ABSTRACT
Background: COVID-19 vaccination has been suggested as very effective in patients with Inflammatory Bowel Disease (IBD), but most studies assess antibody levels within a few weeks after vaccination and do not use the most recent recommendations as seroconversion cut-off. The objective of VACOVEII study is to evaluate the antibody response to vaccination at 6 months using these recommendations, the improvement after a booster dose and the effect of the immunosuppressive therapy (IST). We present the intermediate results of the study. Method(s): Spanish multicentre, prospective and case-control study. 18 years or older IBD patients fully vaccinated against COVID-19 were included. Those with previous COVID infection were not included, but not excluded for the next analyses if the infection was subsequent. Main outcomes were anti-SARS-CoV-2 spike protein antibody (anti S) concentrations and rate of seroconversion (defined above the protection threshold of 260 BAU/mL), measured 6 months after vaccination at a single centralized laboratory. The effect of IST on the main outcomes was analysed, adjusted by age, vaccine type and COVID infection. Groups of treatment considered for the analysis were: Patients without IST (without treatment or under salicylates alone), anti-TNF in combination with immunomodulators (IMM), anti-TNF in monotherapy, IMM in monotherapy, ustekinumab and anti-integrin. Result(s): We included 313 patients with IBD (46.5% ulcerative colitis and 52.3% Crohn's disease, median age 49 years) vaccinated either with non-mRNA vaccines (14%) or mRNA vaccines (86%). Baseline therapy was: 124 patients without IST, 21 with anti-TNF plus IMM, 67 with anti-TNF in monotherapy, 54 with IMM in monotherapy, 28 with ustekinumab and 19 with anti-integrin. Mean anti S concentrations were significant lower in patients with anti-TNF compared with patients without IST (Figure 1). In multivariable analysis, lower antibody concentrations were independently associated with anti-TNF treatment, non-mRNA vaccines and older age. Within the patients with no COVID infection during the follow-up, we found very low rates of seroconversion in patients with anti-TNF (14.1%), ustekinumab (30.8%) and IMM in monotherapy (34.9%), compared with patients without IST (51.5%) (Table 1). In multivariable analysis, anti-TNF treatment, non-mRNA vaccines and older age were independently associated with lower rates of seroconversion, as well as ustekinumab and IMM in monotherapy (Table 2). Conclusion(s): COVID-19 vaccine-induced antibody seroconversion in patients with IBD, measured at 6 months and according to >260 BAU as protection threshold, is clearly lower than previously reported, with a profound impact by some IST therapies, mainly anti-TNF, besides age and type of vaccine.
ABSTRACT
Introduction: Multiple sclerosis drugs (DMTs) were expected to increase the incidence and risk of severe infection for SARSCoV- 2 and to decrease the response to the vaccine, but has it been the case? Objectives: 1) To evaluate the relationship between the use of DMTs and the incidence and severity of SARS-CoV-2 infection. 2) To evaluate the relationship between the use of DMTs and the incidence and severity of SARS-CoV-2 infection after vaccination. Aim(s): To demonstrate that treatment with DMTs does not increase the incidence and risk of severe illness or the response to vaccination due to SARS-CoV-2 infection. Method(s): Retrospective cohort study of 472 adults with MS in a MS Unit between March, 2020 and March, 2022. All DMTs were prescribed prior to COVID-19 testing. Variables: Demographics data, DMTs, SARS-CoV-2 test results, severity of the infection (hospitalized and death), infection after vaccination. Result(s): Among 472 patients with MS, 120 patients (25.4%) had SARS-CoV-2 infection (Incidence in the general population of Catalonia: 22.7%);83 (26%) were women;mean age: 49 years (44.5 yrs for infected;50.6 yrs for not infected);there was no significant difference in the incidence of infection between 66 (29.3%) of the 213 treated and 52 (21.8 %) of the 259 untreated patients (p=0,059). There was also no significant difference in hospitalization between the 4 treated (5.9 %) and 3 untreated (2.5 %) patients. None of them died. There wasn't a significant difference between post-vaccination incidence of infection between the 26 treated (41.3%) and 16 untreated (36.4%) patients either. Conclusion(s): The use of DMTs was not associated with an increase in incidence or severity of SARS-CoV-2 infection, and a favorable vaccine-induced SARS-CoV-2 response was observed. Further research is needed to determine the possible protective role of MS drugs on risk and severity of SARS-CoV-2 and the mechanisms that underlie these findings.
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
Introduction: The exhaustive registry of COVID-19 cases in patients with IBD is a unique opportunity to learn how to deal with this infection, especially in reference to the management of immunosuppressive treatment, isolation measures or if the disease is more severe in IBD patients due to immunosuppression. Aims & Methods: Aims: The aims of this study were to know the incidence and characteristics of COVID-19 in the ENEIDA cohort during the first wave of the pandemic;the outcomes among those under immunosuppressants/ biologics for IBD;the risk factors for contracting the infection and poor outcomes;and the impact of the infection after three-month followup. Methods: Prospective observational cohort study of all IBD patients with COVID-19 included in the ENEIDA registry (with 60.512 patients in that period) between March and July 2020, with at least 3 months of follow-up. Any patient with a confirmed (by PCR or SARS-CoV-2 serology) or probable (suggestive clinical picture) infection was considered as a case. Results: A total of 482 patients with COVID-19 from 63 centres were included: 247 Crohn's disease, 221 ulcerative colitis and 14 unclassified colitis;median age 52 years (IQR: 42-61), 48% women and 44% 1 comorbidity. Diagnosis was made by PCR: 62% and serology: 35%. The most frequent symptoms: fever (69%), followed by cough (63%) and asthenia (38%). During lockdown 78% followed strict isolation. 35% required hospital admission (ICU: 2.7%) and 12% fulfilled criteria for SIRS upon admission. 18 patients died from COVID-19 (mortality:3.7%). 12% stop IBD medication during COVID-19. At 3 months, taken into account all included cases, 76% were in remission of IBD. Age 50 years (OR 2.09;95% CI:1.27-3.4;p=0.004), 1 comorbidities (OR 2.28;95% CI:1.4-3.6;p=0.001), and systemic steroids <3 months before infection (OR 1.3;95%CI:1-1.6;p= 0.003), were risk factors for hospitalisation due to COVID-19. A Charlson score 2 (OR 5.4;95%CI:1.5-20.1;p=0.01) was associated with ICU admission. Age 60 years (OR 7.1;95%CI:1.8-27.4;p=0.004) and having 2 comorbidities (OR 3.9;95% CI:1.3-11.6;p=0.01) were risk factors for COVID- 19 related death. Conclusion: IBD does not seem to worsen the prognosis of COVID-19, even when immunosuppressants and biological drugs are used. Age and comorbidity are the most important prognostic factors for more severe COVID-19 in IBD patients.
ABSTRACT
Introduction: The information regarding IBD patients with COVID-19 suggests that the factors related to bad outcome are older age and comorbidity whereas immunosuppressants do not have a significant impact worsening the disease evolution. Aims & Methods: Aims: To assess if there are differences in epidemiological, demographical, and clinical characteristics between infected and non-infected IBD patients. Methods: Case-control study in IBD patients with COVID-19 (cases) compared to IBD without COVID-19 (controls) in the period March-July/2020 within the ENEIDA registry (promoted by GETECCU and with more than 60.000 IBD patients included). Cases were matched 1:2 by age (±5y), type of disease (CD/UC), gender, and centre. All controls were selected from only one investigator blind to other clinical characteristics of the patients to avoid selection bias. Results: 482 cases and 964 controls from 63 Spanish centres were included. No differences were found within the basal characteristics including CD location, CD behaviour, extraintestinal manifestations, family history of IBD or smoking habits. Cases had ≥ 1 comorbidities (cases:43%vs. controls: 35%, p=0.01) and occupational risk (cases:27% vs. controls:10.6%, p<0.0001) in a higher proportion. Strict lock-down was the only measure demonstrating protection against COVID-19 (cases:49% vs. controls:70%, p<0.0001). There were no differences in the use of systemic steroids (p=0.19), immunosuppressants (p=0.39) or biologics (p=0.28) between cases and controls. Cases were more often treated with aminosalycilates (42% vs.34%, p=0.003). Having ≥ 1 comorbidities (OR:1.6, 95%CI: 1.2-2.1), occupational risk (OR:1.95, 95%CI:1.39-2.7) and the use of aminosalycilates (OR:1.4, 95%CI: 1-1.8) were risk factors for COVID-19. On the other hand, strict lockdown was a protective factor (OR:0.38, CI:0.29-0.49). Conclusion: Comorbidities and epidemiological risk factors are the most relevant aspects for the risk of COVID-19 in IBD patients. This risk of COVID- 19 seems to be increased by aminosalycilates but not by immunosuppressants or biologics. The attitude regarding treating IBD patients with aminosalicylates during COVID-19 pandemic deserves a deeper analysis. (Table Presented).