SAT0394 Immunogenicity and safety of 23-valent pneumococcal vaccine in ra patients: results of a 4- year follow up study
Authors: D. Bukhanova, M. Sergeeva, B. Belov, G. Tarasova, M. Cherkasova, Y. Muraviev, G. Lukina, N. Demidova
Journal: Annals of the Rheumatic Diseases (2018)

<h3>Background</h3> Comorbid infections have significant impact on morbidity and mortality, especially in autoimmune diseases. Prevention of infection is an integral part of supervision of these patients. <h3>Objectives</h3> To investigate immunogenicity and safety of 23-valent polysaccharide pneumococcal vaccine in patients with rheumatoid arthritis (RA) treated with diseases modifying anti rheumatic drugs (DMARDs) and biologic diseases modifying anti rheumatic drugs (bDMARDs). <h3>Methods</h3> The study included 110 patients (females–81 (73,6%), males–29 (26,4%), aged 23–76 y), 79 RA pts and 31 controls with ≥2 recent episodes of upper respiratory tract infections (bronchitis, pneumonia). 52 RA pts were treated with methotrexate (MT), 14 – with leflunomide (Lef), 13– with TNF- α inhibitors+MT. One dose (0,5 ml) of 23-valent polysaccharide pneumococcal vaccine was administered subcutaneously without discontinuing MT/Lef or 28–30 days prior to initiation of TNF- α inhibitors. Control visits were scheduled as follows: at baseline (Visit I), and in 1, 3, and 12 months after immunisation. 39 out of 110 pts were followed for 24 months, 23 pts – for 36 months, and 16 pts – for 48 months. Standard clinical examination and lab tests were performed at each visit. Levels of serum antibodies (AB) to Pneumococcal capsular polysaccharide were measured with VaccZymeTM PCP IgG 2 panels (The Binding Site Group Ltd, Birmingham, UK). Coefficient of post-immunisation response (CPR) was determined for each patient as the ratio of AB levels at Visits II, III, IV, V, VI and VII to AB level at Visit I. <h3>Results</h3> There were no documented clinical or radiological symptoms of bacterial pneumonia in a single patient during the FUP. CPR dynamics in RA pts on different therapeutic regimens and in the controls is shown in the table 1. Pronounced positive immune reaction to the study vaccine was documented in all RA patients on different therapeutic regimens as significant CPR incremental growth. The proportion of responders to the vaccine reached 61% among RA pts. <i>Significant</i> decrease of RA activity according to <i>DAS28</i> scores in RA pts (4,32 and 3,31 at Visits I and IV, respectively, p&lt;0,001) demonstrates absence of any negative effect of vaccination on disease activity. There was a trend to weakening of post-vaccination response in 3 years, although significantly high level of post-immunisation response still persisted after 4 years of FUP. Not a single case of pneumococcal infection was ever documented during 4 years FUP, although one case of interstitial viral pneumonia was registered in 6 month after immunisation. Not a single vaccination-related RA exacerbation episode was documented during the FUP. <h3>Conclusions</h3> Therefore obtained results are indicative of sufficient immunogenicity, good safety and efficacy of 23-valent pneumococcal vaccine in RA pts on different therapeutic regimens. <h3>Disclosure of Interest</h3> None declared