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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.
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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.
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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.
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Background: The antibody response to coronavirus disease 2019 (COVID-19) vaccination in patients with inflammatory bowel disease (IBD) on biological drugs is still unclear. Aim: To determine the anti-SARS-CoV-2 spike 1 (anti-S1-IgG) response rate and antibody levels following a complete COVID-19 vaccination cycle in patients with IBD on biological treatment. Methods: We assessed antibody response to COVID-19 in consecutive patients with IBD on biological drugs and without prior exposure to COVID-19. Sera were prospectively collected at baseline and at 21 days (T1), 42 days (T2), and 3 months (T3) after the first vaccine dose. Results: Among the 42 patients included in the study, the overall response rate at T3 was 97.6%, with no difference across the various biological drugs. After the first dose (T1), the response rate was higher in patients receiving anti-tumour necrosis factor (TNF) compared to patients treated with other biologics (p = 0.031). Among the responders, the anti-S1 levels were not significantly different among the various biological drugs at all study timepoints. Concomitant corticosteroids and disease activity had no impact on the response rate at all study timepoints. No unexpected side events were observed. Discussion: The antibody response to vaccination against COVID-19 in patients with IBD on biological drugs is optimal, independently of their mechanism of action. Patients treated with anti-TNF seem to have an earlier response to vaccination, while concomitant low-dose corticosteroids and disease activity does not seem to impact response. This information can be used to program vaccination and inform patients. © 2022 by the authors.
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Background and aim: Irritable Bowel Syndrome (IBS) is a highly prevalent disorder that greatly affects patients’ quality of life, causing a significant burden to healthcare systems worldwide. Its pathophysiology is incompletely understood but symptoms seem to be the result of an interplay between environmental and patientrelated factors. This study aimed to analyse the influence of lockdown-forced changes in lifestyle habits and COVID-19 pandemic stress on the development of IBS manifestations. Materials and methods: An online survey was sent to groups of people representative of the general population. It contained questions regarding sociodemographic data, dietary habits, alcohol consumption, smoking habits, physical activity, sleeping hours, working activities, stress level and GI symptoms, related to both the pre-pandemic and lockdown period. A P-value<0.05 was considered statistically significant. Uni and Multivariate Cox methods and Wald test were used to evaluate the association between exposure variables and IBS occurrence/resolution. Results: From April 1st to 30th, 2020, 2735 participants completed the survey(mean age:39.7±16.1 years, F:M=2:1). During lockdown 122 IBS patients (46.2%) reported improvement of symptoms while 118 negative subjects (4.8%) developed IBS. Age,gender,BMI,employ ment,teleworking and smoking were not associated with IBS incidence or resolution. Reduced general stress(OR=2.23,95%CI 1.09- 4.56,P=0.029), increased fibers intake(OR=2.83,95%CI 1.60- 5.02,P<0.001) and increased hours of sleep(OR=2.00,95%CI 1.07-3.76,P=0.031) were associated with a high probability of resolution of IBS, while increased intake of anxiolytic pills(OR=0.14,95%CI 0.04-0.46,P=0.001) showed a low probability of resolution of IBS. Reduced physical activity(OR=2.04,95%CI 1.30-3.19,P=0.002), increased anti-inflammatory (OR=2.38,95%CI 1.39-4.10,P=0.002), anxiolytic pills intake(OR=3.52,95%CI 2.08-5.95,P<0.001) and increased work related stress(OR=1.81,95%CI 1.16-2.83,P=0.009) were risk factors for IBS occurrence. Finally, the resolution of IBS did not affect the onset of upper GI functional symptoms(OR=0.18,95%CI 0.11-0.31,P<0.001). (Figure Presented) Conclusions: Lifestyle changes forced by COVID-19 lockdown resulted in a beneficial effect in almost half of IBS patients, whereas they favoured the development of IBS in 5% of healthy subjects, thus confirming that environmental factors play a pivotal role in the pathophysiology of IBS. In particular, stress, fibres and alcohol intake seem to be able to influence IBS occurrence or resolution.
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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).
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Introduction: Irritable Bowel Syndrome (IBS) is a highly prevalent gastrointestinal disorder affecting between 5% and 10% of the general population (1). This functional disorder is characterised by recurrent abdominal pain and altered bowel habits, and greatly affects patients' quality of life, causing a significant burden to the healthcare systems worldwide (2-4). Its pathophysiology is incompletely understood, but is well established that symptoms seem to be the result of an interplay between several environmental-and patient-related factors (5, 6). Aims & Methods: This study aimed to analyse the influence of lockdownforced changes in lifestyle habits and COVID-19 pandemic stress on the development of IBS manifestations. An online survey was sent to three different groups of people representative of the Italian general population. The survey contained questions regarding socio-demographic data, dietary habits, alcohol consumption, smoking habits, physical activity, hours slept per week, working activities, stress level, presence and characteristics of gastrointestinal symptoms, related to both the pre-pandemic period and the first lockdown period. IBS definition was based on Rome IV criteria (7). Statistical analysis was carried out using the statistical software R. A P-value <0.05 was considered statistically significant. Univariate and Multivariate Cox method analysis were used to evaluate the association between exposure categorical variables and occurrence/ resolution of IBS. For the non-binary categorical variables, the Wald test was used to obtain the global value of P. Results: From April 1st to April 30th, 2020, 2,735 participants completed the survey (mean age: 39.7 ± 16.1 years, female gender: 67.6%). In the pre-pandemic era 264 patients complained symptoms consistent with Rome IV criteria for IBS, whereas 2,461 were negative. Among the former group, during lockdown 122 patients (46.2%) reported improvement of symptoms while 118 previously negative subjects (4.8%) developed IBS symptoms. Age, gender, body mass index, type of employment, teleworking and smoking during confinement were not associated with the incidence or resolution of symptoms consistent with IBS. General stress (OR = 0.86, 95%CI 0.79-0.94, P= 0.0014) and reduced fibres intake (OR = 0.33, 95%CI 0.15-0.72, P= 0.005) were associated with a low probability of resolution of IBS. Reduced physical activity (OR = 2.36, 95%CI 1.21-4.60, P= 0.009) and stress linked to COVID-19 (OR = 1.26, 95%CI 1.10-1.45, P= 0.0014) and to work activities (OR = 1.23, 95%CI 1.06-1.43, P= 0.007) were risk factors for the occurrence of IBS, whereas reduced alcohol consumption (OR =0.12, 95%CI 0.03-0.44, P= 0.001) and increased fibres intake (OR = 0.05, 95%CI 0.03-0.07, P= 0.03) showed a protective effect on the occurrence of symptoms consistent with IBS diagnosis. Conclusion: Life-style changes forced by COVID-19 lockdown resulted in a beneficial effect in almost half of patients affected by IBS, whereas they favoured the development of IBS in about 5% of healthy subjects, thus confirming that environmental factors play a pivotal role in the pathophysiology of IBS. In particular, stress, both linked and unrelated to COVID-19, fibres and alcohol intake seem to be able to influence the occurrence or resolution of IBS.