Netakimab is a humanized anti-interleukin-17A monoclonal antibody, it has marketing approval for treatment of adult patients with moderate-tosevere plaque psoriasis, psoriatic arthritis, and ankylosing spondylitis. This paper provides the results of the first 12-week period of phase III BCD-085-16/PLANETA-KIDS clinical study.Objective. The aim of the BCD-085-16/PLANETA-KIDS is to evaluate netakimab efficacy and safety in pediatric patients 6+ years old with moderate-to-severe plaque psoriasis.Methods. BCD-085-16/PLANETA-KIDS (NCT06640517) is a randomized, double-blind, placebo-controlled phase III clinical study with open-label active-comparator arm (adalimumab). A total of 155 male and female patients aged from 6 to 18 years with confirmed moderate-to-severe plaque psoriasis were randomized to receive netakimab (n = 83), placebo (n = 35), or adalimumab (n = 37). Netakimab dosage was weight adjusted: for patients weighing 50 kg or more netakimab dose was 120 mg (two injections of 60 mg/ml each), for patients weighing less than 50 kg netakimab dose was 60 mg (one injection of 60 mg/ml). Patients in the Netakimab group received netakimab subcutaneously once per week for the first three weeks (induction) and once every 4 weeks thereafter (maintenance). Patients in the Placebo group received placebo in blinded manner like netakimab. Adalimumab was administered in open-label way in doses recommended by the product’s SmPC. In this study co-primary efficacy endpoints were the proportion of patients achieving PASI75 and sPGA0/1 at week 12.Results. Netakimab has shown superiority over placebo for both co-primary endpoints. The proportion of patients achieving PASI75 at week 12 was 89.2% in the Netakimab group and 14.3% in the Placebo group, odds ratio (OR) 59.0, 95% CI [16.5; 211.5] (p < 0.0001). The proportion of patients achieving sPGA0/1 at week 12 was 83.1% in the Netakimab group and 8.6% in the Placebo group, OR 54.9, 95% CI [14.6; 206.5] (p < 0.0001). The subgroup analysis has shown consistent netakimab superiority over placebo for both co-primary endpoints, regardless of age, body weight and psoriasis severity. Throughout the 12-week period netakimab has shown favorable safety profile comparable to that in the Placebo group.Conclusion. The results of the 12-week period in the BCD-085-16/PLANETA-KIDS study have shown high efficacy of netakimab compared with placebo with favorable safety profile in children aged 6 years and older and adolescents with moderate-to-severe plaque psoriasis.
Objective. To compare orthostatic heart rate variability (HRV) parameters in elite and junior-ranked cross-country skiers and to assess their dynamics during enforced detraining.Material and methods. Fifteen ortho-HRV parameters were analysed in elite cross-country skiers of the Republic of Tatarstan (ECST) and juniorranked skiers (JCST) over a 6-month preparatory period. Additionally, ortho-HRV dynamics were assessed in elite skier K.D. during 7 months of enforced training cessation.Results. In ECST, medians of 9 HRV parameters (TP, AMHF, AMVLF, AMLF, RRNN, pNN50%, RMSSD, SDNN, MxDMn) were higher, and HR and SI were lower than in JCST; HF%, VLF%, LF%, and AMLF/AMHF did not differ. Following detraining, K.D. demonstrated progressive decline of 12 ortho-HRV parameters to non-athlete levels with concurrent increases in LF%, HR, and SI, while partial preservation of elevated non-neuronal acetylcholine synthesis was suggested by residual HRV signatures.Conclusion. Elite cross-country skiers exhibit higher parasympathetic autonomic nervous system activity and presumably greater non-neuronal acetylcholine synthesis. Athletic bradycardia regresses substantially faster (within months of detraining) than it develops, which requires 13–20 years of continuous high-volume training.
Статья посвящена нейротоксичности противотуберкулёзной терапии. Цель – анализ частоты, структуры и факторов риска неврологических осложнений у пациентов с туберкулёзом. Метод – ретроспективный анализ историй болезни. Выявлена корреляция нейротоксичности с приемом изониазида, циклосерина, линезолида, алкоголем и возрастом. Обоснована необходимость мониторинга неврологического статуса
National projects pay great attention to the preservation of mental health and the development of infrastructure for providing multidisciplinary medical and psychological assistance to minors. The purpose of the study was to describe and evaluate the effectiveness of the implementation of areas for improving interdepartmental measures to preserve mental health and prevent non-psychotic mental disorders in adolescents in a region with average indicators of socio-economic development (Kirov region).The presented materials reflect the advantages and novelty of the implemented (2019-2024) interdepartmental system of events in educational, pediatric and psychiatric organizations. The effectiveness of preventive work with a risk group for non-psychotic mental disorders in educational institutions and psychological and psychotherapeutic care for people with pre-nosological mental conditions in a Crisis Care Center has been proven. The opening of this center on the basis of children’s polyclinics has helped to increase the availability of medical and psychological care, reduce stigmatization and improve the early access of adolescents. The introduction of a unified algorithm for the diagnosis and routing of adolescents with non-psychotic mental disorders and behavioral disorders, including suicidal risk, in medical and educational organizations made it possible to send people with an established disease to psychiatric services in a differentiated manner, which helped to reduce the primary incidence of these disorders and reduce the number of suicides in the region.
Статья посвящена особенностям течения туберкулеза у больных вирусным гепатитом С. Цель – анализ частоты и структуры клинических форм, коморбидной патологии, исходов стационарного лечения у больных туберкулезом в сочетании с вирусным гепатитом С. Метод – ретроспективный анализ историй болезни. Обоснована необходимость разработки комплексных программ лечения и диспансерного наблюдения для данной категории больных с привлечением гепатологов, а также усиления мер по раннему выявлению инфекции среди групп риска. Статья рассматривает особенности туберкулеза у пациентов с гепатитом С. Цель работы – анализ клинических форм, патологий и исходов лечения у больных с данной сочетанной инфекцией. Проведен ретроспективный анализ историй болезни. Обоснована необходимость создания программ лечения с участием гепатологов и усиления мер раннего выявления инфекции среди групп риска для улучшения результатов терапии
