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2.
Gastroenterology ; 162(7):S-596, 2022.
Article in English | EMBASE | ID: covidwho-1967340

ABSTRACT

Background: While vaccines against COVID-19 are effective in healthy individuals, we reported significantly lower serologic responses to BNT162b2 in patients with inflammatory bowel diseases (IBD) treated with anti-tumor necrosis factor (TNF) α agents. As this was apparent already 4 weeks post vaccination, vaccine longevity is concerning. Aim: to assess long-term serologic responses to BNT162b2 in patients with IBD stratified according to medical treatment. Methods: A prospective, observational multi-center Israeli study. Patients with IBD (anti-TNFα treated versus non-anti-TNFα treated) and healthy controls (HC) were followed from before the 1st BNT162b2 dose until 6 months after vaccination. COVID-19 spike (S) and nucleocapsid (N) antibodies (Abs) concentrations were analyzed by ELISA, followed by neutralization studies. Specific anti-receptor binding domain (RBD) memory Bcells response, serologic responses against variants of concern (VOCs), Beta, Gamma and Delta, immunoglobulin levels and lymphocyte cell subsets were evaluated as well. Safety was assessed using questionnaires, clinical and laboratory data. Results: Of 193 subjects, 130 had IBD (45 and 85 in the anti-TNFa and non-anti-TNFα groups, respectively), 63 HC. Serologic response assessed 176 (median) days (IQR 166-186) and compared to 4 weeks after 1st dose significantly declined in all three groups, but was lowest in the anti- TNFα group: 6 months anti-S Abs titer geometric means: 193 (95%CI: 128-292), 703 (520- 951), and 1253 (1023-1534) in anti-TNFα, non- anti-TNFα and HC groups, respectively, p<0.001, Figure 1. This was further supported by neutralization and inhibition studies. Importantly, significantly decreased memory B-cell response towards RBD was detected only in the anti-TNFα group, with the most significant reduction in response to Beta VOC (p<0.0008 and p<0.0001, vs. non-anti-TNFα and HC, respectively). Older age was an additional predictor of lower serologic response. Immunoglobulin levels and lymphocyte cell subsets were comparable between the study groups. Infection rate reflected by anti-N Abs was ~1% in all groups. Safety was comparable in all groups. Conclusion: The 6-months serologic response to BNT162b2 vaccine, evaluated prospectively, decreased in all subjects, most prominently in patients with IBD treated with anti-TNFα. Importantly, the latter also had the sharpest decline in serologies, the lowest functional activity and lowest RBD specific memory B-cells. Older age is an additional predictor of decreased serologic response. Altogether, waning of COVID-19 serologic and functional response over 6 months, specifically in patients with IBD treated with anti-TNFα, supports the need for an early third vaccine dose. (Figure Presented)

3.
Journal of Crohn's and Colitis ; 16:i337-i338, 2022.
Article in English | EMBASE | ID: covidwho-1722324

ABSTRACT

Background: While vaccines against COVID-19 are effective in healthy individuals, we reported significantly lower serologic responses to BNT162b2 in patients with inflammatory bowel diseases (IBD) treated with anti-tumor necrosis factor (TNF) α agents. As this was apparent already, 4 weeks post vaccination, vaccine longevity is concerning. Aim: to assess long-term serologic responses to BNT162b2 in patients with IBD stratified according to medical treatment. Methods: A prospective, observational multi-center Israeli study. Patients with IBD (anti-TNFα treated versus non-anti-TNFα treated) and healthy controls (HC) were followed from before the, 1st BNT162b2 dose until, 6 months after vaccination. COVID-19 spike (S) and nucleocapsid (N) antibodies (Abs) concentrations were analyzed by ELISA, followed by neutralization studies. Specific anti-receptor binding domain (RBD) memory B-cells response, serologic responses against variants of concern (VOCs), Beta, Gamma and Delta, immunoglobulin levels and lymphocyte cell subsets were evaluated as well. Safety was assessed using questionnaires, clinical and laboratory data. Results: Of, 193 subjects, 130 had IBD (45 and, 85 in the anti-TNFα and non-anti-TNFα groups, respectively), 63 HC. Serologic response assessed, 176 (median) days (IQR, 166-186) and compared to, 4 weeks after, 1st dose significantly declined in all three groups, but was lowest in the anti- TNFα group:, 6 months anti-S Abs titer geometric means:, 193 (95%CI:, 128-292), 703 (520-951), and, 1253 (1023-1534) in anti-TNFα, nonanti- TNFα and HC groups, respectively, p<0.001, Figure, 1. This was further supported by neutralization and inhibition studies. Importantly, significantly decreased memory B-cell response towards RBD was detected only in the anti-TNFα group, with the most significant reduction in response to Beta VOC (p<0.0008 and p<0.0001, vs. non-anti-TNFα and HC, respectively). Older age was an additional predictor of lower serologic response. Immunoglobulin levels and lymphocyte cell subsets were comparable between the study groups. Infection rate reflected by anti-N Abs was ∼1% in all groups. Safety was comparable in all groups. Conclusion: The, 6-months serologic response to BNT162b2 vaccine, evaluated prospectively, decreased in all subjects, most prominently in patients with IBD treated with anti-TNFα. Importantly, the latter also had the sharpest decline in serologies, the lowest functional activity and lowest RBD specific memory B-cells. Older age is an additional predictor of decreased serologic response. Altogether, waning of COVID- 19 serologic and functional response over, 6 months, specifically in patients with IBD treated with anti-TNFα, supports the need for an early third vaccine dose. (Figure Presented).

5.
United European Gastroenterology Journal ; 9(SUPPL 8):386-387, 2021.
Article in English | EMBASE | ID: covidwho-1490989

ABSTRACT

Introduction: There is an ongoing concern over the impact of COVID-19 on IBD patients. A significant proportion of IBD patients are treated with immunosuppressive medications and their effects on COVID-19 susceptibility and outcomes remain of concern to patients and physicians alike. Apart from the clinical outcome, the pandemic may have other psychosocial effects on this vulnerable cohort, such as employment stability. Aims & Methods: The primary aim of this study was to analyze the percentage of patients who tested themselves for COVID-19 and the outcome of those who tested positive. A secondary aim was to assess their employment status. This was a multicentre international study whereby IBD patients (>18 years) in clinical remission over the last year, were asked to answer an anonymous questionnaire. Demographic data, type of IBD, current and previous medication, admissions to hospital, were collected. Exclusion criteria included patients with IBD flares requiring corticosteroids in the previous 12 months. Results: 585 patients (CD: n=325) from 8 European Centres and Israel participated in the study. The mean patient age was 40.1 years (SD+/- 13.1). 21.6% were smokers and 48.5% were non-smokers. The rest were ex-smokers. 44.5% (n=255 ) of patients were tested for Covid-19 and 5.1% (n=13) were positive. The majority were treated at home (92.3%) with only one patient requiring hospital admission. This was a 33-year-old female smoker with UC (E3 disease activity) on anti-TNF therapy. 66.7% of positive cases were on anti-TNF medication and 22.2% were on thiopurines. None of the positive cases were on dual antiTNF/thiopurine therapy. 7.2% of patients had family members who also tested positive for Covid-19. Almost half of all patients (45.2%) had their job affected during the pandemic and this was more prevalent in the UC cohort (P<0.05). 70% of patients switched to remote work from home and 21.4% became unemployed. The average age of patients becoming unemployed was 39.3year (SD+/- 11.9). Conclusion: Nearly half of our cohort (45.2%) were tested for Covid-19. The majority (92.3%) were treated at home, even though two thirds of them were on Anti-TNF medication. Unemployment rates affected 1 in 5 individuals and measures promoting remote work have been taken up wisely by IBD patients. Though the clinical outcomes were excellent, the psychological effects of unemployment may have yet to be considered.

6.
Journal of Endocrinology and Metabolism ; 11(1):1-7, 2021.
Article in English | Scopus | ID: covidwho-1143873

ABSTRACT

Diabetes is highly linked to the severity of coronavirus disease 2019 (COVID-19). My recent meta-analysis also suggested a higher prevalence of diabetes in severe COVID-19 as compared with non-severe COVID-19. Recent observational studies have shown that hypergly-cemia was significantly associated with severity of COVID-19 in both diabetic and non-diabetic patients. To prevent worse outcome of COVID-19, more tight glucose control is required. I studied the association between hyperglycemia and worse outcome of COVID-19, the putative beneficial and harmful effects, and clinical outcomes of oral hypoglycemic drugs and insulin use in glycemic control among COVID-19 patients, by searching literatures. Although there were some negative studies, the meta-analysis reported that the treatment using metformin was associated with reduction in mortality due to COVID-19. One study showed that treatment with sitagliptin, one of dipeptidyl peptidase-4 (DPP4) inhibitors, during hospitalization was associated with reduction of mortality, with a clinical improvement as compared with patients on the standard care. There were no clinical studies showed effects of glucagon-like peptide-1 receptor agonists, pioglitazone and sulfonylurea on COVID-19 outcomes. Regarding sodium-glucose cotransporter 2 (SGLT2) inhibitors, a case of eugly-cemic diabetic ketoacidosis (DKA) associated with COVID-19 and a case of DKA that was difficult to distinguish from COVID-19 were reported. COVID-19 patients who need hospital care may deteriorate rapidly, an early and appropriate initiation of insulin therapy in hyper-glycemic COVID-19 patients may be to be encouraged. © The authors ;Journal compilation.

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