Title : Immunogenicity, safety, and efficacy of the novel SARS-CoV-2 vaccines in patients with systemic rheumatic diseases.
Abstract:
Abstract: Systemic rheumatic disease (SRD) patients under immunosuppressive/immunomodulatory therapy are at a higher risk for COVID-19 hospitalization and worse outcomes compared to the general population and as such, were prioritized for immunization against SARS-CoV-2 before the general population. SRD patients, demonstrating hyporesponsiveness to non-COVID-19 vaccines, either were excluded or included in a relatively small number in phase II/III clinical trials evaluating the efficacy and safety of the SARS-CoV-2 vaccines. This presentation aims to review data from the published literature, including our department’s findings, regarding humoral immune responses in patients with SRD after SARS-CoV-2 vaccination. SRD patients show decreased seroconversion rates and cellular immune responses compared to individuals of similar age and sex not on immunosuppressive treatments. High risk factors negatively associated with antibody responses are increased age and use of rituximab, mycophenolate, and glucocorticoids. Results regarding methotrexate and anti-cytokine treatment remain controversial. Therefore, treatment modifications during SARS-CoV-2 vaccination were rapidly recommended by experts and rheumatology societies; (a) temporal withhold (1-2 week and/or after dose administration) of conventional synthetic disease modifying drugs, (b) decrease in corticosteroids dose and (c) longer time intervals between immunization and rituximab administration until B-cell repopulation. As far as safety is concerned, adverse events (such as pain at the injection site, fatigue, fever), though common, were mild, self-limiting, and comparable to those reported among healthy individuals. Among disease flares of the underlying SRD reported (up to 10% of vaccinated patients), the majority were mild not necessitating treatment adjustments. Data on efficacy of SARS-CoV-2 vaccination in SRD patients are now emerging and fully vaccinated SRD patients with breakthrough COVID-19 demonstrate better outcomes compared with unvaccinated counterparts with similar disease/treatment characteristics. Importantly, most breakthrough infections occur in cases where social preventive measures were omitted. Finally, recent reports have additionally shown the ability of a third dose to induce immune responses in non-responders and boost responders and only those SRD patients treated with rituximab exhibit a significant high risk of not responding.
What will audience learn from your presentation?
- Identify patients with systemic rheumatic diseases who are less likely to develop insufficient humoral immune responses after SARS-CoV-2 vaccination
- Adopt specific vaccination strategies for patients with systemic rheumatic diseases in order to dampen the effect of immunosuppressive therapy and achieve the best possible immune responses following SARS-CoV-2 vaccination.
- Vaccine-induced immunization against SARS-CoV-2 is safe and efficacious for preventing severe COVID-19 and adverse outcomes in patients with systemic rheumatic diseases; however, social protection measures remain the core stone during COVID-19 pandemic.
