rspНаучно-практическая ревматологияRheumatology Science and Practice1995-44841995-4492IMA-PRESS, LLC10.47360/1995-4484-2020-646-657rsp-2962Research ArticleОРИГИНАЛЬНЫЕ ИССЛЕДОВАНИЯORIGINAL RESEARCHЭффективность и безопасность генно-инженерных биологических препаратов для лечения анкилозирующего спондилита: систематический обзор и метаанализ препаратов, зарегистрированных в РФEfficacy and safety of biologics for the treatment of ankylosing spondylitis: systematic literature review and network meta-analysis of treatments registered in the Russian Federationhttps://orcid.org/0000-0002-1771-6246ДубининаТ. В.DubininaT. V.

115522, Москва, Каширское шоссе, 34А

Tatiana V. Dubinina

115522, Moscow, Kashirskoye Highway, 34A

https://orcid.org/0000-0003-3500-7256ГайдуковаИ. З.GaydukovaI. Z.

198015, Санкт-Петербург, ул. Кирочная, 41; 190068, Санкт-Петербург, ул. Большая Подъяческая, 30

Inna Z. Gaydukova

191015, Saint-Petersburg, Kirochnaya str., 41; 190068, Saint Petersburg, Bolshaya Podyacheskaya str., 30

https://orcid.org/0000-0001-7335-4852СоколоваВ. Д.SokolovaV. D.

119571, Москва, просп. Вернадского, 82, стр. 1

Valeriya D. Sokolova

119571, Moscow, Vernadskiy avenue, 82, building 1

https://orcid.org/0000-0001-6835-5578МладовВ. В.MladovV. V.

119571, Москва, просп. Вернадского, 82, стр. 1

Vladimir V. Mladov.

119571, Moscow, Vernadskiy avenue, 82, building 1

https://orcid.org/0000-0002-6314-4218ТолкачеваД. Г.TolkachevaD. G.

119571, Москва, просп. Вернадского, 82, стр. 1

Daria G. Tolkacheva

119571, Moscow, Vernadskiy avenue, 82, building 1

tolkacheva.d@gmail.comФГБНУ Научноисследовательский институт ревматологии им. В.А. НасоновойРоссияV.A. Nasonova Research Institute of RheumatologyRussian FederationФГБОУ ВО СевероЗападный государственный медицинский университет им. И.И. Мечникова Минздрава России; СПб ГБУЗ Клиническая ревматологическая больница № 25РоссияNorth-Western State Medical University named after I.I. Mechnikov; St-Petersburg Clinical Rheumatology Hospital N 25Russian FederationРоссийская академия народного хозяйства и государственной службы при Президенте РФ (РАНХиГС)РоссияThe Russian Presidential Academy of National Economy and Public Administration (RANEPA)Russian Federation202013012021586646657Copyright © Дубинина Т.В., Гайдукова И.З., Соколова В.Д., Младов В.В., Толкачева Д.Г., 20212021Дубинина Т.В., Гайдукова И.З., Соколова В.Д., Младов В.В., Толкачева Д.Г.Dubinina T.V., Gaydukova I.Z., Sokolova V.D., Mladov V.V., Tolkacheva D.G.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://rsp.mediar-press.net/rsp/article/view/2962

Цель исследования — оценить сравнительную эффективность и безопасность генно-инженерных биологических препаратов (ГИБП), зарегистрированных и применяемых в терапии взрослых пациентов с активным анкилозирующим спондилитом в условиях российской системы здравоохранения.

Материал и методы

Материал и методы. Проведен систематический поиск рандомизированных клинических исследований в базах данных PubMed, Embase и eLIBRARY.RU. 17 публикаций по 16 исследованиям были отобраны для дальнейшего анализа. Основные критерии эффективности — ASAS 20/40 после 12—16 недель терапии, дополнительные - BASDAI 50, изменение BASDAI и BASFI относительного исходного уровня.

Безопасность оценена на основе частоты возникновения нежелательных явлений; дополнительно проанализирована доля пациентов с развитием серьезных нежелательных явлений. ГИБП были проранжированы на основе значений SUCRA.

Результаты

Результаты. Анализ по классам ГИБП показал отсутствие статистически значимых различий между ингибиторами ИЛ-17 и ФНО-а, однако класс ингибиторов ИЛ-17 характеризовался более высокими значениями SUCRA. По совокупности всех анализируемых показателей эффективности первые три ранга представлены нетакимабом, инфликсимабом и иксекизумабом. Профили безопасности ГИБП, включенных в обзор, не имели статистически значимых различий с между собой.

Заключение

Заключение. Результаты данного обзора могут быть полезны для специалистов сферы здравоохранения при принятии решений по выбору оптимальной терапии взрослых пациентов с активным анкилозирующим спондилитом.

The aim of the study was to evaluate the comparative efficacy and safety of biologics registered and reimbursed in the Russian healthcare system for the treatment of adult patients with active ankylosing spondylitis.

Material and methods

Material and methods. We performed a systematic literature review of randomized controlled trials in PubMed, Embase, and eLIBRARY.RU databases. 17 articles reporting results from 16 trials were selected for qualitative and quantitative analysis. The main efficacy criteria were ASAS 20/40 over 12-16 weeks of therapy, additional criteria were BASDAI 50, changes from baseline in BASDAI and BASFI indexes. Safety criteria were determined based on the incidence of adverse events; we also analysed the proportion of patients suffering from at least one serious adverse event. Biologics were ranked based on the SUCRA values.

Results

Results. Subgroup analysis showed no statistically significant differences between IL-17 and TNF-a inhibitors, but the IL-17 inhibitor class had a higher SUCRA values. For the combination of all analyzed efficacy outcomes, netakimab, infliximab, and ixekizumab hold the first three ranks. The safety profiles of biologics included in the review were comparable with each other.

Conclusion

Conclusion. The results of this review are intended to help healthcare professionals make decisions about optimal therapy for adult patients with active ankylosing spondylitis.

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