medsovetМедицинский СоветMeditsinskiy sovet = Medical Council2079-701X2658-5790REMEDIUM GROUP Ltd.10.21518/2079-701X-2018-12-136-141medsovet-2577Research ArticleДЕРМАТОЛОГИЯDERMATOLOGYТаргетный синтетический препарат для лечения псориатического артрита и псориаза – апремиластApremilast: target synthetic drug for the treatment of psoriatic arthritis and psoriasisКорсаковаЮ. Л.KorsakovaYu. L.

к.м.н.

PhD in medicine,

КоротаеваТ. В.KorotaevaT. V.

д.м.н.

MD

ФГБНУ «Научно-исследовательский институт ревматологии им. В.А. Насоновой»РоссияV.A. Nasonova Research Institute of ReumatologyRussian Federation201825072018012136141Copyright © Корсакова Ю.Л., Коротаева Т.В., 20182018Корсакова Ю.Л., Коротаева Т.В.Korsakova Y.L., 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://www.med-sovet.pro/jour/article/view/2577

Апремиласт (АП), ингибитор фосфодиэстеразы-4, является новым препаратом для лечения псориаза (Пс) и псориатического артрита (ПсА). Лечение АП способствует уменьшению активности воспалительных изменений за счет снижения уровня провоспалительных цитокинов. Положительное влияние на Пс было доказано в клинических исследованиях, например, в  ESTEEM 1 (Efficacy and Safety Trial Evaluating the Effects of apreMilast in psoriasis), в котором терапия АП привела к уменьшению индекса PASI у больных среднетяжелым и тяжелым бляшечным Пс: через 16 нед. 75%-ное улучшение PASI значительно чаще наблюдалось у больных, принимавших АП в дозе 30 мг 2 р/сут (33%), чем у больных при использовании плацебо (ПЛ) (5%) (p = 0,0001). В исследовании PALACE 1 на 16-й нед. лечения АП 20% улучшение по критериям ACR (ACR20) при использовании АП по 20 и 30 мг 2 р/сут отмечалось достоверно чаще, чем у больных, получавших ПЛ (в 30,4%, 38,1% и 19% случаев, р = 0,0166 и р = 0,0001 соответственно). После 52 нед. лечения АП ACR20 было достигнуто у 63,0% больных, принимавших препарат по 20 мг 2 р/сут, и 54,6% получавших 30 мг 2 р/сут. По данным РКИ (PALACE 1, 2, 3, 4), наиболее частыми неблагоприятными реакциями (НР) были диарея, тошнота, головная боль, инфекции верхних дыхательных путей и назофарингит. Большинство НР были легкой и средней степени тяжести, и частота отмены терапии из-за НР была низкой. На основании данных исследований PALACE, в которых участвовали 1493 больных, доказаны эффективность и  безопасность АП в лечении ПсА с умеренной активностью заболевания.

 

Apremilast (AP), a phosphodiesterase-4 inhibitor, is a novel drug for the treatment of psoriasis (Ps) and psoriatic arthritis (PsA). AP therapy affects the decrease in the activity of inflammatory changes due to reducing the level of proinflammatory cytokines. The clinical trials showed positive effects on Ps, for example ESTEEM 1 trial (Efficacy and Safety Trial Evaluating the Effects of apreMilast in psoriasis), in which AP therapy led to a decrease of PASI index in patients with moderate to severe plaque Ps: 75% improvement in PASI was significantly more frequent in patients taking AP at a dose of 30 mg twice daily (33%) than in patients receiving placebo (PL) (5%) (p = 0.0001) in 16 weeks. In the PALACE 1 study, 20% improvement in the ACR criteria (ACR20) was reported significantly more frequently at the 16th week of AP treatment in patients taking AP at 20 and 30 mg twice daily than in patients receiving PL (in 30.4%, 38.1% and 19% of cases, p = 0.0166 and p = 0.0001, respectively). After 52-week AP therapy, ACR20 was achieved in 63.0% of patients taking the drug at a dose of 20 mg twice a day, and in 54.6% of patients receiving 30 mg twice a day. According to the randomized controlled clinical trial (PALACE 1, 2, 3, 4), the most frequent adverse reactions (AR) included diarrhoea, nausea, headache, upper respiratory tract infections and nasopharyngitis. The most ARs were mild and moderate, and the frequency of discontinuation of therapy due to ARs was low. The PALACE studies, which enrolled 1493 patients, showed the efficacy and safety of AP in the treatment of PsA with moderate disease activity.

 

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