Long-term safety and efficacy of tocilizumab in patients with early rheumatoid arthritis of moderate or high activity (results of phase III...
Насонов Е. Л., Станислав М. Л., Мазуров В. И., Чернyх Т. М., Сороцкайа В. Н., Салникова Т. С., Саиковскy Р. С., Решет’ко О. В., Попова Т. А., Шмидт Е. И., Тюрин В. П., Шилкина Н. П., Бокарев И. Н., Каневскайа М. З., Якушин С. С.
Научно-практическая ревматология
Т. 56, Вып. 3, С. 280-285
Опубликовано: 2018
Тип ресурса: Статья
DOI:10.14412/1995-4484-2018-280-285
Аннотация:
Objective: to assess the long-term safety and efficiency of tocilizumab (TCZ) therapy in patients with early rheumatoid arthritis (RA) of moderate and high activity, who have completed the basic WA19926 study, as well as the rate of sustained drug-free remission. Subjects and methods. A long-term open-label multicenter Phase III extension study (ML28124) was conducted using a group of 49 patients (36 (73.5[%]) women and 13 (26.5[%]) men; mean age 53.3±10.8 years) with early RA of moderate and high activity. All the patients received an intravenous infusion of TCZ 8 mg/kg every 4 weeks for 104 weeks (a total of 27 infusions). The safety assessment criteria were the rate and severity of all adverse events (AE), serious AE (SAE), and AE of particular interest; the rate of AE causing drug dosage changes or withdrawal from the study; the frequency of clinically significant laboratory abnormalities. The analysis of efficiency (secondary end points) included changes of DAS8, which was calculated
Ключевые слова:
Disease-modifying antirheumatic drugs; Early rheumatoid arthritis; Interleukin 6; Remission; Tocilizumab
Язык текста: Русский
ISSN: 1995-4492
Насонов Е. Л. Евгений Львович 1948-
Станислав М. Л.
Мазуров В. И.
Чернyх Т. М.
Сороцкайа В. Н.
Салникова Т. С.
Саиковскy Р. С.
Решет’ко О. В.
Попова Т. А.
Шмидт Е. И.
Тюрин В. П.
Шилкина Н. П.
Бокарев И. Н. Игорь Николаевич 1939-
Каневскайа М. З.
Якушин С. С.
Nasonov E. L. Evgenij L`vovich 1948-
Stanislav M. L.
Mazurov V. I.
Chernykh T. M.
Sorotskaya V. N.
Salnikova T. S.
Saikovsky R. S.
Reshet’ko O. V.
Popova T. A.
Shmidt E. I.
Tyurin V. P.
Shilkina N. P.
Bokarev I. N. Igor` Nikolaevich 1939-
Kanevskaya M. Z.
Yakushin S. S.
Long-term safety and efficacy of tocilizumab in patients with early rheumatoid arthritis of moderate or high activity (results of phase III multicenter extension clinical study ML28124)
Long-term safety and efficacy of tocilizumab in patients with early rheumatoid arthritis of moderate or high activity (results of phase III...
Текст визуальный непосредственный
Научно-практическая ревматология
ИМА-Пресс
Т. 56, Вып. 3 С. 280-285
2018
Статья
Disease-modifying antirheumatic drugs Early rheumatoid arthritis Interleukin 6 Remission Tocilizumab
Objective: to assess the long-term safety and efficiency of tocilizumab (TCZ) therapy in patients with early rheumatoid arthritis (RA) of moderate and high activity, who have completed the basic WA19926 study, as well as the rate of sustained drug-free remission. Subjects and methods. A long-term open-label multicenter Phase III extension study (ML28124) was conducted using a group of 49 patients (36 (73.5[%]) women and 13 (26.5[%]) men; mean age 53.3±10.8 years) with early RA of moderate and high activity. All the patients received an intravenous infusion of TCZ 8 mg/kg every 4 weeks for 104 weeks (a total of 27 infusions). The safety assessment criteria were the rate and severity of all adverse events (AE), serious AE (SAE), and AE of particular interest; the rate of AE causing drug dosage changes or withdrawal from the study; the frequency of clinically significant laboratory abnormalities. The analysis of efficiency (secondary end points) included changes of DAS8, which was calculated