Background Concurrent infections have significant impact on morbidity and mortality, especially in autoimmune diseases. Therefore, prevention of infection is an integral part of supervision of these patients.
Objectives To investigate efficacy, immunogenicity and safety of 23-valent pneumococcal vaccine in patients with rheumatoid arthritis (RA), receiving therapy with diseases modifying anti rheumatic drugs (DMARDs) and biological disease modifying anti rheumatic drugs (bDMARDs).
Methods Out of 131 subjects (108 females, 23 males, aged 23-73 years) included into the study 79 were RA patients and 52 - controls with a history of ≥2 episodes of lower respiratory tract infections (bronchitis, pneumonia). 39 patients with RA were on methotrexate (MTX), 14-leflunomid, 26- tumor necrosis factor alpha (TNF-α) inhibitors+MTX. One dose (0,5 ml) of 23-valent pneumococcal vaccine “Pneumo-23” was administered subcutaneously without discontinuation of MTX/leflunomide, 28-30 days prior to administration of TNF-α inhibitors. Totally four study visits were planned: initial vaccination visit and 3 control visits in 1, 3 and 12 months after vaccination. Routine evaluation during each visit included physical exams and laboratory tests. Levels of antibodies to pneumococcal capsular polysaccharide were measured using VaccZymeTM PCP IgG 2 kit (The Binding Site Group Ltd, Birmingham, UK).
Results Not a single case of clinical or radiographic pneumonia was documented during the follow up period. Dynamic of pneumococcal antibodies is presented in the table.
In RA patients concentration of antibodies significantly increased by visit 2, reached maximum by visit 3 and slightly decreased by the end of the year as compared with the baseline values. Similar dynamics was observed in the control group. In one year after vaccination more than 2-fold increase of pneumococcal antibody titers was documented in RA patients and controls (p=0,001 and p=0,002, respectively). In 89 cases patients tolerated the vaccine perfectly, and there were no complications. In 34 cases injection-site local reactions, such as pain or discomfort, swelling and redness of the skin up to 2 cm was documented, and in 8 cases local reaction was accompanied subfebrile fever. These reactions had no casual relationship with current RA therapy, and fully resolved within 24 hours without additional treatment. During the follow-up period no exacerbations of RA or occurrence of any new autoimmune disorder were registered. Dynamic of DAS28 in RA patients was as follows: 1 visit – 4,2; 2 – 3,7; 3 – 3,4; 4 – 3,25.
Conclusions Thus, obtained results indicate sufficient clinical efficacy, immunogenicity and good tolerability of 23-valent pneumococcal vaccine in RA patients.
Disclosure of Interest None declared