Risk of severe COVID-19 in patients treated with IBD medications: a French nationwide study

International audienceBackground: Recently, the SECURE-IBD study, based on a physician-reported registry, suggested that thiopurines, either alone or combined with anti-TNF, may increase risk of severe COVID-19. Aims: To compare the risk of severe COVID-19 according to IBD medications in a large and unselected population. Methods: Using the French national health data system, the risks of hospitalisation and of death or mechanical ventilation for COVID-19 from 15 February 2020 to 31 August 2020 in IBD patients were compared according to IBD treatment (immunomodulators and biologics), using multivariable Cox models adjusted for socio-demographic characteristics, budesonide/corticosteroids and aminosalicylates use, and comorbidities. Results: Among 268 185 IBD patients, 600 were hospitalised for COVID-19 and 111 of them died or were mechanically ventilated (including 78 deaths). In multivariable analysis, the risk of hospitalisation for COVID-19 did not differ according to IBD treatment category, with adjusted Hazard Ratios (aHR, unexposed patients used as reference) of 0.94 (95%CI: 0.66-1.35) for immunomodulator monotherapy, 1.05 (0.80-1.38) for anti-TNF monotherapy, 0.80 (0.38-1.69) for anti-TNF combination therapy, 1.06 (0.55-2.05) for vedolizumab and 1.25 (0.64-2.43) for ustekinumab. Similarly, the risk of death or mechanical ventilation for COVID-19 did not differ according to IBD treatment. Conclusions: Immunomodulators and biologics prescribed in patients with IBD do not appear to increase the severity of COVID-19 infection

Outcomes of COVID-19 among patients with inflammatory bowel diseases and the influence of IBD-related medications- A Danish prospective population-based cohort study

BACKGROUND: Population-based data regarding outcomes of coronavirus disease 2019 (COVID-19) among patients with ulcerative colitis (UC) and Crohn’s disease (CD) remain limited. METHODS: We conducted a population-based study investigating the outcomes of COVID-19 among patients with UC and CD in Denmark. The Danish COVID-19 IBD Database is an extensive population-based database which prospectively monitors the disease course of laboratory-confirmed COVID-19 among patients with UC and CD. Severe COVID-19 was defined as COVID-19 necessitating intensive care unit admission, ventilator use, or death, while adverse COVID-19 was defined as requirement of COVID-19 related hospitalization. Regression analysis was adjusted for age, sex, disease type, disease activity, cardiovascular disease, and corticosteroids. Outcomes of COVID-19 among patients with UC and CD were compared with those among the background population covering all incidents of COVID-19 in Denmark. RESULTS: The study included 319 patients with UC and 197 patients with CD from January 28(th), 2020, to April 1(st), 2021. Baseline characteristics are presented in Table 1. A significantly higher risk of COVID-19-related hospitalization was observed among patients with UC (N=46(14.4%), RR=2.49 (95%CI 1.91–3.26)) and CD (N=24(12.2%), RR=2.11 (95%CI 1.45–3.07)) as compared with the background population (N=13,306 (5.8%)). A similar pattern was observed for admission to intensive care (UC: N=8(2.51%), RR=27.88 (95%CI 13.88–56.00); CD: N=3 (1.52%), RR=16.92 (95%CI 5.46–52.46)) (Figure 1). The association between these outcomes and IBD-related clinical characteristics and treatments is presented in Tables 2–3. As shown, none of the IBD-related medications were associated with severe COVID-19 in univariate and multivariable analysis. However, systemic steroids were found to be associated with an increased risk of adverse COVID-19 among patients with CD (adjusted odds ratio (aOR)=13.62 (95% CI 1.98–17.77)). [Image: see text] [Image: see text] [Image: see text] [Image: see text] CONCLUSION: This Danish population-based study on COVID-19 outcomes among patients with UC and CD demonstrated severe COVID-19 among only a minority of patients, which was not associated with IBD-related medications. Apart from systemic steroids, this study encourages continued use of IBD therapy to prevent IBD relapse and complications

Outcomes of coronavirus disease 2019 among patients with inflammatory bowel diseases and the influence of IBD-related medications - A Danish prospective population-based cohort study

BACKGROUND: Population-based data regarding outcomes of coronavirus disease 2019 (COVID-19) among patients with ulcerative colitis (UC) and Crohn’s disease (CD) are limited. Studies on the association of COVID-19 outcomes and immunomodulating therapies, are scarce. Therefore, we aimed to conduct a population-based study investigating the outcomes of COVID-19 among patients with UC and CD in Denmark. METHODS: The Danish COVID-19 IBD Database is an extensive population-based database that prospectively monitors the disease course of laboratory-confirmed COVID-19 among patients with UC and CD in Denmark. Severe COVID-19 was defined as COVID-19 necessitating intensive care unit admission, ventilator use, or death. Regression analysis was adjusted for age, sex, disease type, disease activity, cardiovascular disease, and corticosteroids. RESULTS: The study recruited 363 patients (UC: 223; CD: 140) from January 28(th), 2020, to February 7(th), 2021. A total of 36 (16.1%) and 18 (12.9%) patients with UC and CD, respectively, required a COVID-19 related hospitalization, while eight (3.6%) and three (2.1%) patients required intensive care treatment. Death due to COVID-19 was observed among eight (3.6%) and two (1.4%) patients, respectively. The association between these outcomes and IBD-related treatment is presented in Table 1. As shown, none of the IBD-related medications were associated with severe COVID-19 in univariate and adjusted analysis. However, systemic steroids were found to be associated with the risk of COVID-19 related hospital admission among patients with UC (adjusted odds ratio (aOR)=6.54 (95% CI 1.09-36.39)) and CD (aOR=5.45 (95% CI 2.07-12.24)). [Image: see text] CONCLUSION: This ongoing Danish population-based study on COVID-19 outcomes among patients with UC and CD demonstrated severe COVID-19 among only a minority of patients, which was not associated with IBD-related medications. However, use of systemic steroids were associated with COVID-19 necessitating hospital admission among patients with UC and CD

Clinical, biochemical and endoscopic disease activity of Inflammatory Bowel Diseases are not associated with the severity or long-term outcomes of COVID-19-A Danish prospective population-based cohort study

BACKGROUND: Whether the disease activity of ulcerative colitis (UC) and Crohn’s disease (CD) is correlated with the severity of coronavirus disease 2019 (COVID-19) remains poorly investigated with only few selected cohort studies having addressed this in the past. METHODS: We conducted a population-based study investigating the outcomes of COVID-19 among patients with UC and CD in Denmark. The Danish COVID-19 IBD Database is an extensive population-based database which prospectively monitors the disease course of laboratory-confirmed COVID-19 among patients with UC and CD. Severe COVID-19 was defined as COVID-19 necessitating intensive care unit admission, ventilator use, or death, while adverse COVID-19 was defined as requirement of COVID-19 related hospitalization. Clinical disease activity was measured by simple clinical colitis index and Harvey-Bradshaw Index in UC and CD, respectively. The biochemical activity was defined as C-reactive protein higher than 5 mg/L or fecal calprotectin higher than 250 μg/g. The endoscopic activity was defined as Mayo Endoscopic Subscore of at least 2 in UC, or Simple Endoscopic Score Crohn’s Disease of at least 3 for CD. Sequelae following COVID-19 were defined as symptoms that (i) developed during or after an infection consistent with COVID-19, (ii) and were present for more than 12 weeks, (iii) and were not attributable to alternative diagnoses. RESULTS: During the inclusion period between January 28(th), 2020, to April 1(st), 2021, the study included 319 patients with UC and 197 patients with CD who developed laboratory confirmed COVID-19. Of these, data on clinical, biochemical, and endoscopic activity were available among 265/319 (83.1%), 319/319 (100.0%), and 66/319 (20.7%) of patients with UC, respectively, and 140/197 (71.1%), 131/197 (66.5%), and 42/197 (21.3%) of patients with CD. Figures 1–2 outlines the outcomes of COVID-19 according to the degree of clinical, biochemical and endoscopic disease activity. In both UC and CD, clinical, biochemical, and endoscopic activity were not associated with adverse or severe COVID-19, nor long-term outcomes, in unadjusted nor adjusted analysis (Table 1). [Image: see text] [Image: see text] [Image: see text] CONCLUSION: In this population-based study, we found no association between disease activity of UC or CD and severity of COVID-19. These findings have implications for the risk stratification of patients with IBD acquiring COVID-19

Long-term health consequences of COVID-19 in patients with Inflammatory Bowel Diseases - A Danish prospective population-based cohort study

BACKGROUND: The vast majority of patients with ulcerative colitis (UC) and Crohn’s disease (CD) who acquire coronavirus disease 2019 (COVID-19) survive the infection. Still, the long-term health consequences of COVID-19 are not well described in patients with underlying inflammatory bowel disease (IBD). METHODS: We conducted a population-based study investigating the outcomes of COVID-19 among patients with UC and CD in Denmark. The Danish COVID-19 IBD Database is an extensive population-based database which prospectively monitors the disease course of laboratory-confirmed COVID-19 among patients with UC and CD. Severe COVID-19 was defined as COVID-19 necessitating intensive care unit admission, ventilator use, or death, while adverse COVID-19 was defined as requirement of COVID-19 related hospitalization. Sequelae following COVID-19 were defined as symptoms that developed during or after an infection consistent with COVID-19, were present for more than 12 weeks, and were not attributable to alternative diagnoses. RESULTS: The study included 319 patients with UC and 197 patients with CD from January 28(th), 2020, to April 1(st), 2021. Of these, a total of 137 (42.9%) and 85 (43.1%), respectively, participated in a subsequent investigation of post-COVID-19 sequelae after a median of 5.1 months (IQR 4.5–7.9) after infection (Table 1). An equal proportion of patients with UC (58 (42.3%)) and CD (39 (45.9%), p=0.60) reported persisting symptoms of COVID-19 for at least 12 weeks, consistent with the development of post-COVID-19 syndrome. The most common persisting patient-reported symptoms included fatigue (UC: 49 (35.8%), CD: 31 (36.5%), p=0.92), anosmia (UC: 37 (27.0%), CD: 25 (29.4%), p=0.70), ageusia (UC: 26 (19.0%), CD: 24 (28.2%), p=0.11), headache (UC: 19 (13.9%), CD: 16 (18.8%), p=0.32), dyspnea (UC: 19 (13.9%), CD: 16 (18.8%), p=0.32), and arthralgia (UC: 17 (12.4%), CD: 14 (16.5%), p=0.40) (Figure 1). Only discontinuation of immunosuppressive therapies for UC during COVID-19 (OR=1.50 (95% CI 1.07–10.22), p=0.01) and the severity of COVID-19 among patients with CD were independently associated with the long-term effects of COVID-19 (OR=2.76 (95% CI 1.05–3.90), p=0.04) (Tables 2–3). [Image: see text] [Image: see text] [Image: see text] [Image: see text] CONCLUSION: This Danish population-based study found a high occurrence of patient-reported persisting symptoms following the acute phase of COVID-19 infection, which were associated with the discontinuation of immunosuppressive therapies for UC during COVID-19 and the severity of COVID-19 among patients with CD. These findings might have implications for planning the healthcare of patients with inflammatory bowel diseases in the post-COVID-19 era

The impact of COVID-19 on quality of life among patients with inflammatory bowel diseases - A Danish prospective population-based cohort study

BACKGROUND: The coronavirus disease 2019 (COVID-19) pandemic raised concerns among patients with ulcerative colitis (UC) and Crohn’s disease (CD) fearing an increased susceptibility to infection and increased risk of poor outcomes. Furthermore, the impact of COVID-19 on subsequent health-related quality of life (HRQoL) has so far not been described. We aimed to evaluate the HRQoL in relation to the severity of COVID-19 in a cohort of survivors. METHODS: We conducted a population-based study investigating the outcomes of COVID-19 among patients with UC and CD in Denmark. The Danish COVID-19 IBD Database is an extensive population-based database which prospectively monitors the disease course of laboratory-confirmed COVID-19 among patients with UC and CD. Severe COVID-19 was defined as COVID-19 necessitating intensive care unit admission, ventilator use, or death, while adverse COVID-19 was defined as requirement of COVID-19 related hospitalization. HRQoL was assessed using several validated questionnaires, including the EuroQol five-dimension five-level (EQ-5D-5L) questionnaire, EuroQol Visual Analogue Scale (EQ-VAS), Short Inflammatory Bowel Disease Questionnaire (SIBDQ), IBD Disability Index (IBD-DI), and IBD Fatigue Score. RESULTS: HRQoL after COVID-19 was assessed among 137/319 (42.9%) patients with UC of whom 125 (91.2%) and 12 (8.8%) patients experienced mild and adverse COVID-19, respectively. Furthermore, HRQoL was assessed among 85/197 (43.1%) patients with CD of whom 74 (87.1%) and 11 (12.9%) patients experienced mild and adverse COVID-19, respectively. HRQoL was assessed after a median of 5.1 months (IQR 4.5–7.9) after infection. Baseline characteristics are presented according to the availability of HRQoL data in Table 1. No difference was observed in terms of EQ-5D-5L among patients with UC and CD or patients with mild, adverse, or severe COVID-19 (Table 2). Accordingly, the SIBDQ scores were similar among patients with mild, adverse or severe COVID-19 and UC (mild: median 59 (IQR 50–65), adverse: 62 (54–65), severe: 62 (54–65), p=0.89) or CD (mild: 57 (46–65), 58 (49–64), 58 (49–64), p=0.91) as well, and no difference was observed in the subscores (Table 2). In line with these results, the IBD Disability Index (UC: median 10 (IQR 6–16), CD: 13 (6–20), p=0.16) were not associated with the severity of COVID-19 (Table 3). Finally, CD patients with adverse COVID-19 experienced more fatigue than patients with mild COVID-19 (26 (IQR 25–35) vs. 41 (IQR 29–46), p=0.03). [Image: see text] [Image: see text] [Image: see text] CONCLUSION: [Image: see text] This Danish population-based study found no durable impact of COVID-19 on health-related quality of life among patients with inflammatory bowel disease providing further assurance for the clinical guidelines for IBD care during the pandemic