Nearly 30% of patients with lupus show low response to COVID-19 vaccine
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About 29% of patients with systemic lupus erythematosus demonstrate low response to the COVID-19 vaccine, with immunosuppression therapy associated with decreased protection, according to data published in Arthritis & Rheumatology.
“This 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,” Peter M. Izmirly, MD, of the New York University Grossman School of Medicine, told Healio Rheumatology. “This study focused on patients only with systemic lupus erythematosus and showed that a lower response to the vaccine was independently associated with being on any immunosuppressive agent, with the exception of antimalarials such as hydroxychloroquine.”
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.
For their study, Izmirly and colleagues considered all adults with SLE who planned to receive any available COVID-19 vaccine. Exclusion criteria included unwillingness to provide blood after the second dose of the vaccine, incomplete vaccination schedule, or speaking a language other than English, Spanish or Mandarin. Healthy adults with no known rheumatic diseases and no immunosuppressive medications were recruited as controls.
In all, the study included 90 patients with SLE and 20 healthy control participants, all of whom received a complete COVID-19 vaccine regimen. Among those with SLE, 79% were receiving hydroxychloroquine and 29% were on systemic glucocorticoids, with a mean dose of 7 mg of prednisone. In addition, 42% were using at least one immunosuppressant, with mycophenolate mofetil (MMF) being the most common at 21%, followed by belimumab at 11%. Approximately, 17% were on more than one immunosuppressant.
Izmirly and colleagues used IgG seroreactivity to the SARS-CoV-2 spike receptor-binding domain (RBD) and SARS-CoV-2 microneutralization to assess B-cell responses, as well as IFN- production to examine T-cell responses. They measured disease activity using the hybrid SLE disease activity index (SLEDAI), with flares classified based on the SELENA/SLEDAI flare index.
According to the researchers, 28.8% of patients with SLE demonstrated an IgG response below that of the lowest control — less than 100 units/ml. In their logistic regression analyses, the researchers found that any immunosuppressant or prednisone use, and a normal anti-dsDNA level prior to vaccination, were associated with decreased vaccine responses.
In addition, IgG seroreactivity to the SARS-CoV-2 Spike RBD strongly correlated with the coronavirus microneutralization titers and antigen-specific IFN- production.
IFN- production was similarly reduced in a subset of patients with poor antibody responses. Pre- and post-vaccination SLEDAI scores were similar.
Lastly, just 11.4% of patients experienced a disease flare following vaccination. Among the reported flares, 1.3% were severe.
“Overall, the proportion of patients who flared was low, and severe SLE flares were rare,” Izmirly said. “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.”
Perspective
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Paul J. DeMarco, MD, FACP, FACR, RhMSUS
Izmirly and colleagues report on a study of 90 SLE patients and 20 healthy controls completing a vaccination series for COVID-19 to assess seroreactivity and disease flare. This group chose to look at B cell responses as well as IFN-γ responses to see if patterns of vaccine response emerge, as well as traditional risk factors of lupus activity and measures of clinical disease activity, SELENA/SLEDAI flare index.
It may be noteworthy that the 20 healthy controls were all vaccinated with the Pfizer-BioNTech vaccine. No data on the antibody response of the 20 healthy controls is provided except that the lowest antibody response seen in this healthy control group, 100 units/mL, became the standard for suboptimal antibody response. The researchers comment on the 29% of SLE patients in the suboptimal antibody response group, but surprisingly leaves the reader to note 71% of lupus patients are deemed to respond in the range of the healthy controls.
In this discussion, however, immunosuppressant or prednisone use and normal dsDNA antibodies seems to correlate with suboptimal antibody response; this same suboptimal response group had a diminished IFN-γ response. Post-vaccination flare was low at 11.4% without a non-vaccinated SLE control group for comparison; 1.3% of these flares were severe.
As a general overview, immunocompromised patients show a range of response to immunization. According to recent CDC data, between 7 and 27 days after the second Pfizer-BioNTech vaccine, 71% (37-87%) immunosuppressed patient vs. 90% healthy controls demonstrate vaccine effectiveness. After day 7 of a second dose of mRNA vaccine, 80% patients with IBD on immunosuppressives demonstrate vaccine effectiveness. In this context, the findings of Irmirly and colleagues is strongly in keeping with other immunosuppressed populations.
The article adds some scientifically and clinically important elements to our understanding of COVID-19 vaccination in SLE patients. Firstly, the presence of elevated dsDNA antibodies, a potential sign of lupus activity, seems to be a stronger predictor of response to vaccination. Many physicians rendering care to lupus patients may hesitate to vaccinate in the presence of serologic activity but this small cohort suggests that concern may not be clinically relevant. Further, and perhaps most importantly, the flare rate is quite small and severe flare is such that reassurance can be provided to patients pondering vaccination.
The NYU group is to be commended for providing the medical community with some well-collected medical observation to assist rheumatologists in offering the opportunity for protection against infection during the COVID-19 pandemic. It is unfortunate the current general information provides little data about the ability to switch from IgG to IgA in response to acute exposure, perhaps the most critical element of systemic vaccination for a mucosal transmitted infection; however, in this at-risk population, well-collected data should be highly welcomed.
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