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

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dc.contributor.authorRuperto, Nicolino
dc.contributor.authorBrunner, Hermine I
dc.contributor.authorPacheco-Tena, César
dc.contributor.authorLouw, Ingrid
dc.contributor.authorVega-Cornejo, Gabriel
dc.contributor.authorSpindler, Alberto J
dc.contributor.authorKingsbury, Daniel J
dc.contributor.authorSchmeling, Heinrike
dc.contributor.authorBorzutzky, Arturo
dc.contributor.authorCuttica, Rubén
dc.contributor.authorInman, C. J.
dc.contributor.authorMalievskiy, Victor
dc.contributor.authorScott, Christiaan
dc.contributor.authorKeltsev, Vladimir
dc.contributor.authorTerreri, Maria Teresa
dc.contributor.authorViola, Diego Oscar
dc.contributor.authorXavier, Ricardo M
dc.contributor.authorFernandes, Taciana A. Pedrosa [UNESP]
dc.contributor.authorVelázquez, María Del Rocío Maldonado
dc.contributor.authorHenrickson, Michael
dc.contributor.authorClark, Michael B
dc.contributor.authorBensley, Karen A
dc.contributor.authorLi, Xiaoming
dc.contributor.authorLo, Kim Hung
dc.contributor.authorLeu, Jocelyn H
dc.contributor.authorHsu, Chyi-Hung
dc.contributor.authorHsia, Elizabeth C
dc.contributor.authorXu, Zhenhua
dc.contributor.authorMartini, Alberto
dc.contributor.authorLovell, Daniel J
dc.contributor.authorAppenzeller, Simone
dc.contributor.authorOliveira, Sheila
dc.contributor.authorSilva, Clóvis Arthur
dc.contributor.authorLevy, Deborah
dc.contributor.authorNavarrete, Carmen
dc.contributor.authorAviel, Yonatan Butbul
dc.contributor.authorUziel, Yosef
dc.contributor.authorAlexeeva, Ekaterina
dc.contributor.authorChasnyk, Vladimir
dc.contributor.authorSpivakovsky, Yury
dc.contributor.authorGottlieb, Beth
dc.contributor.authorRabinovich, Egla
dc.contributor.authorZeft, Andrew
dc.contributor.authorGriffin, Thomas
dc.contributor.authorDe Ranieri, Deirdre
dc.contributor.authorCarrasco, Ruy
dc.contributor.institutionPRINTO
dc.contributor.institutionUniversity of Cincinnati
dc.contributor.institutionCircuito Universitario Campus II
dc.contributor.institutionRheumatology Private Practice
dc.contributor.institutionHospital México Americano
dc.contributor.institutionRheumatology Section
dc.contributor.institutionRandall Children's Hospital at Legacy Emanuel
dc.contributor.institutionUniversity of Calgary
dc.contributor.institutionPontificia Universidad Católica de Chile
dc.contributor.institutionHospital Pedro de Elizalde
dc.contributor.institutionUniversity of Utah
dc.contributor.institutionMinistry of Healthcare of Russian Federation
dc.contributor.institutionUniversity of Cape Town
dc.contributor.institutionClinical Hospital No. 5
dc.contributor.institutionUniversidade Federal de São Paulo (UNIFESP)
dc.contributor.institutionInstituto CAICI
dc.contributor.institutionUniversidade Federal Do Rio Grande Do sul
dc.contributor.institutionUniversidade Estadual Paulista (UNESP)
dc.contributor.institutionMedicina Interna y Reumatologia
dc.contributor.institutionCincinnati Children's Hospital Medical Center
dc.contributor.institutionLLC
dc.contributor.institutionGenetica e Scienze Materno-Infantili
dc.date.accessioned2022-04-29T08:30:48Z
dc.date.available2022-04-29T08:30:48Z
dc.date.issued2021-10-01
dc.description.abstractObjectives: 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 NCT02277444en
dc.description.affiliationIRCCS Istituto Giannina Gaslini Clinica Pediatrica e Reumatologia PRINTO
dc.description.affiliationCincinnati Children's Hospital Medical Center Division of Rheumatology University of Cincinnati
dc.description.affiliationFacultad de Medicina Universidad Autónoma de Chihuahua Circuito Universitario Campus II
dc.description.affiliationPanorama Medical Centre Rheumatology Private Practice
dc.description.affiliationCentro de Reumatología y Autoinmunidad (CREA) Hospital México Americano, Jalisco
dc.description.affiliationCentro Médico Privado de Reumatología Rheumatology Section, San Miguel de Tucuman
dc.description.affiliationRandall Children's Hospital at Legacy Emanuel
dc.description.affiliationDepartment of Pediatrics Alberta Children's Hospital Cumming School of Medicine University of Calgary
dc.description.affiliationDepartment of Pediatric Infectious Diseases and Immunology School of Medicine Pontificia Universidad Católica de Chile
dc.description.affiliationRheumatology Section Hospital Pedro de Elizalde
dc.description.affiliationPediatric Rheumatology University of Utah
dc.description.affiliationFederal State Budget Educational Institution of Higher Education Bashkir State Medical University Ministry of Healthcare of Russian Federation
dc.description.affiliationRed Cross War Memorial Children's Hospital Groote Schuur Hospital University of Cape Town
dc.description.affiliationPediatric Department Clinical Hospital No. 5
dc.description.affiliationEscola Paulista de Medicina Universidade Federal de São Paulo
dc.description.affiliationInstituto CAICI
dc.description.affiliationHospital de Clínicas de Porto Alegre Universidade Federal Do Rio Grande Do sul
dc.description.affiliationPaediatric Department Hospital das Clinicas-Botucatu Medicine University UNESP
dc.description.affiliationHospital Infantil de México Federico Gómez Medicina Interna y Reumatologia
dc.description.affiliationCincinnati Children's Hospital Medical Center
dc.description.affiliationJanssen Research and Development LLC
dc.description.affiliationUniversità Degli Studi di Genova Dipartimento di Neuroscienze Riabilitazione Oftalmologia Genetica e Scienze Materno-Infantili
dc.description.affiliationUnespPaediatric Department Hospital das Clinicas-Botucatu Medicine University UNESP
dc.format.extent4495-4507
dc.identifierhttp://dx.doi.org/10.1093/rheumatology/keab021
dc.identifier.citationRheumatology (United Kingdom), v. 60, n. 10, p. 4495-4507, 2021.
dc.identifier.doi10.1093/rheumatology/keab021
dc.identifier.issn1462-0332
dc.identifier.issn1462-0324
dc.identifier.scopus2-s2.0-85110584854
dc.identifier.urihttp://hdl.handle.net/11449/229170
dc.language.isoeng
dc.relation.ispartofRheumatology (United Kingdom)
dc.sourceScopus
dc.subjectGolimumab
dc.subjectIntravenous
dc.subjectJuvenile idiopathic arthritis
dc.subjectPharmacokinetics
dc.subjectTumour necrosis factor alpha
dc.titleOpen-label phase 3 study of intravenous golimumab in patients with polyarticular juvenile idiopathic arthritisen
dc.typeArtigo

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