The document provides an update on the Secure-IBD registry, aimed at studying the impact of COVID-19 on patients with inflammatory bowel disease (IBD) through a global database of nearly 1,200 reported cases. It highlights key findings, such as low mortality rates among IBD patients during the pandemic and emphasizes the importance of continuous IBD therapy. Additionally, it outlines the role of patient involvement in research and the ongoing need for data to inform the IBD community about treatment risks and health management during COVID-19.

1. Welcome
Brent Polk, MD
SECURE-IBD REGISTRY AND
IBD PARTNERS UPDATE
Data pulled on 5/21/2020. Updated data from SECURE-IBD can be viewed at covidibd.org. Additional information
on IBD Partners is available at ccfa.med.unc.edu

2. Michael Kappelman MD, MPH (University of North Carolina at Chapel Hill)
Erica Brenner, MD (University of North Carolina at Chapel Hill)
Jean-Frederic Colombel, MD (Icahn School of Medicine at Mount Sinai, New York)
Ryan Ungaro, MD MS (Icahn School of Medicine at Mount Sinai, New York)

3. Purpose
• To rapidly define the impact of coronavirus on patients with IBD
and evaluate how factors such as age, comorbidities, and IBD
treatments affect coronavirus outcomes.
• To openly share findings with the IBD community including the
outcomes of COVID-19 broken down by patient age, gender, IBD
treatments, and other factors.

4. Database
• Web-based survey filled out by IBD health
care providers from across the globe
– Collects data on patient location,
demographics, IBD characteristics,
comorbidities, and coronavirus outcomes
• Data stored on secure, encrypted servers
at the University of North Carolina
• All data are de-identified, in accordance
with HIPAA Safe Harbor standards

5. Website
• Landing page
• Project information and FAQs
• Access to the database
• Facilitate rapid sharing of data
• Link to patient/provider
resources
• Acknowledge partnering
organizations

6. Why is the registry important for patients?
• SECURE-IBD will help
answer important questions
about coronavirus risk for
patients with IBD,
particularly regarding IBD
medications and
characteristics
• The online format allows for
rapid and free data sharing

7. • 1170 reported cases
• 42 different countries
• Median age 45
• 52% Male
• 56% Crohn’s disease
Preliminary data (5/18/20)

8. SECURE-IBD: an International Effort

9. SECURE-IBD Cases over time

10. Outcomes by age

11. Outcomes by comorbidities

12. Outcomes by medication class

13. SECURE-IBD Take Away Points
• Overall low mortality ~ 4%
– No deaths in patients <20 years of age
• Systemic steroids appear to be a risk factor for worse outcomes of
COVID-19
• Anti-TNF biologic therapy appears to be safe
• Need more data and further analyses to fully evaluate safety of
other classes of medications
• In general, data support current recommendations to continue IBD
therapy in healthy patients
– Discuss with physician temporary holding of medications for infected pts

14. Our Partners:
Thank you!
And many more organizations and pharmaceutical partners listed at https://covidibd.org/our-partners/
SECURE-IBD has been funded, in part,
by the Helmsley Charitable Trust,
multi-pharmaceutical sponsorship,
and NC TraCS

15. COVID-19 and Inflammatory Bowel Disease:
IBD Partners Patient Powered Research Network
Millie D. Long MD, MPH
5-20-2020
Associate Professor of Medicine
Vice-Chief for Education
Director, Gastroenterology and Hepatology Fellowship Program
Inflammatory Bowel Diseases Center
University of North Carolina-Chapel Hill

16. What is IBD Partners?
• Large, diverse population
Follow natural history of
disease
• Exposures, health behaviors,
outcomes
Patient generated data
• Surveys, health apps/devices,
personal health records
Include diverse data
sources
• Support a diverse array of
studies
Create widely-used
resource
• Goal of improving outcomes
Increase patient partners/
citizen scientists
Long MD, et al. Inflamm Bowel Dis. 2012 Nov;18(11):2099-106.

17. Who we are: Partners
IBD Patient Community
Crohn’s & Colitis Foundation
Researchers/ UNC Data
Management Center
Long MD, et al. Inflamm Bowel Dis. 2012 Nov;18(11):2099-106.

18. IBD Partners represents the future of IBD research
• A partnership with patients
• Internet increases participation and potentially allow previously under-represented groups to be
included
• Ability to study those questions that matter the most to patients
• Collaborative and open-access research with diverse groups of investigators participating –
including academic faculty, trainees, industry and patients
• Thus far over 50 researchers from various institutions across the country have participated
in IBD Partners research
• Collaborations with federal funding agencies
• Collaborations with industry funding for investigator initiated projects on real world data,
which is increasing recognized by the FDA
• Opportunity for large scale RCTS of modifiable factors in IBD based on data from prospective
cohorts

19. How it works
• Enroll IBD patients from Foundation email rosters, Foundation
web-page link, social media, walks, clinics, etc.
• Baseline survey
– Demographics, disease characteristics, medications, family history, quality
of life scales
– Disease activity instruments
• Follow-up surveys - change in treatment or health status
– Medications, surgery, disease activity
– Addition of modules - pain, fatigue, sleep, physical function, emotional
distress, social support
• Short data collection through portal, can be daily
• Syncing apps to make use of existing “big data” resources

20. Current IBD Partners Enrollment (>15,000!)

21. How it works: Patients Pose Questions
Influence IBD research by proposing, discussing, and
voting on research questions.
Examples of questions proposed by patients:
• “We should compare individuals who manage their disease with medication
and those who manage their disease with popular diets in the IBD
community, such as SCD, FODMAPS, paleo, etc.”
• “Research the validity of VSL#3 probiotic in controlling flare ups or as a
factor in remission.”
• “What is the role of stress and the stress response in autoimmunity?”
• “Compare symptoms of IBD patients who consume dairy and those who
avoid dairy.”
• How is COVID-19 affecting IBD Patients? What are the risks of COVID-19 for
IBD Patients?

22. COVID-19 Survey in IBD Partners
• Questions on symptoms, diagnosis, testing for COVID-19 for each
patient, as well as levels of general knowledge about resources in
their area (testing, etc.)
• Collect data on medication use, disease activity
• Understand health care utilization – access to telemedicine, issues
with obtaining medications, refills, getting to infusions, etc
• Understand level of concern in IBD patients, both for developing
COVID-19 and concerns surrounding particular medications
• Understand loss of employment, insurance due to COVID-19
• Track real time cases in states throughout the US
Goal: Report this information back to patients, in summaries and maps
available on the IBD Partners Website

23. Characteristics of patients (n=1439)
N (Mean) % (SD) Median IQR
Total number of patients 1439
Age (years) 49.7 15.15 49 37.0 ,62.0
Gender (% female) 1050 74.7% 0
Education (% >high school) 1308 90.9%
Race (%)
Caucasian 1269 88.2%
African American 19 1.3%
Other 151 10.5%
Current smoking (% yes) 31 2.2%
BMI 26.0 6.03 24.5 21.9 ,28.7
Disease duration (years) 21.1 13.01 18 12.0 ,28.0
Ever GI surgery (% yes) 649 46.1%
Ever GI hospitalization (% yes) 914 65.0%
Number hospitalizations 3.7 2.65 3 1.0 ,6.0
Current medications (%)
Biologic Anti-TNF 497 35.4%
Immunomodulator* 307 21.8%
Corticosteroids 110 7.8%
5-ASA 397 28.2%
Remission (sCDAI^ <150 or SCCAI ≤2) (% yes) 729 68.7%
sCDAI (median, IQR) 127.0 85.30 107 58.0 ,163.0
SCCAI (median, IQR) 2.1 1.99 2 1.0 ,3.0
Anxiety (PROMIS T score) 51.4 9.46 51.2 40.3 ,57.7

24. Level of Concern about COVID
How concerned are you about COVID? How concerned are you that your medications
increase your COVID risk?

25. Avoiding Healthcare Needs

26. Avoiding Environmental Factors

27. Telehealth and Information Sources for Patients
• 78.5% of IBD patients’ doctors offices are offering telehealth
• 42% of patients have had a telehealth visit
• Where are patients getting data about COVID-19?
– GI physicians (36.7%)
– CDC 78.4%
– News 88.0%
– Social media 37.2%
– Crohns and Colitis Foundation website 38.1%
– Other websites 25.9%
– Family/friends 34.1%
– Other 7.5%

28. Employment Status and Health Insurance Loss Due
to COVID-19
• Employment change due to COVID-19
– Laid off 4.7%
– Reduced hours 9.0%
– Work from home now 39.0%
– Changed jobs 0.3%
– Job responsibilities changed 6.9%
• Health insurance change
– Lost insurance 0.2%
– Change in insurance 0.4%
– Other 0.5%

29. Patients Reporting Sickness (n=557)
• 557 patients (38.7%) report becoming sick
• 62 patients (4.3%) tested
• 44 patients (3.1%) were in contact with someone who tested
positive
• 7 patients (0.5%) with COVID-19 confirmed by testing
• 54 patients (3.8%) stopped a IBD medication when they were sick
• Severity of illness among those who were sick
– Very mild 106 patients, 19%
– Mild 200 patients, 36%
– Moderate 212 patients, 38%
– Severe 34 patients, 6%
– Very severe 3 patients, 1%

30. Interactive Map of Sickness and COVID+ in the US
for IBD Patients

31. Medication Changes Among Those NOT Sick
(n=880)
• Have you temporarily stopped medications due to concerns for
COVID-19?
– 37 patients, 4%
• Why did you stop the medication?
– Doctor told me to (38%)
– I thought it would reduce my chances of COVID (92%)
– I thought it would make COVID infection worse (81%)
– Other (54%)

32. Summary
• IBD patients are extremely concerned about COVID-19 risks generally and
medication-specific risks
• Patients are avoiding many health-related activities like labs, procedures and
even infusions
• Nearly all IBD patients in this survey are self-isolating
• Less than ½ of IBD patients have accessed telehealth
• Many patients have had work-related changes, particularly working from home,
although a minority have been laid off; majority have retained health insurance
• Many patients report sickness symptoms, only a small minority have been
tested
• Some patients (~4%) have stopped medications due to concerns for COVID-19
• Continued surveys will allow us to track rates real-time across the country to
better inform the IBD community

33. UNC Multidisciplinary IBD Center

34. Thank you to our sponsors:
34
Additional support is provided through the Foundation’s
annual giving program and donors.

35. Learn more @ cctakesteps.org
Unite with the IBD community at
our first virtual walk!
Saturday, June 20, 2020
12:00PM to 3:00PM (ET)

36. Please donate today:
crohnscolitisfoundation.org/emergency