Advancing IBD Research: How Real-World Evidence Uncovers Gaps in Care
Global study spurs innovative research and development approaches at AbbVie.
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 Clinico Universitario de Zaragoza in Spain. "Being true, this response is always relative to previous times, when the disease was more active."
While randomized clinical trials remain the gold standard for proving a medicine's safety and effectiveness, 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, how treatments compare with alternatives and what is most cost-effective.
This is where real-world evidence (RWE) studies like IBD PODCAST* become key. The study, funded by AbbVie, revealed striking findings across its investigation of 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.
The insights, which came from data collected from 2,200 patients across 103 sites in 10 countries, provide a comprehensive view of IBD management in actual clinical settings. They underscore the need for better understanding of the disease and its impact on patients to improve therapeutic treatment and patient outcomes.
“RWE is critical to our research and development efforts as it provides insights into patient experiences and 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 important for IBD, where there remains a high disease burden, unmet need and patient heterogeneity.”
*Proportion Of inadequate Disease Control And Strategy of Treatment in IBD
Findings to drive new approach
The findings from the IBD study span three areas: clinical data evaluating safety and effectiveness, economic data assessing value, and humanistic data focusing on quality-of-life measures important to patients. This comprehensive approach has become a catalyst for innovation at AbbVie, driving a three-pronged research and development strategy to help address unmet patient needs:
- Combination treatment: AbbVie is exploring combinations of approved and novel advanced treatments that target different aspects of the disease. AbbVie has already begun treating the first patient in a platform study evaluating the efficacy and safety of investigational combination therapies in Crohn's disease, with plans to evaluate additional novel combinations across immune-mediated diseases.
- New mechanisms of action: AbbVie is investing in both internal pipeline development and external partnerships to develop new mechanisms of action aimed at delivering long-term impact on patients' lives, either as monotherapy or combination treatments.
- Personalized approach: AbbVie is advancing precision medicine approaches to match the right treatment with the right patient. Using one of the most comprehensive databases in immunology, along with investments in biomarker approaches and the evolving AI landscape, teams analyze patient profiles at both molecular and clinical levels to develop solutions for patients who aren't responding to current treatments.
While traditional clinical trials remain essential, Dr. Gomollón emphasizes that RWE 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, European 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."
Reference:
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.
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