Advancing IBD Research: How Real-World Evidence Helps Uncover Gaps in Care
Global study spurs innovative research and development approaches at AbbVie.
Key Takeaways
New insights from a real-world evidence study identify gaps in care and emphasize the importance of innovation in inflammatory bowel disease (IBD).
This global study, supported by AbbVie, collected data from about 2,200 IBD patients in 10 countries and 103 sites.
The findings highlight the need for more consistent and standardized monitoring of IBD in real-life clinical practice to improve outcomes.
AbbVie is responding with a three-pronged R&D strategy: Exploring medication combinations, developing treatments that work in new ways and advancing personalized medicine approaches for patients.
For Dr. Fernando Gomollón in Spain, and for many physicians around the world, understanding disease sometimes starts with a simple question: "How are you?"
"Most times, the patient's quick and direct response is 'fine' or 'very well,'" explains the Professor of Medicine at the University of Zaragoza and Head of the Inflammatory Bowel Disease (IBD) Section at the Hospital Clínico Universitario de Zaragoza in Spain. "Being true, this response is always relative to previous times, when the disease was more active."
Randomized clinical trials, which are research studies that randomly assign participants into two or more groups, remain the gold standard for testing a medicine's safety and effectiveness. However, they don't tell the whole story.
Healthcare providers, payers and patients increasingly want to understand how treatments perform in the complex, unpredictable real world. Which patients benefit most from a certain treatment? How can healthcare providers make the best treatment decisions? How does one treatment compare with alternatives? Which is most cost-effective?
This is where real-world evidence (RWE) studies like IBD-PODCAST* become key. The studies,1,2 funded by AbbVie, revealed striking findings about IBD:
- 52% of study participants with Crohn's disease reported sub-optimally controlled disease despite being on treatment.
- 44% of study participants with ulcerative colitis reported the same.
- Only 40% of study participants were monitored annually via imaging or endoscopy.2
- Physicians adjusted treatment or ordered additional tests in only about half of patients who showed measurable signs of poor disease control — such as ongoing symptoms, abnormal lab results or active inflammation seen on imaging or endoscopy.
The insights came from global data collected from about 2,200 patients across 103 sites in 10 countries. They provide a wide-ranging view of IBD management in actual clinical settings. And they emphasize the need for a better understanding of the disease and its impact on patients to improve treatment and patient outcomes.
To define "suboptimal," the study used STRIDE-II guidelines, adapted by an expert panel. This internationally recognized framework, created by IBD specialists, outlines what successful treatment should achieve, from how a patient feels to what doctors can see during a scope.
*IBD-PODCAST stands for Proportion Of inadequate Disease Control And Strategy of Treatment in IBD
“Real-world evidence (RWE) is essential to our research and development efforts. By providing holistic insights across patient experiences and clinical practice, RWE may lead to more effective, personalized and accessible care for the patients we serve," said Anusha Kheir, vice president, Value & Evidence, AbbVie. "This is especially critical for IBD, where there remains a high disease burden, unmet need and patient heterogeneity.”
The IBD PODCAST Study shows how important imaging tests or endoscopy are for spotting inflammation in people who don’t have obvious symptoms, helping doctors make better decisions about treatment. It also shows the need for more consistent and standardized ways of monitoring IBD in real-life medical practice.
With only 40% of patients getting checked with imaging or endoscopy each year, and with doctors making changes for about half of those whose disease isn’t well controlled, there is a strong foundation for improving care. These results suggest we have a good starting point, but there are still many chances to improve care for people with IBD.
Over the last two decades, several new treatments have been created to help IBD patients achieve and maintain remission, noted AbbVie’s Lorenzo Gemignani, one of the study’s authors. But, he said, "Due to the chronic nature of these diseases and the persistent difficulties of disease management and monitoring, many patients are still living with sub-optimally controlled disease."
How are these findings driving new approaches?
Findings from real-world evidence studies like IBD-PODCAST help drive AbbVie's innovative, three-pronged research and development strategy. These new approaches seek to address unmet patient needs:
- Combination treatments: AbbVie is exploring whether using multiple medications together works better than using them alone. These combinations can help target different parts of the disease process. AbbVie has already started a clinical trial in patients with Crohn's disease and plans to test similar approaches for other immune system disorders.
- New ways medications work: AbbVie is developing medications that work through entirely new biological pathways. These therapies might be used alone or in combination with other treatments, in the hopes of helping to make a long-term impact on patients' lives.
- Personalized approach: AbbVie is advancing precision medicine approaches to match the right treatment with the right patient. Teams look at patient profiles at a molecular level and at a clinical level. This can help to identify better options for patients who aren't responding to current treatments.
"In research and development, we are challenging ourselves to continue to raise the standard of care with therapies that don't just address symptoms, but that can help resolve and potentially cure underlying disease pathology," said Kori Wallace, vice president and therapeutic area head of immunology at AbbVie.
Why do real-world evidence studies matter for IBD patients?
While traditional clinical trials remain essential, Dr. Gomollón emphasizes that real-world evidence studies offer unique value. "If they are well done, they furnish us with invaluable information, much more representative of all the population, and with a perspective from the everyday clinical office or even the daily life of the patient."
For Salvo Leone, Chairman, International Federation of Crohn’s and Ulcerative Colitis Associations and CEO, AMICI Italia, these studies represent more than just data collection. They're an opportunity for patients to shape the future of care. "Your involvement can provide unique insights into how therapies are affecting your quality of life," he explains. "Participation in these studies not only contributes to advancing IBD research but also means your voice is directly influencing future treatments and policies."
The study’s findings shed light on both the progress made and the work still needed in IBD management. As Dr. Gomollón concludes, "This study illustrates that in very different countries, with diverse clinical cultures, there is still a significant population with IBD whose situation is not really 'fine.' We should and can do better."
References:
- D'Amico F, Gomollón F, Bamias G, Magro F, Targownik L, Leitner C, Heatta-Speicher T, Michelena N, Kolterer S, Lapthorn J, Kauffman L, Dignass A; IBD PODCAST investigators. Proportion of inflammatory bowel diseases patients with suboptimal disease control in daily clinical practice-Real-world evidence from the inflammatory bowel diseases-podcast study. United European Gastroenterol J. 2024 Jul;12(6):705-716. doi: 10.1002/ueg2.12572. Epub 2024 May 11.
- Dignass A, Magro F, D'Amico F, Bamias G, Caprioli FA, Franchimont D, Hart A, Koch R, Koutroubakis I, Siffledeen J, Toruner M, Leitner C, Heatta-Speicher T, Michelena N, Tornatore V, Gemignani L, Lapthorn J, Kauffman L, Gomollón F; IBD‐PODCAST Investigators. Disease Monitoring in Inflammatory Bowel Disease Daily Clinical Practice and Impact on Treatment Decision Making: Real World Evidence From the Inflammatory Bowel Disease-PODCAST Study. United European Gastroenterol J. 2025 Dec;13(10):1984-1998. doi: 10.1002/ueg2.70117. Epub 2025 Oct 13.
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