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Abstract
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 investigateimmunogenicity 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) during the 2-year follow-up.
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 with a history of ≥2 episodes of lower respiratory tract infections (bronchitis, pneumonia). 52 patients with RA were on methotrexate (MTX), 14 were on leflunomide (LEF), 13 were ontumor necrosis factor alpha inhibitors (iTNF-α)+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 vaccinationfor 110 patients. 39 RA patients were followed up for 2 years (24 months). Routine evaluation during each visit included physical exams and laboratory tests. Levels of antibodies to pneumococcal capsular polysaccharide were measured using VaccZymeTM PCPIgG 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, IV and V to baseline AB level at Visit I.
Results Not a single caseof clinicallyor radiographically confirmed pneumonia was documented during the follow up period. 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 during one-year follow-up. Dynamics of post-immunization response coefficient in RA patients during 2-year follow up are presented in the Table. RA patients and the control group are marked more than 2-foldsignificant increase in the content of antibodies in 3 monthsafter the vaccination. Despite the decline in their concentrationsto 12 months, it remained at the proper level and was increased to 24 month follow-up.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 subfebrilefever) in 35% of cases. As these reactions had no causal relationship with current RA therapy, and fully resolved within 24 hours without additional treatment, no RA therapy modification was required.Pronounced DAS28 positive dynamics in RA patients (4,27 and 2,68 at Visit I and Visit V, 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,during the 2-year follow-up.
Disclosure of Interest None declared