1. Safety: The vaccine was safe across all groups. Adverse events were similar among participants with rheumatoid arthritis, lupus, and healthy controls. The rheumatoid arthritis patients reported more musculoskeletal side effects, such as joint pain and muscle pain. No serious vaccine-related adverse events were noted, and no increase in rheumatic disease activity was observed.
2. Degree of vaccine response (Immunogenicity): The vaccine was less effective in generating anti-Spike antibodies in patients with rheumatoid arthritis and lupus compared to healthy controls. Specifically, patients with rheumatoid arthritis and lupus had lower levels of antibodies and neutralizing antibodies. Factors such as being over 65 years of age, and treatment with rituximab, were associated with reduced vaccine responses in rheumatoid arthritis patients.
3. COVID-19 Infection Rates: The number of self-reported cases of COVID-19 among rheumatoid arthritis patients was the same to that in healthy controls.

The Moderna Spikevax vaccine is safe in people living with autoimmune rheumatic diseases. The response to the vaccine is very good in most patients but reduced in those over age 65 and in patients on specific treatments (i.e. rituximab).

Following this study, we conducted a trial to evaluate strategies to enhance responses to COVID vaccines in patients on rituximab.

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