ABSTRACT
Background: Coronavirus disease 2019 (COVID-19), had two pandemic waves in 2020, respectively in April and November. In the general population, the first wave has been characterized by a higher prevalence in Northern Italy and a higher mortality rate compared to the second one. The aim of this study was to compare the characteristics of IBD patients and negative outcomes of COVID-19 (pneumonia, hospitalization, ventilatory support, death) between the two pandemic waves in Italy. Methods: Prospective observational cohort study. Patients with diagnosis of IBD and confirmed SARS-CoV-2 infection were enrolled. Differences between first and second wave were tested for significance using the Student's t test and Fisher's test, as appropriate. A two-tailed p value <0.05 was indicative of statistical significance. Results: We enrolled 937 IBD patients from 47 participating IBD centres across Italy (219 in the first wave, 718 in the second wave). There were no significant differences between the first and the second wave in terms of age (46.3 ± 16.0 vs. 44.1 ± 15.5 years, p=0.06) and gender (female 45.7% vs. 48.2%, p= 0.54). In the first wave, a lower percentage of patients was affected by Crohn's disease (CD): 92 (42.0%) vs. 399 (55.6%) (p<0.001) while no differences were observed for disease clinical activity: 97/219 (44.3%) vs. 280/718 (38.9%) in the first and second wave, respectively (p=0.18). Regarding biologic therapy, the percentage of patients on biologics in the two waves was similar: 119/219 (54.3%) vs. 393/718 (54.7%) (p=0.94), without differences in anti-TNFalpha, anti-integrins and anti-IL12/23 distribution. During the first wave, a significantly higher percentage of patients were from Northern Italy compared to Central-Southern Italy: 171/219 (78.1%) vs. 387/718 (53.9%), respectively (p<0.001). Overall, COVID-19 negative outcomes were significantly higher in the first wave compared to the second one: 110 (50.2%) vs. 95 (13.2%), respectively (p<0.001). Also the single negative outcomes were significantly higher in the first wave: 61/219 (27.8%) vs. 84/718 (11.7%) had pneumonia, 62/219 (28.3%) vs. 76/718 (10.6%) required hospitalization, 26/219 (11.9%) vs. 39/718 (5.4%) required ventilatory support, and 12/219 (5.5%) vs. 13/718 (1.8%) died (Figure 1). Conclusion: IBD patients had higher number of COVID-19 negative outcomes in the first wave than in second wave. In the first wave, a significantly higher percentage of patients were from Northern Italy, but no significant differences in negative outcomes were observed in comparison with those from Central- Southern Italy. Overall, findings in IBD population are coherent with those observed in the general population. (Table Presented).
ABSTRACT
Background: In the last year, the severe adult respiratory syndrome coronavirus 2 (SARS-CoV-2) epidemic has spread rapidly around the world. The interactions between SARS-CoV-2 and inflammatory bowel disease (IBD) are so far not fully understood. In particular, no studies evaluated the potential role of SARS-CoV-2 on IBD course. Indeed, it is known that viral infections can be act as triggers for IBD flare and it is reasonable that the possible drug discontinuation during SARS-CoV-2 infection could in turn lead to an IBD flare. Methods: This was a prospective, observational case-control study. From March 11th 2020 to June 30th 2020 we enrolled IBD patients with proven SARS-Cov-2 infection (cases) and IBD patients without SARS-CoV-2 infection matched for sex, age, diagnosis, therapy and clinical activity (controls). Cases and controls were followed-up at least for 6 months. Differences between case and control group were tested for significance using the Students t test and Fishers test, as appropriate. A two-tailed p value < 0.05 was indicative of statistical significance. Results: 219 IBD patients (127 UC, 58.0%) with SARS-CoV-2 infection and 219 IBD patients without SARS-CoV-2 infection were enrolled. Table 1 shows baseline features of the population. Among the 122 cases in clinical remission at the time of viral infection, 28 (22.9%) showed a disease flare;this percentage was significantly higher than that observed in controls: 12/137 (8.8%)(p=0.0018). Among patients with disease flare, there were no significant differences between cases and controls group in terms of age (42.3 ± 16.0 vs. 43.1 ± 15.4 years, p=0.44), gender (female 45.7% vs. 48.2%, p= 0.54), use of biologic therapies (p=0.83) and UC or CD diagnosis (p=0.06). Biologic therapy was temporary withdrawn more significantly in cases than in controls (68/202, 33.6% vs. 14/204, 6.9%) (p<0.001) and overall biologic therapy discontinuation was significantly associated with disease flare (OR 2.56, 95% CI 1.026.41, p=0.04). Conclusion: IBD patients with SARS-CoV-2 infection have an increased risk to have a clinical recurrence in short-term in comparison with IBD patients without SARS-CoV-2 infection. This increased risk could be due to the viral infection and/or to the temporary discontinuation of biologic therapies, because of infection.
ABSTRACT
Background and aim: During coronavirus disease 2019 (COVID-19) pandemic, immumodulatory therapies as well as the access to high-risk places (i.e. hospitals, infusion centers) were associated to an increased risk of infection. Nevertheless, patients with inflammatory bowel diseases (IBD) treated with intravenous (i.v.) biologics had to move to hospital for drug infusion, in contrast to patients treated with subcutaneous (s.c.) therapies who could remain at home, monitored through telemedicine. We investigated whether patients hospitalized or treated at home showed similar COVID-19 risk, as well as the levels of anxiety in both groups Materials and methods: We conducted a survey including consecutive IBD patients in clinical and biochemical remission treated with biologics referring to the lockdown period. Patients underwent the normally scheduled clinical visits, performed at home by means of telemedicine for patients treated with s.c. drugs and only in specific cases for patients treated with i.v. therapies. We administered to all patients the Hospital Anxiety and Depression Scale (HADS) questionnaire and other 12 questions, specifically related to COVID and its implications. Group differences in continuous and nominal variables were tested by Kruskal–Wallis test and Fisher exact test, respectively Results: A total of 189 IBD patients were recruited, 112 (59.3%) treated with i.v. drugs and 77 (40.7%) with s.c. ones. No augmented risk of COVID infection were recorded in both groups (hospitalized vs. non-hospitalized, p=ns). The two groups of patients had similar scores in the 14 single items of the HADS questionnaire (p>0.10 for all). The total HADS score obtained by the sum of all items was also almost identical between groups (37.1±2.8 vs 37.2±2.8;p=0.98). In patients treated with i.v. drugs receiving a televisit (n=17), the rates of satisfaction about telemedicine (58.8%) and the lack of in-person care (33.3%) were significantly lower compared with those treated with s.c. drugs (94.8% and 92.2%, respectively;both p<0.0005). Conclusions: Our results suggest that there is no need to convert patients from i.v. to s.c. therapy during COVID-19 outbreaks, since the risk of infection and its transmission is not increased. Moreover, anxiety levels are similar in both groups, emphasizing that hospitalization seems not affecting the psychological status of the patients and therefore not increasing the relapse rate.