vspВопросы современной педиатрииCurrent Pediatrics1682-55271682-5535Издательство «ПедиатрЪ»10.15690/vsp.v13i1.910vsp-225Research ArticleОРИГИНАЛЬНЫЕ СТАТЬИORIGINAL ARTICLESТЕРАПИЯ ГЕННО-ИНЖЕНЕРНЫМИ БИОЛОГИЧЕСКИМИ ПРЕПАРАТАМИ: ЭФФЕКТИВНОСТЬ И БЕЗОПАСНОСТЬ ПЕРЕКЛЮЧЕНИЯTREATMENT WITH GENETICALLY ENGINEERED BIOLOGICAL AGENTS: EFFICACY AND SAFETY OF CHANGEOVERБарановА. А.BaranovA. A.baranov@nczd.ruАлексееваЕ. И.AlexeevaE. I.

PhD, professor, Head of Rheumatological Department of RAMS, Head of the Faculty of Pediatrics of I.M. Sechenov First Moscow State Medical University

alekatya@ya.ruВалиеваС. И.ValievaS. I.valieva@nczd.ruБзароваТ. М.BzarovaT. M.bzarova@nczd.ruМитенкоЕ. В.MitenkoE. V.alekatya@ya.ruДенисоваР. В.DenisovaR. V.denisova@nczd.ruФетисоваА. Н.FetisovaA. N.alekatya@ya.ruСлепцоваТ. В.SleptsovaT. V.alekatya@ya.ruИсаеваК. Б.IsaevaK. B.alekatya@ya.ruЧистяковаЕ. Г.ChistyakovaE. G.alekatya@ya.ruТайбулатовН. И.TaibulatovN. I.alekatya@ya.ruЧомахидзеА. М.ChomakhidzeA. M.alekatya@ya.ruНаучный центр здоровья детей, Москва Первый Московский государственный медицинский университет им. И.М. Сеченова, МоскваРоссияScientific Centre of Children Health, Moscow I.M. Sechenov First Moscow State Medical University, MoscowRussian FederationНаучный центр здоровья детей, МоскваРоссияScientific Centre of Children Health, MoscowRussian Federation201411012014131Вопросы современной педиатрии3350Copyright © Баранов А.А., Алексеева Е.И., Валиева С.И., Бзарова Т.М., Митенко Е.В., Денисова Р.В., Фетисова А.Н., Слепцова Т.В., Исаева К.Б., Чистякова Е.Г., Тайбулатов Н.И., Чомахидзе А.М., 20142014Баранов А.А., Алексеева Е.И., Валиева С.И., Бзарова Т.М., Митенко Е.В., Денисова Р.В., Фетисова А.Н., Слепцова Т.В., Исаева К.Б., Чистякова Е.Г., Тайбулатов Н.И., Чомахидзе А.М.Baranov A.A., Alexeeva E.I., Valieva S.I., Bzarova T.M., Mitenko E.V., Denisova R.V., Fetisova A.N., Sleptsova T.V., Isaeva K.B., Chistyakova E.G., Taibulatov N.I., Chomakhidze A.M.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/225Цель исследования

Цель исследования: оценить эффективность и безопасность «переключения» на второй генно-инженерный биологический препарат (ГИБП) у пациентов с ювенильным идиопатическим артритом (ЮИА) с неэффективностью и/или непереносимостью первого ГИБП. Пациенты и методы: в статье представлены результаты ретроспективного обсервационного исследования эффективности и безопасности «переключения» на второй ГИБП у 136 пациентов в возрасте от 1 до 17 лет с различными вариантами ЮИА, с первичной неэффективностью, частичным эффектом или утратой эффективности других биологических препаратов. Из них у 41 — системный, у 95 — ЮИА без внесуставных проявлений. У 32 пациентов с ЮИА без внесуставных проявлений оценивали эффективность и безопасность этанерцепта, у 63 — адалимумаба, у 22 пациентов с сЮИА и активными внесуставными проявлениями — тоцилизумаба, у 5 — ритуксимаба, у 14 больных с сЮИА без системных проявлений и активным артритом — ингибиторов фактора некроза опухоли (ФНО) α адалимумаба и этанерцепта. Диагноз ЮИА устанавливали на основании критериев ILAR. Результаты: через 6 и 12 мес терапии вторым ГИБП стадия неактивной болезни / ремиссия была зарегистрирована у 65 и 84% пациентов, соответственно. У 13/22 пациентов с сЮИА и недостаточной эффективностью ритуксимаба была достигнута ремиссия болезни в течение 24 нед наблюдения после переключения на терапию ингибитором рецепторов интерлейкина (ИЛ) 6, у 2/5 пациентов с неэффективностью тоцилизумаба — после переключения на ритуксимаб. Через 1 год терапия вторым ГИБП индуцировала стадию неактивной болезни / ремиссии у 100% детей с ЮИА без внесуставных проявлений, лечившихся этанерцептом в качестве второго ГИБП, у 85% — после переключения на адалимумаб, у 100% пациентов с сЮИА без внесуставных проявлений — после назначения анти-ФНО-терапии. Выводы: переключение на второй ГИБП пациентов с первичной, вторичной неэффективностью или непереносимостью первого ГИБП обеспечило достижение ремиссии системных проявлений у больных с сЮИА и способствовало практически полному восстановлению функции в суставах у пациентов с сЮИА без внесуставных проявлений и суставными формами ЮИА. Наряду с высокой терапевтической эффективностью, второй ГИБП обладал хорошей переносимостью и сопоставимым профилем безопасности.

 

 

 

 

Aim: to assess efficacy and safety of «changeover» to the second genetically engineered biological agent (GEBA) in patients with juvenile idiopathic arthritis (JIA) with resistance or intolerability to the first GEBA. Patients and methods: the results of retrospective observational research of efficacy and safety of «changeover» to the second GEBA in 136 patients with various variants of JIA aged from 1 to 17 years old with primary resistance, partial effect or loss of efficacy to other biological agents are shown in this article. Among those 41 patient have systemic and 95 — JIA without extra-articular involvement. In 32 patients with JIA without extra-articular involvement the efficacy and safety of etanercept were assessed; in 63 — of adalimumab; in 22 patients with JIA and active extra-articular involvement — of tocilizumab, in 5 — of rituximab; in 14 patients with JIA without extra-articular involvement and active arthritis — of tumor necrosis factor (TNF) α inhibitors — adalimumab and etanercept. JIA was diagnosed according to the ILAR criteria. Results: in 6 and 12 months of treatment with the second GEBA inactive stage of disease / remission was detected in 65 and 84% of patients, respectively. In 13/22 patients with JIA and insufficient efficacy of rituximab remission was achieved in 24 weeks of follow-up after switching to the treatment with interleukin (IL) 6 receptors inhibitor, in 2/5 patients with resistance to tocilizumab — after switching to rituximab. In a year of treatment with etanercept as the second GEBA non-active stage / remission was induced in 100% of children with JIA without extra-articular involvement, in 85% — after switching to adalimumab, and in 100% of patients with JIA without extra-articular involvement — after administration of anti-TNF α-therapy. Conclusions: changeover to the second GEBA in patients with primary and secondary resistance or intolerability to the first GEBA allowed achieving of remission of systemic manifestations in patients with JIA and contributed to almost complete restoration of function in the joints in patients with JIA without extra-articular involvement and articular forms of JIA. Along with its high clinical efficacy the second GEBA was characterized by good tolerability and comparable safety profile.

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