В США одобрен новый препарат для лечения атопического дерматита
6 апреля 2017
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№159, апрель 2017
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В США одобрен новый препарат для лечения атопического дерматита
Управление по санитарному надзору за качеством пищевых продуктов и медикаментов США (FDA) одобрило моноклональные антитела дупилумаб (dupilumab) в форме подкожных инъекций для атопического дерматита у взрослых умеренной и тяжелой степени. Соответствующий документ был принят 28 марта 2017 года.
Препарат предназначен для пациентов, у которых экзема не поддается лечению местными средствами или для их применения имеются противопоказания. Дупилумаб может использоваться как совместно с кортикостероидными препаратами, так и без них.
Атопический дерматит — хроническое воспалительное заболевание кожи аллергической природы, которое может существенно снижать качество жизни. При атопическом дерматите характерны кожные высыпания в виде красных чешуйчатых бляшек и зуд. В результате расчесывания кожа огрубевает и утолщается.
Активным компонентом нового препарата являются антитела к субъединице общей для двух провоспалительных интерлейкинов: ИЛ-4 и ИЛ-13. В результате связывания с этими интерлейкинами дупилумаб ингибирует воспалительную реакцию, лежащую в основе атопического дерматита.
Исследования свойств нового препарата проводились в трех плацебо-контролируемых клинических испытаниях, в общей сложности охвативших 2119 взрослых участников с атопическим дерматитом от средней до тяжелой формы. Всем участвовавшим пациентам местные препараты (глюкокортикостероиды и ингибиторы кальциневрина) должным образом не помогали контролировать процесс.
В группе проходивших лечение дупилумабом (одна инъекция в неделю или в две недели) по сравнению с группой плацебо (одна инъекция в неделю) достигнут достоверно больший отклик, определяемый чистой или почти чистой кожей, а также снижением зуда после 16 недель лечения.
В клинических испытаниях была показана результативность дупилумаба при лечении других заболеваний со сходной этиологией — астмы и хронического полипозного синусита, однако одобрения FDA на расширенные показания к применению дупилумаба пока не получено.
Источники:
Medical news todayU. S. Food and Drug AdministrationThe New England Journal of MedicineDrugs.com
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