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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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Background: Suboptimal anti-Sars-Cov2 vaccine response has been demonstrated during immunosuppressive treatments. Liver Transplant Recipients (LTRs) and Inflammatory Bowel Disease (IBD) patients are different setting of populations who are both undergoing immunosuppressive treatments. In this work, we pooled and compared, retrospectively, these two populations to evaluate anti-SARS-CoV2 seroconversion after the second dose of vaccination. Different comorbidities and therapies outcomes have been explored as well. Method(s): The antibody titres standardized of the two cohorts have been analysed. Matched patients of both populations for comorbidities and therapies with application of propensity score have been investigated. Result(s): 240 LTRs and 424 IBD patients were analysed. Most have received an mRNA based vaccine (BNT162b2 or mRNA-1273: 99.1%). The seroconversion rate of 84% for LTRs and 93% for IBD patients was recorded. To multivariate analysis, hypertension (OR 2.8618, 95% CI 1.0012 to 8.1802), the mycophenolate administration (OR 2.9733, 95% CI 1.1820 to 7.4794) and the steroid use (OR 5.4531, 95% CI 1.0706 to 27.7761) were significantly associated with reduced seroconversion in LTRs cohort;meanwhile, the older age (OR 1.0369, 95% CI 1.0076 to 1.0670) and the thiopurine consumption (OR 2.9484, 95% CI 1.0089 to 8.6166) with that in IBD population. After Propensity Score Matching application, the seroconversion rates, not statistically different, of 86% for LTRs and 92% for IBD patients were found. Hypertension (OR 2.73, 95%CI 1.1258 to 6.6138), diabetes (OR 3.16, 95% CI 1.1888 to 8.4217), age > 65y (OR 2.93, 95% CI 1.1712 to 7.3153) and the female sex (OR 2.54, 95% CI 1.0963 to 5.9104) were correlated with reduced seroconversion in both populations. Conclusion(s): After Propensity Score Matching, the seroconversion rates of IBD and LTR patients were not statistically different. Hypertension, diabetes and age > 65y revealed a significant influence on seroconversion and the female showed a reduced seroconversion in comparison to male.
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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 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-SARS-CoV-2 vaccination in a cohort of IBD patients. These are preliminary 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). Methods Anti-SARS-CoV-2 vaccine (Pfizer-BioNTech®) in two shots were administrated to 427 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. 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. Results 427 patients, 252 CD and 175 UC, were enrolled. All patients received two shots of SARS-CoV-2 vaccine. AEs were more common in females (70% vs 50% male gender;p<0.001). Most of them (75%) were in biological or immunomodulatory therapy. About 58% of patients had at least one side effect, following the first dose (13%), the second (22%) or both doses (23%). Local pain at site of injection (31%), fatigue (19%) and fever (15%) 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) and younger age (p=0.016) were significantly associated with the occurrence of AEs. Conclusion 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 good safety profile of SARS-CoV-2 vaccination in our cohort.
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Introduction: Use telemedicine to follow COVID-19 patients at home avoiding hospitalization. Objects: Safely avoid hospitalization and in any case guarantee high-level assistance, limit infections and unnecessary travel. Methods: From 30.03.20 to 31.05.21 we followed 503 families with COVID-19, at home if the following requirements were met: 1. care giver;2. the suitability of the house;3. the possession of a telephone with an internet network to provide the doctor with clinical data and to receive and tutorials;4. pulse oximeter. Therapies were modulated in relation to severity according to the guidelines, noting SPO2, walking test, respiratory rate, fever. Chest ultrasound was performed, according to the Soldiers score. set therapy with Prednisone 0.5-1 mg/kg/day, LMWH, Azithromycin 500, vitamin D 50.000U. All patients received 6 diaphragmatic breathing tutorials. Results: 503 families (1509 pt), 8 hospitalized, 4 men and 4 women four died in hospital. 2 cases of pulmonary embolism. The duration of treatment was from 8-45 days, from 1-3 contacts per day, from 4 to 48 messages per nucleus/day. Conclusions: WhatsApp is a way to monitor patients in the COVID- 19 pandemic, with minimal equipment (ultrasound), patients able to follow the prescriptions provided via social networks and present clinical data daily. Important was the network with the pharmacies for oxygen and drugs even on holidays and with the laboratory for blood sampling at home at a controlled cost.
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Background: Covid-19 infection is an exceptional pandemic that has involved millions of people worldwide with dramatic humane, social and economic concerns. Since December 2020, two mRNA and one inactivated vaccines were approved for people administration. The vaccinal access calendar was scheduled according with risk degree of infection and complications. In some regional setting patients with inflammatory bowel diseases (IBD), Crohn's disease (CD) and ulcerative colitis (UC) were considered fragile and therefore had a priority approach to vaccine administration compared to the general population. The purpose of this work was to measure the satisfaction and the concerns of a cohort of IBD patients who were administered the anti-Sars CoV-2 vaccine inside reference center by their dedicated nursing staff. Methods: Anti-SARS-CoV-2 vaccine (Pfitzerae) in two shots were administrated to 346 IBD patients. Afterwards completed vaccination, all patients were given a questionnaire consisting of 4 items focused on the level of satisfaction and the impact of the pandemic on their illness. Results: 346 patients, 168 CD and 178 UC, 147 female and 199 male, 249 in biologicals and 97 in immunomodulatory therapy, regularly followed up in an IBD unit, were enrolled. All patients received two shots of SARS-CoV-2 vaccine by their IBD nursing staff. Upon close of the vaccination course, a questionnaire was dispensed. 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 the need for a further booster (6%). Almost all patients (99%) felt safer to have vaccinated at their IBD reference center. Conclusion: In this cohort of IBD patients, SARS-CoV-2 vaccination inside reference center has shown broad compliance and a high degree of confidence. Most did not report that the pandemic affected regular IBD management.
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Background and aim: During the SARS-CoV-2 pandemic there was a substantial change in providing medical care. National and international statements recommended avoiding face-to-face visit for treatment of patients especially for chronic disease. Also lockdown and social distancing cause a lot of concern among patients, which prefer avoid hospital facilities due to fear of contracting COVID-19. For these reason there was a reorganization of inflammatory bowel disease follow-up visit shifting from traditional visit to telemedicine whereas it was possible. Our survey aimed to evaluated satisfaction about follow up video-consulting in IBD patients. Materials and methods: From September to December 2020, 75 video-consults were made as follow up in patients with IBD. Videoconsult wasn’t performed as first visit nor in patients with new clinical issue. Every consult lasted about 15 minutes. At the end of the visit, a questionnaire of satisfaction was e-mailed to each patient. This questionnaire evaluated several items: satisfaction, difficulty of connection, opportunity to repeat the video-consult even in post-Covid-19 era, safety compared to face-to-face visit, level of concern about Covid-19 disease and fear of in-hospital transmission. Results: 70% of the patients indicated an high video-consult rating and in most of cases (88%) there were no connection problems. The majority (88%) would like to repeat the tele-visit even in the post-Covid 19 era (77%). Video-consult seemed to be perceived as safer than face-to-face visit even if, in case of urgent consultation, it was preferred a traditional visit. Moreover, Covid-19 infection and fear of in-hospital transmission was a great concern in the 73% and 58% of the patients, respectively. Conclusions: In our survey, outpatients reported a very high degree of satisfaction with video consultations. It was an easy and safe tool that may become an integral part of clinical practice in the future.