Background:Currently, for the treatment of patients with spondyloarthritis (SpA), basic anti-inflammatory drugs and biological drugs are widely used to effectively control the activity of the disease. At the same time, the use of these drugs is associated with an increased risk of developing infections, some of which can be prevented by vaccination.Objectives:The aim of the study was to evaluate the immunogenicity and safety of the 23-valent pneumococcal polysaccharide vaccine (PPV-23) in patients with SpA.Methods:The study included 42 patients with SpA: 30 men, 12 women, age 22-60 years, disease duration 14.8±10.6 years. Ankylosing spondylitis was diagnosed in 30 patients, psoriatic spondyloarthritis – in 12 patients. Activity of diseases was assessed as high in 78% of patients (median BASDAI index was 5.3 [4.1; 6.8]). At the time of inclusion in the study, all patients received nonsteroidal anti-inflammatory drugs, 14 patients - methotrexate, 10 - sulfasalazine, 6 - glucocorticoids, 2 - leflunomide, 2 - etanercept, 2 - secukinumab. 15 patients were planned to be prescribed secukinumab, 3 – etanercept, 3 - adalimumab, 1 – golimumab. 7 patients had a history of more than 2 cases of lower respiratory tract infections, 2 patients reported a monthly exacerbation of chronic sinusitis, 1 patient – the development of otitis every 2-3 months, requiring the use of antibacterial drugs. PPV-23 was administered in the amount of 1 dose (0.5 ml) subcutaneously into the deltoid muscle against the background of anti-rheumatic therapy. The level of antibodies to pneumococcal capsular polysaccharide was determined using the EIA PCP IgG kit (TestLine Clinical Diagnostics s.r.o., Czech Republic) before vaccination, 1, 3 and 12 months after vaccination.Results:The dynamics of the concentration of antibodies to pneumococcal capsular polysaccharide in patients with SpA is presented in the Table 1.Table 1.Concentration of pneumococcal antibodies, U/ml, Me [25; 75 percentile]1 visit (initial)2 visit (after 1 month)3 visit (after 3 month)4 visit (after 12 month)80.0 [35.2; 154.0]160.1 [73.5; 245.7] *214.5 [103.2; 255.0] **175.0 [120.1; 260.1] **p=0.01 **p=0.005At 1, 3 and 12 months after vaccination, the concentration of antibodies to pneumococcal capsule polysaccharide was significantly higher compared to the baseline values. In 81% of patients, vaccination tolerance was good. Reactions at the injection site (pain, swelling and hyperemia of the skin up to 2 cm in diameter), resolved independently after 1-5 days, were observed in 6 patients. In 2 patients, a severe local reaction was registered in the form of pain in the arm, infiltration and hyperemia of the skin up to 8 and 15 cm in diameter, respectively, accompanied by low-grade fever in one patient for 2 days, and febrile fever in the other for 3 days. In both cases, these symptoms were completely stopped after administration of paracetamol and antihistamines. Exacerbation of SpA and the emergence of new autoimmune disorders were not detected. During the follow-up period, no patients developed lower respiratory tract infections. Patients suffering from frequent sinusitis and otitis reported the absence of these infections after vaccination.Conclusion:The obtained data indicate satisfactory immunogenicity and good tolerability of PPV-23 in patients with SpA. Further studies are needed to better assess the immunogenicity and safety of vaccine, as well as to study of the influence of anti-rheumatic therapy on the effectiveness of immunization.Disclosure of Interests:None declared.
EFFICACY AND SAFETY OF 23-VALENT PNEUMOCOCCAL POLYSACCHARIDE VACCINE IN PREVENTION OF LOWER RESPIRATORY TRACT INFECTIONS IN THE CHINESE ELDERLY: A PROSPECTIVE CONCURRENT CONTROLLED TRIAL
