ABSTRACT
Introduction: Pivotal anti-SARS-CoV-2 vaccines clinical trials did not include patients with immune-mediated conditions such as inflammatory bowel disease (IBD). We aimed to describe the implementation of anti-SARS-CoV-2 vaccines among IBD patients, patients' concerns before vaccination and side-effect profile of the anti-SARS-CoV-2 vaccines using real-world data. Methods: An anonymous web-based self-completed survey was distributed in 36 European countries between June and July 2021. The results of patients' characteristics, concerns, vaccination status and side-effect profile were analysed using descriptive statistics and logistic regression. Results: Among the 3272 IBD patients completing the survey (0.1% of the IBD European population), 79.6% had received at least one dose of anti-SARS-CoV- 2 vaccine, and 71.7% had completed the vaccination process. Most of the patients (70.6%) were vaccinated with the Pfizer-BioNTech (BNT162b2) vaccine. Patients over 60 years old had a significantly higher rate of vaccination (OR 2.98, 95% CI 2.20-4.03, p<0.001). Patients' main concerns before vaccination were the possibility of having worse vaccine-related adverse events due to their IBD (24.6%), having an IBD flare after vaccination (21.1%) and reduced vaccine efficacy due to IBD or associated immunosuppression (17.6%). After the first dose of the vaccine, 72.4% had local symptoms at the injection site and 51.4% had systemic symptoms (5 patients had non-specified thrombosis). Adverse events were less frequent after the second dose of the vaccine and in older patients. When comparing with previous studies from the general population, the IBD patients answering the survey did not seem to have increased side effects (table 1). Only a minority of the patients were hospitalized (0.3%), needed a consultation (3.6%) or had to change IBD therapy (13.4%) after anti- SARS-CoV-2 vaccination. Conclusion: Although IBD patients raised concerns about the safety and efficacy of anti-SARS-CoV-2 vaccines, the implementation of vaccination in those responding to our survey was high and the adverse events were comparable to the general population, with minimal impact on their IBD. (Table Presented)
ABSTRACT
BACKGROUND AND AIM: Patients with inflammatory bowel disease (IBD) on immune-modifying treatment could be at an increased risk for severe coronavirus disease of 2019 (COVID-19), thus data on the efficacy and safety of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) vaccines are essential. We have conducted a prospective study of IBD patients vaccinated with BNT162b2, CX- 024414 and ChAdOx1 nCoV-19 vaccines. The aim was to evaluate the rate and the magnitude of seroconversion, to assess the effect of different immune-modifying treatment modalities on the magnitude of anti-SARS-CoV-2 IgG antibody levels, and to analyze the impact of anti-SARS-CoV-2 vaccination on the inflammatory biomarkers of IBD. METHODS: The study included 602 IBD patients and 168 immunocompetent health-care workers serving as controls. Serum anti-SARS-CoV-2 IgG antibodies were measured by chemiluminescent microparticle immunoassay before the vaccination, and 8 weeks after the end of vaccination. RESULTS: Of IBD patients, 82.2% were receiving biological treatment: most of them were treated TNF-alpha inhibitors (48.5%) and just under half of them with concomitant thiopurines or methotrexate, followed by vedolizumab (18.6%) and ustekinumab (15.1%). Only 8.1% of patients were on 5-aminosalicylates, and a minority (2.2%) were treatment-free. The post-vaccine seropositivity rate among IBD patients and controls was 97.8% versus 100%. Median anti-SARS-CoV-2 IgG levels were lower among IBD recipients of ChAdOx1 nCoV-19 compared to two other vaccines (p < 0.0001) and to control ChAdOx1 nCoV-19 recipients (p = 0.01). No correlation was found between serum trough levels and anti-SARS-CoV-2 IgG concentrations for any of the biological drugs used. TNFalpha inhibitors with concomitant immunosuppressive treatment but no other treatment modalities were associated with the lower post-vaccination antibody response ( p <0.0001). When evaluating the laboratory activity of IBD by C-reactive protein and fecal calprotectin levels, no significant differences were found before the vaccination and eight weeks after its completion. CONCLUSION: Our findings warrant particular attention to the anti-SARS-CoV-2 vaccination of IBD patients treated with TNFa inhibitors with concomitant immunomodulators and show priority of mRNA vaccines in this specific group of patients.