COVID-19 vaccine response in patients with lupus ‘blunted’ by immunosuppressant use
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One-third of patients with systemic lupus erythematosus demonstrate low response to the COVID-19 vaccine, a “blunted effect” linked to use of any immunosuppressive agent except antimalarials, according to a presenter at ACR Convergence 2021.
“In December, when the COVID-19 vaccines were starting to get EUA approval from the FDA, there was essentially no data on patients with autoimmune disease on immunosuppression, as those patients were largely excluded from the phase 3 vaccine trials,” Peter M. Izmirly, MD, a rheumatologist at NYU Langone Health, told Healio Rheumatology. “Furthermore, given the potential of disease flares following immunization and the initial absence of data evaluating disease activity in response to vaccination, it was not surprising that studies reported hesitancy for vaccination in patients with rheumatic diseases including patients with lupus.”
He added, “With that as a background, in December 2020, our group started planning our study to address the efficacy and safety of the COVID-19 vaccines in patients with lupus.”
To analyze seroreactivity and disease flares in patients with SLE following COVID-19 vaccination, Izmirly and colleagues recruited participants from the New York University Lupus Cohort. According to the researchers, the cohort is a prospective convenience registry open to enrolling any adult with SLE seen at NYU Langone Health and Bellevue Hospital Center since 2014.
In all, the study included 90 patients with SLE and 20 healthy control participants, all of whom received a complete COVID-19 vaccine regimen. The researchers measured IgG seroreactivity to the SARS-CoV-2 spike receptor-binding domain using ELISA, B-cell responses via SARS-CoV-2 microneutralization assay and interferon-gamma production to assess T-cell responses. Additionally, Izmirly and colleagues measured disease activity by the hybrid SLE disease activity index (SLEDAI) and flares assigned by the SELENA/SLEDAI flare index.
According to study results, 29% of patients with SLE demonstrated an IgG response below that of the lowest responses for healthy controls — less than 100 units/ml. In addition, the researchers noted that patients with SLE who exhibited a poor antibody response to COVID-19 vaccination also had lower interferon gamma production.
In their logistic regression analyses, the researchers found that any immunosuppressant or prednisone use were associated with decreased vaccine responses, including prednisone use in combination with at least one immunosuppressant (P = 0.049), a combination of two immunosuppressants (P = 0.01), prednisone use (P = 0.021), mycophenolate mofetil or mycophenolic acid use (P = 0.001), receiving the Johnson & Johnson/Janssen vaccine (P = 0.04), as well as a normal anti-dsDNA level prior to vaccination (P=0.03).
However, Izmirly and colleagues also found that patients administered antimalarials or no medications (OR 11.8 (95% CI 2.9, 48.5, P = 0.0006)), and those with an elevated anti-dsDNA level prior to vaccination (OR 7.8, 95% CI 2.9, 48.5, P = 0.0047)) exhibited an improved response to COVID-19 vaccination.
The researchers found no change in post-vaccination lupus disease activity scores compared to pre-vaccination, and “the proportion of patients who flared was relatively low (11.4%), and severe SLE flares were rare (1.4%),” according to Izmirly.
“This study supports previous data that has been coming out from our group and others that show patients on certain immunosuppression have a blunted effect to the COVID-19 vaccine,” Izmirly told Healio Rheumatology. “The study also showed that IgG seroreactivity to the SARS-CoV-2 spike receptor-binding domain strongly correlated with a functional assay that measures the ability of post-vaccinated individuals’ plasma to neutralize infectious virus in cultured cells.”
He added, “The results of this work are reassuring regarding the safety of initial vaccination and suggest further studies are needed to assess efficacy and safety of booster vaccination in patients with suboptimal responses to the standard vaccination regimen.”
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Izmirly PM. Abstract 1420. Presented at: ACR Convergence 2021; November 5-9, 2021 (virtual meeting).
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