1 Национальный медицинский исследовательский центр здоровья детей, Москва, Российская Федерация 2 Первый Московский государственный медицинский университет им. И.М. Сеченова (Сеченовский Университет), Москва, Российская Федерация [8,9]. При использовании метотрексата и других иммунодепрес-сантов повышается риск развития не только гепатоток-сичности, нейтро-и/или лимфопении, но и пневмоний, особенно часто -в течение первого года лечения [10]. Ингибиторы фактора некроза опухоли (Тumor necrosis factor, TNF) ␣ повышают риск развития бактериаль-ных, грибковых и оппортунистических инфекций [10]. Приблизительно половина всех инфекционных нежела-тельных явлений у пациентов с ЮИА связана с пораже-нием дыхательных путей [11,12]. Пациенты с ювенильным идиопатическим артритом (ЮИА) имеют повышенный риск развития инфекций. При-близительно половина всех серьезных инфекций у детей с ЮИА связана с поражением дыхательных путей. Цель исследования: изучить эффективность и безопасность 13-валентной пневмококковой конъюгированной вакцины (ПКВ) у детей с ЮИА. Методы. В ходе проспективного когортного исследования было сформировано 5 групп: дети с ЮИА в фазе ремиссии на терапии метотрексатом (группа 1) или этанерцептом (группа 2), с ЮИА в активной фазе до назначения метотрексата (группа 3) или этанерцепта (группа 4), контрольная группа (условно здоровые дети 494Streptococcus pneumoniae (пневмококк) является наиболее частым этиологическим фактором пневмоний в детском возрасте, именно с ним связывают до 50% слу-чаев этого заболевания [13,14]. Кроме того, имеются данные о том, что более высокая смертность среди паци-ентов, получающих ингибиторы TNF ␣, является следстви-ем пневмококковых инфекций [2].Пневмококковая инфекция -это заболевание, пре-дотвращаемое вакцинацией. Полисахаридные капсуль-ные серотипы S. pneumoniae являются факторами виру-лентности, ответственными за инвазивные инфекции [15]. Эта бактерия имеет более 90 серотипов. У людей около 25-30 серотипов отвечают за 90% инвазивных инфекционных случаев [15]. Эффективность пневмокок-ковых вакцин зависит от охвата наиболее распростра-ненных серотипов, а также от их иммуногенности [15,16]. Распространенность серотипов варьирует в зависи-мости от возраста, хронических заболеваний, геогра-фического региона, введения пневмококковых вакцин и использования антибиотиков [16]. Учитывая пробле-мы, связанные с инфекцией, развивающейся на фоне терапии иммунодепрессантами, руководства по лечению ревматических болезней рекомендуют рутинное исполь-зование пневмококковых вакцин у пациентов с осла-бленным иммунитетом [17]. Однако вакцинация детей (например, против пневмококка), страдающих ЮИА, проводится относительно редко по сравнению с общей популяцией [18][19][20]. Частично это объясняется неопре-деленностью профиля безопасности и эффективности вакцин у пациентов, получающих иммуносупрессивные препараты [21,22].Предварительные результаты нашего исследования были опубликованы ранее [23].Цель исследования -изучить эффективность и безо-пасность 13-валентной пневмококковой конъюгирован-ной вакцины...
BackgroundThe use of therapy with anti-cytokine biologicals in routine practice has significantly increased the percentage of children showing good response to therapy and reduced the time to achieve pharmacological remission. Nevertheless, the problem related to selecting the optimal drug for a certain patient still remains to be solved.ObjectivesThis study was aimed at identifying clinical and laboratory parameters associated with response to tocilizumab (TOC) treatment in patients with RF-negative polyarticular JIA.MethodsThe prospective study to assess TOC efficacy involved 55 patients with RF-negative polyarticular JIA aged 9.42 years (IQR 5.96–13.42), with females (85.5%) predominating was conducted at the National Medical Research Centre of Children’s Health (Moscow). Treatment efficacy was evaluated using the ACRPedi criteria; Wallace’s criteria were used to assess whether a patient had reached inactive disease or remission. The potential baseline characteristics associated with treatment response were identified using univariate and multivariate logistic regression analyses. Baseline factors included the clinical, laboratory, and anamnestic data.ResultsTOC therapy showed high efficacy in children with RF-negative polyarticular JIA: 81.8/67.3/47.3/23.6% of patients reached the ACR30/50/70/90 criteria for the end of follow-up, respectively. The median time of achieving at least 30% improvement from baseline (ACR30) was 1 months (IQR 1:3).Univariate analysis showed that earlier age at initiation of Tocilizumab therapy, higher physician’s global assessment score using the 100-point Visual Analogue Scale, and longer morning stiffness were the factors associated with reaching ACR90. Younger age at therapy initiation, greater number of swollen joints and joints with limited range of motion, and history of using fewer biologicals are the factors associated with reaching inactive disease and remission. However, multifactorial analysis showed that only earlier age at initiation of TOC therapy was a statistically significant factor associated with reaching the best response to therapy in all the models.ConclusionsEarlier initiation of TOC therapy is associated with higher chances for reaching ACR90 and pharmacological remission in patients with RF-negative polyarticular JIA. Further studies in larger cohorts are needed to identify the optimal age at therapy initiation.Disclosure of InterestE. Alexeeva: None declared, T. Dvoryakovskaya Grant/research support from: Roche, Pfizer, M. Soloshenko: None declared, R. Denisova: None declared, K. Isaeva: None declared, A. Mamutova: None declared, V. Gladkikh: None declared, A. Moskalev: None declared
Background. To assign genetically engineered biologic drugs, we need data on the predictors for response to therapy. Prognostic factors for the response to tocilizumab in patients with juvenile idiopathic arthritis (JIA) without systemic symptoms are poorly studied.Objective. Our aim was to reveal early predictors for the response to tocilizumab therapy in patients with JIA without systemic symptoms.Methods. A retrospective cohort study enrolled patients with JIA without systemic symptoms who received tocilizumab therapy between July 2009 and August 2017. We assessed the association between the initial demographic, clinical, and laboratory parameters in patients and the best response (according to the ACR90 criteria) to treatment after a year.Results. The study included 95 (girls 85%) patients; the mean age was 10.3 (6.0; 13.6). During the first year of therapy, 71 (75%), 55 (58%), 38 (40%), and 22 (23%) patients achieved the improvement according to ACR30/50/70/90 criteria, respectively; 22 (23%) patients reached disease inactive stage according to the Wallace criteria. When performing multivariate analysis, the following improvement predictors were revealed based on the ACR90 criteria after a year of treatment: decrease in serum C-reactive protein level during the first month of therapy [odds ratio (OR) 1.024; 95% confidence interval (CI) 1.007–1.051], decrease in disease activity score on the visual analogue scale according to the parent/patient assessment (OR 1.048; 95% CI 1.005–1.105), early onset of the disease (OR 0.38; 95% CI 0.16–0.72), persistent oligoarthritis according to the ILAR (OR 9.9; 95% CI 1.5–109.3). During the first year of tocilizumab administration, neutropenia was registered in one patient, leukopenia — in three cases, and urticaria — in one case.Conclusion. The variant of JIA, the age at the disease onset, and the disease course pattern in the first month of tocilizumab therapy are the predictors of treatment efficacy throughout the year.
BackgroundTumor necrosis factor inhibitors are highly effective and safe in treatment of juvenile idiopathic arthritis (JIA). Nonetheless, to select the optimal therapy and to achieve maximum therapeutic effect it is necessary to consider the individual characteristics of the patient. Adalimumab (ADA) is widespread use for mild and severe polyarticular JIA especially in the presence of uveitis, but there is lack of data about clinical and laboratory predictors of response to ADA in different JIA categories.ObjectivesTo identify clinical and laboratory parameters associated with response to adalimumab treatment in 12 months in patients with different JIA category.MethodsAnalysis include patients with enthesitis-related arthritis (ERA, n=56), RF-negative polyarthritis (polyRF-, n=50), extended oligoarthritis (extOligo, n=30), and persistent oligoarthritis (persOligo, n=62) with median age 10.5 (IQR 7–14) and median JADAS-71 19.5 (IQR 15–28). Patients were divided to response groups after 12 month treatment with ADA according to ACRPedi criteria, achieving inactive disease by Wallace criteria and JADAS-71 cut-off point as excellent, intermediate and poor responders. For each of JIA category univariate and multivariate logistic regression analysis was conducted to identify potential baseline factors associated with treatment response. Baseline factors included clinical, laboratory and anamnestic data.ResultsADA was shown to be effective in all groups with 90%/89%/82%/63% children with ACR30/50/70/90 during one year therapy. The most significant factors (p<0.05) associated with response to ADA treatment are presented in summarized table.Table 1FactorsExcellent response to ADAPoor response to ADA CHAQ scorelower at start of ADA (ExtOligo)–VAS disease activity by patient/parenthigher at start of ADA (ERA)lower at start of ADA (ERA)VAS disease activity by physician–lower at start of ADA (PersOligo)Need for corticosteroid eye drops (for uveitis patients)Absence in anamnesis (PersOligo)–Morning stiffnessShorter at start of ADA (ERA), longer at start of ADA (PersOligo)–Joints with active arthritis–higher at start of ADA (PolyRF-)erythrocyte sedimentation rate (ESR)–lower at start of ADA (PolyRF-)Our findings demonstrated that different predictors corresponded with different JIA categories. Interestingly subjective scales of disease activity was shown to be strongly associated with response to therapy. At the same time VAS severity at baseline were inversely correlated with achievement of good response. Duration of morning stiffness correlated with excellent response in children with 2 different categories. However, for ERA patients shorter duration was associated with better response to treatment while vice versa for PersOligo patients.ConclusionsPredictors of response to ADA treatment differ in JIA categories. Low disease activity parameters (clinical and laboratory) at baseline not always predict good response to therapy.Disclosure of InterestE. Kashchenko Grant/research support from: Novartis, E. Alexeeva Grant/research ...
26,1 (14,3; 52,1) до 73,0 (52,5; 156,0) мг/л (р = 0,001), с ЮИА в фазе ремиссии -с 27,4 (18,2; 59,1) до 54,6 (35,3; 96,0) мг/л (р = 0,029). Увеличения концентрации белка S100 -предиктора обострения повышения активности болезни -после вакцинации не отмечено (р = 0,192 Целью нашего исследования было оценить эффек-тивность и безопасность 13-валентной пневмококковой полисахаридной вакцины (ППВ) у детей с ЮИА. МЕТОДЫ Дизайн исследованияПроведено проспективное открытое исследование. Критерии соответствияКритерии включения: диагноз ЮИА, соответствующий критериям EULAR/ACR (2011) [6]; наличие в анамнезе у 2 случаев острых инфекций нижних дыхательных путей; возраст младше 18 лет.Критерии невключения: непереносимость компонен-тов вакцины в анамнезе; симптоматика выраженной печеночной и/или почечной недостаточности; пневмо-кокковая вакцинация в предыдущие 3 года; наличие при-знаков текущей инфекции дыхательных путей. Условия проведенияИсследование проводилось в период с 2015 по 2016 г. на базе специализированного ревматологиче-ского отделения ФГАУ «ННПЦЗД» Минздрава России, Москва (далее ННПЦЗД).Описание медицинского вмешательства Вакцинация 13-валентной ППВ (Pfizer, США) проводи-лась однократно в дозе 0,5 мл подкожно на фоне терапии основного заболевания метотрексатом/этанерцептом (у больных в стадии ремиссии) либо за 3 нед до назна-чения метотрексата/этанерцепта (у больных в стадии активного заболевания). Исходы исследования Основной исход исследованияЭффективность вакцинации оценивали по динамике уровня антител к капсульному полисахариду пневмокок-ка через 1 мес после вакцинации. 26.1 (14.3; 52.1) to 73.0 (52.5; 156.0) mg/l (p = 0.001), 59.1) to 54.6 (35.3; 96.0) mg/l (p = 0.029). The concentration of the predictor of S-100 protein high activity after vaccination was not increased (p = 0.192 Efficacy and Safety of Immunization
Background. Cytomegalovirus infection (CMVI) is the reason of high mortality in perinatal period, disability in children from risk groups with further development of congenital malformations and chronic diseases. Clear understanding of epidemiology and determination of focus population groups is crucial for development of measures and algorithms of congenital CMVI prevention.Objective. The aim of the study is to study CMVI seroprevalence among immunocompetent adolescents in Russian Federation with reference to the gender, regional, social and economic, and age factors.Methods. We have used for our study data from the survey of senior schoolchildren from 7 municipalities representing various regions of Russian Federation: group 1 (10–12 years old) and group 2 (14–16 years old). The study of CMVI seroprevalence and immune response was performed via the analysis of the level of IgG antibodies to cytomegalovirus (CMV) in blood serum. The social and economic well-being of the region was determined by "RIA Rating" experts.Results. Serological prevalence of CMVI in the study group of adolescents (n = 1403) was 70.6% (n = 990). There were no statistically significant gender differences in the distribution of seropositive children in regions (p = 0.525). Infection in boys (72.6%; n = 455; median age — 12.9 (11.0; 14.9)) did not prevail over the infection in girls (68.8%; n = 535; median age — 13.1 (11.0; 14,9)); p = 0,117. The overall prevalence of CMVI increased statistically significant with age — from 68% (n = 486) in group 1 to 73% (n = 504) in group 2 (p = 0.036). The prevalence of CMVI varied statistically significant by region (p = 0.003). There was no correlation between the regional seropositive level and the social and economic situation in the region (r = 0.034, p = 0.192). Immune response intensity did not differ by age, gender, and region with the antibody median of 88.9 CU/ml.Conclusion. More than half of adolescents (by the age of 10) in Russian Federation are infected, and infection increases with approaching to childbearing age, however, age is not the only aspect associated with serological status. Factors affecting immune response intensity require further study. Understanding of the CMV prevalence among children is crucial for determining future prevention approaches in target groups.
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