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Updates on COVID-19 Research: SECURE-IBD & IBD Partners


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In this global pandemic, IBD patients and their healthcare providers from around the world share similar fears and concerns. SECURE-IBD is an international database to monitor and report on COVID-19 in IBD patients. By working across borders, we are learning how factors like age, other conditions, and IBD treatments impact COVID-19 outcomes. This slide deck also shares information about other research efforts that are ongoing to better understand the impact of COVID-19 on IBD patients.

The Foundation would like to thank AbbVie Inc., Genentech, Inc., Gilead Sciences, Inc., Janssen Biotech, Inc., Shire, and Takeda Pharmaceuticals U.S.A., Inc., sponsors of our COVID-19 materials. Additional support is provided through the Foundation’s annual giving program and individual donors.

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Updates on COVID-19 Research: SECURE-IBD & IBD Partners

  1. 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 Additional information on IBD Partners is available at
  2. 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. 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. 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. 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. 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. 7. • 1170 reported cases • 42 different countries • Median age 45 • 52% Male • 56% Crohn’s disease Preliminary data (5/18/20)
  8. 8. SECURE-IBD: an International Effort
  9. 9. SECURE-IBD Cases over time
  10. 10. Outcomes by age
  11. 11. Outcomes by comorbidities
  12. 12. Outcomes by medication class
  13. 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. 14. Our Partners: Thank you! And many more organizations and pharmaceutical partners listed at SECURE-IBD has been funded, in part, by the Helmsley Charitable Trust, multi-pharmaceutical sponsorship, and NC TraCS
  15. 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. 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. 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. 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. 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. 20. Current IBD Partners Enrollment (>15,000!)
  21. 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. 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. 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. 24. Level of Concern about COVID How concerned are you about COVID? How concerned are you that your medications increase your COVID risk?
  25. 25. Avoiding Healthcare Needs
  26. 26. Avoiding Environmental Factors
  27. 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. 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. 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. 30. Interactive Map of Sickness and COVID+ in the US for IBD Patients
  31. 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. 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. 33. UNC Multidisciplinary IBD Center
  34. 34. Thank you to our sponsors: 34 Additional support is provided through the Foundation’s annual giving program and donors.
  35. 35. Learn more @ Unite with the IBD community at our first virtual walk! Saturday, June 20, 2020 12:00PM to 3:00PM (ET)
  36. 36. Please donate today: