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Войти в исследования Long-term safety and efficacy of abatacept in children with juvenile idiopathic arthritis.
Обработка статьи · этапы, ошибки и управление
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Ruperto Nicolino, Lovell Daniel J, Quartier Pierre, Paz Eliana, Rubio-Pérez Nadina, Silva Clovis A, Abud-Mendoza Carlos, Burgos-Vargas Ruben, Gerloni Valeria, Melo-Gomes Jose A, Saad-Magalhães Claudia, Chavez-Corrales J, Huemer Christian, Kivitz Alan, Blanco Francisco J, Foeldvari Ivan, Hofer Michael, Horneff Gerd, Huppertz Hans-Iko, Job-Deslandre Chantal, Loy Anna, Minden Kirsten, Punaro Marilynn, Nunez Alejandro Flores, Sigal Leonard H, Block Alan J, Nys Marleen, Martini Alberto, Giannini Edward H, Paediatric Rheumatology International Trials Organization and the Pediatric Rheumatology Collaborative Study Group
Аннотация
METHODS: This report describes the long-term, open-label extension phase of a double-blind, randomized, controlled withdrawal trial in 190 patients with JIA ages 6-17 years. Children were treated with 10 mg/kg abatacept administered intravenously every 4 weeks, with or without methotrexate. Efficacy results were based on data derived from the 153 patients who entered the open-label LTE phase and reflect >or=21 months (589 days) of treatment. Safety results include all available open-label data as of May 7, 2008.
RESULTS: Of the 190 enrolled patients, 153 entered the LTE. By day 589, 90%, 88%, 75%, 57%, and 39% of patients treated with abatacept during the double-blind and LTE phases achieved responses according to the American College of Rheumatology (ACR) Pediatric 30 (Pedi 30), Pedi 50, Pedi 70, Pedi 90, and Pedi 100 criteria for improvement, respectively. Similar response rates were observed by day 589 among patients previously treated with placebo. Among patients who had not achieved an ACR Pedi 30 response at the end of the open-label lead-in phase and who proceeded directly into the LTE, 73%, 64%, 46%, 18%, and 5% achieved ACR Pedi 30, Pedi 50, Pedi 70, Pedi 90, and Pedi 100 responses, respectively, by day 589 of the LTE. No cases of tuberculosis and no malignancies were reported during the LTE. Pneumonia developed in 3 patients, and multiple sclerosis developed in 1 patient.
CONCLUSION: Abatacept provided clinically significant and durable efficacy in patients with JIA, including those who did not initially achieve an ACR Pedi 30 response during the initial 4-month open-label lead-in phase.