BackgroundIn rheumatology, comorbid infections have significant impact on patients’ morbidity, mortality and quality of life. Prevention of infections is an integral part of supervision of these patients.ObjectivesThe aim of the study is to investigate immunogenicity and safety of 23-valent polysaccharide pneumococcal vaccine (PPV-23) in patients with rheumatoid arthritis (RA) in a five-years period.MethodsThe study included 79 RA patients with ≥2 recent episodes of respiratory tract infections (bronchitis, pneumonia). 52 RA pts were treated with methotrexate (MT), 14 – with leflunomide (Lef), 13– with TNF- α inhibitors + MT. One dose (0,5 ml) of PPV-23 was administered subcutaneously without discontinuing MT/Lef or 28-30 days prior to initiation of TNF- α inhibitors. Control visits were scheduled as follows: at baseline (Visit 1), and in 1, 3, and every year after immunization. 39 out of 110 pts were followed for 24 months, 23 pts – for 36 months, 23 pts – for 48 months, and 18 - for 60 months. Standard clinical examination and lab tests were performed at each visit.Levels of serum antibodies (AB) to Pneumococcal capsular polysaccharide were measured with VaccZymeTM PCP IgG 2 panels (The Binding Site Group Ltd, Birmingham, UK). Coefficient of post-immunization response (CPR) was determined for each patient as the ratio of AB levels at Visits II, III, IV, V, VI and VII to AB level at Visit I.Results53 (67%) patients did not have any reactions to the vaccine, 26 (33%) patients indicated pain, swelling and hyperemia of the skin (diameter up to 2 cm) at the injection site of the vaccine, low-grade fever. These typical reactions following vaccination are completely regressed within days without any additional treatment. They were not associated with RA therapy and did not require changes in ist schemes.Pronounced positive immune reaction to PPV-23 was documented in all RA patients on different therapeutic regimens as significant AB incremental growth. Significantly high level of post-immunization response still persisted after 4 and 5 years of follow-up.The proportion of responders to PPV-23 after 5 years reached 73% among RA patients. (Table).No case of clinically or radiographically confirmed pneumonia was documented during the follow up period, although one case of interstitial viral pneumonia was registered in 6 month after immunization.Not a single vaccination-related RA exacerbation episode or new autoimmune phenomenon was documented during the follow-up.Table. AB dynamics in RA pts during 5-year FUP, M± σ. Visit II(1 month)Visit IV(12 month)Visit V (24 month)Visit VI (36 month)Visit VII (48 month)Visit VIII (60 month)RA patients82,20 [46,00; 133,50]250,62*[187,70; 316,90]298,70*[175,99;420,81]107,8[98,2;159,4140,5* [107,9;208,3]194,8*[120,1;361,4]*p<0,05ConclusionThus, all given prove the sufficient immunogenicity and safety of 23-valent pneumococcal vaccine in RA patients after 5 years of follow-up, getting different therapeutic regimens.Disclosure of InterestsNone declared

В современной ревматологии несомненного внимания заслуживает проблема коморбидных инфекций, формирование которых обусловлено как самим ревматическим заболеванием (РЗ), так и необходимостью применения препаратов с иммуносупрессивным действием. Многочисленные проблемы, обусловленные инфекциями в ревматологии и иных отрас-лях клинической медицины, нельзя решить только путем использования большого количества антиинфекционных пре-паратов, которые доступны на сегодняшний день. Следовательно, в ближайшей перспективе важная роль будет отведена созданию, совершенствованию и быстрому (по возможности) внедрению в клиническую практику вакцин различной направленности. В данном обзоре рассмотрены вопросы, касающиеся применения вакцин против гриппа и пневмококко-вой инфекции у больных РЗ, а также сформулированы перспективы дальнейшего внедрения вакцинопрофилактики в ревматологии.

BackgroundComorbid infections have significant impact on morbidity and mortality, especially in autoimmune diseases. Prevention of infection is an integral part of supervision of these patients.ObjectivesTo 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).MethodsThe study included 110 patients (females–81 (73,6%), males–29 (26,4%), aged 23–76 y), 79 RA pts and 31 controls with ≥2 recent episodes of upper respiratory tract infections (bronchitis, pneumonia). 52 RA pts were treated with methotrexate (MT), 14 – with leflunomide (Lef), 13– with TNF- α inhibitors+MT. One dose (0,5 ml) of 23-valent polysaccharide pneumococcal vaccine was administered subcutaneously without discontinuing MT/Lef or 28–30 days prior to initiation of TNF- α inhibitors. Control visits were scheduled as follows: at baseline (Visit I), and in 1, 3, and 12 months after immunisation. 39 out of 110 pts were followed for 24 months, 23 pts – for 36 months, and 16 pts – for 48 months. Standard clinical examination and lab tests were performed at each visit. Levels of serum antibodies (AB) to Pneumococcal capsular polysaccharide were measured with VaccZymeTM PCP IgG 2 panels (The Binding Site Group Ltd, Birmingham, UK). Coefficient of post-immunisation response (CPR) was determined for each patient as the ratio of AB levels at Visits II, III, IV, V, VI and VII to AB level at Visit I.ResultsThere were no documented clinical or radiological symptoms of bacterial pneumonia in a single patient during the FUP. CPR dynamics in RA pts on different therapeutic regimens and in the controls is shown in the table 1.Abstract SAT0394 – Table 1CPR dynamics in RA pts and the controls during 1-year FUP, M±&x03C3;.Visit II(1 month)Visit IV(12 month)Visit V (24 month)Visit VI (36 month)Visit VII (48 month) RA patients2,33*[1,6;3,8]2,64*[2,03;6,39]3,07*[1,56;6,18]1029[0,74;1,32]2,08*[0,69;3,80]*p<0,05Pronounced positive immune reaction to the study vaccine was documented in all RA patients on different therapeutic regimens as significant CPR incremental growth. The proportion of responders to the vaccine reached 61% among RA pts. Significant decrease of RA activity according to DAS28 scores in RA pts (4,32 and 3,31 at Visits I and IV, respectively, p<0,001) demonstrates absence of any negative effect of vaccination on disease activity. There was a trend to weakening of post-vaccination response in 3 years, although significantly high level of post-immunisation response still persisted after 4 years of FUP. Not a single case of pneumococcal infection was ever documented during 4 years FUP, although one case of interstitial viral pneumonia was registered in 6 month after immunisation. Not a single vaccination-related RA exacerbation episode was documented during the FUP.ConclusionsTherefore obtained results are indicative of sufficient immunogenicity, good safety and e...

Immunogenicity and efficiency of a 23-valent pneumococcal vaccine in patients with rheumatoid arthritis: results of a 5-year follow up study Bukhanova D.V.

Intoduction. Currently, for the treatment of patients with rheumatoid arthritis (RA) and spondyloarthritis (SpA), basic anti-inflammatory drugs and biological drugs are widely used to effectively control the activity of the disease. However, the use of these drugs is associated with an increased risk of developing comorbid infections, some of which can be prevented by vaccination. Objective. To evaluate the immunogenicity, safety, and clinical efficacy of the 23-valent pneumococcal polysaccharide vaccine (PPV-23) in patients with RA and SpA.Materials and methods. The study included 122 patients: 79 - with RA, 43-with SpA. Most patients had a history of two or more cases of lower respiratory tract infections, 2 patients reported a monthly exacerbation of chronic sinusitis, one patient reported the development of otitis media every 2-3 months. At the time of inclusion in the study, most patients received immunosuppressive therapy. PPV-23 was administered in an amount of 1 dose (0.5 ml) subcutaneously against the background of anti-rheumatic therapy. The level of antibodies to pneumococcal capsular polysaccharide was determined using the EIA PCP IgG kit (TestLine Clin-ical Diagnostics s.r.o., Czech Republic) before vaccination, 1, 3 and 12 months after vaccination. In addition, the tolerance of PPV-23, the frequency of pneumonia, and the effect on the activity of RA and SpA were evaluated (according to the dynamics of DAS28 and BASDAI).Results. At 1, 3, and 12 months after vaccination, the concentration of antibodies to pneumococcal capsular polysaccharide was significantly higher than the baseline values, which indicates sufficient immunogenicity of PPV-23. There was no negative effect of vaccination on the activity of the underlying disease and the occurrence of new autoimmune disorders. In the majority of patients (67% - RA, 81.4% - SpA), the tolerance of the vaccine was good. During the follow-up period, none of the patients developed pneumonia. Patients suffering from frequent sinusitis and otitis media reported the absence of these infections after vaccination.Conclusion. Preliminary results of the study indicate sufficient immunogenicity, safety, and clinical efficacy of PPV-23 in patients with RA and SpA.