BackgroundThe incidence of infections, mainly pneumonias, is significantly increased in patients with rheumatoid arthritis (RA). The risk increases more in persons treated with targeted anti-inflammatory drugs (tDMARDs), biological or targeted synthetic.Pneumococcal vaccination is recommended for most patients with rheumatic diseases. However, only the immunological effectiveness of such vaccination has been sufficiently confirmed. There is sparse evidence of its clinical efficacy in patients with rheumatic diseases.Objectivesto evaluate the effect of 23-valent pneumococcal polysaccharide vaccine (PPV23) and 13-valent pneumococcal conjugate vaccine (PCV13) on the risk of infections in RA patients receiving tDMARDs.MethodsThe data from the Moscow Unified Arthritis Registry (MUAR) for the period 2018-2020 were analyzed. We included patients with RA, over 18 years old, received tDMARDs (all available biologics or tofacitinib).The analysis included episodes of observation from the moment of vaccination with pneumococcal vaccine until the development of the analyzed event (any infection, respiratory infection or serious infection) or until the end of follow up. For unvaccinated patients, episodes began since October 20, 2018 (the average date of vaccination of persons who received immunization).The risks were compared using Cox regression. An adjustment was made for confounders identified in an earlier study: age and smoking.ResultsThe analysis included 832 patients: 40 were vaccinated with PCV13, 35 – with PPV23. There were 144 men (17.3%). The mean age was 55.4 ± 12.1 years. The duration of observation was 319 ± 198 days.A total of 237 infectious events were registered, of which 201 were respiratory and 21 serious (Table 1). There was a significantly lower risk of any infection (relative risk (RR) – 0.39 CI: 0.18 - 0.84, p = 0.015) and the risk of respiratory infection (RR - 0.32; CI: 0.13 -0.79; p = 0.014) in the group of patients vaccinated with PCV13 compared with unvaccinated. The differences remained statistically significant after adjusting for the age and smoking, Figure 1.Table 1.Registered infectious eventsEvent groupsLocalisationNumberOf them seriousRespiratory infectionsEar, paranasal sinuses, tonsils162Upper respiratory tract1660Pneumonia1814Lung abscess11Other infectionsEye and appendages30Skin and subcutaneous tissue71Bones and joint22Urogenital tract60Digestive system, including the oral cavity21Herpes infections*160* - events are included in the group, regardless of localization, these events were not included in other sectionsFigure 1.Survival without infectious events (A) and without respiratory infections (B) adjusted for age and smokingThe interaction of the effects of vaccination with the factor of the used tDMARD, as well as with the factor of the use of methotrexate in their effect on the risk of any and respiratory infections was evaluated. There was no significant interaction between these variables.There were no significant differences in the risk of serious infections due to a small number of events of this kind. No serious infections were registered among patients vaccinated with PCV13.ConclusionVaccination with 13-valent conjugated pneumococcal vaccine in patients with rheumatoid arthritis receiving tDMARDs can significantly reduce the risk of infectious complications, mainly due to acute respiratory infections. We found no significant effect of targeted drug and treatment with methotrexate on the effectiveness of vaccination.Disclosure of InterestsEvgeniy Zhilyaev Speakers bureau: UCB Pharma, Biocad, Galina Lukina Speakers bureau: Pfizer, MSD, Biocad, Ekaterina Koltsova: None declared, Dzhamilya Murtazalieva: None declared, Evgeniya Shmidt: None declared, Karine Lytkina Speakers bureau: UCB Pharma, Anna Shmitko: None declared, Dmitry Blagovidov: None declared, Mikhail Kostinov: None declared
BackgroundRheumatoid arthritis (RA) is accompanied by a significant increase in the risk of infection and serious infections, among which pneumonia occupies a leading place. (1) The use of targeted anti-inflammatory drugs is accompanied by an additional increase in the risk of infectious complications. In this regard, vaccination is crucial in the management of such patients.ObjectivesTo evaluate the safety and efficacy of the 13-valent pneumococcal vaccine in patients with RA undergoing various types of antirheumatic therapy.MethodsThe study included 60 patients with a reliable diagnosis of RA, according to the criteria of ACR/EULAR, among them 8 men and 52 women, average age 63 years (from 29 to 69 years) with disease activity at the time of inclusion of Das-28 – 4.9 (2.2-7.7), bionaive patients with insufficient response to DMARDs who will be prescribed tofacitinib (TOFA) for the first time or receiving TOFA for at least 3 months (30 patients in each group). Both groups of patients were further subdivided into two groups, 15 vaccinated and unvaccinated patients in each. The exclusion criteria were: age over 70 years; patients with infectious diseases in the acute stage; having a history of intolerance to diphtheria toxoid, patients who had previously been vaccinated with pneumococcal vaccines. For the prevention of pneumococcal infection, a pneumococcal 13-valent polysaccharide conjugated adsorbed vaccine was used. Visits to assess the condition were made in the period of 0-3-12 months. The activity of the disease was assessed by the DAS 28, CDAI, SDAI indices.ResultsAmong vaccinated patients with PCV 13 the most common adverse events were: pain at the injection site (16%), fever up to 37.6C (13%), redness at the injection site (6%), infiltration at the injection site (2%), myalgia (2%). These adverse events resolved spontaneously within 3 days. In a comparative assessment of infectious events during 12 months before vaccination and the next 12 months after it, there were no significant differences between vaccinated and unvaccinated patients. In patients who had a history of pneumococcal etiology infections after vaccination, the incidence decreased by 33%.ConclusionVaccination against pneumococcal infection is a safe and effective method of preventing pneumococcal infection in patients with rheumatoid arthritis.References[1]Koivuniemi R., Leirisalo-Repo M., Suomalainen R., etc. Infectious causes of death in patients with rheumatoid arthritis: an autopsy study. Scand J Rheumatol 2006; 35)4): 273-6Disclosure of InterestsGalina Lukina Speakers bureau: Ebbvie, Biocad, Pfizer, Roche, Dzhamilya Murtazalieva: None declared, Ekaterina Koltsova: None declared, Mikhail Kostinov: None declared, Anna Shmitko: None declared, Dmitry Blagovidov: None declared, Evgeniy Zhilyaev Speakers bureau: Ebbvie, Biocad, Pfizer, Roche
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