Background Patients with inflammatory bowel disease (IBD) may be at risk for development of COVID-19 infection due to innate immune dysfunction and/or immunosuppressive medication use. We sought to 1) evaluate the incidence of COVID-19 infection in a large, U.S. cohort of patients with IBD and 2) evaluate associations between demographic, clinical, and treatment-related factors and the development of COVID-19 infection. Methods Participants in 3 adult IBD studies sponsored by the Crohn’s & Colitis Foundation, IBD Partners, IBD QORUS (Improving the Quality of Care for Adults with Inflammatory Bowel Disease), and SPARC IBD (Study of a Prospective Adult Research Cohort with IBD), were invited to participate in a prospective, direct-to-patient cohort study about COVID-19 from April 23, 2020 until August 30, 2021. Each cohort received online surveys with questions on comorbidities, medication utilization and development of laboratory confirmed COVID-19 at times 0, 2, 4, 6, 8 weeks and then every 6 months. We calculated the incidence rate of COVID-19 and performed bivariate and multivariate analyses to describe associations between age, immunosuppression use, obesity, and race on the development of COVID-19. Results A total of 3953 patients with IBD were followed for a mean duration of 212 days (SD 157). Demographic, clinical and treatment factors are shown in Table 1. A total of 103 individuals developed COVID-19 during follow up (2.6%, rate of 45 per 1,000 person-years). Severity of infection was generally mild. Clinical characteristics were similar among those who developed COVID-19 as compared to not. African American race was associated with incident COVID-19 infection (OR 3.37, 95% CI 1.18–9.59). Immunosuppression use was not associated with development of COVID-19 (OR 1.19, 95% CI 0.72–1.75), nor was age (OR 1.00, 95% CI 0.99–1.02), nor obesity (OR 1.01, 95% CI 0.61–1.66). Conclusion The overall incidence of COVID-19 infection among this large U.S. cohort of IBD patients was relatively low. Immunosuppression use did not increase the risk of development of COVID-19. Therapeutic management of IBD should not be altered to prevent a risk of developing COVID-19.
Background Primary and secondary non-response to Anti-Tumor Necrosis Factor (TNF) therapy is common in patients with ulcerative colitis (UC), yet limited research has compared the effectiveness of subsequent biological therapy. Objective We sought to compare the effectiveness of vedolizumab and tofacitinib in anti-TNF experienced patients with UC, focusing on patient-prioritized patient reported outcomes (PROs). Methods We conducted a prospective cohort study nested within the Crohn’s & Colitis Foundation’s IBD Partners and SPARC IBD initiatives. We identified anti-TNF experienced patients with UC initiating vedolizumab or ustekinumab and analyzed PROs reported approximately 6 months later (minimum 4 months, maximum 10 months). Co-primary outcomes were Patient Reported Outcome Measurement Information System (PROMIS) domains of Fatigue and Pain Interference. Secondary outcomes included PRO-2, treatment persistence, and need for colectomy. Results We compared 72 vedolizumab initiators and 33 tofacitinib initiators. At follow-up, Pain Interference (P=0.04), but not Fatigue (P=0.53,) was lower among tofacitinib initiators. A trend towards higher Social Role Satisfaction was not significant. The remainder of secondary outcomes (PRO2, treatment persistence, colectomy) did not differ between treatment groups. Conclusion Among anti-TNF experienced patients with UC, Pain Interference 4-10 months after treatment initiation was lower among tofacitinib users as compared to vedolizumab users. Many, but not all, secondary endpoints and subanalyses also favored favored tofacitinib. Future studies with larger sample sizes are needed to further evaluate these findings.
Background/Aims Patients with inflammatory bowel disease (IBD) may be at risk for complications due to the COVID-19 pandemic. We performed a qualitative study to better understand IBD patient experiences and concerns when navigating the COVID-19 pandemic, with the goal of prioritizing patients’ information needs. Methods We conducted a series of semi-structured virtual focus groups at 6 months, then member-checking focus groups 1 year into the COVID-19 pandemic. We included questions on patients’ experiences navigating the pandemic with IBD, differences in their experience as compared to peers, their concerns and fears, as well as preferred information sources. Transcribed focus groups were coded and content-analyzed to summarize key areas of interest and identify themes. We focused on four areas in our content analysis process: fears, challenges, information preferences and research questions. Results A total of 26 IBD patient participants were included in the initial focus groups. Findings highlighted the many challenges faced by patients during the COVID-19 pandemic, ranging from access (bathrooms, medications, healthcare) to significant fears and concerns surrounding medications used for IBD worsening risks of COVID-19. Research questions of importance to patients centered on understanding risks for COVID-19 complications, particularly pertaining to medication utilization, with a shift over time towards understanding COVID-19 vaccination. In our member checking focus groups (n=8 participants), themes were reiterated, with a central focus of research questions pertaining to COVID-19 vaccination. Conclusions Information needs for patients during the COVID-19 pandemic centered upon understanding disease specific risks. Identified challenges and fears will inform future research agendas and communication with patients.
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