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.
- Colmegna A, et al. COVID-19 vaccine in immunosuppressed adults with autoimmune diseases. Abstract L02, ACR Convergence 2021, 03–10 November.
- Colmegna A. 6S229. Press conference: infectious & rare disease, ACR Convergence 2021, 03–10 November.
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Table of Contents: ACR 2021
Featured articles
Late-Breaking Abstracts
Vaccine booster improves immune response in patients treated with rituximab
IL-17 inhibition showing efficacy in GCA in phase 2 trials
Spotlight on Rheumatoid Arthritis
Cycling JAK inhibitors shows similar effectiveness to switching to a bDMARD in difficult-to-treat RA
Pre-existing heart failure affects safety of hydroxychloroquine in RA patients
Patients with RA-associated interstitial lung disease benefit from antifibrotic agent
Ultra-low dosing of rituximab in RA is a viable treatment option
Kidney disease and hydroxychloroquine dose are risk factors for developing retinopathy
More pros than cons for the use of statins in RA
Psoriatic Arthritis: Novel Developments
Selective IL-23 inhibition: a new option in active PsA
Ustekinumab: highly efficacious in PSA independent of methotrexate
COVID-19: What You Need to Know
Vaccinated rheumatic patients carry increased risk for COVID-19 breakthrough infections
B-cell depleting medication increases COVID-19 breakthrough infection outcome risk
COVID-19 mRNA vaccine safe and tolerable in adults with autoimmune disease
SLE Treatment: What Is New
Iberdomide: an upcoming new treatment possibility in lupus erythematosus
Sequential rituximab after belimumab does not improve disease control in SLE
Lupus patients less protected by COVID-19 vaccine
Late-Breaking Posters
Promising results in uric acid-lowering in gout patients with a new xanthine oxidase inhibitor
Laboratory and clinical signs 24h after hospitalisation predict MIS-C in children
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