mrjСовременная ревматологияModern Rheumatology Journal1996-70122310-158XIMA-PRESS, LLC10.14412/1996-7012-2016-4-57-63mrj-720Research ArticleНОВЫЕ МЕДИЦИНСКИЕ ТЕХНОЛОГИИNEW MEDICAL TECHNOLOGIESРЕЗУЛЬТАТЫ ОЦЕНКИ СРАВНИТЕЛЬНОЙ ЭФФЕКТИВНОСТИ ПРИМЕНЕНИЯ СЕКУКИНУМАБА И АДАЛИМУМАБА В ЛЕЧЕНИИ ПСОРИАТИЧЕСКОГО АРТРИТА С ИСПОЛЬЗОВАНИЕМ МЕТОДА СОГЛАСОВАННОГО СКОРРЕКТИРОВАННОГО НЕПРЯМОГО СРАВНЕНИЯRESULTS OF EVALUATING THE EFFICACY OF SECUKINUMAB VERSUS ADALIMUMAB IN TREATING PSORIATIC ARTHRITIS BY USING THE MATCHING-ADJUSTED INDIRECT COMPARISON METHODКоротаеваТ. В.KorotaevaT. V.

Контакты: Татьяна Викторовна Коротаева; ФГБНУ «Научно-исследовательский институт ревматологии им. В.А. Насоновой», 115522, Москва, Каширское шоссе, 34A

Contact: Tatiana Viktorovna Korotaeva; V.A. Nasonova Research Institute of Rheumatology, 34A, Kashirskoe Shosse,Moscow115522 

tatianakorotaeva@gmail.comНаучно-исследовательский институт ревматологии им. В.А. НасоновойРоссияV.A. Nasonova Research Institute of RheumatologyRussian Federation2016161220161045763Copyright © Коротаева Т.В., 20162016Коротаева Т.В.Korotaeva T.V.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://mrj.ima-press.net/mrj/article/view/720

До настоящего времени отсутствуют результаты прямого сравнения эффективности применения при псориатическом артрите (ПсА) препаратов – ингибиторов фактора некроза опухоли α (ФНОα), в частности секукинумаба (СКМ) и адалимумаба (АДА). Это свидетельствует о необходимости использования метода согласованного скорректированного непрямого сравнения (MatchingAdjusted Indirect Comparison – MAIC), что позволит осуществлять выбор вариантов терапии ПсА. Цель исследования – сравнение эффективности СКМ и АДА с помощью метода MAIC у пациентов с активным ПсА.

Пациенты и методы

Пациенты и методы. Выполнено сравнение результатов применения АДА, полученных в рандомизированном клиническом исследовании (РКИ) ADEPT, а также СКМ, полученных в РКИ FUTURE 2, по критериям ACR и PASI. В анализ по принципам MAIC включены агрегированные данные о 151 пациенте с активным ПсА из РКИ ADEPT и 189 пациентах из РКИ FUTURE 2.

Результаты

Результаты. Установлено, что на 16-й неделе ответ по критериям ACR20/50/70 наблюдался соответственно у 74,4/50,1/18,5% больных на фоне терапии СКМ 150 мг, у 65,5/50,1/50,1% – на фоне терапии СКМ 300 мг и у 55,6/32,5/20,5% – на фоне терапии АДА. Показано значимое преимущество обоих доз СКМ по сравнению с АДА по критериям ответа ACR20 и ACR50. Ответ по PASI75 для АДА и СКМ 150/300 мг отмечался у 60,9 и 59,5/64,1%, а PASI 90 – у 39,1 и 47,7/40,8% пациентов соответственно. На 24-й неделе лечения ответ по ACR20, ACR50 и HAQ-DI в группе пациентов, получавших СКМ в дозах 150 и 300 мг, был значимо выше, чем у больных ПсА, в лечении которых был использован АДА. По показателю ACR70 статистически значимых различий не выявлено. Аналогичным было соотношение показателей через 48 нед после начала лечения по критериям ACR20 и ACR50. Сходные результаты получены и при оценке динамики псориаза.

Выводы

Выводы. У пациентов с активным ПсА продемонстрировано преимущество терапии СКМ в дозах 150 и 300 мг по сравнению с АДА. У больных ПсА, в лечении которых был использован СКМ, отмечено более выраженное улучшение качества жизни.

To date there have been no results of a direct comparison of the efficiency of using tumor necrosis factor-α inhibitors, secukinumab (SCM) and adalimumab (ADA) in particular, to treat psoriatic arthritis (PsA). This suggests that there is a need to apply the Matching-Adjusted Indirect Comparison (MAIC) method that will be able to choose a treatment option for PsA. Objective: to compare the efficacy of SCM andADAby using the MAIC method in patients with active PsA.

Patients and methods

Patients and methods. The results of usingADAin the Adalimumab Effectiveness in Psoriatic Trial (ADEPT), a randomized clinical trial (RCT), and SCM in the FUTURE 2 RCT were compared according to theAmericanCollegeof Rheumatology (ACR) and Psoriatic Area and Severity Index (PASI) criteria. The analysis based on the MAIC principles included aggregated data on 151 patients with active PsA from the ADEPT RCT and 189 patients from the FUTURE 2 RCT.

Results

Results. At 16 weeks, ACR20/50/70 responses were observed in 74.4/50.1/18.5% of the patients treated with SCM 150 mg, in 65.5/50.1/50.1% of those treated with SCM 300 mg, and in 55.6/32.5/20.5% of those receivingADA, respectively. Both doses of SCM had a significant advantage over the dose ofADAaccording to ACR20 and ACR50 responses. A PASI75 response forADAand SCM 150/300 mg was observed in 60.9 and 59.5/64.1% of the patients; and a PASI90 response was seen in 39.1 and 47.7/40.8% of the patients, respectively. At 24 weeks of treatment, ACR20, ACR50, and HAQ-DI responses in patients receiving SCM 150 and 300 mg were significantly higher than in PsA patients takingADA. No statistically significant differences were observed in ACR70 response rates. The ratio of ACR20 and ACR50 indicators was similar after 48 weeks of treatment initiation. Assessment of the dynamics of psoriasis yielded similar results.

Conclusion

Conclusion. Patients with active PsA demonstrated the advantage of therapy with SCM 150 and 300 mg over that withADA. There was a greater improvement in quality of life in patients with PSA treated with SCM. 

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