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COVID-19 mRNA vaccine safe and tolerable in adults with autoimmune disease

Presented by
Dr Inés Colmegna, McGill University Health Centre, Canada
ACR 2021
A Canadian study revealed that the Moderna mRNA-1273 SARS-CoV-2 vaccine is safe in immunocompromised adults with autoimmune disease and not associated with severe disease flares. Interestingly, patients with rheumatoid arthritis (RA) ≥65 years had similar immune responses compared with younger patients.

Immunocompromised patients or those with a history of autoimmune disease have mainly been excluded from clinical vaccination trials against COVID-19. Therefore, a Canadian study (NCT04806113) assessed the safety and efficacy of 2 doses of the mRNA-1273 SARS-CoV-2 vaccine in patients with autoimmune diseases [1,2]. “Our study was designed as a prospective, randomised, open-label comparative trial that was conducted at 2 centres,” Dr Inés Colmegna (McGill University Health Centre, Canada) said. The safety of the vaccine was the primary outcome. The researchers also assessed the effect of age and medication on the safety and immunogenicity of the vaccine. “The design we used was the same design of the large phase 3 trials that led to the approval of the mRNA vaccine in the general population,” Dr Colmegna explained.

Included participants had either seropositive RA on stable treatment for ≥3 months, systemic lupus erythematosus (SLE) on stable therapy with mycophenolate mofetil (MMF), or other rheumatic diseases receiving ≥10 mg of prednisone per day. These 3 groups were compared with age/sex-matched healthy controls. All in all, 220 patients were enrolled, including 131 RA patients, 23 SLE patients, 8 patients with other rheumatic diseases, and 58 controls. Local and systemic adverse events were more frequently reported after the second dose in all subjects (94% 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 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 RA, 34.8% in SLE, and 87.5% in other rheumatic diseases. After the second dose, seropositivity remained 100% in controls, increased to 88.5% in RA and 78.3% in SLE, and persisted at 87.5% in other rheumatic diseases. Older patients with RA (>65 years) had a similar seropositivity post-second dose compared with younger patients (88% anti-Spike and anti-RBD positivity versus 88.8%). 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 RA patients on rituximab and SLE patients on MMF, reduced vaccine-induced humoral responses have to be expected. These data are consistent with the general efficacy of vaccination, albeit more nuanced in patients with autoimmune diseases.

  1. Colmegna A, et al. COVID-19 vaccine in immunosuppressed adults with autoimmune diseases. Abstract L02, ACR Convergence 2021, 03–10 November.

  2. Colmegna A. 6S229. Press conference: infectious & rare disease, ACR Convergence 2021, 03–10 November.


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