This article has an accompanying continuing medical education activity, also eligible for MOC credit, on page e12. Learning Objective: Upon completion of this CME activity, successful learners will be able to discuss how steroids are associated with severe outcomes from COVID-19 among patients with inflammatory bowel disease (IBD). See Covering the Cover synopsis on page 407. BACKGROUND AND AIMS: The impact of Coronavirus disease 2019 (COVID-19) on patients with inflammatory bowel disease (IBD) is unknown. We sought to characterize the clinical course of COVID-19 among patients with IBD and evaluate the association among demographics, clinical characteristics, and immunosuppressant treatments on COVID-19 outcomes. METHODS: Surveillance Epidemiology of Coronavirus Under Research Exclusion for Inflammatory Bowel Disease (SECURE-IBD) is a large, international registry created to monitor outcomes of patients with IBD with confirmed COVID-19. We calculated age-standardized mortality ratios and used multivariable logistic regression to identify factors associated with severe COVID-19, defined as intensive care unit admission, ventilator use, and/or death. RESULTS: 525 cases from 33 countries were reported (median age 43 years, 53% men). Thirty-seven patients (7%) had severe COVID-19, 161 (31%) were hospitalized, and 16 patients died (3% case fatality rate). Standardized mortality ratios for patients with IBD were 1.8 (95% confidence interval [CI], 0.9-2.6), 1.5 (95% CI, 0.7-2.2), and 1.7 (95% CI, 0.9-2.5) relative to data from China, Italy, and the United States, respectively. Risk factors for severe COVID-19 among patients with IBD included increasing age (adjusted odds ratio [aOR], 1.04; 95% CI, 1.01-1.02), 2 comorbidities (aOR, 2.9; 95% CI, 1.1-7.8), systemic corticosteroids (aOR, 6.9; 95% CI, 2.3-20.5), and sulfasalazine or 5-aminosalicylate use (aOR, 3.1; 95% CI, 1.3-7.7). Tumor necrosis factor antagonist treatment was not associated with severe COVID-19 (aOR, 0.9; 95% CI, 0.4-2.2). CONCLUSIONS: Increasing age, comorbidities, and corticosteroids are associated with severe COVID-19 among patients with IBD, although a causal relationship cannot be definitively established. Notably, tumor necrosis factor antagonists do not appear to be associated with severe COVID-19.

ObjectiveWe sought to evaluate COVID-19 clinical course in patients with IBD treated with different medication classes and combinations.DesignSurveillance Epidemiology of Coronavirus Under Research Exclusion for Inflammatory Bowel Disease (SECURE-IBD) is a large, international registry created to monitor outcomes of IBD patients with confirmed COVID-19. We used multivariable regression with a generalised estimating equation accounting for country as a random effect to analyse the association of different medication classes with severe COVID-19, defined as intensive care unit admission, ventilator use and/or death.Results1439 cases from 47 countries were included (mean age 44.1 years, 51.4% men) of whom 112 patients (7.8%) had severe COVID-19. Compared with tumour necrosis factor (TNF) antagonist monotherapy, thiopurine monotherapy (adjusted OR (aOR) 4.08, 95% CI 1.73 to 9.61) and combination therapy with TNF antagonist and thiopurine (aOR 4.01, 95% CI 1.65 to 9.78) were associated with an increased risk of severe COVID-19. Any mesalamine/sulfasalazine compared with no mesalamine/sulfasalazine use was associated with an increased risk (aOR 1.70, 95% CI 1.26 to 2.29). This risk estimate increased when using TNF antagonist monotherapy as a reference group (aOR 3.52, 95% CI 1.93 to 6.45). Interleukin-12/23 and integrin antagonists were not associated with significantly different risk than TNF antagonist monotherapy (aOR 0.98, 95% CI 0.12 to 8.06 and aOR 2.42, 95% CI 0.59 to 9.96, respectively).ConclusionCombination therapy and thiopurines may be associated with an increased risk of severe COVID-19. No significant differences were observed when comparing classes of biologicals. These findings warrant confirmation in large population-based cohorts.MKH should be changed to MDK for co-last author line

Introduction There is limited literature comparing the experiences and attitudes of patients with chronic idiopathic constipation (CIC) to those of healthcare professionals (HCPs) treating CIC patients. The BURDEN-CIC study was conducted to better understand the experiences and ongoing needs of CIC patients and to assess their alignment versus disconnection with the perceptions and needs of HCPs who treat CIC patients.MethodsThe BURDEN-CIC study was an author-developed, online questionnaire that used KnowledgePanel® to survey individuals with CIC (n = 1223). HCPs who treat CIC patients were recruited separately and participated in a complementary online questionnaire (n = 331).ResultsMost patients had used (58%) or were using (51%) over-the-counter treatments for their CIC, with only 16% currently on prescription therapy. More than half (59%) of current CIC prescription users were not satisfied/completely satisfied with their current chronic treatment. Many patients (42%) felt frustrated regarding their CIC, and a similar percentage (40%) expressed acceptance that CIC was part of their daily life. The majority of HCPs agreed that CIC patients were frustrated (72%), stressed (50%), or fed up (43%) with current treatment options but were relatively unaware (21%) that patients were accepting of their CIC. HCPs reported the greatest challenges in treating CIC patients as response rates to current therapies (55%), treatment adherence (55%), management of treatment-related diarrhea (34%), and lack of treatment options (34%).ConclusionBURDEN-CIC identified that many patients and HCPs are frustrated and not satisfied with current CIC treatments due to lack of efficacy and side effects, such as diarrhea. The survey identified that many patients are “accepting” of their disease, potentially compromising treatment outcomes. More dialogue is needed between HCPs and CIC patients, especially regarding management of treatment expectations and side effects. Further, additional treatment options would be useful for both patients and HCPs.FundingSynergy Pharmaceuticals Inc.

Bowel Disease (SECURE-IBD) database, an international, collaborative database created to monitor COVID-19 outcomes in patients with inflammatory bowel disease (IBD), has previously reported that corticosteroids and mesalamine or sulfasalazine are associated with an increased risk of severe COVID-19 and tumor necrosis factor (TNF) antagonists do not impact risk. 1 A follow-up report observed that patients on combination therapy with TNF antagonists and thiopurines appeared to be at higher risk of severe COVID-19. 2 However, at that time, the number of reported cases was too low to fully evaluate the risk of other IBD therapies. As the cases reported to SECURE-IBD have increased substantially, more granular analyses evaluating other IBD medication classes (including combination therapies) and adjusting for more covariates are possible. In this study, we compared associations between multiple medication classes and adverse COVID-19 outcomes in the SECURE-IBD database.We analyzed reports to SECURE-IBD from inception (March 13, 2020) through May 21, 2021. Details regarding data and analysis are provided in the Supplementary Material.Demographic and clinical characteristics of 6144 included reports stratified by medication type are provided in Supplementary Table 1. Figure 1 summarizes the independent associations of medication classes on adverse COVID-19 outcomes among all cases reported to SECURE-IBD. Systemic corticosteroids were associated and methotrexate was marginally associated with an increased odds of hospitalization or death or both. Medications associated with a decreased odds of COVID-19-related hospitalization or death or both included TNF, interleukin-12/23, and integrin antagonists. Systemic corticosteroids were significantly associated with increased odds of severe COVID-19, and TNF and interleukin-12/23 antagonists were associated with a decreased odds of severe COVID-19. Systemic corticosteroids were associated with increased odds of death due to COVID-19, and biologics were not. Notably, there were no statistically significant associations between mesalamine or sulfasalazine and any adverse COVID-19 outcome. We also observed that TNF antagonist and thiopurine combination therapy was associated with a significantly increased risk of hospitalization or death (adjusted odds ratio [aOR], 1.82; 95% confidence interval [CI], 1.26-2.62), but not severe 1.63; 95% CI,. In contrast, a combination of TNF antagonist and methotrexate was not significantly associated with risk of either adverse COVID-19 outcome (aOR, 0.82; 95% CI, 0.42-1.60 and OR, 2.44; 95% CI, 0.55-10.74).

Introduction: The BURDEN IBS-C study was conducted to better understand the experiences, attitudes, and unmet needs of sufferers of irritable bowel syndrome with constipation (IBS-C) in comparison to the perceptions and challenges of healthcare providers (HCPs) who treat IBS-C patients. Methods: This was an author-developed, online questionnaire using KnowledgePanel Ò to survey individuals with IBS-C (N = 1311). HCPs participated in a complementary online questionnaire and were recruited separately (N = 331).