vspВопросы современной педиатрииCurrent Pediatrics1682-55271682-5535Издательство «ПедиатрЪ»10.15690/vsp.v12i2.626vsp-352Research ArticleВ ПОМОЩЬ ВРАЧУA DOCTOR’S AIDЭффективность и безопасность длительного применения ритуксимаба у пациентов с системным ювенильным идиопатическим артритомEfficacy and Safety of Prolonged Rituximab Treatment in Patients with Systemic Juvenile Idiopathic ArthritisАлексееваЕ. И.AlexeevaE. I.

Contacts: Alekseyeva Yekaterina Iosifovna, PhD, MD, professor, Head of Rheumatological Department, National Center of Children’s Health, Russian Academy of Medical Sciences, Dean of Pediatric Faculty, I.M. Sechenov First Moscow State Medical University Address: 119991, Moscow, Lomonosovskiy Prospect, 2, bldg. 1, Tel.: (499) 134-02-97, e-mail: alekatya@yandex.ru

alekatya@ya.ruВалиеваС. И.ValievaS. I.alekatya@ya.ruАкуловаС. С.AkulovaS.S.alekatya@ya.ruБзароваТ. М.BzarovaT. M.alekatya@ya.ruДенисоваР. В.DenisovaR. V.alekatya@ya.ruИсаеваК. Б.IsaevaK. B.alekatya@ya.ruСлепцоваТ. В.SteptsovaT. V.alekatya@ya.ruМитенкоЕ. В.MitenkoE. V.alekatya@ya.ruЧистяковаЕ. Г.ChistyakovaE. G.alekatya@ya.ruФетисоваА. Н.FetisovaA. N.alekatya@ya.ruСемикинаЕ. Л.SemikinaE. L.alekatya@ya.ruНаучный центр здоровья детей РАМН, Москва; Первый Московский государственный медицинский университет им. И.М. СеченоваРоссияScientific Centre of Children Health, RAMS, Moscow; I.M. Sechenov First Moscow State Medical UniversityRussian FederationНаучный центр здоровья детей РАМН, МоскваRussian FederationScientific Centre of Children Health, RAMS, MoscowRussian FederationНаучный центр здоровья детей РАМН, МоскваРоссияScientific Centre of Children Health, RAMS, Moscow, Russian FederationRussian FederationНаучный центр здоровья детей РАМН, Москва, Российская ФедерацияРоссияScientific Centre of Children Health, RAMS, MoscowRussian FederationНаучный центр здоровья детей РАМН, Москва; Первый Московский государственный медицинский университет им. И.М. СеченоваРоссияScientific Centre of Children Health, RAMS, MoscowRussian Federation201319032013122Вопросы современной педиатрии89100Copyright © Алексеева Е.И., Валиева С.И., Акулова С.С., Бзарова Т.М., Денисова Р.В., Исаева К.Б., Слепцова Т.В., Митенко Е.В., Чистякова Е.Г., Фетисова А.Н., Семикина Е.Л., 20132013Алексеева Е.И., Валиева С.И., Акулова С.С., Бзарова Т.М., Денисова Р.В., Исаева К.Б., Слепцова Т.В., Митенко Е.В., Чистякова Е.Г., Фетисова А.Н., Семикина Е.Л.Alexeeva E.I., Valieva S.I., Akulova S., Bzarova T.M., Denisova R.V., Isaeva K.B., Steptsova T.V., Mitenko E.V., Chistyakova E.G., Fetisova A.N., Semikina E.L.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://vsp.spr-journal.ru/jour/article/view/352

Цель исследования: оценить эффективность и безопасность лечения ритуксимабом при длительном наблюдении детей с системным ювенильным идиопатическим артритом. Участники и методы исследования: были проанализированы результаты лечения 60 детей, страдающих системным вариантом ювенильного идиопатического артрита (33 девочки и 27 мальчиков), в возрасте от 1 года до 18 лет (средний возраст 8,7 лет), наблюдавшихся в ревматологическом отделении ФГБУ «НЦЗД» РАМН. Длительность болезни на момент назначения ритуксимаба в среднем составила 5,3 года. На момент начала терапии ритуксимабом у всех детей присутствовал активный суставной синдром, тяжелые системные проявления и высокие лабораторные показатели активности заболевания. В качестве показателей улучшения были использованы педиатрические критерии Американской коллегии ревматологов. Перед применением препарата было получено одобрение Локального этического комитета ФГБУ «НЦЗД» РАМН; представителями пациентов и больными старше 14 лет подписано информированное согласие. Результаты: препарат индуцировал ремиссию у 26 из 60 (43%) пациентов: у 9 после 1-го курса лечения, у 8 — после 2-го, у 6 — после 3-го, у 3 — после 4-го. Максимальная длительность ремиссии составила 5 лет 4 мес, минимальная — 6 мес. Другие генно-инженерные биологические препараты были назначены 34 (57%) пациентам: в связи с развитием первичной неэффективности — 15, вторичной неэффективности — 10; в связи с парциальной неэффективностью — 9 пациентам. Переносимость препарата была удовлетворительной у большинства детей. Нежелательные явления проявлялись трансфузионными реакциями на введение ритуксимаба, инфекциями различной степени тяжести, нейтропенией. Выводы: ритуксимаб высокоэффективен у больных тяжелым системным вариантом ювенильного идиопатического артрита. Препарат индуцировал ремиссию болезни у пациентов, ранее считавшихся малокурабельными, с низким статусом физической и социальной адаптации.

Aim: to assess efficacy and safety of rituximab treatment in children with systemic juvenile idiopathic arthritis under prolonged follow-up. Patients and methods: results of treatment of 60 children (33 girls and 27 boys) with systemic variant of juvenile idiopathic arthritis being followed-up in rheumatology department of the Federal State Institution «Scientific Centre of Children Health» of RAMS (FSI «SCCH» RAMS) were analyzed. The mean age of children was 8,7 years. The mean duration of disease course at the moment of first rituximab administration was 5,3 years. At the beginning of rituximab therapy all children had active articular syndrome, severe systemic manifestations and significantly increased laboratory markers of activity. As the signs of improvement the authors used pediatric criteria of the American College of Rheumatology. The treatment was approved by the local ethic committee of the FSI «SCCH» RAMS; the patients’ representatives and patients older than 14 years old had signed informed agreement. Results: remission was induced in 26 of 60 (43%) patients: in 9 of them after the 1st course of treatment, in 8 — after the 2nd, in 6 — after the 3d and in 3 — after the 4th. The maximal duration of remission was 5 years 4 months, minimal — 6 months. Other genetically engineered drugs were administered to 34 (57%) of the patients: due to the primary inefficiency in 15, secondary inefficiency — in 10; due to partial inefficiency — in 9 children. The drug was well-tolerated in most of the patients. Undesirable effects were represented by transfusional reactions to the rituximab infusion, infections with different severity and granulocytopenia. Conclusions: rituximab has high efficiency in patients with severe systemic variant of juvenile idiopathic arthritis. The drug induced remission in patients who had been considered almost incurable, with low status of physical and social adaptation.

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