months of patient follow-up. The large sample size of each of these groups enable Target RWE to conduct advanced analytics on subpopulations of interest. This includes collective measures that fully contextualize patient journeys, relevant variables, and endpoints within unique subpopulations for GI conditions of growing prevalence and concern.

The initial partnership with AGA allows Target RWE to expand its insights on patients with EGIDs. Target RWE is working with AGA and a group of thought leaders to validate the Index of Severity for EoE (I-SEE) in the real world. The powerful combination of tools like the I-SEE with real world, longitudinal data from TARGET-GASTRO will help inform how emerging treatment options for EoE are optimized and improve patient care. 

Separately, TARGET-IBD research was recently accepted for publication in the peer-reviewed Journal of Clinical Gastroenterology, "Factors Predicting Loss of Remission in Crohn's Disease Patients in Endoscopic Remission in the Real World: Results from TARGET-IBD." This study found that active histologic inflammation, despite endoscopic remission, was independently associated with risk of subsequent loss of remission (LOR), suggesting that histologic remission may improve outcomes in Crohn's disease (CD). TARGET-IBD is a longitudinal, observational cohort study under the TARGET-GASTRO protocol.

Other findings on factors related to loss of remission in CD include:

• Of 658 CD patients with steroid-free endoscopic remission, the majority were female (57%), white (83%), non-Hispanic (93%); 20% had ileal and 20% isolated colonic disease. Inflammatory (B1) disease was the most common phenotype (43%).
• Of these 658, 257 (39%) had histologic inflammation on index colonoscopy. Histologic inflammation at index colonoscopy was associated with nearly twice the LOR risk (HR 1.96, 95% CI 1.50-2.57) with median time to relapse of 1.20 years. Biologic use at index was associated with lower LOR risk (monotherapy, HR 0.61, 95% CI 0.45-0.82; combination therapy, HR 0.43, 95% CI 0.28-0.66).

"Understanding associations between treatment targets in CD and longer-term patient outcomes informs decisions on prognosis and treatment modification. This research demonstrated that histologic inflammation, despite endoscopic remission was associated with risk of subsequent loss of remission, an important finding," said study author and co-chair of TARGET-IBD, Millie D. Long, MD, MPH. Dr. Long is a professor of medicine in the division of gastroenterology and hepatology at the University of North Carolina School of Medicine, Chapel Hill.

"TARGET-GASTRO is a rich and growing dataset to help track serious GI diseases that are increasing in prevalence. With the integration of the AGA's I-SEE tool in combination with our advanced analytics, we are helping inform important treatment pathways for countless patients. As TARGET-IBD and TARGET-GASTRO continue to expand, we look forward to applying these tools to improve patient care," said Michael W. Fried, MD, FAASLD, Co-Founder and Chief Medical Officer of Target RWE. 

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Target RWE sources unique, connected data sets across multiple therapeutic areas representing granular data from diverse patients in academic and community settings. Our rigorous, interactive, and advanced RWE analytics extract deep insights from RWD to answer important questions in healthcare. Target RWE brings together the brightest minds in healthcare through an unmatched community of key opinion leaders, patients, and healthcare stakeholders in a collaborative and dynamic model. www.targetrwe.com

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