ABSTRACT
Background: there are some concerns among patients (pts) with rheumatic diseases regarding the tolerability and efficacy of SARS-CoV-2 vaccination. The impact effect of vaccination on the course of Sjogreǹs syndrome (SjS) is not entirely clear. Objectives: to evaluate the efficacy and tolerability of the heterologous recombinant adenovirus (rAd)-based vaccine Sputnik in pts with SjS receiving various types of therapy. Methods: single center observational retrospective study. Diagnosis of SjS was based on ACR/EULAR 2016 criteria. Rituximab (RTM) was administered in two 1000 mg infusions 14 days apart for the 1 st course, then 500 mg every 6 months. Results: 70 pts with a defnite diagnosis of SjS were included in the study. Four out of 70 were women. The mean age was 52.5±14.6 years, the average duration of the SjS was 72 (36-120) months. Three pts had concomitant RA, 3 pts-SLE, 2 pts-Systemic sclerosis. Extraglandular manifestations of SjS were detected in 35 cases. Five pts received single-dose rAd26 vector-based COVID-19 vaccine 'Sputnik Light', other 65 pts received 2 doses of Gam-COVID-Vac (Sputnik V). Eighteen pts did not receive any immunosuppressive therapy and were vaccinated before RTM therapy. One patient of them just diagnosed with lymphoma, 8 pts had extraglandular manifestations of the SjS (hypergam-maglobulinemic purpura, cryoglobulinemic vasculitis with polyneuropathy, interstitial lung disease). 20 pts at the time of vaccination received various immunosuppressive drugs: 1-cyclophosphamide (CYC), 1-lefunomide, 1-Azathioprine, 3-methotrexate, 2-mycophenolate mofetil (MMF), 10-hydroxychloroquine, 13-low doses of methylprednisolone. Thirty-two pts received anti B-cells therapy with RTM. The duration of RTM therapy before vaccination was 18 (12-36) months, the period of time between the last injection of the RTM and the vaccine was on average 6 (5-8) months. B-cells level was determined in 18 pts immediately before vaccination and it was normal only in 10 pts. The level of neutralizing antibodies after vaccination was monitored in 44 pts. The level of IgG antibodies against SARS-CoV-2 was positive in 15 of 22 pts who did not receive RTM and in 10 of 22 pts who received the RTM (p>0.05). Neutralizing antibodies did not develop in 4 pts despite complete recovery of B cells. It is important that none of the vaccinated pts was infected COVID-19 within at least 6 months after vaccination. Various types of adverse reactions were observed in 8 pts. The most common was fu-like syndrome. In one case this syndrome required the prescription of dexameth-asone. In 3 cases disease exacerbation occurred after vaccination. These pts had extraglandular manifestations of SjS and received immunosuppressants (CYC, MMF or RTM), 2 of them required treatment intensifcation, in one case the exacerbation was self-limiting. Conclusion: vaccination against SARS-CoV-2 infection was well tolerated by pts with SjS even in the absence of immunosuppressive therapy. In most cases, there were no exacerbation of the SjS and pts could continue immunosuppres-sive therapy without becoming infected COVID-19.