Background 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.
Objectives 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).
Methods Out of 110 subjects (81 females (73,6%), 29 males (26,4%) aged 23–76 years) included into the study, 79 were RA patients and 31 were controls (GK) with a history of ≥2 episodes of lower respiratory tract infections (bronchitis, pneumonia). 52 patients with RA were on methotrexate (MTX), 14 were on leflunomid (LEF), 13 were on tumor necrosis factor alpha (iTNF-α) inhibitors+MTX. One dose (0,5 ml) of 23-valent polysaccharide pneumococcal vaccine was administered subcutaneously without discontinuation of MTX/LEF or 28–30 days prior to initiation of iTNF-α. Totally four study visits were preplanned: 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). Post-immunization response coefficient was calculated for each participant as the ratio of AB levels during visits II, III, and IV to baseline AB level at Visit I.
Results Not a single case of clinically or radiographically confirmed pneumonia was documented during the follow up period. Dynamics of post-immunization response coefficient in RA patients on different therapeutic modalities and in the controls are presented in the Table. Pronounced positive immune reaction after administration of the vaccine under investigation was documented in RA patients during different therapies, i.e., significant post-immunization response coefficient increase. There were 61% responders among RA patients and 70% responders among the controls. Good tolerability of the vaccine was documented in 65% of cases, satisfactory (injection site pain, swelling and hyperemia of the skin up to 2 cm in diameter and subfebrile fever) in 35% of cases. As these reactions had no casual relationship with current RA therapy, and fully resolved within 24 hours without additional treatment, no RA therapy modification was required. Univariate analysis of total 21 variables showed that negative results at Visit II (in one month after vaccination, OR 5,47, 95% CI 1,3–22,9) and Visit III (in three months after vaccination, OR 4,49 95% CI 1,6 -12,7) may cause negative response to vaccination in RA patients after 12 months follow up. Pronounced DAS28 positive dynamics in RA patients (4,32 and 3,31 at Visit I and Visit IV, respectively, p<0,001) indicates the absence of any negative impact of vaccination on disease activity).
Conclusions Thus, all given prove the sufficient immunogenicity and safety of 23-valent pneumococcal vaccine in RA patients, getting different therapeutic regimens.
Disclosure of Interest None declared
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