Growth during tocilizumab therapy for polyarticular-course juvenile idiopathic arthritis: 2-year data from a phase III clinical trial
Bharucha K. N., Brunner H. I., Penadés I. C., Nikishina I., Rubio-Pérez N., Oliveira S., Kobusinska K., Schmeling H., Sztajnbok F., Weller-Heinemann F., Zholobova E. S., Zulian F., Allen R., Chaitow J., Frane J., Wells C., Ruperto N., De B. F.
Journal of Rheumatology
Vol.45, Issue8, P. 1173-1179
Опубликовано: 2018
Тип ресурса: Статья
DOI:10.3899/jrheum.170326
Аннотация:
Objective: Evaluate growth in patients with polyarticular-course juvenile idiopathic arthritis (pcJIA) treated with tocilizumab (TCZ) for up to 2 years in a phase III trial. Methods: Patients with pcJIA lasting at least 6 months and inadequate response to methotrexate received open-label TCZ intravenously every 4 weeks (randomly assigned to 8 or 10 mg/kg if they weighed < 30 kg; received 8 mg/kg if they weighed ≥ 30 kg) for 16 weeks. Patients with JIA American College of Rheumatology 30 response at Week 16 were randomly assigned to TCZ or placebo for 24 weeks, with an open-label extension through Week 104. Mean ± SD height velocity (cm/yr) and World Health Organization (WHO) height SD score (SDS) were measured in patients receiving ≥ 1 dose of TCZ who did not receive growth hormone and in patients whose baseline Tanner stage was ≤ 3. Results: The study included 187 of 188 patients (99.5[%]) with mean WHO height SDS -0.5 ± 1.2, which was unrelated to age or disease duration (Spearman rank
Ключевые слова:
Biological Therapy; Growth; Interleukins; Juvenile Idiopathic Arthritis
methotrexate; tocilizumab; antirheumatic agent; monoclonal antibody; tocilizumab; adolescent; Article; body height; child; child growth; controlled study; disease duration; disease severity assessment; drug efficacy; female; growth rate; human; juvenile rheumatoid arthritis; major clinical study; male; outcome assessment; phase 3 clinical trial; polyarticular course juvenile idiopathic arthritis; polyarticular course juvenile idiopathic arthritis; priority journal; randomized controlled trial; scoring system; Tanner stage; child development; clinical trial; double blind procedure; drug effect; juvenile rheumatoid arthritis; pathophysiology; preschool child; treatment outcome; Adolescent; Antibodies, Monoclonal, Humanized; Antirheumatic Agents; Arthritis, Juvenile; Body Height; Child; Child Development; Child, Preschool; Double-Blind Method; Female; Humans; Male; Treatment Outcome
Язык текста: Английский
ISSN: 1499-2752
Bharucha K. N.
Brunner H. I.
Penadés I. C.
Nikishina I.
Rubio-Pérez N.
Oliveira S.
Kobusinska K.
Schmeling H.
Sztajnbok F.
Weller-Heinemann F.
Zholobova E. S. Elena Spartakovna 1959-
Zulian F.
Allen R.
Chaitow J.
Frane J.
Wells C.
Ruperto N.
De B. F. Benedetti F.
Бхаруча К. Н.
Бруннер Х. И.
Пенадéс И. C.
Никишина И.
Рубио-Пéрез Н.
Оливеира С.
Кобусинска К.
Счмелинг Х.
Сзтайнбок Ф.
Wеллер-Хеинеманн Ф.
Жолобова Е. С. Елена Спартаковна 1959-
Зулиан Ф.
Аллен Р.
Чаитоw Й.
Фране Й.
Wеллс C.
Руперто Н.
Де Б. Ф. Бенедетти Ф.
Growth during tocilizumab therapy for polyarticular-course juvenile idiopathic arthritis: 2-year data from a phase III clinical trial
Текст визуальный непосредственный
Journal of Rheumatology
Journal of Rheumatology Publishing Co., Ltd.
Vol.45, Issue8 P. 1173-1179
2018
Статья
Biological Therapy Growth Interleukins Juvenile Idiopathic Arthritis
methotrexate tocilizumab antirheumatic agent monoclonal antibody tocilizumab adolescent Article body height child child growth controlled study disease duration disease severity assessment drug efficacy female growth rate human juvenile rheumatoid arthritis major clinical study male outcome assessment phase 3 clinical trial polyarticular course juvenile idiopathic arthritis polyarticular course juvenile idiopathic arthritis priority journal randomized controlled trial scoring system Tanner stage child development clinical trial double blind procedure drug effect juvenile rheumatoid arthritis pathophysiology preschool child treatment outcome Adolescent Antibodies, Monoclonal, Humanized Antirheumatic Agents Arthritis, Juvenile Body Height Child Child Development Child, Preschool Double-Blind Method Female Humans Male Treatment Outcome
Objective: Evaluate growth in patients with polyarticular-course juvenile idiopathic arthritis (pcJIA) treated with tocilizumab (TCZ) for up to 2 years in a phase III trial. Methods: Patients with pcJIA lasting at least 6 months and inadequate response to methotrexate received open-label TCZ intravenously every 4 weeks (randomly assigned to 8 or 10 mg/kg if they weighed < 30 kg; received 8 mg/kg if they weighed ≥ 30 kg) for 16 weeks. Patients with JIA American College of Rheumatology 30 response at Week 16 were randomly assigned to TCZ or placebo for 24 weeks, with an open-label extension through Week 104. Mean ± SD height velocity (cm/yr) and World Health Organization (WHO) height SD score (SDS) were measured in patients receiving ≥ 1 dose of TCZ who did not receive growth hormone and in patients whose baseline Tanner stage was ≤ 3. Results: The study included 187 of 188 patients (99.5[%]) with mean WHO height SDS -0.5 ± 1.2, which was unrelated to age or disease duration (Spearman rank