AB0500 Tolerability, efficacy and immunogenicity of 23-valent pneumococcal vaccine in sle patients
Authors: GM Tarasova, BS Belov, MS Sergeeva, SK Soloviev, EA Aseeva, NG Klukvina, TV Popkova, EN Alexandrova, AA Novikov, MV Cherkasova
Journal: Annals of the Rheumatic Diseases (2017)

<h3>Background</h3> Concurrent infections turn out to be the second leading cause of death in systemic lupus erythematosus (SLE) pts after SLE per se. Immunization of SLE pts with pneumococcal vaccine is an important prophylactic approach to prevent severe lower respiratory tract (LRT) infections in SLE pts. <h3>Objectives</h3> To study the relevance of 23-valent pneumococcal vaccine for immunization of SLE pts. <h3>Methods</h3> The study included 30 SLE pts, 27 females, 3 males, aged 19 - 62 y. Duration of follow up (FUP) was 12 months in 24 pts, and 7–10 months – in 6 pts. High disease activity at the time of immunization was documented in 1 patient, low activity – in 20 pts, moderate – in 4 pts, and remission – in 5. 29 pts were treated with glucocorticosteroids (GCs), 23 – with hydroxychloroquine, 14 pts – with cytostatic (CS) agents. Twelve pts were on biological disease-modifying antirheumatic drugs (bDMARDs). One dose (0,5 ml) of 23-valent polysaccharide pneumococcal vaccine was administered subcutaneously. The duration of FUP was 7–12 months. Control visits were scheduled as follows: at baseline (Visit 1), at 1st, 3rd, and 12th months (Visit 4) after immunization. Standard clinical examination and lab tests, including blood immunology, were performed at each visit. Vaccine immunogenicity was evaluated based on the level of serum antibodies (AT) to Streptococcus pneumoniae capsular polysaccharide (VaccZymeTM PCP Ig 2 panels (The Binding Site Ltd, Birmingham, UK)) – 4 times during 1 year. <h3>Results</h3> No post-immunization complications were seen in 11 (36,7%) pts, local reactions of varying intensity lasting from 2 to 7 days were documented in 18 (60%) pts. One patient (3,3%) developed the local <i>type</i> III hypersensitivity reaction known as Arthus phenomenon. All symptoms subsided within 7 days after administration of antihistaminic agents and local GCs. Not a single vaccination-related SLE exacerbation episode was documented in 24 pts during the FUP. Significant (≥2-fold vs baseline) increase of serum AT levels to S. pneumoniae polysaccharide was observed during the FUP (Table). In 10 (41,7%) out of 24 pts ("non-responders") more than 2-fold increase of anti- S. pneumoniae ATs was not achieved by 12th month of FUP. Among them 7 (70%) pts were receiving bDMARDs. 4 (28,6%) out of 14 "responders " were also treated with bDMARDs. Non-severe pneumonia was documented in 2 out of 24 pts within1 year after vaccination; both cases successfully resolved after 7- and 5-days of oral antibiotic treatment in an out-patient setting. Both pts had episodes of pneumonia in past medical history. One of them had SLE-induced interstitial lung disease. This patient was treated with GCs, mycophenolate mofetil, and rituximab, no post-vaccination response was documented. The second patient had two previous pneumonia episodes, she demonstrated 4–5-fold increase in anti- S. pneumoniae AT titre; her therapy included GCs (10 mg/day) and hydroxychloroquine. There were no clinical or radiological symptoms of pneumonia in remaining 22 pts during the whole FUP. <h3>Conclusions</h3> Obtained results are indicative of good tolerability, safety and immunogenicity of 23-valent pneumococcal vaccine in SLE pts. Further studies are necessary for more comprehensive evaluation of vaccine clinical efficacy. <h3>Disclosure of Interest</h3> None declared