LAUSR

Background Immunisation with pneumococcal vaccine is the key prophylactic measure to protect patients with systemic lupus erythematosus (SLE) against severe respiratory infections. Objectives To study the efficacy and immunogenicity of 23-valent polysaccharide pneumococcal vaccine in SLE pts. Methods The study included 30 SLE pts, 27 females, 3 males, aged 19–62 y, the follow up (FUP) was 12 mo. Disease activity at vaccination was high – in 1 patient, moderate – in 4 pts, and low – in 20 pts; drug-induced remission – in 5. Therapy: 29 pts were on glucocorticoids (GCs), 23 – on hydroxychloroquine, 14 – on cytostatic (CS) drugs, 9 – on biologic diseases modifying anti rheumatic drugs (bDMARDs): 4 – on rituximab, and 5 – on belimumab. One dose (0,5 mL) of 23-valent polysaccharide pneumococcal vaccine was administered subcutaneously. Standard clinical examination and lab tests were performed, and vaccine immunogenicity was determined by measuring antibody (AB) levels against Streptococcus pneumoniae (VaccZymeTM PCP IG 2 panels (The Binding Site Ltd, Birmingham, UK)) at control visits. Results Local injection site reactions of varying intensity were registered in 19 (63,3%) pts, lasting from 2 to 7 days. One patient developed an immediate hypersensitivity reaction – the Arthus phenomenon-type. All accompanying symptoms completely resolved within 7 days with the intake of antihistaminic drug and local use of GCs. Mean (Me (25,75 percentiles)) SLEDAI scores for SLE activity prior to and 1 year after vaccination did not differ significantly: 2 (2;4) and 2 (0;4), respectively. Mean values of SLE immunological activity parameters (a-dsDNA, C3 and C4 components of the complement) also did not differ significantly, with a visible trend for a-dsDNA reduction and complement components increase: C3 (0,86 (0,81;1.07) and 0,93 (0,86;1,05)); C4 (0,16 (0,13;0,19) and 0,18 (0,13;0,19), respectively. (table 1)Abstract SAT0397 – Table 1 Dynamics of immunological activity parameters (Me) and SLE SLEDAI (Me) scores prior to and after the vaccination (12 mo). FUP A-dsDNA<20 C30,9–1,8 C40,1–0,4 SLEDAI Visit 1 (baseline) 21,3(4,7; 48,4 0,86(0,81;1,07) 0,16(0,13;0,19) 2(2;4 Visit 2(1 mo) 25,0(4,7; 48,4 1,1(0,9; 1,2) 0,17(0,13; 0,19) 2(0;4) Visit 3(3 mo) 20,9(8,2; 34,5 0,91(0,8; 1,0) 0,17(0,14; 0,2) 2(2;4 Visit 4(12 mo) 18,7(8,7;68,7 0,93(0,86;1,05) 0,18(0,12;0,19) 2(0;4) There were no SLE exacerbations with definite casual relationship with the vaccination. Significant increase (≥2 fold vs the baseline values) of AB levels against S.pneumoniae polysaccharides was documented in 25 (83,3%) pts 1 mo post-vaccination. High AB titers still persisted 1 year post-vaccination in 19 (63,3%) pts (responders). More than 2-fold increase of anti- S.pneumoniae AB concentrations was not maintained by the end of FUP (12 mo) in 11 (36,7%) «non-responders». 7 (63,6%) out of them were treated with GEBA (4-rituximab, 3 – belimumab). 2 (10,5%) pts out of 19 «responders» were also treated with GEBA (belimumab). The difference was statistically significant, p=0008. Conclusions Obtained results demonstrate the safety and immunogenicity of 23-valent pneumococcal vaccine in SLE patients during one year FUP. The negative effect of bDMARDs on post-vaccination response was noticed. Future studies of vaccine efficacy and safety are needed in larger SLE populations. Disclosure of Interest None declared