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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:i359, 2022.
Article in English | EMBASE | ID: covidwho-1722327

ABSTRACT

Background: Inflammatory bowel diseases are varied in the way they present, progress and respond to treatment. IBD patients frequently complain about the lack of proper knowledge and support systems, this gap leads to an extensive online search for information. The aim of our study was to characterize the trends in IBD-related Google searches by exploring the Google Trends query tool Methods: We retrieved worldwide Google Trends data related to Crohn's Disease and Ulcerative Colitis over the past, 10 years (Jan, 2011 - Oct, 2021). The search terms selection was based on preferences and knowledge gaps identified by an online survey by the members of the of the israeli Crohn's Disease and Ulcerative Colitis patients association, coupled with data from available literature and Google autocompletion data. We also compared the search volume of the two diseases using the “Topic” feature in google trends, which allows us to utilize google's search terms aggregation by a specific topic. Google trends provide RSV (Relative Search Volume) over time, and over different regions. The results are normalized on a scale of, 0-100 (100 signifying the most highly-search item).We also compared the RSV for searches related to UC and CD. Results: Out of the, 20 domains researched over, 370 months, the, 10 most searched domains in Crohn's disease related searches was 'diet'(41.30%), 'cancer'(14.22%), 'weight'(7.52%), 'pregnancy'( 4.44%), 'disability'(4.05%), 'COVID'(3.45%), 'alcohol' (3.22%), 'vaccine' (3.17%), 'stress' (2.54%) and 'smoking' (2.47%). The, 10 most searched domain in ulcerative colitis related searches was 'diet' (41.72%), 'cancer' (18.69%), 'weight' (5.47%), 'pregnancy'(4.77%), 'smoking'(3.76%), 'alcohol'(3.63%), 'probiotics(3.27%), 'disability'( 2.77%), 'stress'(2.62%) and 'covid'(2.12%). When focusing at the time period between March, 2020 and October, 2021, the most searched domain in crohn's disease was 'COVID'(22.67%) followed by 'diet'(21.81%), 'cancer'(12.52%), 'vaccine'(10.70%), 'weight'(7.07%), 'disability' (4.34%), 'alcohol' (2.82%), 'pregnancy' (2.67%), 'stress' (2.22%) and 'biologics' (2.17%). Over the same time span, the most searched domain in ulcerative colitis was 'diet' (29.59%) followed by 'cancer' (18.32%), 'COVID' (11.84%), 'weight' (6.32%), 'vaccine' (5.75%), 'alcohol' (4.07%), 'pregnancy' (3.66%), 'disability' (3.06%), 'smoking' (2.61%) and 'probiotics' (2.46%). Conclusion: Patients have numerous interests related to their IBD disease. The most searched IBD-related item is diet, with COVID-19 leading since the break of the pandemic. Our results are a surrogate representation of the patient's knowledge gaps and needs, and we suggest that IBD healthcare providers should focus their guidance on the issues identified by the patients as such.

4.
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).

6.
United European Gastroenterology Journal ; 9(SUPPL 8):553-554, 2021.
Article in English | EMBASE | ID: covidwho-1490988

ABSTRACT

Introduction: A subcutaneous (SC) infliximab (IFX), CT-P13 SC, has received regulatory approval from the European Medicines Agency for indications including inflammatory bowel disease.1 In response to the coronavirus disease 2019 (COVID-19) pandemic, clinical guidance has recommended considering switching from intravenous (IV) treatment to SC alternatives to minimise hospital visits.2 Aims & Methods: In this analysis, data from the pivotal randomised controlled trial (NCT02883452) of CT-P13 SC in patients with active Crohn's disease (CD) and ulcerative colitis (UC) were analysed to investigate the clinical impact of switching from IV to SC IFX.3 Patients in the CT-P13 IV arm of the pivotal trial received CT-P13 5 mg/kg IV every 8 weeks from Week (W) 6 until W22. At W30, patients switched to receive CT-P13 SC every 2 weeks up to W54 (dose 120 mg or 240 mg for patients <80 kg or ≥80 kg, respectively).3 This post hoc analysis compared per-patient pairwise data at W30 (pre-switch) and W54 (post-switch) from the CT-P13 IV arm for the following outcomes: trough serum concentration (Ctrough;5 μg/mL was considered to be the target exposure level), clinical response (for CD patients, ≥100-point decrease in Crohn's Disease Activity Index score;for UC patients, ≥2-point decrease in partial Mayo score with accompanying ≥1-point decrease in rectal bleeding subscore or an absolute rectal bleeding subscore of 0 or 1) and immunogenicity (anti-drug antibody [ADA] and neutralising antibody [NAb] positivity;as measured by a drug tolerant assay;ADA negative was regarded as NAb negative). For pairwise comparisons, patients with missing data at either W30 or W54 were excluded from the analysis. Statistical comparisons used Fisher's exact test. The differences are reported in a descriptive manner. Results: Overall, 65 patients (25 CD;40 UC) were included in the CT-P13 IV arm. The proportion of patients with a Ctrough level exceeding target exposure was significantly higher post-switch (36/41, 87.8%) than pre-switch (8/41, 19.5%;p<0.00001) (Table). Clinical response rates were comparable at both pre- and post-switch timepoints (40/49 [81.6%] vs 44/49 [89.8%], respectively;p=0.3873). Positive ADA and NAb rates at pre-switch and post-switch were also comparable, in which some changes were regarded from patients with marginal value (Table). Conclusion: Switching from IV to SC IFX did not detrimentally affect the clinical outcomes of patients with active CD or UC. Further, switching from IV to SC IFX might confer more favourable pharmacokinetic outcomes, although larger comparative studies are warranted. (Table Presented).

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