Advancing precision medicine in inflammatory bowel disease: the role of IBD Plexus in real-world evidence generation
Advancing medical innovation in the era of precision medicine requires a fundamental shift in how research is approached, especially in complex, heterogeneous diseases like inflammatory bowel disease (IBD). The rapidly evolving landscape of IBD care, marked by diverse patient experiences and urgent unmet needs, calls for tailored, innovative solutions, with comprehensive, patient-centered data platforms increasingly recognized as essential. In this Guest Column, Angela Dobes, Senior Vice President of IBD Plexus® at the Crohn’s & Colitis Foundation, explores how IBD Plexus is bridging critical gaps in real-world evidence (RWE), accelerating research, and catalyzing innovation across the IBD treatment landscape.
Harnessing multimodal data at scale: the IBD Plexus advantage
Harnessing multimodal data at scale is transforming IBD research and patient care. Nearly one in 100 Americans lives with IBD, facing persistent symptoms, psychological distress, and concerns about long-term medication effects. Despite decades of research, hospitalization and surgery rates remain high, and systemic challenges persist such as rising healthcare costs and slow translation of research into practice. There is an urgent need for robust, integrated data infrastructure to advance research and care.
Significant gaps persist in our understanding of IBD progression and the reasons why current therapies often fail to deliver sustained remission. The promise of precision medicine in IBD hinges on the ability to integrate vast, multimodal data streams that reflect the real-world complexity and lived experience of IBD. Data platforms like the Crohn’s & Colitis Foundation’s IBD Plexus are redefining the boundaries of medical research by systematically aggregating and harmonizing research-grade data from sources beyond the reach of traditional claims databases or electronic health records. By unifying fragmented information, including detailed patient-reported outcomes, longitudinal disease measures, genetic and molecular profiles, and imaging data, IBD Plexus empowers precision medicine research and bridges the gap between routine clinical care and groundbreaking scientific discovery.
IBD Plexus is a transformative research accelerator that captures research-relevant data during routine care and at home, integrating diverse data from patient symptom reports and biomarker assays to longitudinal treatment histories. This comprehensive, patient-centered approach facilitates understanding the full spectrum of IBD progression and treatment outcomes, overcoming the limitations of traditional electronic health records and registries. It enables deeper understanding of disease mechanisms and more personalized, effective care for people with IBD.
This focus on patient-fueled impact is further reinforced by IBD Plexus being housed within the Crohn’s & Colitis Foundation, which is the leading nonprofit organization focused on both research and patient support for IBD. The Foundation has played a role in every major research breakthrough and its research agenda is guided by patient input and experience.
Demonstrating the power of Plexus in action, researchers leveraged its extensive, multi-omics dataset, uniquely linked to longitudinal clinical and patient-reported data, to accurately distinguish Crohn’s disease from ulcerative colitis and identify new biomarkers associated with disease severity. This work highlights how the integration of large-scale molecular and clinical data can uncover patient subgroups and accelerate the development of more personalized IBD therapies.
The essential role of longitudinal data in understanding IBD heterogeneity
Longitudinal real-world data (RWD) is a critical driver of progress in precision medicine for IBD. Unlike static snapshots, longitudinal molecular profiling allows researchers to monitor changes within individuals over time, providing valuable insights into the underlying biology of disease and how patients respond to treatment. This approach is particularly valuable in IBD, where genetic predictors alone have not delivered clear therapeutic targets. By strategically generating and analyzing longitudinal molecular data, scientists can identify more precise, actionable targets and refine patient stratification to pave the way for more effective and efficient drug development.
A compelling example comes from Harvard, where researchers used IBD Plexus’ microbial sequencing data and longitudinal clinical records to improve treatment decision-making in ulcerative colitis. By integrating this data, the team validated microbiome-derived enzymes that inactivate 5-ASA, a frontline therapy for ulcerative colitis, revealing why it fails in certain patients. This breakthrough, powered by IBD Plexus, opens the door to more personalized treatment strategies and is one of the first real-world examples of how the microbiome can propel precision medicine in IBD.
Rethinking foundations in science and regulation for complex disease innovation
The promise of precision medicine for complex diseases like IBD lies in its ability to address the substantial heterogeneity of treatment effect. This variability highlights the need for personalized care. However, traditional clinical trials are often not designed to identify these nuanced patient-by-treatment interactions rigorously. As a result, the transformative potential of precision medicine remains largely untapped during clinical development, particularly for chronic, multifactorial conditions such as IBD.
To realize this potential, innovation in drug development must be seen as an ongoing, adaptive process rather than a single breakthrough event. Platforms like IBD Plexus are advancing this paradigm by providing the infrastructure for rapid prototyping, adaptive clinical trials, and real-time data analysis. This iterative approach allows researchers to test new hypotheses quickly, refine study designs, and respond dynamically to emerging insights all within a secure, scalable environment. Yet, to fully harness these advances, regulatory frameworks must also evolve. Current systems are often rooted in population-level safety and efficacy standards, which can be at odds with the personalized care goals of patients. Embracing adaptive methodologies and integrating diverse, RWD sources will be essential to ensure that tomorrow’s therapies are scientifically rigorous and truly patient-centered.
An example of this shift is the use of longitudinal RWD to develop a risk score, such as a Crohn’s disease progression score, which can provide insight into the diverse trajectories of disease over time. While such a score requires further validation, it illustrates how longitudinal RWD can enable more refined patient stratification and serves as an exploratory endpoint or covariate in clinical trials. This approach can improve the interpretation of trial results and guide long-term Crohn’s disease management strategies, prioritizing patient-valued outcomes, such as avoiding surgery.
The power of partnership: advancing patient-centric innovation in IBD
The true power of IBD Plexus lies in its patient-centered design and collaborative framework, which integrates the art of understanding patient experiences with the science of data-driven research. Patients actively contribute data and help shape research priorities, ensuring that investigations focus on real-world needs and lead to meaningful clinical impact. This approach enhances the relevance of findings and fosters trust and engagement, which are critical for capturing high-quality RWD. By unifying patient insights and cutting-edge technology, IBD Plexus is advancing precision medicine strategies that can predict disease progression, treatment response, and ultimately improve personalized care.
IBD Plexus accelerates innovation across the entire drug development continuum from biomarker discovery to post-marketing studies by breaking down traditional silos and providing researchers with streamlined access to richly annotated, standardized datasets. Its collaborative model has already supported over 200 publications worldwide. This integrated platform exemplifies a new era where precision medicine is not just a goal but an achievable reality, delivering safer, more effective therapies that truly reflect the complexity of each patient’s disease.
Breakthroughs in complex diseases like IBD rarely happen in isolation. They are the product of interdisciplinary collaboration among patients, clinicians, academic researchers, and industry partners working together to tackle challenges from every angle. Now is the time for the broader research community to join forces, leverage the unique strengths of IBD Plexus, and help shape the next generation of precision medicine.
Connect with IBD Plexus to explore partnership opportunities and be part of the movement transforming the future of IBD care through powerful collaboration.
LEARN MORE ABOUT IBD PLEXUS HERE
Author
Angela Dobes
Senior Vice President, IBD Plexus
Crohn's & Colitis Foundation
Angela Dobes, MPH, Senior Vice President, IBD Plexus, is responsible for the overall success and growth of the IBD Plexus program, including delivering against its core goal of accelerating R&D timelines and advancing precision medicine strategies.
Angela devotes much of her time to advancing high-impact, patient-centered research and is passionate about ensuring research, care interventions and treatments are meaningful to patients. Her work has been funded through organizations such as the Patient-Centered Outcomes Research Institute, Agency for Healthcare Research and Quality and The Leona M and Harry B Helmsley Charitable Trust. She also strives to elevate the important role patient registries and biorepositories play in the pursuit of high-value research through her roles on external committees and initiatives, including The National Academies of Science, Engineering & Medicine project titled, Data Capacity for Patient-Centered Outcomes Research: An Agenda for 2021 to 2030.
Prior to her experience at the Foundation, Angela worked for clinical technology and pharmaceutical organizations, where she has led the implementation of various technology solutions focused on business optimization and accelerating the delivery of new therapies to patients safely.
Acknowledgments
Writing assistance, provided by Jo Walker of The Evidence Base, was used in an earlier version of this column.
Sponsorship for this Guest Column was provided by the Crohn’s & Colitis Foundation