perinatologyРоссийский вестник перинатологии и педиатрииRossiyskiy Vestnik Perinatologii i Pediatrii (Russian Bulletin of Perinatology and Pediatrics)1027-40652500-2228Ltd. “The National Academy of Pediatric Science and Innovation”10.21508/1027-4065-2025-70-2-59-69perinatology-2186Research ArticleОРИГИНАЛЬНЫЕ СТАТЬИORIGINAL ARTICLESОсобенности применения биологической терапии при воспалительных заболеваниях кишечника в педиатрической практикеBiological therapy in pediatric inflammatory bowel diseasehttps://orcid.org/0000-0001-9536-5819РимскаяА. М.RimskayaA. M.

Римская Алена Михайловна — асп. кафедры детских болезней Клинического Института детского здоровья им. Н.Ф. Филатова

199991 Москва, ул. Трубецкая, д. 8, стр. 2 

Moscow 

https://orcid.org/0000-0003-3364-610XЯблоковаЕ. А.YablokovaE. A.

Яблокова Екатерина Александровна — к.м.н., вед. науч. сотр. Отдела педиатрии, доц. кафедры детских болезней Клинического Института детского здоровья им. Н.Ф. Филатова

199991 Москва, ул. Трубецкая, д. 8, стр. 2 

Moscow 

https://orcid.org/0000-0002-8307-5168СамолыгоИ. С.SamolygoI. S.

Самолыго Иван Сергеевич — студент IV курса Клинического Института детского здоровья им. Н.Ф. Филатова

199991 Москва, ул. Трубецкая, д. 8, стр. 2 

Moscow 

https://orcid.org/0000-0003-4893-6185БорисоваЕ. В.BorisovaE. V.

Борисова Елена Васильевна — к.м.н., зав. отделением гастроэнтерологии Университетской детской клинической больницы

199991 Москва, ул. Трубецкая, д. 8, стр. 2 

Moscow 

https://orcid.org/0000-0001-9257-0171ГореловА. В.GorelovA. V.

Горелов Александр Васильевич — д.м.н., акад. РАН, проф. кафедры детских болезней Клинического Института детского здоровья им. Н.Ф. Филатова; зам. дир. по научной работе Центрального научно-исследовательского института эпидемиологии

111123 Москва, Новогиреевская ул., д. 3А 

Moscow 

https://orcid.org/0000-0002-0178-2265ШавровА. А.ShavrovA. A.

Шавров Антон Андреевич — к.м.н., зав. эндоскопическим отделением Сеченовского центра материнства и детства, асс. кафедры детской хирургии и урологии-андрологии им. проф. Л.П. Александрова

199991 Москва, ул. Трубецкая, д. 8, стр. 2 

Moscow 

ФГАОУ ВО «Первый Московский государственный медицинский университет им. И.М. Сеченова» Минздрава России (Сеченовский университет)РоссияSechenov First Moscow State Medical University (Sechenov University)Russian FederationФГАОУ ВО «Первый Московский государственный медицинский университет им. И.М. Сеченова» Минздрава России (Сеченовский университет) ; ФБУН «Центральный научно-исследовательский институт эпидемиологии» РоспотребнадзораРоссияSechenov First Moscow State Medical University (Sechenov University) ; Central research institute of epidemiologyRussian Federation2025140520257025969Copyright © Ltd. “The National Academy of Pediatric Science and Innovation”, 20252025Ltd. “The National Academy of Pediatric Science and Innovation”Ltd. “The National Academy of Pediatric Science and Innovation”https://www.ped-perinatology.ru/jour/about/submissions#copyrightNoticehttps://www.ped-perinatology.ru/jour/article/view/2186

Генно-инженерные биологические препараты на протяжении многих лет используются в лечении воспалительных заболеваний кишечника, однако их первичная и вторичная неэффективность, необходимость в подборе терапии следующих линий требуют более тщательного изучения, особенно в педиатрической когорте.Цель исследования. Изучить особенности переключения генно-инженерной биологической терапии у детей с воспалительными заболеваниями кишечника.Материал и методы. В ретроспективно-проспективном исследовании проведен анализ историй болезни педиатрических пациентов с язвенным колитом и болезнью Крона в период с 2018 г. по 2023 г. Изучены демографические и клинические особенности заболевания, причины назначения и переключения генно-инженерной биологической терапии, выживаемость первой линии. Эффективность терапии оценивали на основании индексов активности: PUCAI/ PCDAI, UCEIS/ SES-CD, IBD-DCA. Проводили лабораторную оценку совокупности показателей общего и биохимического анализов крови.Результаты. Из 163 пациентов с воспалительными заболеваниями кишечника 70 (43,9%) получали биологическую терапию. Было сформировано 4 группы в зависимости от нозологии и линии терапии: 1-я и 2-я группа — пациенты с язвенным колитом и болезнью Крона на фоне терапии первой линии соответственно, 3-я группа с болезнью Крона и 4-я группа с язвенным колитом — с переключением на терапию второй линию. В 1-ю и 2-ю группы вошли 42 (60%) и 17 (24,3%) пациентов соответственно, в 3-ю и 4-ю группы — 7 (10%) и 4 (5,7%) пациентов. Не выявлено статистичеки значимых различий по уровням клинической, эндоскопической и морфологической активности между группами. Протяженность поражения была статистически значимо больше в группах переключения. Самым частым внекишечным проявлением (ВКП) стал суставной синдром — 51,4%. В 1-й группе главной причиной назначения биологический терапии в 19 (45,2%) случаях было наличие внекишечных проявлений, а во 2-й группе — стероидозависимость в 8 (47,1%) случаях. Выживаемость на фоне генно-инженерной биологической терапии первой линии составила 43,57±30,21 и 57,00±54,00 мес 3-й и 4-й в группах соответственно.Заключение. Выявлена высокая частота развития стероидозависимости, стероидорезистентности и внекишечных проявлений, что повлекло за собой раннее назначение биологической терапии. Учитывая особенности клинической картины и неэффективность генно-инженерной биологической терапии первой линии в исследуемой нами когорте не по назначению («off-label») был использован широкий спектр биологических препаратов.

Biological therapy has been used for many years in the treatment of inflammatory bowel disease; however, the primary and secondary ineffectiveness, the need to select the next line of therapy, requires more research, especially in the pediatric cohort.Objective: the present study aims to investigate the features of switching biological therapy (BT) in pediatric practice.Materials and Methods: in this retrospective prospective study, included cases of children with ulcerative colitis and Crohn’s disease between 2018 and 2023. Demographic and clinical features of the disease, reasons for prescribing and switching BT, and 1st-line survival were studied. The efficacy of therapy was evaluated based on activity indices: PUCAI/ PCDAI, UCEIS/ SES-CD, IBD-DCA. Height-weight indices were evaluated using the standard deviation coefficient. Laboratory evaluation of a set of indices of general and biochemical blood tests were performed.Results: out of 163 patients with IBD, 70 (43.9%) were receiving BT, the 1st line therapy groups included 42 (60%) with CD (group 1) and 17 (24.3%) with UC (group 2), the 2nd line groups included 7 (10%) with CD (group 3) and 4 (5.7%) with UC (group 4). There were no significant differences in clinical, endoscopic and morphologic activity levels between the groups. Lesion extent was significantly greater in the switching groups. The most frequent extraintestinal manifestation (EIM) was joint syndrome 51.4%. In 1st group, the leading reason for BT prescription 19 (45.2%) was the presence of EIM, and in the 2nd group, steroid dependence 8 (47.1%). The 1-line BT survival was 43.57 (30.21) months and 57.00 (54.00) months in 3d and 4th groups, respectively.Conclusions: a high frequency of steroid dependence, steroid resistance and EIM was revealed, which entailed early prescription of BT. Given the peculiarities of the clinical picture and ineffectiveness of 1st-line BT in our cohort, a wide range of biologic agents were used off-label.

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The authors declare that there are no conflicts of interest present.