For patients living with IBD, the two main types being Crohn’s disease or ulcerative colitis (UC), finding the right treatment is rarely a straight line.
Despite a growing number of effective therapies, clinicians face unresolved questions; which patients will respond to a given treatment, and how should we track progress? Through platforms like Vivli, investigators can access anonymized individual participant-level data from completed clinical research and use it to generate new evidence to advance understanding of IBD progression and improve treatment approaches.
Data used in these studies was made possible through Vivli’s data sharing platform, spanning a range of questions working to advance the field of IBD care.
Significant findings have emerged from researchers looking across multiple studies. By pooling individual patient-level data, Vipul Jairath and his team from Alimentiv found that placebo response rates vary significantly across UC trials. The same research group also examined how patient age affects the efficacy and safety of advanced therapies during induction in UC, finding that trial populations do not always reflect the broader, more complex patients seen in everyday practice. Knowing where evidence holds and where it has limits allows clinicians to apply it more appropriately.
Other work is tackling one of the more consequential problems in IBD care: identifying in advance which patients will respond to a given therapy. Neeraj Narula and colleagues at Hamilton Health Sciences found that eosinophil levels in blood and tissue predict which UC patients are likely to benefit from mirikizumab, a biologic therapy. For patients who have cycled through multiple treatments without success, a reliable predictor of response before starting therapy could mean the difference between months of ineffective treatment and a faster path to remission. The same research group also found that early endoscopic changes during treatment can identify Crohn’s disease patients whose response is delayed, giving clinicians a window to intervene earlier in the treatment course.
Not all insights emerging from this research are purely biological. Shenghong Zhang and colleagues at Sun Yat-sen University found that early improvement in mental health symptoms predicts long-term disease remission in UC. IBD is typically monitored through endoscopy and blood tests. The finding suggests that psychological state during treatment may carry more clinical information than is currently recognized, and that a more complete picture of disease control may require looking beyond biology alone.
Behind each of these studies are patients who enrolled in research in the hope that their experience would help others. That contribution does not end at publication. IBD affects millions of people worldwide, and for many, the path to effective treatment involves years of diagnostic delay, failed therapies, and significant impact on quality of life. The work being done with Vivli-accessed data is producing findings that are reshaping how the field understands treatment response, disease monitoring, and the design of future research. Each new analysis builds on the last. This cumulative progress exists because study sponsors are meeting their obligations to participants, ensuring research data is used responsibly beyond the original study.
Learn more about accessing data through Vivli at vivli.org
Recent gastroenterology and IBD public disclosures associated with Vivli-hosted data include:
Placebo rates in randomized clinical trials of ulcerative colitis: an individual patient data meta-analysis— Journal of Crohn’s and Colitis | PI: Vipul Jairath, Alimentiv Inc. | Data Request 7288
Impact of concomitant corticosteroid use on adverse events in ulcerative colitis clinical trials — Journal of Crohn’s and Colitis | PI: Neeraj Narula, Hamilton Health Sciences | Data Request 10381. Read the full case study on Vivli’s website.
Early Improvement of Mental Health Is Associated With Long-Term Disease Remission in Ulcerative Colitis— American Journal of Gastroenterology | PI: Shenghong Zhang, Sun Yat-sen University | Data Request 11327
Patients with ulcerative colitis that have endoscopic Mayo score 1 and active histologic inflammation have similar outcomes to mild-moderate patients: a post hoc analysis of the VARSITY trial— European Journal of Gastroenterology & Hepatology | PI: Neeraj Narula, Hamilton Health Sciences | Data Request 11369
Serum and Histologic Eosinophilia as a Predictive Biomarker of Response to Mirikizumab in Ulcerative Colitis— Inflammatory Bowel Diseases | PI: Neeraj Narula, Hamilton Health Sciences | Data Request 11425
Estimation of the Harvey Bradshaw Index from the Patient-Reported Outcome 2 in Crohn’s Disease— Inflammatory Bowel Diseases | PI: Reena Khanna, Lawson Health Research Institute | Data Request 7404
Comparative Predictive Utility of MM-SES-CD and SES-CD for Week 52 Endoscopic Remission in Crohn’s Disease— Inflammatory Bowel Diseases | PI: Neeraj Narula, Hamilton Health Sciences | Data Request 10706
Week 12 Reduction in MM-SES-CD is Predictive of Delayed Response to Upadacitinib in Crohn’s Disease— Clinical Gastroenterology and Hepatology | PI: Neeraj Narula, Hamilton Health Sciences | Data Request 11350
Impact of Age on Efficacy and Safety of Advanced Therapies During Induction in Ulcerative Colitis— Digestive Diseases and Sciences | PI: Vipul Jairath, University of Western Ontario | Data Request 7850
One-year Dynamics of Clinical Activity During Biologics Therapy in Ulcerative Colitis— Journal of Crohn’s and Colitis | PI: Shenghong Zhang, Sun Yat-sen University | Data Request 10032