The Moderna mRNA 1273 SARS-CoV-2 vaccine is safe in immunosuppressed adults with autoimmune disease and not associated with severe disease flares. However, therapy with mycophenolate mofetil and rituximab is associated with a distinct reduction in vaccine-induced humoral responses. Patients with immunocompromised disorders, a history of autoimmune disease, or immunocompromised conditions have mainly been excluded from clinical vaccination trials against COVID-19. Therefore, a Canadian study (NCT04806113) assessed the safety and efficacy of two doses of the mRNA-1273 SARS-CoV-2 vaccine in patients with autoimmune diseases.1,2 “Our study was designed as a prospective, randomized, open-label comparative trial that was conducted at two centers,” Dr. Ines Colmegna (McGill University Health Centre, Canada) said. Safety of the vaccine was the primary outcome. The researchers also assessed the effect of age and medication on safety and immunogenicity of the vaccine. “The design we used was the same design of the large phase III trials that led to the approval of the mRNA vaccine in the general population,” Dr. Colmegna explained. Included participants had either seropositive rheumatoid arthritis (RA) on stable treatment for at least 3 months, systemic lupus erythematosus (SLE) on stable therapy with mycophenolate mofetil (MMF), or other rheumatic disease receiving at least 10 mg of prednisone per day. These three groups were compared with age/sex-matched healthy controls. Overall, 220 patients were enrolled, including 131 patients with RA, 23 with SLE, eight with other rheumatic diseases, and 58 controls. Local and systemic adverse events were more frequently reported after the second dose in all subjects (94.0% vs 86.8%). Pain at the injection site was the most common side effect. Disease activity scores post-vaccination did not increase in patients with a rheumatic disease. Regarding immunogenicity, controls fared substantially better than patients with autoimmune disease. After the first shot, positivity for serum IgG antibodies against SARS-CoV-2 spike protein and its receptor-binding domains was 100% in controls compared with only 67.7% in those with RA, 34.8% in those with SLE, and 87.5% in those with other rheumatic diseases. After the second dose, seropositivity remained 100% in controls, increased to 88.5% in those with RA and 78.3% in those with SLE, and persisted at 87.5% in those with other rheumatic diseases. Interestingly, older patients with RA (>65) had a similar seropositivity post-second dose compared with younger patients. Patients treated with rituximab or MMF had lower humoral responses than patients not on those drugs (17.6% and 78.3% after the second dose, respectively). “This study is reassuring in terms of the adverse event profile after complete vaccination of mRNA vaccines, specifically Moderna, in patients with autoimmune diseases,” Dr. Colmegna said. No serious adverse events were reported, and vaccination did not lead to severe disease flares. However, in patients with RA on rituximab and patients with SLE on MMF, reduced vaccine-induced humoral responses have to be expected.

  1. Colmegna A, et al. COVID-19 vaccine in immunosuppressed adults with autoimmune diseases. L02. ACR Convergence 2021, 3-10. November.
  2. Colmegna A. 6S229. Press conference: infectious & rare disease.

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