ABSTRACT
Background: As patients with immune conditions were excluded from COVID-19 vaccine clinical trials, it is important to accumulate realworld data in this setting, particularly to identify those who would benefit from repeated doses. Method(s): Effectiveness and Safety of COVID-19 Vaccine in Patients with Inflammatory Bowel Disease (IBD) Treated with Immunomodulatory or Biological Drugs (ESCAPE) is a prospective, multicentre, observational study assessing effectiveness and safety of COVID-19 vaccines in patients with IBD (ClinicalTrials.gov ID: NCT04769258). Here we present data on the rate of breakthrough SARS-CoV-2 infections in the timeframe between 14 days after the second dose and the third dose of COVID-19 vaccine (or a maximum of 9 months from the second dose). The risk factors for SARS-CoV-2 infection, including lack of seroconversion (cut-off for IgG anti-SARS-CoV-2: OD 0.28) and IgG anti-SARS-CoV-2 levels after 8 weeks from the second dose, and treatment for IBD, were assessed. Result(s): Out of the 1076 patients with IBD enrolled in the ESCAPE study, data on breakthrough SARS-CoV-2 infection were available in 953 cases. Most of the patients received homologous, doubledose mRNA-based vaccines (BNT162b2 or mRNA-1273: 99.2%). Seroconversion was reported in 92.7% of cases (median OD 1.60 [IQR 0.8-3.6]), while SARS-CoV-2 infection was documented in 95 patients (10.0%), of whom 9 died. At multivariable regression analyses, age (OR 0.97, 95% CI 0.96-0.99;p<0.001) being former smoker (OR 2.23, 95% CI 1.26-3.88;p=0.005), and lack of seroconversion (OR 0.42, 95% CI 0.20-0.99;p=0.034) were independent predictors of SARS-CoV-2 infection. Conversely, none of the treatments for IBD was associated with breakthrough SARS-CoV-2 infection. Notably, all 9 patients who died had reported seroconversion after the second dose. Conclusion(s): IBD patients without seroconversion after COVID-19 vaccines are at increased risk for SARS-CoV-2 infection, while medications for IBD had no impac.
ABSTRACT
Introduction: The mental health of subjects with chronic medical illnesses, such as Inflammatory Bowel Disease (IBD- Crohn's Disease and Ulcerative Colitis), is typically compromised and the current COVID-19 pandemic might have additionally increased this burden. Objective(s): The aim of the present study was to investigate, during the COVID-19 pandemic, if the presence of a comorbid psychiatric disorder has played a role as an aggravating factor on mental health in patients with IBD. Method(s): Twenty Five patients with psychiatric comorbidities (PC+) and twenty five without (PC-) comparable for age and gender, were recruited at the Gastroenterology department at Sacco University Hospital in Milan. Participants were assessed a psychiatric evaluation, collecting socio-demographic variables and measures of anxiety and depression [on the Hospital Anxiety Depression Scale (HADS)], sleep patterns [on the Insomnia Severity Index (ISI)] and general health status [on the Short Form Health Survey 36 (SF-36)]. Comparative statistical analyses were performed with t test with Bonferroni correction. Result(s): PC+ (n=25) showed more severe anxiety and depressive symptoms compared with PC- (n=25) (p <.001) and worse sleep pattern (p<.05). With respect to general health status, PC+ showed reduced physical activities (p<.05), social activities (p<.05), mental health (p<.01) and role limitations due to physical health (p<.05) Conclusion(s): The present findings showed a worse mental health in subjects with IBD and psychiatric comorbidities during Covid-19 pandemic, highlighting the importance of screening and treatment of psychiatric symptoms disorders in these patients.
ABSTRACT
Introduction: Vaccination is the most effective method to prevent and control the SARS-CoV-2 infection. Recommendations consider patients with inflammatory bowel disease (IBD), Crohn's disease (CD) and ulcerative colitis (UC), a high-priority population to COVID-19 vaccine administration. There were a lot of concerns about vaccination safety in the setting of biological and immunomodulatory drugs. The purpose of this study was to present data on safety about anti-SARSCoV- 2 vaccination in a cohort of IBD patients. These are data of an ongoing multicenter study assessing effectiveness and safety of COVID-19 vaccines in patients with IBD treated with immunomodulatory or biological drugs (ESCAPE-IBD) sponsored by the Italian Group for the study of Inflammatory Bowel Disease (IG-IBD - ClinicalTrials.gov Identifier: NCT04769258). Aims & Methods: Anti-SARS-CoV-2 vaccination was administrated to 809 IBD patients. Afterwards completed vaccination, telephone or in-person interviews were conducted from February to July 2021 by gastroenterologists from referral center to report local and/or systemic adverse events (AEs) related to vaccination. Data on medical history and treatment was collected from electronic health records. Of these 809, 346 patients were surveyed on the pandemic burden and the main reason for hesitancy in Covid-19 vaccination. Chi-square test was used to compare categorical variables. Logistic regression was used to assess the relationship between disease-related characteristics and the onset of AEs. Result(s): 809 patients, 456 CD and 353 UC, regularly followed in IBD unit, were enrolled. All patients received a complete SARS-CoV-2 vaccination cycle. Most of them (68%) were in biological or immunomodulatory therapy. About 45% of patients had at least one side effect, following the first dose (10%), the second (15%) or both doses (20%). Local pain at site of injection (24%), fatigue (33%) and fever (30%) were the three most common AEs. Flares of the underlying IBD were not reported. The vast majority of AE were mild and lasted only a few days. No serious AEs were reported and no patient was hospitalized. Logistic regression analysis revealed that female gender (p<0.001), younger age (p=0.001), seroconversion (p=0.002) and comorbidity (p<0.001) were significantly associated with the occurrence of AEs. Futhermore the survey showed that the pandemic did not affect IBD at all in 37.5%, and a lot in 9.2% of participants. The majority (95%) of patients welcomed the possibility of getting vaccinated;only 7% feared the vaccine's influence on the course of the IBD. The main concerns were the possibility of adverse effects (33%) and the failure to achieve immunity (17%), few for the type of vaccine (3%) and for the need to a further booster (6%). Almost all patients (99%) felt safer to have vaccinated at their IBD reference center. Conclusion(s): The short-term vaccine reactions experienced in this cohort of IBD patients were mostly self-limiting, including local pain at the injection site, fatigue and fever. We found a high acceptance rate and a good safety profile of SARS-CoV-2 vaccination in our cohort.
ABSTRACT
Introduction: Patients on immunosuppressive drugs have been excluded from COVID-19 vaccines trials, creating concerns regarding their efficacy in this setting. Aims & Methods: Effectiveness and Safety of COVID-19 Vaccine in Patients with Inflammatory Bowel Disease (IBD) Treated with Immunomodulatory or Biological Drugs (ESCAPE-IBD) is a prospective, multicentre study promoted by the Italian Group for the study of Inflammatory Bowel Disease. We present data on serological response eight weeks after the second dose of COVID-19 vaccination in IBD patients and healthy controls (HCs). Result(s): 1076 patients with IBD and 1126 HCs were analyzed. Seropositivity for anti-SARS-CoV-2 IgG was reported for most IBD patients, even if with a lesser rate compared with HCs (92.1% vs. 97.9%;p<0.001). HCs had higher antibody concentrations (median OD 8.72 [IQR 5.2-14-2]) compared to the whole cohort of IBD patients (median OD 1.54 [IQR 0.8-3.6];p<0.001) and the subgroup of IBD patients (n=280) without any treatment or on aminosalicylates only (median OD 1.72 [IQR 1.0-4.1];p<0.001). IBD patients treated with anti-TNFs showed significantly lower median anti-SARS-CoV-2 IgG levels compared with those without any treatment or on aminosalicylates only (OD 1.30 [IQR 0.7-3.0] vs.1.72 [IQR 1.0-4.1];p<0.001), those treated with Vedolizumab (OD 1.78 [IQR 1.1-4.1];p=0.001), and Ustekinumab (OD 1.71 [IQR 0.9-4.9];p=0.03). Conclusion(s): Although most IBD patients showed seropositivity after two doses of COVID-19 vaccines, the magnitude of the humoral response was significantly lower than in HCs. Differently from other studies, these findings seem to be mostly unrelated to the use of immune-modifying treatments. Regarding COVID-19 vaccination, patients with IBD should be regarded as a whole as a "frail" category, therefore requiring booster/additional doses of COVID-19 vaccine.
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).