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2.
Gastroenterology ; 162(7):S-1007, 2022.
Article in English | EMBASE | ID: covidwho-1967395

ABSTRACT

Background: Patients with inflammatory bowel diseases (IBD) are commonly treated with immunosuppressive agents. Following the novel corona virus (SARS-CoV-2) pandemic, these patients received early the currently EMA approved vaccines. Data on efficacy and safety of SARS-CoV-2 vaccination on this population are lacking. Methods: Greek IBD patients, from 10 tertiary referral centres, who had completed the initial vaccination protocol with the available anti-COVID-19 vaccines (BNT162b2, mRNA-1273, Ad26.CoV2.S, ChAdOx1) at least two weeks before enrolment, were prospectively studied. Demographic and safety data were collected and blood samples were drawn for serum Anti-S1 IgG measurement [Euroimmun Anti-SARS-CoV-2 QuantiVac ELISA (IgG)]. Results: In total 403 IBD patients (59% Crohn's disease, median age 45 years, 53% male) and 124 healthy controls (HC) were included (Table 1). Antibody testing was conducted after a median of 31 (IQR, 23-46) days post-vaccination. Following a full vaccination regimen, 98% of IBD patients seroconverted (anti-S1 IgG³11 RU/ml). In total, IBD patients had lower anti-S1 levels than HC (RU/ ml 108 vs 133 RU/ml, P=0.00009) Administration of mRNA vaccines resulted in higher seroconversion rates and higher antibody titers than viral vector ones (98.6% vs 93.6%, P= 0.02 and 111.2 RU/ml vs 76 RU/ml, P<0.0001, respectively). Treatment with vedolizumab monotherapy was associated with higher antibody levels than anti-TNFα or ustekinumab monotherapy (P=0.02 and P=0.03). Longer timing between vaccination and antibody measurement was independently associated with impaired vaccine response. In multivariable analysis, specifically in mRNA-vaccinated cohort, older age, anti-TNFα treatment and treatment with biologics plus IMMs were significantly associated with lower antibody response (P=0.01, P=0.008, and P=0.02 respectively). Patients with prior COVID-19 infection showed numerically higher levels of antibodies. All vaccines were safe in IBD patients. Conclusions: Patients with IBD have high seroconversion rates to anti-SARS-CoV-2 vaccines. However, they demonstrate impaired antibody responses compared to HC. Patients receiving viral vector vaccines, and those on anti-TNFα or combination treatment may have further response impairment and it is important to consider booster vaccination in those low-response groups. (Table Presented)

3.
Gastroenterology ; 162(7):S-1006-S-1007, 2022.
Article in English | EMBASE | ID: covidwho-1967394

ABSTRACT

Introduction Since inflammatory bowel disease (IBD) patients were excluded from vaccine authorization studies, limited knowledge exists regarding perceptions for and unfavorable effects of COVID-19 vaccination in this group. The aim of this study was to investigate the real world use and adverse events (AE) of vaccines against COVID-19 in IBD patients. Aims and Methods Fully vaccinated IBD patients followed in Greek centers were invited to participate in an anonymous online self reporting survey that included information regarding their demographics, clinical characteristics, treatment, vaccination perceptions and potential AE. Patients were vaccinated with either messenger-RNA or viral vector vaccines that are currently EMA approved. AE were stated as any kind of new symptom or sign onset, including localized (at the injection site) or systematic ones (fatigue, headache, allergic reactions, fever, lymphadenopathy, myalgias/arthralgias and gastrointestinal disorders). Results A total of 1007 IBD patients [male 50.5%, median age (IQR) 44 (35-55) years, Crohn's disease 64.3%, history of COVID-19 infection 2.6%] who completed the survey after they have fulfilled their vaccination program were included. Detailed demographics and clinical characteristics of the study population are presented in Table 1. More than half of the patients (51%) stated that they show confidence in vaccination whereas the rest although hesitant admitted the protection it offers. The median (IQR) time between 2nd vaccine dose and questionnaire completion was 15 (5-43) days. There were no serious AE leading to emergency room visit or hospitalization. Total AE were reported by 81% after dose 1 (D1) and 76% after dose 2 (D2), reduced to 44% and 51% when excluding isolated injection site reactions respectively. Systemic AEs were more common after D2 (P<0.0001). Very few patients reported new onset abdominal symptoms [abdominal pain 4% (D1), 6% (D2) and diarrhea 5% (D1), 7% (D2)]. In the multiple regression analysis AE occurrence was positively associated with young age, female gender and blood type AB rhesus positiveafter both doses, whereas inactive disease was negatively associated with AE only in D1 (p= 0.044) No association with the use of medications including advanced therapy was found (p>0.05), except from corticosteroids after D2 (p=0.003) but it was a small (32/1007 patients) heterogenous (monotherapy, double or triple immunosupression) sample to draw conclusions (Table 2). Conclusions The presence of SARs-CoV-2 vaccination AE in Greek patients with IBD is similar to the reported in other populations. Young age and female gender but not IBD related medications are associated with the development of AEs after both doses. (Table Presented) (Table Presented)

4.
Journal of Crohn's and Colitis ; 16:i581, 2022.
Article in English | EMBASE | ID: covidwho-1722360

ABSTRACT

Background: The novel corona virus (SARS-CoV-2) outbreak was declared as a pandemic in March 2020;this prompted the need for rapid vaccine development. Currently four EMA approved vaccines exist but their efficacy and safety data on patients with Inflammatory Bowel diseases are limited. Methods: Greek IBD patients, from 10 tertiary referral centres, who had completed the initial vaccination protocol with the available anti-COVID-19 vaccines at least two weeks before enrolment, were prospectively studied. Demographic and safety data were collected and blood samples were drawn for serum Anti-S1 IgG measurement [Euroimmun Anti-SARS-CoV-2 QuantiVac ELISA (IgG)]. Results: In total 403 IBD patients (59% Crohn's disease, median age 45 years, 53% male) and 124 healthy controls (HC) were included (Table 1). Antibody testing was conducted after a median of 31 (IQR, 23-46) days post-vaccination. Following a full vaccination regimen, 98% of IBD patients seroconverted (anti-S1 IgG≥11 RU/ ml). Administration of mRNA vaccines resulted in higher seroconversion rates and higher antibody titers than viral vector ones (98.6% vs 93.6%, P=0.02 and 111.2 RU/ml vs 76 RU/ml, P<0.0001, respectively). In total, IBD patients had lower anti-S1 levels than HC (RU/ ml 108 vs 133 RU/ml, P=0.00009). IBD patients without immunosuppression had higher antibody titers than immunocompromised patients (P=0.012). In univariable analysis, older age, longer time since vaccination, and treatment with corticosteroids, immunomodulators, anti-TNFα or combination therapy were associated with lower anti- S1 titers. In contrast, higher anti-S1 levels were detected in patients on vedolizumab monotherapy or non-immunosuppressive treatment. In multivariable analysis, only age, time since vaccination, and anti- TNFα therapy remained significant (P=0.011, P=0.002, and P=0.013 respectively). Treatment with vedolizumab monotherapy was associated with higher antibody levels than anti-TNFα or ustekinumab monotherapy (P=0.023 and P=0.032). Patients with prior COVID-19 infection showed numerically higher levels of Abs. All vaccines were safe in IBD patients. Conclusion: Patients with IBD have high seroconversion rates to anti- SARS-CoV-2 vaccines, with mRNA vaccines being more efficacious. However, IBD patients have impaired response to vaccination comparing to HC. Lower antibody responses were observed in patients who received viral vector vaccines, in older patients, and in those on anti- TNFα treatment. It is important to consider booster vaccination in those low-response groups.

5.
Journal of Crohn's and Colitis ; 16:i576-i577, 2022.
Article in English | EMBASE | ID: covidwho-1722358

ABSTRACT

Background: Since inflammatory bowel disease (IBD) patients were excluded from vaccine authorization studies, limited knowledge exists regarding perceptions for and unfavorable effects of COVID-19 vaccination in this group. The aim of this study was to investigate the real world use and adverse events (AE) of vaccines against COVID-19 in IBD patients. Methods: Fully vaccinated IBD patients followed in Greek centers were invited to participate in an anonymous online self reporting survey that included information regarding their demographics, clinical characteristics, treatment, vaccination perceptions and potential AEs. Patients were vaccinated with either messenger-RNA or viral vector vaccines that are currently EMA approved. AEs were stated as any kind of new symptom or sign onset, including localized (at the injection site) or systematic ones (fatigue, headache, allergic reactions, fever, lymphadenopathy, myalgias/arthralgias and gastrointestinal disorders). Results: A total of 1007 IBD patients [male 50.5%, median age (IQR) 44 (35-55) years, Crohn's disease 64.3%, history of COVID- 19 infection 2.6%] who completed the survey after they have fulfilled their vaccination program were included. Detailed demographics and clinical characteristics of the study population are presented in Table 1. More than half of the patients (51%) stated that they show confidence in vaccination whereas the rest although reluctant/hesitant admitted the protection it offers. The median (IQR) time between 2nd vaccine dose and questionnaire completion was 15 (5-43) days. There were no serious AEs leading to emergency room visit or hospitalization. Total AEs were reported by 81% after dose 1 (D1) and 76% after dose 2 (D2), reduced to 44% and 51% when excluding isolated injection site reactions respectively. Systemic AEs were more common after D2 (P<0.0001). Very few patients reported new onset abdominal symptoms [abdominal pain 4% (D1), 6% (D2) and diarrhea 5% (D1), 7% (D2)]. In the multiple regression analysis AE occurrence was positively associated with young age and female gender after both doses, whereas inactive disease was negatively associated with AE only in D1 (p=0.044). No association with the use of medications including advanced therapy was found (p>0.05), except from corticosteroids after D2 (p=0.003) but it was a small (32/1007 patients) heterogenous (monotherapy, double or triple immunosupression) sample to draw conclusions. Conclusion: The presence of SARs-CoV-2 vaccination AEs in Greek patients with IBD is similar to the reported in other populations. Young age and female gender but not IBD related medications are associated with the development of AEs after both doses.

6.
Journal of Crohn's and Colitis ; 16:i283-i284, 2022.
Article in English | EMBASE | ID: covidwho-1722318

ABSTRACT

Background: Patients with Inflammatory Bowel Disease (IBD), especially those on immunosuppressive (IMS) treatment should be vaccinated against SARS-CoV-2 to prevent hospitalization, mechanical ventilation, and death. However, IMS may adversely affect vaccination, raising concerns as to how vulnerable these patients are to break through COVID-19 infections. Thus, we aimed to assess the proportion of IBD patients who despite complete vaccination developed COVID-19, as well as the course of the infection. Methods: This study was an initiative of the Hellenic Group for the study of IBD which involved seven IBD referral Centers. Patients attending these Centers who reported a COVID-19 infection at least 3 weeks after vaccination completion were asked to complete an on-line anonymous questionnaire which included patient demographics and IBD clinical and therapeutic data, a detailed vaccination history, and the course and outcome of COVID-19, especially the need for hospitalization, oxygen supply, and admission to ICU. In patients with grave outcome information was sought by family members Results: On estimate, 2940 patients reported full vaccination (Pfizer vaccine) in the 7 centers. Between 1st May 2021 and 30th October 2021, 46 (1.5%) fully vaccinated IBD patients reported COVID-19 infection [25 male, 32 CD, 14 UC, mean (SD) age 40.8 (13.7) years, mean (SD) IBD duration mean, 11.2 (10.8) years]. Five patients were receiving 5-ASAs, 2 corticosteroids, 5 azathioprine/methotrexate, 23 anti-TNFs as monotherapy and 3 in combination with azathioprine/methotrexate, and 1 with corticosteroids, 3 vedolizumab and 1 each ustekinumab, tofacitinib and rizakinzumab at the time of COVID-19 diagnosis;one patient was receiving no treatment. IBD was in remission in 37/46 patients (80.4%). Comorbidities were seen in 21 patients (thyroid disease 11;diabetes mellitus 2;hypertension 2;psoriasis 1;prior breast cancer 1;spondyoartropathy 2;dyslipidemia 1;and PSC 1 patient). The mean (SD) time between last vaccination dose and infection was 3.2 (1.4) months. Overall, 40 (86.9%) patients reported mild constitutional and respiratory symptoms, 4 (8.7%) were asymptomatic and only 2 patients (4.3%) required hospitalization which was uneventful in both. None needed high flow oxygen supply or ICU admission, and none reported symptoms of long COVID. No deaths were reported by patient relatives. IBD medications were stopped in 21 patients (45.6%) during the COVID-19 infection. Conclusion: A minority of fully vaccinated IBD vaccinated patients developed COVID-19 which was relatively mild and uneventful. These results reinforce the importance of vaccination especially in vulnerable populations.

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