Dataset Information

Safety of SARS-CoV-2 vaccination in patients with inflammatory bowel disease: A systematic review and meta-analysis.

ABSTRACT:

Introduction

Risk of adverse effects and flare of inflammatory bowel disease (IBD) are frequently cited reasons for COVID-19 vaccine hesitancy.

Methods

Electronic databases were searched to identify studies reporting the use of COVID-19 vaccine in IBD. We selected studies reporting the incidence of various adverse effects (local or systemic) and flares of IBD after COVID-19 vaccination. The pooled incidence rates for various adverse effects, stratified for the dose and the type of vaccine (adenoviral or mRNA) were estimated.

Results

Nine studies (16 vaccination cohorts) were included. The pooled incidence rate of overall adverse events was 0.55 (95%CI, 0.45-0.64, I²= 95%). The pooled incidence rate of local adverse events was 0.64 (0.47-0.78, I²= 100%). The pooled incidence rates of fatigue, headache, myalgia, fever and chills were 0.30 (0.21-0.40, I²= 99%), 0.23 (0.17-0.30, I²= 99%), 0.18 (0.13-0.24, I²= 99%), 0.10 (0.06-0.17, I²= 98%) and 0.15 (0.06-0.3, I²= 86%), respectively. The pooled incidence rates of severe adverse events, adverse events requiring hospitalization and flares of IBD following COVID-19 vaccination were 0.02 (0.00-0.12, I²= 97%), 0.00 (0.00-0.01, I²= 27%) and 0.01 (0.01-0.03, I²= 45%), respectively.

Conclusion

COVID-19 vaccination in patients with IBD appears to be safe with only mild adverse events. Flares of IBD and severe adverse events requiring hospitalization were infrequent.

SUBMITTER: James D

PROVIDER: S-EPMC8938236 | biostudies-literature | 2022 Jun

REPOSITORIES: biostudies-literature

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Publications

Safety of SARS-CoV-2 vaccination in patients with inflammatory bowel disease: A systematic review and meta-analysis.

James Deepak D Jena Anuraag A Bharath Pardhu Neelam PN Choudhury Arup A Singh Anupam K AK Sebastian Shaji S Sharma Vishal V

Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver 20220322 6

<h4>Introduction</h4>Risk of adverse effects and flare of inflammatory bowel disease (IBD) are frequently cited reasons for COVID-19 vaccine hesitancy.<h4>Methods</h4>Electronic databases were searched to identify studies reporting the use of COVID-19 vaccine in IBD. We selected studies reporting the incidence of various adverse effects (local or systemic) and flares of IBD after COVID-19 vaccination. The pooled incidence rates for various adverse effects, stratified for the dose and the type of ...[more]

PMID: 35382972

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Project description:BackgroundPatients with inflammatory bowel disease (IBD) have an attenuated serologic response to COVID-19 vaccination. It is unclear whether an impaired immune response in vaccinated IBD patients impacts the susceptibility to SARS-CoV-2 infection and occurrence of severe COVID-19.ObjectivesTo evaluate SARS-CoV-2 breakthrough infection rates and the disease course of COVID-19 in vaccinated IBD patients.DesignA systematic literature search and meta-analysis was performed.Data sources and methodsThe search was performed in Embase, Medline, Web of Science Core Collection, Cochrane Central Register of Controlled Trials and CINAHIL. The articles were independently screened and selected by two reviewers. A random-effects model was used to calculate the pooled relative risk for breakthrough infections in vaccinated IBD patients and controls.ResultsA total of 16 studies were included, with study periods ranging from January 2020 to October 2021 and follow-up time from 3 weeks to 6 months. The breakthrough infection rates range from 0 to 37.4% in vaccinated IBD patients. The disease course of COVID-19 was generally mild, with low hospitalization and mortality rates (0-8.7% and 0-4.3%, respectively). Vaccinated IBD patients had a significantly lower relative risk of breakthrough infection rate compared to unvaccinated controls (risk ratio: 0.07, 95% CI: 0.03-0.18). No difference was observed between IBD patients and non-IBD controls, and between partially and fully vaccinated IBD patients. The impact of immunosuppressive therapy on breakthrough infection rates differs between studies. Most studies showed no impact from immunosuppressive treatment, anti-tumour necrosis factor alpha or corticosteroids and other biologics; one study reported higher rates for patients treated with infliximab versus vedolizumab.ConclusionVaccination is effective to prevent COVID-19 infections in patients with IBD. Breakthrough infections do occur, but the disease course is generally mild. Available data seem to suggest a declining trend of breakthrough infections during calendar time.RegistrationThe protocol was published in the PROSPERO database (CRD42021292853).

Project description:ObjectivesThe treatment for COVID-19 often utilizes immune-modulating drugs. These drugs are also used in immune mediated inflammatory diseases (IMIDs). We performed a systematic review about seroconversion after SARS-CoV-2 vaccination in patients with IMIDs and impact of various drugs on seroconversion rates.MethodsElectronic databases were searched to identify relevant studies reporting seroconversion rates following SARS-CoV-2 vaccination in IMIDs. We calculated the pooled seroconversion rates after a single or two doses of vaccination, pooled seroconversion rates in patients with specific IMIDs, and rates in patients on various drugs/drug classes.ResultsTwenty-five studies were included in the systematic review. The pooled seroconversion rates after two doses of mRNA vaccination were higher (83.1, 95%CI: 74.9-89.0, I2 = 90%) as compared to a single dose (69.3, 52.4-82.3, I2 = 95%). The odds of seroconversion were lower in IMIDs as compared to healthy controls (0.05, 0.02-0.13, I2 = 21%). The seroconversion rates in patients with inflammatory bowel disease (95.2, 95%CI: 92.6-96.9, I2 = 0%), spondyloarthropathy (95.6, 95% CI: 83.4-98.9, I2 = 35%), and systemic lupus erythematosus (90.7, 95%CI: 85.4-94.2, I2 = 0%) were higher as compared to rheumatoid arthritis (79.5, 95% CI: 65.1-88.9, I2 = 85%), and vasculitis (70.5, 95% CI: 52.9-83.5, I2 = 51%). The seroconversion rates following double dose of mRNA were excellent (>90%) in those on anti-tumour necrosis factor (TNF), anti-integrin (vedolizumab), anti-IL 17 (secukinumab), anti-IL6 (Tocilizumab) and anti-IL12/23 (Ustekinumab) therapies but attenuated (<70%) in patients on anti-CD20 (Rituximab) or anti-cytotoxic T lymphocyte associated antigen (CTLA-4) therapies (Abatacept). The seroconversion rates were good (70-90%) with steroids, hydroxychloroquine, JAK inhibitors, mycophenolate mofetil and leflunomide. Combination of anti-TNF with immunomodulators (azathioprine, 6-meracptopurine, methotrexate) resulted in an attenuated vaccine response as compared to anti-TNF monotherapy.ConclusionSeroconversion rates after SARS-CoV-2 vaccination are lower in patients with IMIDs. Certain therapies (anti-TNF, anti-integrin, anti-IL 17, anti-IL6, anti-12/23) do not impact seroconversion rates while others (anti-CD20, anti-CTLA-4) result in poorer responses.

Project description:Background and aimsSARS-CoV-2 is a worldwide serious health problem and vaccination seems to have a crucial role in managing the COVID-19 pandemic. The aim of this prospective observational study was to monitor the trend of antibodies against SARS-CoV-2 after vaccination with BNT162b2 (COMIRNATY) in patients with inflammatory bowel disease treated by immunosuppressive and/or biological therapy, demonstrate whether any type of this therapy is associated with poorer production of antibodies against COVID-19 and evaluate the safety of vaccination against COVID-19 in these patients.MethodsEighty-seven eligible patients from one tertiary gastroenterological center with inflammatory bowel disease (60 with CD, 27 with UC) treated by immunosuppressive and/or biological therapy from the antiTNFα group were indicated to vaccination against SARS-CoV-2. Effectiveness of vaccination was evaluated by the values of antibodies before and 4 weeks after 2nd dose of vaccine. Additional goal was to evaluate adverse events of vaccination.ResultsBefore the 2nd dose of vaccine, geometric mean of SARS-CoV-2 IgG antibodies were 40.7 U/ml in the biological therapy group, 34.8 U/ml in the azathioprine group and 44.8 U/ml in the combination therapy group of patients. The geometric means were 676.5.7 U/ml in the biological therapy group, 614.4 U/ml in the azathioprine group and 500.1 U/ml in the combination therapy group of patients four weeks after 2nd dose. Statistically significant differences between these groups were not proved. Several non-severe local and general adverse events were present in our patients with a majority of these events on the day of vaccine administration and the day after, no anaphylactic reactions were present.ConclusionsOur measurements proved the efficacy and safety of vaccination against SARS-CoV-2 in patients with inflammatory bowel disease treated by immunosuppressive and/or biological therapy. Statistically significant differences between our groups of patients were not proved.

Dataset Information

Safety of SARS-CoV-2 vaccination in patients with inflammatory bowel disease: A systematic review and meta-analysis.

Introduction

Methods

Results

Conclusion

Publications

Safety of SARS-CoV-2 vaccination in patients with inflammatory bowel disease: A systematic review and meta-analysis.

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