Evaluation of the efficacy and safety of the sars-cov-2 vaccine in patients with chronic inflammatory diseases treated with biological therapy

Abstract

In the current situation of the SARS-CoV-2 pandemic, the Spanish Society of Rheumatology recommends vaccination of patients with chronic inflammatory diseases (CID) under treatment with biological DMARDs (bDMARDs). However, the data regarding the generation of protective antibody titers after mRNA vaccines in patients with CID is limited. The objective of this study was to determine the seroconversion rate and safety after the SARS-CoV-2 vaccine in patients with CID under treatment with bDMARDs. A cross-sectional observational study was conducted with 81 patients with CID from the HURS in Córdoba, who received full vaccination for SARS-CoV-2 (without having previously suffered from COVID-19 disease) according to national guidelines. A determination of specific IgG-type antibodies against the trimeric spike protein of SARS-CoV-2 was performed on all of them. The chemiluminescence technique with the kit was used in serum samples taken 4–5 weeks after administration of the second dose of the vaccine. Information about sociodemographic characteristics, disease, type of bDMARDs, concomitant treatments, and adverse effects after the second dose of the vaccine were collected in each patient. A total of 81 patients were included (mean age 59.5, 72.8% females). 50.6% of patients had RA, 17.3% SpA, 11% PsoA, and 18.5% other CID. 23.5% were under treatment with Rituximab, 38.8% antiTNF, 13.6% Tocilizumab, 9.9% Abatacept, 5% anti-JAK, and 14.2% under other treatments. Anti-SARS-CoV-2 antibodies and neutralizing activity were detected in 80% of study participants. Rituximab treatment was significantly associated with negative seroconversion in comparison with patients under antiTNF treatment (OR 84.0 [95% CI 12.9–1709.2]). No interaction was found between the bDMARDs treatment and the type of vaccine with regard to the seroconversion, nor between bDMARDs and concomitant synthetic DMARD.