Immunogenicity and safety of the BBIBP‐CorV vaccine in patients with autoimmune inflammatory rheumatic diseases undergoing immunosuppressive therapy in a monocentric cohort

Abstract

Introduction Vaccination plays a fundamental role in mastering the COVID‐19 pandemic and protecting vulnerable groups. Persons with autoimmune inflammatory rheumatic diseases (AIIRD) requiring immunosuppressive therapies are prioritized for vaccination. However, data concerning immunogenicity and safety of the BBIBP‐CorV vaccine in immunosuppressed patients are not found. This study presents data on the efficacy and safety of the BBIBP‐CorV vaccine in immunosuppressed patients compared to healthy controls. Methods Study population consisted of 100 healthy controls and 100 patients with AIIRD. Vaccination was performed according to national guidelines with the BBIBP‐CorV vaccine. SARS‐CoV‐2 neutralizing antibody titers were quantified by enzyme‐linked immunosorbent assay before initial vaccination and 1–3 months after secondary vaccination. Adverse events were assessed before study initiation and 7 days after the second dose. Disease activity was studied before entering the study and 3–8 weeks after the second dose. Results Vaccination‐induced positive immunogenic response rates and SARS‐CoV‐2 neutralizing antibody titers were significantly lower in the AIIRD patients than healthy subjects (p < .05). There are significant differences in neutralizing antibody titers among patients suffering from rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), systemic sclerosis, and ankylosing spondylitis (p < .01–.05). The rates of seropositive vaccine responses were similarly distributed across all diseases. Healthy and AIIRD individuals had a similar profile in adverse events. No significant difference was observed in SARS‐CoV‐2 antibody titers between subjects suffering from side effects and those who did not have. SARS‐CoV‐2 neutralizing antibody levels were significantly higher in subjects with a history of COVID‐19 infection than seronegative individuals (p < .01–0.05). Seropositive subjects had a significant increase in the percentage of vaccine‐related adverse events compared to seronegative persons (p < .05). Despite a minor change in the disease activity of patients with RA and SLE, disease activity indices were overall stable in the AIIRD patients. Conclusion These findings revealed that the BBIBP‐CorV vaccine is effective in the development of neutralizing antibodies in immunosuppressed patients without considerable reactogenicity or induction of disease flares.

Effectiveness and Safety of the COVID-19 Vaccine in Patients With Rheumatoid Arthritis in a Real-World Setting

“…Previous SARS-CoV-2 infection revealed to be one of the main factors associated with increased immunogenicity to COVID-19 vaccine in our population, in line with data reported in literature [23,31,34,37]. A study by Saleem et al involving 100 patients with RA reported lower seroconversion rates (55.4%) in patients without previous COVID-19 than in those previously infected (100%) [31].…”

Effectiveness and Safety of the COVID-19 Vaccine in Patients with Rheumatoid Arthritis in a Real-World Setting

“…Previous SARS-CoV-2 infection was revealed to be one of the main factors associated with increased immunogenicity to COVID-19 vaccine in our population, in line with the data reported in the literature [ 23 , 31 , 34 , 37 ]. A study by Saleem et al involving 100 patients with RA reported lower seroconversion rates (55.4%) in patients without previous COVID-19 than in those previously infected (100%) [ 31 ].…”

Immunogenicity and adverse events of the COVID-19 vaccines in healthy and individuals with autoimmune diseases in an Iranian population

“… 36 These findings are consistent with other studies indicating the immunogenicity of COVID-19 vaccines against SARS-CoV-2 in these patients. 9 , 37 It is reported that immunization with SARS-CoV-2 mRNA and inactivated CoronaVac vaccines provided a suitable titer of neutralizing antibody in the majority of patients with autoimmune diseases, however, the patients had a reduction in antibody response compared to the healthy individuals. 9 , 38 , 39 These observations propose that the reduction in production of SARS-CoV-2 neutralizing antibodies may correlate to the undesirable effects of immunosuppressive treatments on the immunogenicity of COVID-19 vaccines.…”

“…This finding is consistent with some reports showing the first dose of mRNA vaccine produced antibody responses in seropositive subjects, which were sometimes exceeded titers observed in seronegative subjects received two doses of the mRNA vaccines. 9 , 49 It is shown that the BNT162b2 SARS‐CoV‐2 vaccine had the ability to induce IgG level in both seropositive and seronegative individuals; however, only individuals with pre‐existing immunity showed the increased levels of IgM and IgA after primary vaccination. In line with the impacts of the Oxford-AstraZeneca, subjects already contracted SARS-CoV-2 produced neutralizing antibodies against alpha, D614 G, beta, delta, and gamma variants.…”

“…Today, vaccination has been proposed as the most effective approach for controlling the disease, especially in patients with autoimmune diseases. 6 – 9 These patients are usually more susceptible to infectious diseases and experience COVID-19 with more severity, possibly due to immunomodulatory impacts of immunosuppressive treatments. Thus, SARS-CoV-2 vaccination and follow-up in patients with autoimmune disorders are critical.…”