No link between mRNA COVID-19 vaccines and increased flare risk in rheumatic disease
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mRNA COVID-19 vaccines were not linked to severe disease flares in patients with rheumatic diseases, although use of rituximab or mycophenolate mofetil dampened vaccine response, according to a presenter at ACR Convergence 2021.
“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,” Ines Colmegna, MD, of The Research Institute of the McGill University Health Centre, in Montreal, said in her presentation. “This was simply because immunocompromised patients were excluded from the initial SARS-CoV-2 clinical trials.”
The current prospective, non-randomized, open label, comparative clinical trial included 220 patients overall. There were 131 patients with rheumatoid arthritis, 23 with systemic lupus erythematosus, eight with other rheumatic diseases and 58 controls.
Eligibility criteria dictated that RA patients were on stable treatment for 3 months, while those with SLE were stable on mycophenolate mofetil (MMF) and those with other diseases were being treated with 10 mg of prednisone.
“The design of the study was exactly the same as the design of the studies that led to the approval of mRNA vaccines in the general population,” Colmegna said.
Local and systemic reactogenicity adverse events in the 7 days following each dose served as the primary endpoint. In addition, the researchers also assessed for unsolicited adverse events — including disease flares — within 28 days of each dose. the presence of serum IgG antibody against SARS-CoV-2 spike protein (IgG-S) and its’ receptor binding domain (IgG-RBD) as a function of age and treatment served as the secondary endpoint.
The mean age of the cohort was 60.4 years (SD ±12.2), while 72% were women.
Results showed that local and systemic solicited adverse events occurred after 94% of second doses and after 86.8% of first doses (95% CI, 2.8%-11.7%). “The most common adverse event post-vaccination was pain in the injection site,” Colmegna said.
Swollen joints were reported after both doses in 22.9% of RA patients and just 3.4% of controls (95% CI, 10.9%-28%). “Patients that had arthritis were more likely to report those adverse events,” Colmegna said.
Importantly, Colmegna stressed that RA disease activity scores were not elevated following doses of the vaccine. In addition, she noted that no serious adverse events were associated with the vaccine.
Following the first vaccine dose, seropositivity for both IgG-S and IgG-RBD was reported in all control patients. However, just 67.7% of those with RA, 34.8% of those with SLE and 87.5% of patients with other rheumatic diseases demonstrated both types of seropositivity.
The trend toward full seropositivity for both IgG-S and IgG-RBD persisted after the second dose. However, following the second dose, seropositivity for both IgG-S and IgG-RBD increased to 88.5% in RA patients and 78.3% in SLE. This rate remained at 87.5% in other rheumatic diseases.
Age had no impact on seropositivity after the second dose in RA patients. The dual seropositivity rate for those aged older than 65 years was 88%, compared with 88.8% for those aged younger than 65 (95% CI, -12.1%-10.6%).
Rituximab (Rituxan, Genentech) yielded just a 9% rate of humoral response after the second dose, compared with 88% in patients not treated with that drug (95% CI, -98.1%- -59.5%). Similarly, MMF was associated with a lower humoral response compared with individuals not on that drug, 39% vs. 58% (95% CI, -36.4%- -2.2%).
“The results of this study showed that the frequency of adverse events, specifically reactogenicity in patients with autoimmune conditions regardless of their diagnosis, was similar to health controls,” Colemegna said. “This study is reassuring in terms of the adverse event profile after completing immunization with an mRNA vaccine, typically the Moderna vaccine, in people with autoimmune diseases.”
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Colmegna I. Abstract #L02. Presented at: ACR Convergence 2021; November 5-9, 2021 (virtual meeting).
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