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

Registro completo de metadados
MetadadosDescriçãoIdioma
Autor(es): dc.contributorIRCCS Ist Giannina Gaslini Clin Pediat & Reumatol-
Autor(es): dc.contributorUniv Cincinnati-
Autor(es): dc.contributorUniv Autonoma Chihuahua-
Autor(es): dc.contributorPanorama Med Ctr-
Autor(es): dc.contributorHosp Mexico Americano-
Autor(es): dc.contributorCtr Med Privado Reumatol-
Autor(es): dc.contributorRandall Childrens Hosp Legacy Emanuel-
Autor(es): dc.contributorUniv Calgary-
Autor(es): dc.contributorPontificia Univ Catolica Chile-
Autor(es): dc.contributorHosp Pedro de Elizalde-
Autor(es): dc.contributorUniv Utah-
Autor(es): dc.contributorBashkir State Med Univ Minist Healthcare Russian-
Autor(es): dc.contributorUniv Cape Town-
Autor(es): dc.contributorClin Hosp 5-
Autor(es): dc.contributorUniversidade Federal de São Paulo (UNIFESP)-
Autor(es): dc.contributorInst CAICI-
Autor(es): dc.contributorUniv Fed Rio Grande do Sul-
Autor(es): dc.contributorUniversidade Estadual Paulista (UNESP)-
Autor(es): dc.contributorHosp Infantil Mexico Dr Federico Gomez-
Autor(es): dc.contributorCincinnati Childrens Hosp Med Ctr-
Autor(es): dc.contributorJanssen Res & Dev LLC-
Autor(es): dc.contributorUniv Genoa-
Autor(es): dc.creatorRuperto, Nicolino-
Autor(es): dc.creatorBrunner, Hermine-
Autor(es): dc.creatorPacheco-Tena, Cesar-
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, Ruben-
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 [UNESP]-
Autor(es): dc.creatorMaldonado Velazquez, Maria del Rocio-
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.creatorPediat Rheumatology Collaborative-
Autor(es): dc.creatorPaediat Rheumatology Int Trials Or-
Data de aceite: dc.date.accessioned2022-08-04T21:58:56Z-
Data de disponibilização: dc.date.available2022-08-04T21:58:56Z-
Data de envio: dc.date.issued2022-04-28-
Data de envio: dc.date.issued2022-04-28-
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/11449/218692-
Fonte: dc.identifier.urihttp://educapes.capes.gov.br/handle/11449/218692-
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 >= 2months received 80 mg/m(2) 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 (AUC(ss)) 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 AUC(ss) were 0.40 mu g/ml and 399 mu g. day/ml at week 28. PK exposure was maintained at week 52. Steady-state trough golimumab concentrations and AUC(ss) were consistent across age categories and comparable to i.v. golimumab dosed 2mg/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.-
Descrição: dc.descriptionJanssen Research & Development, LLC-
Descrição: dc.descriptionIRCCS Ist Giannina Gaslini Clin Pediat & Reumatol, PRINTO, Genoa, Italy-
Descrição: dc.descriptionUniv Cincinnati, Cincinnati Childrens Hosp Med Ctr, Div Rheumatol, Cincinnati, OH USA-
Descrição: dc.descriptionUniv Autonoma Chihuahua, Fac Med, Circuito Univ Campus 2, Chihuahua, Mexico-
Descrição: dc.descriptionPanorama Med Ctr, Cape Town, South Africa-
Descrição: dc.descriptionHosp Mexico Americano, Ctr Reumatol & Autoinmunidad CREA, Guadalajara, Jalisco, Mexico-
Descrição: dc.descriptionCtr Med Privado Reumatol, Rheumatol Sect, San Miguel De Tucuman, Tucuman, Argentina-
Descrição: dc.descriptionRandall Childrens Hosp Legacy Emanuel, Portland, OR USA-
Descrição: dc.descriptionUniv Calgary, Alberta Childrens Hosp, Cumming Sch Med, Dept Pediat, Calgary, AB, Canada-
Descrição: dc.descriptionPontificia Univ Catolica Chile, Sch Med, Dept Pediat Infect Dis & Immunol, Santiago, Chile-
Descrição: dc.descriptionHosp Pedro de Elizalde, Rheumatol Sect, Buenos Aires, DF, Argentina-
Descrição: dc.descriptionUniv Utah, Pediat Rheumatol, Salt Lake City, UT USA-
Descrição: dc.descriptionBashkir State Med Univ Minist Healthcare Russian, Fed State Budget Educ Inst Higher Educ, Ufa, Russia-
Descrição: dc.descriptionUniv Cape Town, Red Cross War Mem Childrens Hosp, Cape Town, South Africa-
Descrição: dc.descriptionUniv Cape Town, Groote Schuur Hosp, Paediat Rheumatol, Cape Town, South Africa-
Descrição: dc.descriptionClin Hosp 5, Pediat Dept, Tolyatti, Russia-
Descrição: dc.descriptionUniv Fed Sao Paulo, Escola Paulista Med, Pediat, Sao Paulo, Brazil-
Descrição: dc.descriptionInst CAICI, Rheumatol, Rosario, Argentina-
Descrição: dc.descriptionUniv Fed Rio Grande do Sul, Hosp Clin Porto Alegre, Porto Alegre, RS, Brazil-
Descrição: dc.descriptionUNESP, Hosp Clin Botucatu Med Univ, Paediat Dept, Botucatu, SP, Brazil-
Descrição: dc.descriptionHosp Infantil Mexico Dr Federico Gomez, Med Interna & Reumatol, Mexico City, DF, Mexico-
Descrição: dc.descriptionCincinnati Childrens Hosp Med Ctr, Cincinnati, OH 45229 USA-
Descrição: dc.descriptionJanssen Res & Dev LLC, Spring House, PA USA-
Descrição: dc.descriptionJanssen Res & Dev LLC, Raritan, NJ USA-
Descrição: dc.descriptionUniv Genoa, Dipartimento Neurosci Riabilitaz Oftalmol Genet &, Genoa, Italy-
Descrição: dc.descriptionUNESP, Hosp Clin Botucatu Med Univ, Paediat Dept, Botucatu, SP, Brazil-
Formato: dc.format4495-4507-
Idioma: dc.languageen-
Publicador: dc.publisherOxford Univ Press-
Relação: dc.relationRheumatology-
???dc.source???: dc.sourceWeb of Science-
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-
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