Table 1.

The systematic review research questions and study outcomes.

Research questions

1.What is the rate of immunological response to COVID-19 vaccines in patients with ARD? 2.How effective are COVID-19 vaccines in patients with ARD in terms of protection from symptomatic breakthrough COVID-19 infections? 3.What is the safety profile of the COVID-19 vaccines in patients with ARD? 4.Does the use of COVID-19 vaccine is associated with new-onset ARD precipitation or reactivation of an indolent disease? 5.How to manage immunosuppressive medications at the time of COVID-19 vaccination?

The PICO question

P: Patients with autoimmune rheumatic diseases

I: Receiving at least two doses of any of the UK-licensed COVID-19 vaccines

C: The population in the control group

O: Outcomes measures including:

Primary outcome:

Immunological response to COVID-19 vaccine defined by anti-SARS-COV-2 Antibody titer and/or cellular response measured by SARS-CoV-2 specific interferon release essay

Secondary outcomes:

Severity of breakthrough COVID-19 infection post vaccination defined according to the National Institute of Health 2021 criteria [27] (Supplementary Table 1)

Biological agents’ effects on COVID-19 vaccine immunological response

DMARDs’ effect on COVID-19 disease vaccine immunological response

Incidence of vaccine-related adverse events

Exacerbation of ARD activity

Precipitation of new-onset ARD