JMIR Publications

ABSTRACT

Background:

Patients with immune-mediated inflammatory disease (IMID), including autoimmunity, fared significantly worse than the general population during the COVID-19 pandemic both in terms of infection outcomes and levels of life disruption. Despite this, COVID-19 vaccine uptake has not been universal. The absence of IMID patients from clinical trials and the subsequent lack of precision in vaccine safety profiling adds to vaccine hesitancy in this high-risk group.

Objective:

The present protocol sets out an investigation that aims to address this by enhancing COVID-19 vaccine pharmacovigilance for patients with IMID. Combining the international data and knowledge assets of the COVID-19 Vaccination in Autoimmune Diseases (COVAD) 1 Study and the electronic Delphi Study to Define and Risk-Stratify Immunosuppression (DESTINIES), its objective is to differentiate patient-reported COVID-19 infection and vaccine outcomes between systemic, single site and overlap IMID patients and general population controls.

Methods:

The COVAD 1 Study successfully collected data on the demographic, health, COVID-19 infection and COVID-19 vaccination outcomes of a broad range of IMID patients between March and December 2021. The present protocol expands on this initial analysis, utilising IMID expertise within the DESTINIES Consortium to allocate survey respondents into single site and systemic categories and thereby produce comparative vaccine benefit-risk profiles between these and general population controls. Due to respondents’ ability to self-declare multiple diagnoses, an overlap group was introduced for those affected by both single site and systemic diagnoses. Descriptive statistics, Chi-squared tests of independence, incidence rate ratios and multivariable logistic regressions will be utilised to test for significant differences in COVID infection rates, severity, duration and vaccine side effects between populations.

Results:

We anticipate that more severe COVID-19 infection outcomes (hospitalisation with and without Oxygen support) and vaccine side effects (mild and major) were reported amongst systemic patients than single site IMID patients. We expect this will be moderated by factors including age, prior health status and medication, however. The multimorbidity of the overlap IMID category is also expected to result in increased adverse COVID-19 infection and vaccine outcomes compared to exclusively single site patients.

Conclusions:

Advocating for direct-to-patient vaccine reporting pathways, this study intends to provide more precise vaccine safety profiles of IMID patients. It seeks to address current gaps in pharmacovigilance and potentially remedy vaccine hesitancy in high-risk groups by doing so.