Эффективность адалимумаба при раннем ревматоидном артрите в зависимости от уровня препарата в сыворотке крови и наличия антилекарственных антител

Цель – оценить взаимосвязь эффективности терапии адалимумабом (АДА) при раннем ревматоидном артрите (РА) с уровнем препарата в сыворотке крови и наличием антител (АТ) к нему.

Материал и методы. Концентрацию АДА (мкг/мл) и уровень АТ к AДA в сыворотке крови определяли методом иммуноферментного анализа у 25 больных ранним РА до начала терапии, а затем через 12 и 24 нед лечения. Все больные получали базисный противовоспалительный препарат (метотрексат) и АДА в дозе 40 мг 1 раз в 2 нед подкожно. Для всех пациентов АДА был первым генно-инженерным биологическим препаратом.

Результаты. Больные были разделены на группы: с уровнем АДА в сыворотке крови: <2,85 (первая группа, n=7) и ≥2,85 (вторая группа, n=13). К 24-й неделе лечения среди пациентов первой группы отмечалась более высокая активность болезни (DAS28 составлял 4,5 [3,3; 4,9]), а также уровень острофазовых показателей (СОЭ – 44 [18; 57] мм/ч, уровень С-реактивного белка – СРБ – 10,1 [4,9; 34,5] мг/мл) по сравнению с больными второй группы (3,5 [2,9; 3,9], 15,0 [6,0; 17,0] мм/ч, 1,9 [0,75; 6,7] мг/мл соответственно; p<0,05). Также на 24-й неделе была выявлена отрицательная корреляция уровня АДА и DAS28 (r=-0,46; p=0,04), СРБ (r=-0,54; p=0,02) и СОЭ (r=-0,5; p=0,02). АТ к AДA выявлялись у 3 пациентов через 12 нед и у 2 больных через 24 нед терапии. К 24-й неделе лечения у 100% больных с наличием АТ к AДA зарегистрировано отсутствие клинического эффекта. В группе пациентов без АТ к AДA отмечалось меньшее количество не ответивших на лечение – 11%.

Заключение. У пациентов с ранним РА, получающих терапию АДА, низкий уровень препарата (<2,85 мкг/мл) в сыворотке крови ассоциируется с более высокой клинико-лабораторной активностью заболевания. К 12–24-й неделе терапии АДА у 10–12,5% больных выявляются АТ к нему, образование которых сопровождается снижением эффективности терапии

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