Subcutaneous golimumab for children with active polyarticular-course juvenile idiopathic arthritis: Results of a multicentre, double-blind,...
Brunner H. I., Ruperto N., Tzaribachev N., Horneff G., Chasnyk V. G., Panaviene V., Abud-Mendoza C., Reiff A., Alekseeva E. I., Rubio-Pérez N., Keltsev V., Kingsbury D. J., Del R. M. V. M., Nikishina I., Silverman E. D., Joos R., Smolewska E., Bandeira M., Minden K., Van R. A., Emminger W., Foeldvari I., Lauwerys B. R., Sztajnbok F., Gilmer K. E., Xu Z., Leu J. H., Kim L., Lamberth S. L., Loza M. J., Lovell D. J., Martini A.
Annals of the Rheumatic Diseases
Vol.77, Issue1, P. 21-29
Опубликовано: 2018
Тип ресурса: Статья
DOI:10.1136/annrheumdis-2016-210456
Аннотация:
Objective: This report aims to determine the safety, pharmacokinetics (PK) and efficacy of subcutaneous golimumab in active polyarticular-course juvenile idiopathic arthritis (polyJIA). Methods: In this three-part randomised double-blinded placebo-controlled withdrawal trial, all patients received open-label golimumab (30 mg/m2 of body surface area; maximum: 50 mg/dose) every 4 weeks together with weekly methotrexate during Part 1 (weeks 0-16). Patients with at least 30[%] improvement per American College of Rheumatology Criteria for JIA (JIA ACR30) in Part 1 entered the double-blinded Part 2 (weeks 16-48) after 1:1 randomisation to continue golimumab or start placebo. In Part 3, golimumab was continued or could be restarted as in Part 1. The primary outcome was JIA flares in Part 2; secondary outcomes included JIA ACR50/70/90 responses, clinical remission, PK and safety. Results: Among 173 patients with polyJIA enrolled, 89.0[%] (154/173) had a JIA ACR30 response and 79.2[%]/65.9[%]/36.4[%] dem
Ключевые слова:
alanine aminotransferase; aspartate aminotransferase; golimumab; methotrexate; placebo; antirheumatic agent; golimumab; methotrexate; monoclonal antibody; abdominal pain; adverse outcome; alanine aminotransferase blood level; antibody titer; appendicitis; Article; aspartate aminotransferase blood level; bacterial skin disease; child; conjunctivitis; connective tissue disease; constipation; controlled study; demyelination; diarrhea; double blind procedure; drug efficacy; drug safety; drug withdrawal; female; fever; gall bladder edema; gallbladder disease; gastritis; gastrointestinal disease; headache; human; hypertransaminasemia; hypoglycemia; immunogenicity; injection site reaction; iridocyclitis; juvenile rheumatoid arthritis; major clinical study; male; mood disorder; multicenter study; musculoskeletal disease; nausea; neurologic disease; open study; otitis media; outcome assessment; peritonsillar abscess; pneumonia; priority journal; pyelonephritis; randomized controlled trial; remi
Язык текста: Английский
ISSN: 1468-2060
Brunner H. I.
Ruperto N.
Tzaribachev N.
Horneff G.
Chasnyk V. G.
Panaviene V.
Abud-Mendoza C.
Reiff A.
Alekseeva E. I. Ekaterina Iosifovna 1962-
Rubio-Pérez N.
Keltsev V.
Kingsbury D. J.
Del R. M. V. M. Rocio Maldonado Velázquez M.
Nikishina I.
Silverman E. D.
Joos R.
Smolewska E.
Bandeira M.
Minden K.
Van R. A. Royen-Kerkhof A.
Emminger W.
Foeldvari I.
Lauwerys B. R.
Sztajnbok F.
Gilmer K. E.
Xu Z.
Leu J. H.
Kim L.
Lamberth S. L.
Loza M. J.
Lovell D. J.
Martini A.
Бруннер Х. И.
Руперто Н.
Тзарибачев Н.
Хорнефф Г.
Часнyк В. Г.
Панавиене В.
Абуд-Мендоза C.
Реифф А.
Алексеева Е. И. Екатерина Иосифовна 1962-
Рубио-Пéрез Н.
Кельцев В.
Кингсбурy Д. Й.
Дел Р. М. В. М. Роcио Малдонадо Велáзqуез М.
Никишина И.
Силверман Е. Д.
Йоос Р.
Смолеwска Е.
Бандеира М.
Минден К.
Ван Р. А. Роьен-Керхоф А.
Еммингер W.
Фоелдвари И.
Лауwерyс Б. Р.
Сзтайнбок Ф.
Гилмер К. Е.
Ху З.
Леу Й. Х.
Ким Л.
Ламбертх С. Л.
Лоза М. Й.
Ловелл Д. Й.
Мартини А.
Subcutaneous golimumab for children with active polyarticular-course juvenile idiopathic arthritis: Results of a multicentre, double-blind, randomised-withdrawal trial
Subcutaneous golimumab for children with active polyarticular-course juvenile idiopathic arthritis: Results of a multicentre, double-blind,...
Текст визуальный непосредственный
Annals of the Rheumatic Diseases
BMJ Publishing Group
Vol.77, Issue1 P. 21-29
2018
Статья
alanine aminotransferase aspartate aminotransferase golimumab methotrexate placebo antirheumatic agent golimumab methotrexate monoclonal antibody abdominal pain adverse outcome alanine aminotransferase blood level antibody titer appendicitis Article aspartate aminotransferase blood level bacterial skin disease child conjunctivitis connective tissue disease constipation controlled study demyelination diarrhea double blind procedure drug efficacy drug safety drug withdrawal female fever gall bladder edema gallbladder disease gastritis gastrointestinal disease headache human hypertransaminasemia hypoglycemia immunogenicity injection site reaction iridocyclitis juvenile rheumatoid arthritis major clinical study male mood disorder multicenter study musculoskeletal disease nausea neurologic disease open study otitis media outcome assessment peritonsillar abscess pneumonia priority journal pyelonephritis randomized controlled trial remi
Objective: This report aims to determine the safety, pharmacokinetics (PK) and efficacy of subcutaneous golimumab in active polyarticular-course juvenile idiopathic arthritis (polyJIA). Methods: In this three-part randomised double-blinded placebo-controlled withdrawal trial, all patients received open-label golimumab (30 mg/m2 of body surface area; maximum: 50 mg/dose) every 4 weeks together with weekly methotrexate during Part 1 (weeks 0-16). Patients with at least 30[%] improvement per American College of Rheumatology Criteria for JIA (JIA ACR30) in Part 1 entered the double-blinded Part 2 (weeks 16-48) after 1:1 randomisation to continue golimumab or start placebo. In Part 3, golimumab was continued or could be restarted as in Part 1. The primary outcome was JIA flares in Part 2; secondary outcomes included JIA ACR50/70/90 responses, clinical remission, PK and safety. Results: Among 173 patients with polyJIA enrolled, 89.0[%] (154/173) had a JIA ACR30 response and 79.2[%]/65.9[%]/36.4[%] dem