By tracking patients in local community clinics, the large-scale real world evidence study aims to better understand treatment patterns and outcomes in routine clinical practice
Millions of people around the globe live with inflammatory bowel disease (IBD) like Crohn’s disease and ulcerative colitis. These chronic conditions cause inflammation of the gastrointestinal tract that severely impacts quality of life, productivity and long-term health.
Though treatments exist, doctors and researchers still lack a clear picture of how they perform for patients outside of a controlled clinical trial environment and in everyday settings. They don’t know how well the treatments control symptoms over time, how long patients stay on their prescribed therapies, why they switch treatments or how these choices ultimately impact hospitalizations, emergency visits and healthcare costs.
To help close the knowledge gaps, Cardinal Health Real-World Data and Evidence, in collaboration with Eli Lilly and Company (“Lilly”) has launched a study called INSIGHT-IBD leveraging its Specialty Networks Research Network of community gastroenterology practices. This real-world evidence study will leverage first-party electronic health records, prospective data collection and patient surveys to capture a long-term picture of what IBD patient care looks like outside of a clinical trial.
"Lilly is pleased to collaborate on efforts to generate evidence in the management of inflammatory bowel disease," said Anabela Cardoso, senior vice president, Lilly Immunology Medical Affairs. "Research conducted in routine clinical practice can help advance understanding of optimized patient care and inform future decision-making across the healthcare community."
A real-world evidence study: INSIGHT-IBD
INSIGHT-IBD is designed to compare outcomes between patients receiving mirikizumab (Omvoh®), an approved biologic therapy from Lilly that blocks a key protein causing chronic inflammation, and patients who receive other biologic therapies chosen by their physicians.
The study will include approximately 400 adult patients across 20 community gastroenterology practices from The Specialty Alliance. Half of the patients will have diagnoses of ulcerative colitis and half will have Crohn’s disease. Each patient’s health and treatment patterns will be tracked for 18 months. The entire research project, which will allow researchers to evaluate how different treatments impact patient health in typical care settings, will span three years.
Dr. Casey Chapman, MD, GI Alliance’s chief medical officer and the study’s principal investigator, emphasized the potential impact of INSIGHT-IBD. "Patients living with IBD often face a lifelong journey marked by periods of uncertainty, treatment adjustments and changing disease activity. By capturing the realities of living with these conditions, INSIGHT-IBD will help us build the evidence we need to support truly patient-centered disease management."
Nicholas Lazarou, MPH, MBA, Senior Director, science, data and delivery at Cardinal Health said, "Rather than burdening practices with new workflows, we’ll be gathering actionable data from care that physicians are already providing. And we hope our findings will provide insights relevant to everyday clinical practice."
From clinical trials to community practice
For decades, randomized controlled trials (RCTs) have been the gold standard of modern medicine. Designed to test whether a new therapy works under ideal conditions, they rely on narrow patient eligibility criteria, strict protocols and specialized academic research centers.
Though RCTs remain essential in establishing therapies’ safety and efficacy, they do not always answer fundamental questions that community physicians face every day: How does this treatment perform in the real world? How does the treatment work in diverse patients with multiple health issues, when real-life factors like diet and exercise, medication adherence, mental health, and environmental and socioeconomic conditions are factored in?
Real-world evidence (RWE) studies like INSIGHT-IBD center on the physician practice and the patient’s lived experience. For the study’s participating community gastroenterologists, RWE initiatives not only offer data collection, but also provide access to network-wide insights, so that practices can benchmark results against their peers and continually refine treatment protocols. For patients, the study ensures that daily health realities and personal treatment goals remain at the center of medical progress.
The study will measure the overall burden of managing IBD disease, including unplanned outpatient or emergency department visits, IBD-related hospitalizations, the need for treatment changes and how well a treatment helps patients achieve symptom relief and tissue healing. The study also will prioritize the patient voice by measuring self-reported outcomes like bowel urgency, general health status and work productivity. Initial insights are anticipated within six to eight months, giving the medical community timely, real-world data well before the overall study conclusion.
“Through INSIGHT-IBD, we hope to generate meaningful evidence that will provide additional information to help support clinical decision making for individuals living with Crohn's disease and ulcerative colitis,” Lazarou explained.
He added that INSIGHT-IBD has successfully enrolled its first patient, officially launching the new study. "We appreciate the commitment of the clinicians, patients and research teams for working together to find ways to truly improve care for IBD patients."
Editor’s note: Omvoh and its delivery device base are trademarks owned by Eli Lilly and Company.