Registries & Real-World Data in IBD

Registries collect information from people living with inflammatory bowel disease during routine care. This “real‑world data” helps answer questions that clinical trials cannot, such as long‑term safety, pregnancy outcomes, rare side effects, and how well treatments work outside research settings. Regulators now publish guidance on using these data, which are shaping care and policy for Crohn’s disease and ulcerative colitis. (fda.gov)

Key takeaways

• Registries reveal long‑term and rare safety signals that short trials may miss. (pmc.ncbi.nlm.nih.gov)

• Some real‑world findings change practice, for example higher infection risk with steroids and with some combinations. (pubmed.ncbi.nlm.nih.gov)

• Pregnancy and infant outcomes with many modern IBD therapies have been reassuring in large registries. (pianostudy.org)

• Real‑world data guided care in fast‑moving situations like COVID‑19. (pubmed.ncbi.nlm.nih.gov)

• Quality and methods matter. Regulators define what “fit‑for‑purpose” real‑world evidence looks like. (fda.gov)

What are registries and real‑world data

• A registry is a database that follows people with a condition or exposure over time, usually during routine care. It may link to electronic health records, insurance claims, patient‑reported outcomes, or biosamples. (fda.gov)

• Real‑world data are these routine data sources; real‑world evidence is the clinical insight gained from analyzing them. U.S. and European regulators publish frameworks on how such evidence can inform decisions. (fda.gov)

What have IBD registries taught so far

• Anti‑TNF safety over years: Large infliximab registries in North America and Europe found similar mortality to non‑biologic therapy, with higher serious infections linked to infliximab use and to corticosteroids and older age. Cancer risk tracked more with age, disease duration, and smoking than with infliximab itself. (pubmed.ncbi.nlm.nih.gov)

• Thiopurines and lymphoma: Multiple cohorts and meta‑analyses show a small but real increase in lymphoma while taking thiopurines, with risk declining after stopping. Absolute risk is highest after age 50. (pubmed.ncbi.nlm.nih.gov)

• Pregnancy: The PIANO registry reports no increase in birth defects, miscarriages, preterm birth, low birth weight, infant infections, or early development delays with maternal use of most IBD medicines, including biologics and thiopurines. Disease control remains important. (pianostudy.org)

• COVID‑19: The international SECURE‑IBD registry showed higher risk of severe COVID‑19 with systemic steroids and thiopurine combination therapy, while anti‑TNF and vedolizumab were not associated with worse outcomes. These data informed society guidance during the pandemic. (pubmed.ncbi.nlm.nih.gov)

• Effectiveness in everyday care: Multicenter consortia, such as VICTORY for vedolizumab, report real‑world remission and steroid‑free remission rates and highlight factors that predict response, helping set expectations and sequencing choices. (pmc.ncbi.nlm.nih.gov)

Examples of IBD registries and platforms

Note: National registries evolve. For example, the UK IBD Registry ceased operations in March 2024, with data stewardship transferred to the Royal College of Physicians, reflecting changes in the NHS data landscape. (ibdregistry.org.uk)

Why registries matter alongside clinical trials

• Trials test whether a drug works under controlled conditions for months to a few years. Registries show how people do on therapies for many years, across ages, comorbidities, and care settings, and can detect rare events. (pmc.ncbi.nlm.nih.gov)

• Registries can compare outcomes across therapies and sequences, evaluate steroid‑free remission, hospitalization and surgery rates, and describe response in special groups such as older adults, pregnant people, or those with perianal disease. (pmc.ncbi.nlm.nih.gov)

• Regulators increasingly accept fit‑for‑purpose registry studies when methods, data quality, and transparency are strong. FDA and EMA outline what good looks like, including data provenance, validation, and bias control. (fda.gov)

How to judge real‑world studies

• Look for clear definitions of who was included, how exposures and outcomes were measured, and how missing data were handled. Active‑comparator, new‑user designs and propensity methods help reduce bias from who gets which drug. (fda.gov)

• Prefer analyses that adjust for disease activity and steroid use, since both strongly influence infection and hospitalization risk. (pubmed.ncbi.nlm.nih.gov)

• Check whether results align across settings or in meta‑analyses. Divergent findings often reflect differences in populations, follow‑up, or confounding.

How people and clinics participate

• Many registries enroll through IBD centers. Some add patient‑reported outcomes through mobile or web tools and may collect biosamples. Participation is voluntary and governed by consent and privacy standards. (targetrwe.com)

• Pediatric networks such as ImproveCareNow use registry data to drive quality improvement, track remission, reduce steroid exposure, and share best practices across centers. (improvecarenow.org)

What is next

• Integration and interoperability are growing. Platforms like IBD Plexus and new global collaborations aim to connect datasets and biosamples to answer complex questions faster. (crohnscolitisfoundation.org)

• As methods and standards mature, expect more real‑world evidence to complement trials in guiding long‑term safety, sequencing, and precision treatment in IBD. (fda.gov)

FAQs

Can registry data replace randomized trials

No. Registries complement trials. Trials establish efficacy and minimize bias. Registries add long‑term safety, rare events, and everyday effectiveness across broader groups. Regulators now describe how both types of evidence work together. (fda.gov)

Are registry findings trustworthy

They can be, when data are complete and methods address confounding and misclassification. FDA and EMA publish detailed guidance on how to design and judge registry studies. (fda.gov)

How do registries improve care today

Findings have influenced counseling on steroid risks, thiopurine safety, vaccine and infection prevention, pregnancy planning, and therapy sequencing based on real‑world response. (pubmed.ncbi.nlm.nih.gov)