Assessment of clinical and immunological efficacy and safety of 23-valent pneumococcal vaccine in patients with rheumatoid arthritis

The objective of this trial was to assess clinical efficacy, immunogenicity, and safety of 23valent pneumococcal vaccine (PPV23) in patients with rheumatoid arthritis (RA).

Methods. The trial enrolled 95 patients (75 women and 20 men aged 23 to 70 years) including 68 patients with RA and 27 subjects without systemic inflammatory rheumatic diseases (a control group) who had a recent history of ≥ 2 episodes of lower respiratory tract infection. At enrollment, all the patients received antiinflammatory therapy with methotrexate (MT) (n = 48), leflunomide (LEF) (n = 10), or MT + tumor necrosis factorα (TNFα) inhibitors (n = 10). A single 0.5ml dose of PPV23 (Pneumo23, Sanofi Pasteur) was administered subcutaneously under the regular therapy with MT or LEF or 3–4 weeks before TNFα inhibitor administration. During followup (1 and 3 months and 1 year after the vaccination), the patients underwent physical examination and routine clinical and laboratory investigations. Antipneumococcal capsular polysaccharide antibodies were measured in the serum using ELISA assay with commercial VaccZymeTM AntiPCP IgG Enzyme Immunoassay Kit (The Binding Site Group Ltd, Birmingham, UK).

Results. Noone case of pneumonia was registered in vaccinated patients during 12month followup. A twofold increase in antipneumococcal antibody level was found 1 year after the vaccination in RA patients and the control group. The vaccine was well tolerated by 63 patients (66%); 25 patients (26%) experienced pain, swelling and hyperemia at the area of vaccine injection and 7 patients (8%) had lowgrade fever. Neither RA exacerbation nor new autoimmune disorders were diagnosed during the followup.

Conclusion. The findings suggest that PPV23 showed good clinical efficacy, adequate immunogenicity and good tolerability in RA patients.

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