Background/Purpose: Infections in patients with systemic autoimmune disease (SAD) are associated with immune dysfunction, disease activity and immunosuppression. Synthetic and biologic disease-modifying drugs (DMARDs) have improved the prognosis of ARD. However, concerns persist about infectious complications in these patients. Previous studies of our group have shown that sublingual polybacterial vaccines decrease the rateo of recurrent respiratory tract infections (RRTI) and recurrent urinary tract infections (RUTI).

We aimed to evaluate the number of respiratory and urinary tract infections during 2018-2021 in patients who received sublingual polybacterial vaccines until 2018, when their administration was discontinued due to regulatory issues.

Methods: A retrospective observational study was conducted from a cohort of patients with SAD who had received sublingual polybacterial vaccines between 2014 – 2018. From 2018 onward, the incidence of UTI and incidence of RUTI and RRTI was analyzed and compared with annual incidence prior to vaccine vaccine administration and after one year post-vaccination.

Results: RRTI and RUTI were analyzed in 50 patients with SAD and active immunosuppression during the years 2018-2021. A significant increase in the number of infections was observed from 2018 to 2021, compared to the post-vaccination year, for both RUTI (1.53±2.17 vs 0.63±1.13; p=0.005) and RRTI (1.63±2.32 vs 0.67±0.92; p=0.003). When categorizing by number of infections, we observed that despite the increase in the average number of RUTI and RRTI, approximately half of the patients had no infections in the 2018-2021 period (51.2% RUTI and 43.5% RRTI). Making a comparison with the pre-vaccine year, despite the increase in the number of infections during the 2018-2021 period with respect to the immediate post-vaccination, the number of RRTI episodes was still lower (1.61±2.26 vs 2.76± 2.57; p= 0.002), as was the number of RUTI (1.56±2.12 vs 2.69±3.07; p= 0.010).

Conclusion: The effect of sublingual polybacterial vaccines was maintained up to 3 years, with a significant decrease in infections with respect to the year prior to vaccination, suggesting that these vaccines may have long-term benefit. The number of respiratory and urinary tract infections increased during the years when the vaccine administration was not available. However, an absence of infections was also observed in half of the patients.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/long-term-effectiveness-of-sublingual-polybacterial-vaccines-in-patients-with-systemic-autoimmune-disease-and-active-pharmacological-immunosuppression/