Impaired Immunogenicity to COVID-19 Vaccines in Autoimmune Systemic Diseases - High Prevalence of Non-Response in Different Patients’ Subgroups (preprint)

ABSTRACT

Background: Autoimmune systemic diseases (ASD) may show impaired immunogenicity to COVID-19 vaccines . Our prospective observational multicenter study aimed to evaluate the seroconversion after the vaccination cycle and at 6-12-month follow-up, as well the safety and efficacy of vaccines in preventing COVID-19.Methods: The study included 478 unselected ASD patients (mean age 59±15 years), namely 101 rheumatoid arthritis (RA), 38 systemic lupus erythematosus (SLE), 265 systemic sclerosis (SSc), 61 cryoglobulinemic vasculitis (CV), and a miscellanea of 13 systemic vasculitis. The control group included 502 individuals from the general population (mean age 59±14SD years). The immunogenicity of mRNA COVID-19 vaccines (BNT162b2 and mRNA-1273) was evaluated by measuring serum IgG-neutralizing antibody (NAb) (SARS-CoV-2 IgG II Quant antibody test kit; Abbott Laboratories, Chicago, IL) on samples obtained within 3 weeks after vaccination cycle.Findings: The short-term results of our prospective study revealed significantly lower NAb levels in ASD series compared to controls [286 (53-1203) vs 825 (451-1542) BAU/mL, p<0.0001], as well as between single ASD subgroups and controls. More interestingly, higher percentage of non-responders to vaccine was recorded in ASD patients compared to controls [13.2% (63/478), vs 2.8% (14/502); p<0.0001]. Increased prevalence of non-response to vaccine was also observed in different ASD subgroups, in patients with ASD-related interstitial lung disease (p=.009), and in those treated with glucocorticoids (p=.002), mycophenolate-mofetil (pInterpretations Patients with weak/absent seroconversion, believed to be immune to SARS-CoV-2 infection, are at high risk to develop COVID-19. Early determination of serum NAb after vaccination cycle may allow to identify three main groups of ASD patients responders, subjects with suboptimal response, non-responders. Patients with suboptimal response should be prioritized for a booster-dose of vaccine; while a different type of vaccine could be administered to non-responder individuals.Funding Information None.Declaration of Interests The authors do not have conflict of interest.Ethics Approval Statement The study protocol was approved by local ethic committee (RETRO-CoV2 study code #17886_bio); informed consent was obtained from all patients before participation.