No Link Found Between mRNA COVID-19 Vaccine and Severe Disease Flares in Patients with Rheumatic Diseases

According to results presented at ACR Convergence 2021, the mRNA COVID-19 vaccine was not associated with severe disease flares in patients with rheumatic diseases, although certain medications that are used to treat these conditions were associated with a reduction in vaccine-induced humoral responses.

“The study started in February 2021, when we really did not have much information about the safety and immunogenicity of vaccines in people with autoimmune diseases,” said Inés Colmegna, MD, Associate Professor, Rheumatology, Division of Experimental Medicine, Research Institute of the McGill University Health Centre, Montreal, Canada, during the presentation. “This was simply because immunocompromised patients were excluded from the initial SARS-CoV-2 clinical trials.”

To assess the safety and immunogenicity of the mRNA COVID-19 vaccine in patients with rheumatic diseases, the researchers conducted a prospective, nonrandomized, open-label, comparative clinical trial at 2 academic centers in Quebec, Canada. Of the 220 patients enrolled in the trial, 131 were diagnosed with rheumatoid arthritis (RA), 23 were diagnosed with systemic lupus erythematosus (SLE), 8 were diagnosed with other rheumatic diseases, and 58 served as controls. According to the eligibility criteria for the trial, the patients with RA needed to be on stable treatment for 3 months, those with SLE needed to be on stable treatment with mycophenolate mofetil, and those with other diseases needed to be on ≥10 mg of prednisone per day.

The average age of patients was 60.4 years and 72% were female.

The primary outcome measures were the frequency of prespecified (ie, solicited) local and systemic adverse events (AEs) in the 7 days after each vaccine dose and any other (ie, unsolicited) AEs—including disease flares—in the 28 days following each dose. As a secondary outcome measure, the investigators assessed the effects of age and treatment on seropositivity, defined by the presence of serum IgG antibody against SARS-CoV-2 spike protein (IgG-S) and its receptor binding domain (IgG-RBD).

Safety Results

Local and systemic solicited AEs occurred after 94% of second doses of the vaccine and after 86.8% of first doses. The most common AE postvaccination was pain at the site of injection. Swollen joints (a solicited AE) were reported after both doses of the vaccine in 22.9% of patients with RA and 3.4% of controls. More importantly, RA disease activity scores were not elevated following doses, and no serious AEs were attributed to the vaccine.

Immunogenicity Results

After the first vaccine dose, seropositivity for IgG-S and IgG-RBD was 100% in the controls, but only 67.7% in patients with RA, 34.8% in patients with SLE, and 87.5% in patients with other rheumatic diseases. After the second dose, positivity for IgG-S and IgG-RBD remained at 100% in the control group, and was 88.5%, 78.3%, and 87.5% in patients with RA, SLE, and other rheumatic diseases, respectively.

Age appeared to have no effect on seropositivity after the second vaccine dose in patients with RA. The dual seropositivity rate for those aged ≥65 years was 88% compared with 88.8% for those aged <65 years. After the 2 vaccine doses, the humoral response rate in patients treated with rituximab (Rituxan) was just 9%, compared with 88% in patients not treated with that drug. Similarly, the humoral response rate in patients treated with mycophenolate mofetil was lower than that of patients not treated with that drug (39% vs 58%, respectively).

The study is ongoing and antibody responses will be assessed at 6 months postvaccination, as well as after a third vaccine dose. Cellular responses will also be evaluated.

“These findings help to reassure patients with rheumatic diseases and their providers who are concerned that COVID-19 vaccines could lead to an increase in disease activity,” said Dr Colmegna. “It highlights the importance of having a complete vaccine scheme in order to enhance vaccine responses. It confirms reduced immunogenicity in patients on drugs that affect B-cell function, emphasizing the importance of the Cocoon Strategy (vaccinating those in close contact with these vulnerable patients) and other measures to prevent infection.”

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