Open-label phase 3 study of intravenous golimumab in patients with polyarticular juvenile idiopathic arthritis

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MetadadosDescriçãoIdioma
Autor(es): dc.contributorPRINTO-
Autor(es): dc.contributorUniversity of Cincinnati-
Autor(es): dc.contributorCircuito Universitario Campus II-
Autor(es): dc.contributorRheumatology Private Practice-
Autor(es): dc.contributorHospital México Americano-
Autor(es): dc.contributorRheumatology Section-
Autor(es): dc.contributorRandall Children's Hospital at Legacy Emanuel-
Autor(es): dc.contributorUniversity of Calgary-
Autor(es): dc.contributorPontificia Universidad Católica de Chile-
Autor(es): dc.contributorHospital Pedro de Elizalde-
Autor(es): dc.contributorUniversity of Utah-
Autor(es): dc.contributorMinistry of Healthcare of Russian Federation-
Autor(es): dc.contributorUniversity of Cape Town-
Autor(es): dc.contributorClinical Hospital No. 5-
Autor(es): dc.contributorUniversidade Federal de São Paulo (UNIFESP)-
Autor(es): dc.contributorInstituto CAICI-
Autor(es): dc.contributorUniversidade Federal Do Rio Grande Do sul-
Autor(es): dc.contributorUniversidade Estadual Paulista (UNESP)-
Autor(es): dc.contributorMedicina Interna y Reumatologia-
Autor(es): dc.contributorCincinnati Children's Hospital Medical Center-
Autor(es): dc.contributorLLC-
Autor(es): dc.contributorGenetica e Scienze Materno-Infantili-
Autor(es): dc.creatorRuperto, Nicolino-
Autor(es): dc.creatorBrunner, Hermine I-
Autor(es): dc.creatorPacheco-Tena, César-
Autor(es): dc.creatorLouw, Ingrid-
Autor(es): dc.creatorVega-Cornejo, Gabriel-
Autor(es): dc.creatorSpindler, Alberto J-
Autor(es): dc.creatorKingsbury, Daniel J-
Autor(es): dc.creatorSchmeling, Heinrike-
Autor(es): dc.creatorBorzutzky, Arturo-
Autor(es): dc.creatorCuttica, Rubén-
Autor(es): dc.creatorInman, C. J.-
Autor(es): dc.creatorMalievskiy, Victor-
Autor(es): dc.creatorScott, Christiaan-
Autor(es): dc.creatorKeltsev, Vladimir-
Autor(es): dc.creatorTerreri, Maria Teresa-
Autor(es): dc.creatorViola, Diego Oscar-
Autor(es): dc.creatorXavier, Ricardo M-
Autor(es): dc.creatorFernandes, Taciana A. Pedrosa-
Autor(es): dc.creatorVelázquez, María Del Rocío Maldonado-
Autor(es): dc.creatorHenrickson, Michael-
Autor(es): dc.creatorClark, Michael B-
Autor(es): dc.creatorBensley, Karen A-
Autor(es): dc.creatorLi, Xiaoming-
Autor(es): dc.creatorLo, Kim Hung-
Autor(es): dc.creatorLeu, Jocelyn H-
Autor(es): dc.creatorHsu, Chyi-Hung-
Autor(es): dc.creatorHsia, Elizabeth C-
Autor(es): dc.creatorXu, Zhenhua-
Autor(es): dc.creatorMartini, Alberto-
Autor(es): dc.creatorLovell, Daniel J-
Autor(es): dc.creatorAppenzeller, Simone-
Autor(es): dc.creatorOliveira, Sheila-
Autor(es): dc.creatorSilva, Clóvis Arthur-
Autor(es): dc.creatorLevy, Deborah-
Autor(es): dc.creatorNavarrete, Carmen-
Autor(es): dc.creatorAviel, Yonatan Butbul-
Autor(es): dc.creatorUziel, Yosef-
Autor(es): dc.creatorAlexeeva, Ekaterina-
Autor(es): dc.creatorChasnyk, Vladimir-
Autor(es): dc.creatorSpivakovsky, Yury-
Autor(es): dc.creatorGottlieb, Beth-
Autor(es): dc.creatorRabinovich, Egla-
Autor(es): dc.creatorZeft, Andrew-
Autor(es): dc.creatorGriffin, Thomas-
Autor(es): dc.creatorDe Ranieri, Deirdre-
Autor(es): dc.creatorCarrasco, Ruy-
Data de aceite: dc.date.accessioned2025-08-21T23:10:58Z-
Data de disponibilização: dc.date.available2025-08-21T23:10:58Z-
Data de envio: dc.date.issued2022-04-29-
Data de envio: dc.date.issued2022-04-29-
Data de envio: dc.date.issued2021-10-01-
Fonte completa do material: dc.identifierhttp://dx.doi.org/10.1093/rheumatology/keab021-
Fonte completa do material: dc.identifierhttp://hdl.handle.net/11449/229170-
Fonte: dc.identifier.urihttp://educapes.capes.gov.br/handle/11449/229170-
Descrição: dc.descriptionObjectives: To assess efficacy, pharmacokinetics (PK) and safety of intravenous (i.v.) golimumab in patients with polyarticular-course JIA (pc-JIA). Methods: Children aged 2 to <18 years with active pc-JIA despite MTX therapy for ≥2 months received 80 mg/m2 golimumab at weeks 0, 4, then every 8 weeks through week 52 plus MTX weekly through week 28. The primary and major secondary endpoints were PK exposure and model-predicted steady-state area under the curve (AUCss) over an 8-week dosing interval at weeks 28 and 52, respectively. JIA ACR response and safety were also assessed. Results: In total, 127 children were treated with i.v. golimumab. JIA ACR 30, 50, 70, and 90 response rates were 84%, 80%, 70% and 47%, respectively, at week 28 and were maintained through week 52. Golimumab serum concentrations and AUCss were 0.40 μg/ml and 399 μg day/ml at week 28. PK exposure was maintained at week 52. Steady-state trough golimumab concentrations and AUCss were consistent across age categories and comparable to i.v. golimumab dosed 2 mg/kg in adults with rheumatoid arthritis. Golimumab antibodies and neutralizing antibodies were detected via a highly sensitive drug-tolerant assay in 31% (39/125) and 19% (24/125) of patients, respectively. Median trough golimumab concentration was lower in antibody-positive vs antibody-negative patients. Serious infections were reported in 6% of patients, including one death due to septic shock. Conclusion: Body surface area-based dosing of i.v. golimumab was well tolerated and provided adequate PK exposure for clinical efficacy in paediatric patients with active pc-JIA. ClinicalTrials.gov number NCT02277444-
Descrição: dc.descriptionIRCCS Istituto Giannina Gaslini Clinica Pediatrica e Reumatologia PRINTO-
Descrição: dc.descriptionCincinnati Children's Hospital Medical Center Division of Rheumatology University of Cincinnati-
Descrição: dc.descriptionFacultad de Medicina Universidad Autónoma de Chihuahua Circuito Universitario Campus II-
Descrição: dc.descriptionPanorama Medical Centre Rheumatology Private Practice-
Descrição: dc.descriptionCentro de Reumatología y Autoinmunidad (CREA) Hospital México Americano, Jalisco-
Descrição: dc.descriptionCentro Médico Privado de Reumatología Rheumatology Section, San Miguel de Tucuman-
Descrição: dc.descriptionRandall Children's Hospital at Legacy Emanuel-
Descrição: dc.descriptionDepartment of Pediatrics Alberta Children's Hospital Cumming School of Medicine University of Calgary-
Descrição: dc.descriptionDepartment of Pediatric Infectious Diseases and Immunology School of Medicine Pontificia Universidad Católica de Chile-
Descrição: dc.descriptionRheumatology Section Hospital Pedro de Elizalde-
Descrição: dc.descriptionPediatric Rheumatology University of Utah-
Descrição: dc.descriptionFederal State Budget Educational Institution of Higher Education Bashkir State Medical University Ministry of Healthcare of Russian Federation-
Descrição: dc.descriptionRed Cross War Memorial Children's Hospital Groote Schuur Hospital University of Cape Town-
Descrição: dc.descriptionPediatric Department Clinical Hospital No. 5-
Descrição: dc.descriptionEscola Paulista de Medicina Universidade Federal de São Paulo-
Descrição: dc.descriptionInstituto CAICI-
Descrição: dc.descriptionHospital de Clínicas de Porto Alegre Universidade Federal Do Rio Grande Do sul-
Descrição: dc.descriptionPaediatric Department Hospital das Clinicas-Botucatu Medicine University UNESP-
Descrição: dc.descriptionHospital Infantil de México Federico Gómez Medicina Interna y Reumatologia-
Descrição: dc.descriptionCincinnati Children's Hospital Medical Center-
Descrição: dc.descriptionJanssen Research and Development LLC-
Descrição: dc.descriptionUniversità Degli Studi di Genova Dipartimento di Neuroscienze Riabilitazione Oftalmologia Genetica e Scienze Materno-Infantili-
Descrição: dc.descriptionPaediatric Department Hospital das Clinicas-Botucatu Medicine University UNESP-
Formato: dc.format4495-4507-
Idioma: dc.languageen-
Relação: dc.relationRheumatology (United Kingdom)-
???dc.source???: dc.sourceScopus-
Palavras-chave: dc.subjectGolimumab-
Palavras-chave: dc.subjectIntravenous-
Palavras-chave: dc.subjectJuvenile idiopathic arthritis-
Palavras-chave: dc.subjectPharmacokinetics-
Palavras-chave: dc.subjectTumour necrosis factor alpha-
Título: dc.titleOpen-label phase 3 study of intravenous golimumab in patients with polyarticular juvenile idiopathic arthritis-
Tipo de arquivo: dc.typelivro digital-
Aparece nas coleções:Repositório Institucional - Unesp

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