Background It is unclear whether patients with inflammatory bowel disease (IBD) are at increased risk of COVID-19. Objectives This observational study compared the prevalence of COVID-19 symptoms, diagnosis and hospitalization in IBD patients with a control population with non-inflammatory bowel disorders. Methods This multicentre study, included 2733 outpatients (1397 IBD patients and 1336 controls), from eight major gastrointestinal centres in Lombardy, Italy. Patients were invited to complete a web-based questionnaire regarding demographic, historical and clinical features over the previous 6weeks. The prevalence of COVID-19 symptoms, diagnosis and hospitalization for COVID-19 was assessed. Results 1810 patients (64%) responded to the questionnaire (941 IBD patients and 869 controls). IBD patients were significantly younger and of male sex than controls. NSAID use and smoking were more frequent in controls. IBD patients were more likely treated with vitamin-D and vaccinated for influenza. Highly probable COVID-19 on the basis of symptoms and signs was less frequent in the IBD group (3.8% vs 6.3%; OR:0.45, 95%CI:0.28–0.75). IBD patients had a lower rate of nasopharyngeal swab-PCR confirmed diagnosis (0.2% vs 1.2%; OR:0.14, 95%CI:0.03–0.67). There was no difference in hospitalization between the groups (0.1% vs 0.6%; OR:0.14, 95%CI:0.02–1.17). Conclusion IBD patients do not have an increased risk of COVID-19 specific symptoms or more severe disease compared with a control group of gastroenterology patients.
Background and Aim: Since the outbreak of COVID-19, concerns have been raised as to whether inflammatory bowel disease (IBD) patients under biologic therapy may be more susceptible to the disease. This study aimed to determine the incidence and outcomes of COVID-19 in a large cohort of IBD patients on biologic therapy. Methods: This observational retrospective multicenter study collected data about COVID-19 in IBD patients on biologic therapy in Italy, between February and May 2020. The main end-points were (i) to assess both the cumulative incidence and clinical outcome of COVID-19, according to different biologic agents and (ii) to compare them with the general population and a cohort IBD patients undergoing non-biologic therapies. Results: Among 1816 IBD patients, the cumulative incidence of COVID-19 was 3.9 per 1000 (7/1816) with a 57% hospitalization rate and a 29% case-fatality rate. The class of biologic agents was the only risk factor of developing COVID-19 (P = 0.01). Non-gut selective agents were associated with a lower incidence of COVID-19 cases, related symptoms, and hospitalization (P < 0.05). Compared with the general population of Lombardy, an overall lower incidence of COVID-19 was observed (3.9 vs 8.5 per 1000, P = 0.03). Compared with 565 IBD patients on non-biologic therapies, a lower rate of COVID-19 symptoms was observed in our cohort (7.5% vs 18%, P < 0.001). Conclusions: Compared with the general population, IBD patients on biologic therapy are not exposed to a higher risk of COVID-19. Non-gut selective agents are associated with a lower incidence of symptomatic disease, supporting the decision of maintaining the ongoing treatment.
We have shown 4 that exposure to tocilizumab was associated with de novo liver function test abnormalities in patients with COVID-19. From that data set, we selected only patients with clinical characteristics similar to those of the patients presented by Guaraldi and colleagues (eg, respiratory rate ≥30 breaths per minute, peripheral blood oxygen saturation <93% in room air, and a PaO 2 /FiO 2 ratio of <300 mm Hg). We identified 367 patients, 60 (16%) of whom were treated with tocilizumab. Despite of having a similar extent of liver function test abnormalities at admission (appendix p 2), patients treated with tocilizumab more frequently had a worsening of liver function tests during hospitalisation and had liver function tests that exceeded 3-times the upper limit of normal, com pared with those not treated with tocilizumab (52% vs 29%, respectively; appendix p 2). Alanine aminotransferase concentrations at days 7 (range 5-9), 14 (12-16), and 21 (19-23) after admission were significantly higher in patients treated with tocilizumab than controls (p<0•05). Although no patient treated with tocilizumab developed acute liver failure, we strongly suggest monitor ing liver func tion tests in patients with COVID-19 who are treated with tocilizumab. SP, RV, and PA report grants from Cassa di Risparmio di Padova e Rovigo (Cariparo) during the study. PA also reports personal fees from Biovie, Grifols, Sequana Medical, and grants from Boehringer Ingelheim, outside the submitted work. COVID-LIVER study group members are listed in the appendix (p 3).
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