Seroprevalence of ANTI-SARS-CoV-2 antibodies in patients with inflammatory bowel disease.

Patients with inflammatory bowel disease (IBD) treated with biologic and/or immunosuppressant drugs are at increased risk for opportunistic infections. Seroprevalence studies can confirm the diagnosis of SARS-CoV-2 infections as well as the associated risk factors. This is a descriptive study which primary endpoints were to highlight the prevalence of SARS-CoV-2 antibodies in a cohort of IBD patients in March 2021, and to analyze seroconversion in patients with known COVID-19 infection and its relationship with IBD treatments. Patients filled in a questionnaire about symptoms of COVID-19 infection and clinical information about their IBD. All included patients were tested for SARS-CoV-2 antibodies. 392 patients were included. Among patients with clinical infection, 69 patients (17,65%) were IgG-positive, 286 (73,15%) IgG-negative and 36 (9,21%) indeterminate. In relation to seroconversion among patients under biologic treatment, 13 patients of the 23 with a previous positive CRP developed antibodies (56.5%). However, when the influence of immunosuppressive treatment on the probability of developing antibodies was analyzed, no significant differences were seen between those patients with or without treatment (77.8% vs. 77.1%, p = 0.96). In our cohort of IBD patients, after one year of pandemic, there were 18.64% IgG positive patients, a higher prevalence than the general population (15.7%).

Serologic response to COVID-19 vaccines in IBD patients: A prospective study

Background: Our objective is to evaluate the serologic response to the SARS-CoV-2 vaccine in patients with Inflammatory Bowel Disease (IBD). In addition to that, we want to analyze the influence of immunosuppressive drugs in that response, as well as describe the adverse events in this population. Methods: We included 266 patients in a unicentric prospective study. All patients signed informed consent. A serologic blood test was made days before the first dose and 2-4 weeks after the complete immunization. We used Siemens Atellica Anti-SARS-CoV-2 (N) and Vircell Virclia (S and N) electrochemiluminescence immunoassay to detect antibodies to SARS-CoV-2). If they were discordant, the results were considered as undetermined. The IBD treatment was stable along the study. The statistics analysis of data was done with Stata 16. Results: Basal characteristics are described in table 1. The patients were on treatment with: 15 (5.66%) had no treatment, 47 (17.7%) had mesalamine, 4 (1.51%) had corticosteroids, 41 (15.47%) had immunomodulator, 113 (42.64%) had biologic and 45 (16.98%) had combo. Amongst the biologic drugs: Infliximab 51 (32,3%), Adalimumab 50 (31,6%), Vedolizumab 19 (12,03%) y Ustekinumab 31 (19,6%). The vaccines were messenger RNA BNT162b2 (Pfizer-BioNTech) in 154 12 months are presented as a real world evidence (RWE) comparison of UST vs anti-TNF. Methods: After exclusion of other biologics than UST and anti-TNF and missing outcomes, the final sample consisted of 607 CD-patients. Clinical remission (HBI ≤ 4) was the predefined endpoint at month 12. Patients were analyzed on a modified intent-to-treat basis (mITT;switchers considered as outcome failure). To reduce the effect of confounders, propensity score (PS) adjustment with inverse probability of treatment weighting (IPTW) was implemented. A weighted logistic regression was used, and the results were reported as odds ratio (OR) and 95% confidence interval (CI). Results: 343 UST (naïve: 35) and 264 anti-TNF (naïve: 175) (ADA 61%, IFX 39%) CD-patients were included. PS removed systematic differences between both groups (mean of both groups: 15% perianal disease, 36% surgical resection, 41% EIM). Overall, the number of switches was lower in the UST group than in the anti- TNF group (Tab. 1). However, the number of switches within 12 months was significantly lower in the UST group only when compared to the IFX group (16.3% vs 27.2%;p=0.045) (Fig. 1). Clinical remission rates at 1 year (Tab. 2) were not statistically different for the overall UST vs. anti-TNF groups (65.8% vs 60.0%). Remission rates were similar for UST vs ADA, while these were significantly higher for UST vs. IFX (61.6% vs 41.8%;p=0.009). Looking at clinical remission in the week 16 responder group (Tab. 3), a statistically significantly higher remission rate was found in the overall group for UST (77.6%) vs anti-TNF (65.4%) (p=0.041), which was mainly driven by the higher UST remission rate in biologic-naïve CD patients (p=0.026). Conclusion: This 1-year maintenance phase RWE-comparison with UST vs anti-TNF showed remarkably high clinical remission rates in both groups. Also due to a more frequent switching within the IFX group, the clinical remission rate at 1 year was significantly higher with UST than with IFX and higher with UST vs anti-TNF in the biologic-naïve groups. These results support together with the known favorable safety profile consideration of UST as a first-line targeted therapy for CD.

Serum prevalence of SARS-COv2 antibodies in patients with inflammatory bowel disease before vaccination

Introduction: Patients with inflammatory bowel disease (IBD) treated with biologic and/or immunosuppressant drugs are at increased risk for opportunistic infections, including viral infections (1) Previous studies have postulated that patients with IBD were not at increased risk of severe SARS-CoV-2 infections (2) although given the absence of microbiological confirmation at the onset of the pandemic, past infection could not be confirmed. Seroprevalence studies can confirm the diagnosis of SARS-CoV-2 infections as well as the associated risk factors. Aims & Methods: This is a descriptive study which primary endpoint was to highlight the prevalence of SARS-CoV-2 antibodies in a cohort of patients diagnosed with IBD followed in our unit, between 26 February and 26 March 2021, one year after the start of the pandemic. Patients with scheduled on-site visits to our unit were included;they filled in a detailed questionnaire about symptoms of COVID-19 infection, demographic data and clinical information about their IBD. All included patients were tested for SARS-CoV-2 antibodies by ELISA. Results: 338 patients were included: 181 with a diagnosis of Crohn's disease, 132 with ulcerative colitis and 25 with indeterminate colitis;baseline characteristics are shown in Table 1. There were 74 patients with clinically suspected infection compared to 264 without compatible clinical features. Among patients with clinical infection, 63 patients (18,64%) were IgG-positive, 243 (71,89%) IgG-negative and 32 (9,47%) indeterminate;These results were compared with the prevalence data of the Spanish Government in the community of Madrid (IgG positive 15,7%);differences were not statistically significant (p<0.05) (5). The positivity rate was analysed according to the treatment received. At the beginning of the pandemic, there were 46 patients without treatment (serological positivity rate 13,04%), 90 patients receiving mesalazine (IgG positive 27,78%), 51 patients receiving immunomodulators (IgG positive 27,45%), 85 patients with biological treatment (IgG positive 17,64%) and 56 patients combined biological and immunosuppressive treatment (serological positivity rate 5,36%).);these results were statistically significant (p <0,05). It is difficult to establish whether these differences between treatments are due to a lower number of infections (more patient care in the immunocompromised groups) or a lower seroconversion rate. (Table Presented) Conclusion: Although SARS-CoV-2 infection has been a diagnostic challenge in some cases, the presence of antibodies by ELISA allows confirmation of past infection. In our cohort of IBD patients, after one year of pandemic, there were 18.64% IgG positive patients, a higher prevalence than the general population (15.7%) (4). These differences may be justified by a higher number of hospital visits, the inflammatory disease itself or the treatments received.