Researchers receive funding award to compare targeted treatment approaches to improve long-term outcomes in patients with IBD

NEW YORK, NY – Crohn’s disease and ulcerative colitis, also known as inflammatory bowel disease (IBD), affect millions of Americans and can significantly impair patient quality of life. Currently, there are no cures for these debilitating diseases and treatment often includes the use of medications to resolve symptoms (known as symptomatic remission) and inflammation in the gastrointestinal (GI) tract as seen during endoscopy (referred to as endoscopic remission). However, even patients who adhere to their medication regimen may continue to experience symptom flares or persistent inflammation. Moreover, many patients, despite experiencing no symptoms, may continue to have inflammation in their GI tract which causes bowel damage. Because of this, clinicians are utilizing a treatment approach called treat-to-target. Treat-to-target involves closely monitoring inflammation, and adjusting medications to heal the intestines more effectively, with the hope of helping patients achieve better long-term outcomes. 

The Patient-Centered Outcomes Research Institute (PCORI) recently issued a funding award for $6.4 million to study a treatment strategy, which may result in better longer-term patient outcomes, among patients enrolled in IBD Qorus™, the adult quality improvement initiative of the Crohn’s & Colitis Foundation. Through this clinical trial, Drs. Siddharth Singh from the University of California San Diego and Jason Hou from Baylor College of Medicine and the Michael E. DeBakey VA Medical Center in Houston, TX, leaders in IBD Qorus, will examine whether aggressively treating intestinal inflammation in patients who may not be experiencing any IBD symptoms is beneficial or may be harmful. Patients will be assigned either to continue their current treatment plan or, following a treat-to-target strategy, switch medication with the goal of healing the inflammation in their GI tract, in addition to controlling symptoms. 

“While clinical trials have shown benefit in resolving inflammation from a treat-to-target strategy, the pragmatic implementation of this approach and its impact on patient-centered outcomes and healthcare utilization is unknown,” said Dr. Singh. 

Conducting this research in real-world practices through the Foundation’s IBD Qorus program will provide new insights and learnings. “We are eager to begin as this research will provide much needed guidance to the IBD community and could significantly impact the long-term well-being for IBD patients everywhere,” said Dr. Hou. 

IBD Qorus is the first-ever adult IBD learning health system that is focused on improving health outcomes and how care is delivered to patients across a range of U.S. geographic locations, practice settings, and disease complexities. More than 55 GI practices across the nation are currently participating in this program serving over 20,000 patients.

This study was selected for PCORI funding through a highly competitive review process in which patients, clinicians and other stakeholders joined clinical scientists to evaluate the proposals. Applications were assessed for scientific merit, how well they will engage patients and other stakeholders and their methodological rigor among other criteria.

“This study was selected for PCORI funding not only for its scientific merit and commitment to engaging patients and stakeholders in research, but also for its potential to fill an important evidence gap and give people information to help them better assess their care options,” said PCORI Executive Director Nakela L. Cook, MD, MPH. “We look forward to following the study’s progress and working with the Crohn’s & Colitis Foundation to share the results.”

This funding award has been approved pending completion of a business and programmatic review by PCORI staff and issuance of a formal award contract. 

PCORI is an independent, nonprofit organization authorized by Congress in 2010. Its mission is to fund research that will provide patients, their caregivers and clinicians with the evidence-based information needed to make better-informed healthcare decisions. For more information about PCORI’s funding, visit www.pcori.org.