Таргетный синтетический препарат для лечения псориатического артрита и псориаза – апремиласт

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.

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